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OMLYCLO omalizumab-igec 300 mg/2mL Injection — NDC 72606-0054-01 package photo

Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OMLYCLO omalizumab-igec 300 mg/2mL Injection — NDC 72606-054-01 (Billing 72606-0054-01)

by CELLTRION USA, Inc. · 1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS

This is a package of OMLYCLO omalizumab-igec 300 mg/2mL Injection from CELLTRION USA, Inc., marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 72606-0054-01

🏷️ FDA NDC (as labeled) 72606-054-01 billing pads the product segment with a zero

This package

Contains2 mL in 1 syringe, glass Pack sizes2 compare ↓

Main listing for product 72606-054 · Also comes in: 2 syringes 72606-054-02

Rx only Brand On market Non-controlled ⇄ Compare with another NDC

🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72606-054-01

Product NDC 72606-054

11-digit billing NDC 72606005401

RxCUI 2726001, 2726008, 2726010, 2726011, 2735283, 2751593

UNII 2P471X1Z11

Application # BLA761399

SPL Set ID dbd8709f-1636-45d9-ba94-5a3bc5f22f84

Established class (EPC) Anti-IgE

Mechanism of action IgE-directed Antibody Interactions

Physiologic effect Decreased IgE Activity

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-09-01

Route SUBCUTANEOUS

Dosage form INJECTION

Substance OMALIZUMAB

Biologic (Purple Book) 351(k) Interchangeable · interchangeable biosimilar

Reference product omalizumab

Quick answers

RxCUI (RxNorm): 2726001

Why two NDCs? The FDA registers this code as 72606-054-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72606-0054-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Anti-IgE class.

Pharmacologic class Anti-IgE

Drug family (ATC) Other systemic drugs for obstructive airway diseases

How it works IgE-directed Antibody Interactions

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 2 syringes

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
72606-0054-01 You're viewing this Main listing	1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS	2026-09-01	—	Active
72606-0054-02 72606-054-02	2 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS	2026-09-01	—	Active

Pack size FAQ

What quantity is in this package?

This package is listed by the FDA — 1 syringe, glass in 1 carton / 2 ml in 1 syringe, glass.

What NDC number is used to bill for this package of OMLYCLO omalizumab-igec 300 mg/2mL Injection?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Omlyclo 300 mg/2mLthis 72606-0054-01	CELLTRION	1 syringe	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Purple Book · refreshed Sep 5, 2026
CMS NADAC weekly file

Availability & biosimilar status

🏛️

2025

First FDA approval

Mar 2025

📍

2026

Currently FDA-listed

1 year listed

🔓

2026

Biosimilars listed

1 FDA-licensed

🧬FDA-licensed biosimilars listed

1 interchangeable is FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to Mar 2037.

📅 FDA approved Mar 7, 2025

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Xolairomalizumab

Interchangeable 1

Omlycloomalizumab-igec

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Patents & exclusivity — FDA Purple Book

Exclusivity RefProduct

2025 2027 2029 2031 2033 2035 2037

Today

LOE

Biologic patent Exclusivity

🏛️Reference-product exclusivity

A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.

🧪Listed biologic patents

Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.

🔁Interchangeability

An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.

🛈 What do these terms mean?

Biologic patent: A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity: A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity: The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE): The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity

Code	What it grants	Expires
RefProduct	Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date	Mar 7, 2037

Common questions

Is there a biosimilar for this drug?

Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.

Why do different websites show different biosimilar dates?

Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.

Can a biosimilar launch before the last patent expires?

Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.

What does “current Purple Book estimate” mean?

It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.

What does “FDA listed” mean?

It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.

Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

FDA Purple Book · refreshed Sep 5, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

84.26 mg / 2 mL UNII F7LTH1E20Y
Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
2.74 mg / 2 mL UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
4.68 mg / 2 mL UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
0.8 mg / 2 mL UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCELLTRION USA, Inc.

FDA applicationBLA761399 (BLA)

Labeler code72606

First marketedSep 2026

Product typeHuman Prescription Drug

Portfolio30 products on file

🔎 All NDCs from CELLTRION USA, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel

🚨 Boxed Warning ~1 min read ▾

WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration.

Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] .

WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred after the first dose of omalizumab products but also has occurred beyond 1 year after beginning treatment.

Initiate OMLYCLO therapy in a healthcare setting, closely observe patients for an appropriate period of time after OMLYCLO administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis.

( 2.6 , 5.1 , 6.1 , 6.2 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE OMLYCLO is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods.

To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment ( 1.4 ) Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis ( 1.3 ) Not indicated for other forms of urticaria. ( 1.4 )

1.1Asthma OMLYCLO is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Limitations of Use: OMLYCLO is not indicated for the relief of acute bronchospasm or status asthmaticus.

