Home › NDC Lookup › Ingredients › Crizanlizumab › 00078-0883-61
ADAKVEO crizanlizumab 10 mg/mL Injection, 10 mL — NDC 00078-0883-61 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ADAKVEO crizanlizumab 10 mg/mL Injection, 10 mL — NDC 0078-0883-61 (Billing 00078-0883-61)

by Novartis Pharmaceuticals Corporation · 10 mL in 1 VIAL, GLASS

This is a package of 10 mL of ADAKVEO crizanlizumab 10 mg/mL Injection from Novartis Pharmaceuticals Corporation, marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.

NDC 00078-0883-61
🏷️ FDA NDC (as labeled) 0078-0883-61 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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

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

NDC database record

One package, one record: these facts belong to NDC 0078-0883-61 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0078 labeler · 0883 product · 61 package
Package marketed since
Nov 15, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
10 mL per package
Barcode (UPC-A, from the NDC)
3 0078088361 0
Medicaid fills, this package
3,426 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0078-0883-61
Product NDC 0078-0883
11-digit billing NDC 00078088361
NCPDP billing unit ML — per mL (volume)
RxCUI 2262425, 2262430
UNII L7451S9126
Application # BLA761128
SPL Set ID b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6
Established class (EPC) Selectin Blocker
Mechanism of action P-Selectin Blockers
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-15
Route INTRAVENOUS
Dosage form INJECTION
Substance CRIZANLIZUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 82807020702020
GPI class Adakveo
GCN Seq No 080477
GCN 47334
HICL code 046209
Ingredient (HICL) Crizanlizumab-Tmca
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1H
Therapeutic class — specific (HIC3) Sickle Cell Anemia Agents
AHFS code 20:92.00.00
AHFS class Blood Form.,Coag,Thrombosis Agents Misc.
FDB label name ADAKVEO 100 MG/10 ML VIAL
FDB brand name Adakveo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080477
  • GCN: 47334
  • GPI-14 (Medi-Span): 82807020702020
  • HICL (First Databank): 046209
  • AHFS class code: 20:92.00.00
  • RxCUI (RxNorm): 2262425
Why two NDCs? The FDA registers this code as 0078-0883-61 — a 4-4-2 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 labeler segment → 00078-0883-61. 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.

RxNorm drug class

This medicine belongs to the Selectin Blocker class.

Pharmacologic class Selectin Blocker
Drug family (ATC) Other hematological agents
How it works P-Selectin Blockers
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.

Clinical

Label name ADAKVEO 100 MG/10 ML VIAL Ingredient Crizanlizumab-Tmca
📖 What it is MedlinePlus · NLM

Crizanlizumab-tmca injection is used to reduce the number of pain crises (sudden, severe pain that may last several hours to several days) in adults and children 16 years of age and older with sickle cell disease (an inherited blood disease). Crizanlizumab-tmca is in a class of medications called monoclonal antibodies. It works by blocking certain blood cells from interacting.

Read the full MedlinePlus article ↗

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.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $234.90 $234.90 / 1 vial
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0791 $129.937 / J0791 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0078-0883-61
11-digit billing NDC00078-0883-61
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0791
DescriptorInjection, crizanlizumab-tmca, 5 mg
Billing units / pkg20 units
How the units are derivedThis package is 10; the HCPCS unit is 5 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$5,989,584 · 605 claims · $9,900.14 per claim (all NDCs under J0791)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00078-0883-61 You're viewing this Main listing 10 mL in 1 VIAL, GLASS 2019-11-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adakveo 10 mg/mLthis 00078-0883-61 Novartis 10 ml — — 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.

Availability & biosimilar status

🏛️
2019
First FDA approval
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2031. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 15, 2019 ⏳ ~5.1 yr to latest listed protection

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
Adakveocrizanlizumab-tmca
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2019 2021 2023 2025 2027 2029 2031
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
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateNov 15, 2031
Common questions
Is there a biosimilar for ADAKVEO 100 MG/10 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
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.

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.

  • 0.54 mg / 1 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 0.200 mg / 1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 5.053 mg / 1 mL UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 75.33 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

LabelerNovartis Pharmaceuticals Corporation
FDA applicationBLA761128 (BLA)
Labeler code00078
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio209 products on file

More NDCs from Novartis Pharmaceuticals Corporation labeler code 00078

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.

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.
🎯 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.2 )

2.1Recommended Dosage Administer ADAKVEO 5 mg/kg by intravenous infusion over a period of 30 minutes at Week 0, Week 2, and every 4 weeks thereafter. If a dose is missed, administer ADAKVEO as soon as possible. If ADAKVEO is administered within 2 weeks after the missed dose, continue dosing according to the patient's original schedule.

If ADAKVEO is administered more than 2 weeks after the missed dose, continue dosing every 4 weeks thereafter. Physicians should reevaluate the treatment at least yearly, to assess individual patient’s response to treatment and consider discontinuing therapy with ADAKVEO if no perceived benefit is achieved. ADAKVEO may be given with or without hydroxyurea.

2.2Preparation and Administration ADAKVEO should be prepared and administered by a healthcare professional. Preparation Use aseptic technique to prepare the solution for infusion. Calculate the dose (mg) and the total volume (mL) of ADAKVEO solution required, and the number of ADAKVEO vials needed based on the patient’s actual body weight.

Prepare 5 mg of ADAKVEO per kg of actual body weight. Calculate the volume of ADAKVEO to be used according to the following equation: Dilution Dilute ADAKVEO in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a total volume of 100 mL for intravenous infusion as follows: Obtain the number of vials required. One vial is needed for every 10 mL of ADAKVEO.

Bring vials to room temperature for a maximum of 4 hours prior to the start of preparation (piercing the first vial). Visually inspect the vials. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

ADAKVEO is clear to opalescent, colorless or may have a slightly brownish-yellow tint. Do not use if particles are present in the solution. Obtain a 100 mL 0.9% Sodium Chloride Injection or 5% Dextrose Injection infusion bag/container.

Infusion bags/containers must be made of either polyvinyl chloride (PVC), polyethylene (PE), or polypropylene (PP). Remove a volume of 0.9% Sodium Chloride Injection or 5% Dextrose Injection from the infusion bag/container that is equal to the required volume of ADAKVEO solution. Withdraw the necessary amount of ADAKVEO solution and dilute by adding to the infusion bag/container containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

The volume of ADAKVEO added to the infusion bag/container should not exceed 96 mL. Gently invert the infusion bag to mix the diluted solution. DO NOT SHAKE.

Single-dose vials. Discard unused portion. Storage Conditions of the Diluted Solution Administer ADAKVEO diluted solution as soon as possible.

If not administered immediately, store the prepared solution either: At room temperature up to 25°C (77°F) for no more than 4.5 hours from the start of the preparation (piercing the first vial) to the completion of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, from the start of the time of the preparation (piercing the first vial) to the completion of infusion. This includes the storage of the diluted solution and the time to warm up to room temperature.

Protect the diluted solution from light during storage under refrigeration. Administration Administer ADAKVEO diluted solution by intravenous infusion over a period of 30 minutes through an intravenous line, which must contain a sterile, nonpyrogenic 0.2-micron inline filter. No incompatibilities have been observed between ADAKVEO and infusion sets composed of PVC, polyethylene (PE-lined PVC), polyurethane (PU), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged), positively charged polyamide (PA), and po… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/10 mL (10 mg/mL) as a clear to opalescent, colorless to slightly brownish-yellow solution in a single-dose vial. Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions: Monitor for and advise patients of signs and symptoms. Discontinue ADAKVEO infusion for severe reactions and manage medically. Temporarily interrupt or slow the rate of infusion for mild or moderate infusion-related reactions and initiate symptomatic treatment.