1.2Chronic Rhinosinusitis with Nasal Polyps OMLYCLO is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

1.3IgE-Mediated Food Allergy OMLYCLO is indicated for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. OMLYCLO is to be used in conjunction with food allergen avoidance. Limitations of Use: OMLYCLO is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

1.4Chronic Spontaneous Urticaria OMLYCLO is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: OMLYCLO is not indicated for treatment of other forms of urticaria.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous (SC) administration only. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for administration instructions ( 2.6 , 2.7 ). Asthma: OMLYCLO 75 to 375 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.2 ) Chronic Rhinosinusitis with Nasal Polyps : OMLYCLO 75 to 600 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.3 ) IgE-Mediated Food Allergy : OMLYCLO 75 mg to 600 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination chart. ( 2.4 ) Chronic Spontaneous Urticaria : OMLYCLO 150 or 300 mg SC every 4 weeks.

Dosing in CSU is not dependent on serum IgE level or body weight. ( 2.5 )

2.1Overview of Dosage Determination Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Determine dosage of OMLYCLO by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy, dosage determination should be based on the primary diagnosis for which OMLYCLO is being prescribed. Adjust doses for significant changes in body weight during treatment.

Refer to Tables 1 and 2 for the recommended dosage for treatment of asthma, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during OMLYCLO treatment cannot be used as a guide for dose determination.

Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination. Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination (Table 1 or 2 for treatment of asthma, based on the patient's age, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy). Chronic Spontaneous Urticaria Dosage of OMLYCLO in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE (free or total) level or body weight [see Dosage and Administration (2.5) ] .

2.2Recommended Dosage for Asthma The recommended dosage for asthma is OMLYCLO 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1. Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 2.

Table 1. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Patients 12 Years of Age and Older with Asthma Table 2. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin OMLYCLO Between the Ages of 6 to <12 Years Table 1 Table 2 Duration of Therapy Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

2.3Recommended Dosage for Chronic Rhinosinusitis with Nasal Polyps The recommended dosage for chronic rhinosinusitis with nasal polyps (CRSwNP) is OMLYCLO 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measure before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Refer to Table 3 for recommended dosage based on serum total IgE level and body weight for patients with CRSwNP. Table 3.

Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Adult Patients wit… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 110 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 75 mg/0.5 mL is a clear to opalescent and colorless to pale brownish- yellow solution in a single-dose prefilled syringe with yellow plunger rod and safety guard. Injection: 150 mg/mL is a clear to opalescent and colorless to pale brownish- yellow solution in a single-dose prefilled syringe with blue plunger rod and safety guard. Injection: 300 mg/2 mL (150 mg/mL) is a clear to opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with white plunger rod and safety guard Injection: 75 mg/0.5 mL,150 mg/mL, and 300 mg/ 2 mL (150 mg/mL), solution in a single-dose prefilled syringe ( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS OMLYCLO is contraindicated in patients with severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis: Initiate OMLYCLO therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration. ( 5.1 ) Malignancy: Malignancies have been observed in clinical studies. ( 5.2 ) Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus.

( 5.3 ) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of OMLYCLO therapy. ( 5.4 ) Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.5 ) Fever, Arthralgia, and Rash: Stop OMLYCLO if patients develop signs and symptoms similar to serum sickness.

( 5.6 ) Potential Medication Error Related to Emergency Treatment of Anaphylaxis: OMLYCLO should not be used for emergency treatment of allergic reactions, including anaphylaxis. ( 5.9 )

5.1Anaphylaxis Anaphylaxis has been reported to occur after administration of omalizumab products in premarketing clinical trials and in postmarketing spontaneous reports [see Boxed Warning and Adverse Reactions (6.2) ] . Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Some of these events have been life-threatening.

In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3,507 (0.1%) patients. Anaphylaxis occurred with the first dose of omalizumab in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

A case-control study in asthma patients showed that, among omalizumab users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with omalizumab products, compared to those with no prior history of anaphylaxis [see Adverse Reactions (6.1) ] . In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients based on an estimated exposure of 57,300 patients from June 2003 through December 2006.

Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond one year after beginning regularly scheduled treatment. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of omalizumab, with additional cases occurring sporadically beyond the third dose. Initiate OMLYCLO only in a healthcare setting equipped to manage anaphylaxis, which can be life-threatening.

Observe patients closely for an appropriate period of time after administration of OMLYCLO, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports [see Adverse Reactions (6.1 , 6.2) ] . Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur. Once OMLYCLO therapy has been established, administration of OMLYCLO prefilled syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients.

Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g., prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with OMLYCLO prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use [see Dosage and Administration (2.6) , Adverse Reactions (6.1 , 6.2) ].