Exercise caution with corticosteroids in patients with sickle cell disease unless clinically indicated (e.g., treatment of anaphylaxis). ( 5.1 ) Interference With Automated Platelet Counts (platelet clumping): Run test as soon as possible or use citrate tubes. ( 5.2 )

5.1Infusion-Related Reactions In the SUSTAIN clinical trial, infusion-related reactions (IRRs) (defined as occurring during/within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. In the STAND clinical trial, IRRs were observed in 6 (7%) patients treated with ADAKVEO 5 mg/kg. IRRs presented most frequently as pain, nausea, vomiting, fatigue, dizziness, pruritis, diarrhea, and pyrexia.

Some IRRs have required hospitalizations. The majority of these IRRs occurred during the first and second infusions. Monitor for and advise patients to report signs and symptoms of IRRs.

Discontinue ADAKVEO infusion for severe IRRs and institute appropriate medical care. Consider permanent discontinuation of ADAKVEO treatment in case of severe IRRs. Manage mild to moderate infusion-related reactions with temporary interruption of infusion, slowing the rate of infusion, symptomatic treatment (e.g., acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS), opioids, antihistamines, intravenous fluids, and/or oxygen therapy).

For subsequent infusions, consider premedication and/or infusion rate reduction. Exercise caution with corticosteroids in patients with sickle cell disease unless clinically indicated (e.g., treatment of anaphylaxis). Use of corticosteroids may increase the risk of complications such as acute chest syndrome and fat embolism.

Infusion-Related Reactions and Vaso-occlusive Crises Infusion-related reactions are sometimes indistinguishable from vaso-occlusive crisis (VOC) events. IRRs and VOCs may occur concomitantly and/or VOCs may occur as a consequence of an IRR.

5.2Laboratory Test Interference Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing ethylenediaminetetraacetic acid (EDTA). Mitigation strategies are recommended [see Drug Interactions (7.1)] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions (5.1)] The most common adverse reactions (incidence ≥ 10%) were headache, arthralgia, nausea, back pain, fatigue, abdominal pain, pyrexia, diarrhea, vomiting, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 practice. Sickle Cell Disease SUSTAIN Trial The safety of ADAKVEO was evaluated in the SUSTAIN trial [see Clinical Studies (14.1)] . Eligible patients were diagnosed with sickle cell disease (any genotype, including HbSS, HbSC, HbS beta 0 -thalassemia, HbS beta + -thalassemia, and others).

Patients received ADAKVEO 5 mg/kg (N = 66) or 2.5 mg/kg (N = 64) or placebo (N = 62) administered by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter. The safety evaluation below is limited to the patients who received the recommended dose of 5 mg/kg. Among the 66 patients that received the recommended dose (5 mg/kg), 83% were exposed for 6 months or longer and 61% were exposed for approximately one year; forty-two (64%) patients were treated with ADAKVEO in combination with hydroxyurea.

Serious adverse reactions were reported in 2 patients (3%) treated with ADAKVEO 5 mg/kg; both reactions were pyrexia. Two deaths (3%) occurred in the ADAKVEO 5 mg/kg treatment group. None of the deaths were considered to be related to ADAKVEO.

The most common adverse reactions (≥ 10%) were arthralgia, nausea, back pain, abdominal pain, pyrexia, and diarrhea. Table 1 summarizes the adverse reactions in the SUSTAIN trial. Table 1: Adverse Reactions (≥ 10%) in Patients Receiving ADAKVEO With a Difference Between Arms of > 3% Compared to Placebo in SUSTAIN a Abdominal pain: abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal tenderness.

ADAKVEO 5 mg/kg N = 66 % Placebo N = 62 % Adverse Reactions All Grades % Grade ≥ 3 % All Grades % Grade ≥ 3 % Arthralgia 18 2 8 2 Nausea 18 0 11 2 Back pain 15 0 11 0 Abdominal pain a 12 0 5 0 Pyrexia 11 12 7 0 Diarrhea 11 0 3 2 Clinically relevant adverse reactions (all Grades) that were reported in less than 10% of patients treated with ADAKVEO included: oropharyngeal pain, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

STAND Trial The safety of ADAKVEO was also evaluated in the STAND trial [see Clinical Studies (14.1)] . Eligible patients were diagnosed with sickle cell disease (any genotype, including HbSS, HbSC, HbS beta 0 -thalassemia, HbS beta + -thalassemia, and others). Patients received ADAKVEO 5 mg/kg (N = 84) or 7.5 mg/kg (N = 83) or placebo (N = 85) administered by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter.

The safety evaluation below is limited to the patients who received the recommended dose of 5 mg/kg. Among the 84 patients that received the recommended dose (5 mg/kg), 93% were exposed for approximately 6 months or longer and 88% were exposed for approximately one year; sixty-two (74%) patients were treated with ADAKVEO in combination with hydroxyurea. Serious adverse reactions were reported in 2 patients (2%) treated with ADAKVEO 5 mg/kg and this reaction was pain.

The most common adverse reactions (≥ 10%) were headache, nausea, fatigue, vomiting, and oropharyngeal pain. Table 2: Adverse Reactions (≥ 10%) in Patients Receiving ADAKVEO With a Difference Between Arms of > 3% Compared… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 64 words ▾

7 DRUG INTERACTIONS

7.1Laboratory Test Interference Platelet Tests ADAKVEO interferes with automated platelet counts (platelet clumping) in particular when blood samples are collected in tubes containing EDTA, which may lead to unevaluable or falsely decreased platelet counts. Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary Based on data from animal studies, ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. In an animal reproduction study, intravenous administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from the onset of organogenesis through delivery resulted in a non-dose related increased fetal loss (abortions/stillbirths) at doses approximately 2.8 times the exposure at the recommended clinical dose at 5 mg/kg/dose once every 4 weeks (see Data) . There are insufficient human data on ADAKVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is approximately 14% and up to 43%, respectively.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus. Pregnant women are at greater risk for VOCs, pre-eclampsia, eclampsia, and maternal mortality.

For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality. Data Animal Data In an enhanced pre- and postnatal development study in cynomolgus monkeys, pregnant animals received intravenous doses of crizanlizumab-tmca at 10 and 50 mg/kg once every 2 weeks during the period of onset of organogenesis through delivery. No maternal toxicity was observed.

Maternal exposures at doses of 10 and 50 mg/kg were between 2.8 and 16 times, respectively, the human clinical exposure based on area under the curve (AUC) in patients with sickle cell disease at 5 mg/kg/dose once every 4 weeks. There was an increase in fetal loss (abortions or still births) at both crizanlizumab-tmca doses which was higher in the third trimester. There were no effects on infant growth and development through 6-months postpartum that were attributable to crizanlizumab-tmca.

Measurable crizanlizumab-tmca serum concentrations were observed in the infant monkeys at postnatal Day 28, confirming that crizanlizumab crosses the placental barrier.

8.2Lactation Risk Summary There is no data on the presence of crizanlizumab-tmca in human or animal milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to crizanlizumab-tmca are unknown.

The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for ADAKVEO and any potential adverse effects on the breastfed child from ADAKVEO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ADAKVEO for sickle cell disease have been established in pediatric patients aged 16 years and older. Use of ADAKVEO for sickle cell disease is supported by evidence from adequate and well-controlled studies in adults and pediatric patients (SUSTAIN trial). The SUSTAIN trial enrolled one pediatric patient treated with ADAKVEO 5 mg/kg aged 16 years old [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)] .

The safety and efficacy of ADAKVEO in pediatric patients below the age of 16 years have not been established.

8.5Geriatric Use There were no ADAKVEO-treated patients 65 years of age and older in the clinical studies for sickle cell disease [see Clinical Studies (14)] . Clinical studies of ADAKVEO did not include sufficient numbers of su… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on data from animal studies, ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. In an animal reproduction study, intravenous administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from the onset of organogenesis through delivery resulted in a non-dose related increased fetal loss (abortions/stillbirths) at doses approximately 2.8 times the exposure at the recommended clinical dose at 5 mg/kg/dose once every 4 weeks (see Data) . There are insufficient human data on ADAKVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is approximately 14% and up to 43%, respectively.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus. Pregnant women are at greater risk for VOCs, pre-eclampsia, eclampsia, and maternal mortality.