Discontinu… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma: The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (≥ 3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.

( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps : The most common adverse reactions (≥ 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness. ( 6.1 ) IgE-Mediated Food Allergy: The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia. ( 6.1 ) Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions from Clinical Studies in Adult and Adolescent Patients 12 Years of Age and Older with Asthma The data described below reflect omalizumab exposure for 2,076 adult and adolescent patients ages 12 and older, including 1,687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies.

The mean age of patients receiving omalizumab was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received omalizumab 150 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. The adverse reactions most frequently resulting in clinical intervention (e.g., discontinuation of omalizumab, or the need for concomitant medication to treat an adverse reaction) were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%).

These reactions were observed at similar rates in omalizumab-treated patients and control patients. Table 6 shows adverse reactions from four placebo-controlled asthma trials that occurred ≥1% and more frequently in adult and adolescent patients 12 years of age and older receiving omalizumab than in those receiving placebo. Adverse reactions were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary.

Injection site reactions were recorded separately from the reporting of other adverse reactions. Table 6. Adverse Reactions ≥1% More Frequent in omalizumab-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials Adverse reaction Omalizumab n=738 Placebo n=717 Body as a whole Pain 7% 5% Fatigue 3% 2% Musculoskeletal system Arthralgia 8% 6% Fracture 2% 1% Leg pain 4% 2% Arm pain 2% 1% Nervous system Dizziness 3% 2% Skin and appendages Pruritus 2% 1% Dermatitis 2% 1% Special senses Earache 2% 1% There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race.

Anaphylaxis Case Control Study A… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 65 words ▾

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with omalizumab products. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of omalizumab products and allergen immunotherapy has not been evaluated. In patients with CSU, the use of omalizumab products in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary A registry study of omalizumab exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. There was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking omalizumab during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [ see Data ]. There are risks associated with poorly or moderately controlled asthma in pregnancy [ see Clinical Considerations ].

Human IgG antibodies are known to cross the placental barrier; therefore, omalizumab products may be transmitted from the mother to the developing fetus. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Human Data A prospective cohort pregnancy exposure registry study conducted in the US from 2006 to 2018, included 250 pregnant women with asthma treated with omalizumab. Of these, 246 patients were exposed to omalizumab in the first trimester of pregnancy, and the median exposure duration was 8.7 months.

The registry findings for applicable mother and infant subgroups were compared to age- adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to omalizumab) identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort ("comparator cohort"). Among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%).

Among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. There was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking omalizumab during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. The registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort.

Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the MRHD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing.

8.2Lactation Risk Summary There is no information regarding the presence of omalizumab products in human milk, or the eff… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Asthma Safety and effectiveness of OMLYCLO for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. Use of OMLYCLO for this indication is supported by evidence from adequate and well-controlled studies of omalizumab. Omalizumab was evaluated in 2 trials in 926 (omalizumab 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen.

One trial was a pivotal trial of similar design and conduct to that of adult and adolescent Asthma Trials 1 and 2. The other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal trial, omalizumab-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose) [see Clinical Studies (14.1) ] .

Safety and efficacy of OMLYCLO in pediatric patients with asthma below 6 years of age have not been established. Chronic Rhinosinusitis with Nasal Polyps Safety and effectiveness of OMLYCLO in pediatric patients with chronic rhinosinusitis with nasal polyps (CRSwNP) below 18 years of age have not been established. IgE-Mediated Food Allergy The safety and effectiveness of OMLYCLO for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with IgE-mediated food allergy.

Use of OMLYCLO for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. A significantly greater percentage of omalizumab-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose-limiting symptoms [see Clinical Studies (14.3) ]. Safety and effectiveness in pediatric patients with IgE-mediated food allergy below 1 year of age have not been established.

Chronic Spontaneous Urticaria The safety and effectiveness of OMLYCLO for chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment have been established in pediatric patients aged 12 years and older. Use of OMLYCLO in this population is supported by evidence from adequate and well-controlled studies of omalizumab. Adolescent patients with CSU were evaluated in 39 patients 12 to 17 years of age (omalizumab 29, placebo 10) included in three randomized, placebo-controlled CSU trials.

A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. Safety and effectiveness of OMLYCLO in pediatric patients with CSU below 12 years of age have not been established.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with omalizumab. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab products inhibit the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab products inhibit IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.

Chronic Spontaneous Urticaria Omalizumab products bind to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab products result in an improvement of chronic spontaneous urticaria (CSU) symptoms is unknown.

12.2Pharmacodynamics Asthma In clinical studies, serum free IgE levels were reduced in a dose-dependent manner within 1 hour following the first dose and maintained between doses. Mean serum free IgE decrease was greater than 96% using recommended doses. Serum total IgE levels (i.e., bound and unbound) increased after the first dose due to the formation of drug:IgE complexes, which have a slower elimination rate compared with free IgE.

At 16 weeks after the first dose, average serum total IgE levels were five-fold higher compared with pre-treatment when using standard assays. After discontinuation of omalizumab dosing, the omalizumab -induced increase in total IgE and decrease in free IgE were reversible, with no observed rebound in IgE levels after drug washout. Total IgE levels did not return to pre-treatment levels for up to one year after discontinuation of omalizumab.

Chronic Rhinosinusitis with Nasal Polyps In clinical studies in chronic rhinosinusitis with nasal polyps (CRSwNP) patients, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentrations at baseline were 168 IU/mL and 218 IU/mL in CRSwNP Trial 1 and 2, respectively. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, the mean predose free IgE concentrations at Week 16 were

10.0 IU/mL in CRSwNP Trial 1 and

11.7IU/mL in CRSwNP Trial 2 and remained stable at 24 weeks of treatment. Total IgE levels in serum increased due to the formation of omalizumab-IgE complexes, which have a slower elimination rate compared with free IgE. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, mean and median predose serum total IgE levels at Week 16 were 3- to 4- fold higher compared with pre-treatment levels, and remained stable between 16 and 24 weeks of treatment.

IgE-Mediated Food Allergy In a clinical study in patients with IgE-mediated food allergy, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentration at baseline was 810 IU/mL. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 4, the mean pre-dose free IgE concentration at Week 16 was

10.0IU/mL. Mean total IgE levels in serum increased about 2.4-fold due to the formation of omalizumab-IgE complexes, which have a longer half-life compared with free IgE. Chronic Spontaneous Urticaria In clinical studies in chronic spontaneous urticaria (CSU) patients, omalizumab treatment led to a dose-dependent reduction of serum free IgE and an increase of serum total IgE levels, similar to the observations in asthma patients.

Maximum suppression of free IgE was observed 3 days following the first subcutaneous dose. After repeat dosing once every 4 weeks, predose serum free IgE levels remained stable between 12 and 24 weeks of treatment. Total IgE levels in serum increased after the first dose due to the formation of omalizumab-IgE complexes which have a… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 112 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Injection (Prefilled Syringe) OMLYCLO (omalizumab-igec) injection is a clear to opalescent and colorless to pale brownish-yellow solution for subcutaneous use. OMLYCLO injection is provided in a single-dose prefilled glass syringe with a 27-gauge special thin wall needle. The syringe plunger stopper and needle cap are not made with natural rubber latex.

OMLYCLO is available as prefilled syringe as described in Table 17. Table 17. OMLYCLO Prefilled Syringe Strengths and Package Configurations Package Configuration Strength NDC Syringe Counts 1 prefilled syringe with a 27-gauge staked needle syringe with a yellow plunger rod 75 mg/ 0.5 mL 72606-035-01 1 1 prefilled syringe with a 27-gauge staked needle syringe with a blue plunger rod 150 mg/mL 72606-036-01 1 1 prefilled syringe with a 27-gauge staked needle syringe with a white plunger rod 300 mg/2 mL (150 mg/mL) 72606-054-01 1 2 prefilled syringes with a 27-gauge staked needle syringe with a white plunger rod 300 mg/2 mL (150 mg/mL) 72606-054-02 2 (2 × 1) (multipack) The OMLYCLO prefilled syringe is not made with natural rubber.

Storage OMLYCLO prefilled syringe should be shipped and stored under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton. Protect from direct sunlight. OMLYCLO prefilled syringe can be removed from and placed back in the refrigerator if needed.

The total combined time out of the refrigerator may not be more than 7 days. Do not use if prefilled syringe is left at temperatures above 77°F (25°C ). Do not freeze.

Do not use if the prefilled syringe has been frozen. Do not shake.

📦 Storage and Handling 86 words ▾

The total combined time out of the refrigerator may not be more than 7 days. Do not use if prefilled syringe is left at temperatures above 77°F (25°C ). Do not freeze.

Do not use if the prefilled syringe has been frozen. Do not shake.

📋 Description 216 words ▾

11 DESCRIPTION Omalizumab-igec is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. OMLYCLO is produced by a Chinese hamster ovary cell suspension culture.

OMLYCLO (omalizumab-igec) is administered as a subcutaneous (SC) injection and is available in prefilled syringes. OMLYCLO Injection (Prefilled Syringe) OMLYCLO (omalizumab-igec) injection is supplied as a sterile, preservative-free, clear to opalescent and colorless to pale brownish-yellow solution for subcutaneous injection. OMLYCLO (omalizumab-igec) injection is available as a single-dose prefilled syringe.