For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality. Data Animal Data In an enhanced pre- and postnatal development study in cynomolgus monkeys, pregnant animals received intravenous doses of crizanlizumab-tmca at 10 and 50 mg/kg once every 2 weeks during the period of onset of organogenesis through delivery. No maternal toxicity was observed.

Maternal exposures at doses of 10 and 50 mg/kg were between 2.8 and 16 times, respectively, the human clinical exposure based on area under the curve (AUC) in patients with sickle cell disease at 5 mg/kg/dose once every 4 weeks. There was an increase in fetal loss (abortions or still births) at both crizanlizumab-tmca doses which was higher in the third trimester. There were no effects on infant growth and development through 6-months postpartum that were attributable to crizanlizumab-tmca.

Measurable crizanlizumab-tmca serum concentrations were observed in the infant monkeys at postnatal Day 28, confirming that crizanlizumab crosses the placental barrier.

🧒 Pediatric Use 93 words ▾

8.4Pediatric Use The safety and effectiveness of ADAKVEO for sickle cell disease have been established in pediatric patients aged 16 years and older. Use of ADAKVEO for sickle cell disease is supported by evidence from adequate and well-controlled studies in adults and pediatric patients (SUSTAIN trial). The SUSTAIN trial enrolled one pediatric patient treated with ADAKVEO 5 mg/kg aged 16 years old [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)] .

The safety and efficacy of ADAKVEO in pediatric patients below the age of 16 years have not been established.

🧓 Geriatric Use 51 words ▾

8.5Geriatric Use There were no ADAKVEO-treated patients 65 years of age and older in the clinical studies for sickle cell disease [see Clinical Studies (14)] . Clinical studies of ADAKVEO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Crizanlizumab-tmca is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Crizanlizumab can also dissociate preformed P-selectin/PSGL-1 complex. Binding P-selectin on the surface of the activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.

12.2Pharmacodynamics ADAKVEO resulted in a dose-dependent P-selectin inhibition (measured ex vivo ) in patients with sickle cell disease and healthy volunteers.

12.3Pharmacokinetics The pharmacokinetics of crizanlizumab-tmca were evaluated in healthy volunteers and patients with sickle cell disease. The mean crizanlizumab-tmca C max , AUC last , or AUC inf increased disproportionally over the dose range of 0.2 to 8 mg/kg (0.04 to 1.6 times the approved recommended dosage) in healthy volunteers. In healthy volunteers administered the 5 mg/kg dose, the mean [coefficient of variation (CV%)] crizanlizumab-tmca C max , AUC last , or AUC inf were 0.16 (15.3%) mg/mL, 33.6 (12.6%) mg*hr/mL and 34.6 (13.1%) mg*hr/mL, respectively.

Distribution The mean (% CV) volume of distribution was 4.26 (25.1%) L after a single crizanlizumab-tmca 5 mg/kg intravenous infusion in healthy volunteers. Elimination The mean (% CV) terminal elimination half-life (t 1/2 ) of crizanlizumab-tmca was 10.6 (20.5%) days and the mean clearance was 11.7 (16.2%) mL/hr at 5 mg/kg doses in healthy volunteers. The mean (% CV) elimination t 1/2 of crizanlizumab-tmca was 11.4 (31.5%) days during dosing interval in patients with sickle cell disease.

Metabolism Crizanlizumab-tmca is expected to be metabolized into small peptides by catabolic pathways. Specific Populations The effect of renal or hepatic impairment on the pharmacokinetics of crizanlizumab-tmca is unknown. Drug Interaction Studies Hydroxyurea had no clinically meaningful effect on crizanlizumab-tmca pharmacokinetics in patients in clinical studies.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ADAKVEO or of other crizanlizumab products. The immunogenicity of ADAKVEO was evaluated using a validated bridging immunoassay for the detection of binding anti-crizanlizumab-tmca antibodies.