Each 75 mg prefilled syringe delivers 75 mg omalizumab-igec in 0.5 mL and contains arginine hydrochloride (21.065 mg), histidine (0.685 mg), L-histidine hydrochloride monohydrate (1.17 mg), and polysorbate 20 (0.2 mg) in Water for Injection (WFI), USP. The pH of the product is 6.0. Each 150 mg prefilled syringe delivers 150 mg omalizumab-igec in 1 mL and contains arginine hydrochloride (42.13 mg), histidine (1.37 mg), L-histidine hydrochloride monohydrate (2.34 mg), and polysorbate 20 (0.4 mg) in WFI, USP.

The pH of the product is 6.0. Each 300 mg prefilled syringe delivers 300 mg omalizumab-igec in 2 mL and contains arginine hydrochloride (84.26 mg), histidine (2.74 mg), L-histidine hydrochloride monohydrate (4.68 mg), and polysorbate 20 (0.8 mg) in WFI, USP. The pH of the product is 6.0.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Anaphylaxis Inform patients of the risk of life-threatening anaphylaxis with OMLYCLO including the following points [see Boxed Warning and Warnings and Precautions (5.1) ] : There have been reports of anaphylaxis occurring up to 4 days after administration of omalizumab products Initiate OMLYCLO only in a healthcare setting by healthcare providers Observe patients closely following administration Inform patients of the signs and symptoms of anaphylaxis Instruct patients to seek immediate medical care should such signs or symptoms occur Potential Medication Error Related to Emergency Treatment of Anaphylaxis Advise patients, parents, or caregivers that OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis [see Warnings and Precautions (5.9) ] .

Continuation of Other Medications Instruct patients receiving OMLYCLO not to decrease the dose of, or stop taking any other asthma, CRSwNP, CSU or IgE-mediated food allergy medications or allergen immunotherapy unless otherwise instructed by their physician. Inform patients that they may not see immediate improvement in their asthma, CRSwNP, CSU or IgE-mediated food allergy symptoms after beginning OMLYCLO therapy. Instruction on Injection Technique If a patient or caregiver is to administer subcutaneous OMLYCLO prefilled syringe, instruct on injection technique and assess ability to inject subcutaneously to ensure proper administration of OMLYCLO.

For patients who require more than 1 injection to complete their prescribed dose, instruct patients to administer all injections consecutively and in one sitting [ See Dosage and Administration (2.7) , Warnings and Precautions (5.1) , and Instructions for Use ].

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 12/2025 MEDICATION GUIDE OMLYCLO ® (OM-ly-clo) (omalizumab-igec) injection, for subcutaneous use What is the most important information I should know about OMLYCLO?

OMLYCLO may cause serious side effects, including: Severe allergic reaction . A severe allergic reaction called anaphylaxis can happen when you receive OMLYCLO. The reaction can occur after the first dose, or after many doses.

It may also occur right after a OMLYCLO injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom" flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving OMLYCLO and for a period of time after treatment is initiated.

Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. What is OMLYCLO? OMLYCLO is an injectable prescription medicine used to treat: moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids.

A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if OMLYCLO is safe and effective in people with asthma under 6 years of age. chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if OMLYCLO is safe and effective in people with CRSwNP under 18 years of age. food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic.

While taking OMLYCLO you should continue to avoid all foods to which you are allergic. It is not known if OMLYCLO is safe and effective in people with food allergy under 1 year of age. chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if OMLYCLO is safe and effective in people with CSU under 12 years of age.

OMLYCLO should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. OMLYCLO should also not be used to treat other forms of hives, or sudden breathing problems. Who should not receive and use OMLYCLO?

Do not receive and use OMLYCLO if you: are allergic to omalizumab products or any of the ingredients in OMLYCLO. See the end of this Medication Guide for a complete list of ingredients in OMLYCLO. What should I tell my healthcare provider before receiving OMLYCLO?

Before receiving OMLYCLO, tell your healthcare provider about all of your medical conditions, including if you: have sudden breathing problems (bronchospasm). have ever had a severe allergic reaction called anaphylaxis. have or have had a parasitic infection. have or have had cancer. are pregnant or plan to become pregnant. It is not known if OMLYCLO may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if OMLYCLO passes into your breast milk.

Talk with your healthcare provider about the best way to feed your baby while you receive and use OMLYCLO. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I receive and use OMLYCLO?… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics After SC administration, omalizumab was absorbed with an average absolute bioavailability of 62%. Following a single SC dose in adult and adolescent patients with asthma, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7– 8 days. In patients with CSU, the peak serum concentration was reached at a similar time after a single SC dose.

The pharmacokinetics of omalizumab was linear at doses greater than 0.5 mg/kg. In patients with asthma, following multiple doses of omalizumab, areas under the serum concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those after the first dose. In patients with CSU, omalizumab exhibited linear pharmacokinetics across the dose range of 75 mg to 600 mg given as single subcutaneous dose.

Following repeat dosing from 75 to 300 mg every 4 weeks, trough serum concentrations of omalizumab increased proportionally with the dose levels. In vitro, omalizumab formed complexes of limited size with IgE. Precipitating complexes and complexes larger than 1 million daltons in molecular weight were not observed in vitro or in vivo.

Tissue distribution studies in Cynomolgus monkeys showed no specific uptake of 125 I-omalizumab by any organ or tissue. The apparent volume of distribution of omalizumab in patients with asthma following SC administration was 78 ± 32 mL/kg. In patients with CSU, based on population pharmacokinetics, distribution of omalizumab was similar to that in patients with asthma.

Clearance of omalizumab involved IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE. Liver elimination of IgG included degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG was also excreted in bile.

In studies with mice and monkeys, drug:IgE complexes were eliminated by interactions with Fcɣ receptors within the RES at rates that were generally faster than IgG clearance. In asthma patients omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1 mL/kg/day. Doubling body weight approximately doubled apparent clearance.

In CSU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days and apparent clearance averaged 240 mL/day (corresponding to 3.0 mL/kg/day for an 80 kg patient). Specific Populations Asthma The population pharmacokinetics of omalizumab was analyzed to evaluate the effects of demographic characteristics in patients with asthma. Analyses of these data suggested that no dose adjustments are necessary for age (6 to 76 years), race, ethnicity, or gender.

Chronic Rhinosinusitis with Nasal Polyps The population pharmacokinetics analyses of omalizumab suggested that the pharmacokinetics of omalizumab in chronic rhinosinusitis with nasal polyps (CRSwNP) were consistent with that in asthma. Graphical covariate analyses were performed to evaluate the effects of demographic characteristics and other factors on omalizumab exposure and clinical responses. These analyses demonstrate that no dose adjustments are necessary for age (18 to 75 years) or gender.

Race and ethnicity data are too limited in CRSwNP studies to inform dose adjustment. IgE-Mediated Food Allergy Population pharmacokinetic (PK) analyses of omalizumab suggested that the PK of omalizumab in patients with IgE-mediated food allergy were generally consistent with that in patients with asthma. Covariate analyses were performed to evaluate the effects of demographic characteristics and other factors on omalizumab exposure and clinical responses.

These analyses demonstrate that no dose adjustments are necessary for age (1 year and older), race, ethnicity, or gender. Chronic Spontaneous Urticaria The population pharmacokinetics of omalizumab was analyzed to evaluate the effects of demographic characteristics and other factors on omalizumab exposure in patients wit… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

10.0 IU/mL in CRSwNP Trial 1 and

After repeat dosing once every 4 weeks at 75 mg up to 300 mg, average predose serum total IgE levels at Week 12 were two- to three-fold higher compared with pre-treatment levels, and remained stable between 12 and 24 weeks of treatment. After discontinuation of omalizumab dosing, free IgE levels increased and total IgE levels decreased towards pre-treatment levels over a 16-week follow-up period.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Asthma Adult and Adolescent Patients 12 Years of Age and Older The safety and efficacy of omalizumab were evaluated in three randomized, double-blind, placebo-controlled, multicenter trials. The trials enrolled patients 12 to 76 years old, with moderate to severe persistent (NHLBI criteria) asthma for at least one year, and a positive skin test reaction to a perennial aeroallergen. In all trials, omalizumab dosing was based on body weight and baseline serum total IgE concentration.

All patients were required to have a baseline IgE between 30 and 700 IU/mL and body weight not more than 150 kg. Patients were treated according to a dosing table to administer at least 0.016 mg/kg/IU (IgE/mL) of omalizumab or a matching volume of placebo over each 4-week period. The maximum omalizumab dose per 4 weeks was 750 mg.

In all three trials an exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose. Most exacerbations were managed in the outpatient setting and the majority were treated with systemic steroids. Hospitalization rates were not significantly different between omalizumab and placebo-treated patients; however, the overall hospitalization rate was small.

Among those patients who experienced an exacerbation, the distribution of exacerbation severity was similar between treatment groups. Asthma Trials 1 and 2 At screening, patients in Asthma Trials 1 and 2 had a forced expiratory volume in one second (FEV 1 ) between 40% and 80% predicted. All patients had a FEV 1 improvement of at least 12% following beta 2 -agonist administration.

All patients were symptomatic and were being treated with inhaled corticosteroids (ICS) and short-acting beta 2 -agonists. Patients receiving other concomitant controller medications were excluded, and initiation of additional controller medications while on study was prohibited. Patients currently smoking were excluded.

Each trial was comprised of a run-in period to achieve a stable conversion to a common ICS (beclomethasone dipropionate), followed by randomization to omalizumab or placebo. Patients received omalizumab for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation necessitated an increase. Patients then entered an ICS reduction phase of 12 weeks during which ICS dose reduction was attempted in a step-wise manner.

The distribution of the number of asthma exacerbations per patient in each group during a study was analyzed separately for the stable steroid and steroid-reduction periods. In both Asthma Trials 1 and 2 the number of exacerbations per patient was reduced in patients treated with omalizumab compared with placebo (Table 10). Measures of airflow (FEV 1 ) and asthma symptoms were also evaluated in these trials.

The clinical relevance of the treatment-associated differences is unknown. Results from the stable steroid phase Asthma Trial 1 are shown in Table 11. Results from the stable steroid phase of Asthma Trial 2 and the steroid reduction phases of both Asthma Trials 1 and 2 were similar to those presented in Table 11.

Table 10. Frequency of Asthma Exacerbations per Patient by Phase in Asthma Trials 1 and 2 Stable Steroid Phase (16 wks) Asthma Trial 1 Asthma Trial 2 Exacerbations per patient omalizumab N=268 Placebo N=257 omalizumab N=274 Placebo N=272 0 85.8% 76.7% 87.6% 69.9% 1 11.9% 16.7% 11.3% 25.0% ≥2 2.2% 6.6% 1.1% 5.1% p-Value 0.005 <0.001 Mean number exacerbations/patient 0.2 0.3 0.1

0.4Steroid Reduction Phase (12 wks) Exacerbations per patient omalizumab N=268 Placebo N=257 omalizumab N=274 Placebo N=272 0 78.7% 67.7% 83.9% 70.2% 1 19.0% 28.4% 14.2% 26.1% ≥2 2.2% 3.9% 1.8% 3.7% p-Value 0.004 <0.001 Mean number exacerbations/patient 0.2 0.4 0.2

0.3Table 11. Asthma Symptoms and Pulmonary Function During Stable Steroid Phase of Asthma Trial 1 omalizumab N=268 Number of patients available for analysis ranges 255-258 in the omalizumab group and 23… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 62 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed in animals to evaluate the carcinogenic potential of omalizumab products. There were no effects on fertility and reproductive performance in male and female Cynomolgus monkeys that received omalizumab at subcutaneous doses up to 75 mg/kg/week (approximately 5 times the maximum recommended human dose on a mg/kg basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 59 words ▾

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE OMLYCLO® [OM-ly-clo] (omalizumab-igec) injection, for subcutaneous use Single-Dose Prefilled Syringe Read and follow the Instructions for Use that come with your Omlyclo Prefilled Syringe before you start using it and each time you get a refill. There may be new information. Before you use Omlyclo Preﬁlled Syringe for the ﬁrst time, make sure your healthcare provider shows you the right way to use it.

Do not use OMLYCLO for the emergency treatment of any allergic reactions, including anaphylaxis, hives or sudden breathing problems. For children 12 years of age and older, OMLYCLO Prefilled Syringe may be self-injected under adult supervision. For children 1 to 11 years of age, OMLYCLO Prefilled Syringe should be injected by a caregiver and healthcare provider.

Parts of the Prefilled Syringe (see Figure A ) Figure A Choose the Correct Prefilled Syringe or Combination of Prefilled Syringes Omlyclo Prefilled Syringes are available in 3 dose strengths (see Figure B ). These instructions are to be used for all dose strengths. Figure B Your prescribed dose may require more than 1 injection.

The Dosing Table ( Figure C ) below shows the combination of Prefilled Syringes needed to give your full dose. Check the label on the Omlyclo carton to make sure you have received the correct Prefilled Syringe or combination of Prefilled Syringes for your prescribed dose. If your dose requires more than 1 injection, complete all injections for your prescribed dose, immediately one after another.

Contact your healthcare provider if you have any questions. Dosing Table Note: Your healthcare provider may prescribe a different combination of Prefilled Syringes for your complete dose. How Should I Store OMLYCLO?

Store the unused Prefilled Syringe in the original carton and store the carton in a refrigerator between 36°F to 46°F (2°C to 8ºC). Do not remove the Prefilled Syringe from its original carton during storage. Keep the Prefilled Syringe out of direct light.

Do not freeze. Do not use if the Prefilled Syringe has been frozen. Before giving an injection, the carton can be removed from and placed back in the refrigerator if needed.

The total combined time out of the refrigerator may not exceed 7 days. If the Prefilled Syringe is exposed to temperatures above 77°F (25°C), do not use it and throw away in a FDA-cleared sharps disposal container. Keep the Prefilled Syringe, and all medicines out of reach of children.

Prefilled Syringe contains small parts. Important information Do not open the sealed carton until you are ready to inject the Prefilled Syringe. Do not use if the carton or the Prefilled Syringe is damaged or appears to be tampered with.

Do not take the Cap off until you are ready to inject the Prefilled Syringe. Do not use if the Prefilled Syringe has been dropped on a hard surface or dropped after removing the Cap. Do not reuse the same Prefilled Syringe.

Do not leave the Prefilled Syringe unattended. Do not try to take the Prefilled Syringe apart at any time. This Instructions for Use has been approved by the U.S.

Food and Drug Administration 12/2025 Preparing for the Injection 1. Take the carton containing the Prefilled Syringe out of the refrigerator. 1a.

If you need more than 1 Prefilled Syringe to deliver your prescribed dose (see Figure C ), take all the cartons out of the refrigerator at the same time (each carton contains 1 Prefilled Syringe). The following steps must be followed for each Prefilled Syringe. Figure D 2.

Gather the supplies needed to give your injection (see Figure D ). - Carton containing Prefilled Syringe Not included in the carton: - Alcohol swab - Cotton ball or gauze - Adhesive bandage - FDA-cleared Sharps disposal container Note : You may need more than 1 Prefilled Syringe for your prescribed dose. See the Dosing Table (Figure C) above for more information. Each carton contains 1 Prefilled Syringe.

Figure E 3. Check the expiration on the carton (see Figure E ). Do not use it if the expirat… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 23 words ▾

Dosage and Administration, Recommended Dosage for Chronic Spontaneous Urticaria ( 2.5 ) 12/2025 Dosage and Administration, OMLYCLO Prefilled Syringe ( 2.7 ) 12/2025

📄 Package Label / Principal Display Panel 218 words ▾

PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Syringe Carton Rx only NDC 72606-035-01 Omlyclo ® omalizumab-igec Injection 75 mg/0.5 mL FOR SUBCUTANEOUS USE ATTENTION: Dispense the enclosed Medication Guide to each patient x 1 1 single-dose Prefilled Syringe with safety guard Do not use for emergency treatment. Your dose may require more than 1 injection. For questions, contact your healthcare provider.

CELLTRION USA CELLTRION PRINCIPAL DISPLAY PANEL - 75 mg/0.5 mL Syringe Carton

PRINCIPAL DISPLAY PANEL - 150 mg/mL Syringe Carton Rx only NDC 72606-036-01 Omlyclo ® omalizumab-igec Injection 150 mg/mL FOR SUBCUTANEOUS USE ATTENTION: Dispense the enclosed Medication Guide to each patient x 1 1 single-dose Prefilled Syringe with safety guard Do not use for emergency treatment. Your dose may require more than 1 injection. For questions, contact your healthcare provider.

CELLTRION USA CELLTRION PRINCIPAL DISPLAY PANEL - 150 mg/mL Syringe Carton

PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton Rx only NDC 72606-054-01 Omlyclo ® omalizumab-igec Injection 300 mg/2 mL (150 mg/mL) FOR SUBCUTANEOUS USE ATTENTION: Dispense the enclosed Medication Guide to each patient x 1 1 single-dose Prefilled Syringe with safety guard Do not use for emergency treatment. Your dose may require more than 1 injection. For questions, contact your healthcare provider.

CELLTRION USA CELLTRION PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arthralgia: Joint pain.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

epistaxis: A nosebleed.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

injection site reaction: Redness, swelling, pain, or itching in the spot where a shot was given.

lactation: The making and release of milk from a mother's breasts after giving birth.

linear pharmacokinetics: When blood levels of a medicine rise in direct proportion to the size of the dose.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

p-value: A number showing how likely a result could have happened by chance; smaller numbers make the result more convincing.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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NDC identity (package / product / labeler codes)	✓ Available
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Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
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NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CELLTRION USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 2 syringes (72606-0054-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

CELLTRION USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

← 72606-0051-01 · CELLTRION 72606-0058-01 · CELLTRION →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

OMLYCLO omalizumab-igec 300 mg/2mL Injection — NDC 72606-054-01 (Billing 72606-0054-01)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & biosimilar status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

10.0 IU/mL in CRSwNP Trial 1 and

10.0 IU/mL in CRSwNP Trial 1 and

14 CLINICAL STUDIES

13 NONCLINICAL TOXICOLOGY

About this NDC listing & data coverage

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