In a single arm, open label multiple dose study, 0 of the 45 patients with sickle cell disease treated with ADAKVEO 5 mg/kg tested positive for treatment-induced anti-crizanlizumab-tmca antibodies. In a single-dose study in healthy subjects, 1 of the 61 (1.6%) evaluable subjects tested positive for a treatment-induced anti-crizanlizumab-tmca antibodies. No treatment induced anti-crizanlizumab-tmca antibodies were detected (0 of 84 patients) in a Phase 3 study at 5 mg/kg over the 52 week time period (samples collected at baseline, Weeks 3, 15, 19, 27, and 51).

Therefore, no significant effect on pharmacokinetics or pharmacodynamics has been observed or is expected.

🧬 Mechanism of Action 57 words ▾

12.1Mechanism of Action Crizanlizumab-tmca is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Crizanlizumab can also dissociate preformed P-selectin/PSGL-1 complex. Binding P-selectin on the surface of the activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.

📦 How Supplied / Storage and Handling 92 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ADAKVEO (crizanlizumab-tmca) injection is a sterile, clear to opalescent, colorless to slightly brownish-yellow solution for intravenous infusion supplied as: Carton containing one 100 mg/10 mL (10 mg/mL) single-dose vial NDC 0078-0883-61 The single-dose vial has a rubber stopper and an aluminum cap with a plastic flip-off disk. Each 10 mL vial is made of Type 1 glass. Storage and Handling Store and transport refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do not shake. Do not freeze.

📋 Description 116 words ▾

11 DESCRIPTION Crizanlizumab-tmca is a P-selectin blocker humanized IgG2 kappa monoclonal antibody that binds to P-selectin. Crizanlizumab-tmca is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is composed of 2 heavy chains, each containing 448 amino acids, and 2 light chains each containing 218 amino acids, with a theoretical molecular weight of approximately 146 kDa.

ADAKVEO (crizanlizumab-tmca) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to slightly brownish-yellow solution for dilution and subsequent administration by intravenous infusion. Each 10 mL vial contains 100 mg crizanlizumab-tmca, citric acid (5.4 mg), polysorbate 80 (2 mg), sodium citrate (50.5 mg), sucrose (753.3 mg), and water for injection with a pH of 6.

💬 Information for Patients 99 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Infusion-Related Reactions Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.1)] . Interference With Automated Platelet Counts Advise patients to inform their healthcare provider that they are receiving ADAKVEO prior to any blood tests due to the potential interference with laboratory tests used to measure platelet counts [see Warnings and Precautions (5.2)] .

Manufactured by: Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, New Jersey 07936 US License No. 1244 © Novartis T2024-48

🧬 Pharmacokinetics 210 words ▾

12.3Pharmacokinetics The pharmacokinetics of crizanlizumab-tmca were evaluated in healthy volunteers and patients with sickle cell disease. The mean crizanlizumab-tmca C max , AUC last , or AUC inf increased disproportionally over the dose range of 0.2 to 8 mg/kg (0.04 to 1.6 times the approved recommended dosage) in healthy volunteers. In healthy volunteers administered the 5 mg/kg dose, the mean [coefficient of variation (CV%)] crizanlizumab-tmca C max , AUC last , or AUC inf were 0.16 (15.3%) mg/mL, 33.6 (12.6%) mg*hr/mL and 34.6 (13.1%) mg*hr/mL, respectively.

Distribution The mean (% CV) volume of distribution was 4.26 (25.1%) L after a single crizanlizumab-tmca 5 mg/kg intravenous infusion in healthy volunteers. Elimination The mean (% CV) terminal elimination half-life (t 1/2 ) of crizanlizumab-tmca was 10.6 (20.5%) days and the mean clearance was 11.7 (16.2%) mL/hr at 5 mg/kg doses in healthy volunteers. The mean (% CV) elimination t 1/2 of crizanlizumab-tmca was 11.4 (31.5%) days during dosing interval in patients with sickle cell disease.

Metabolism Crizanlizumab-tmca is expected to be metabolized into small peptides by catabolic pathways. Specific Populations The effect of renal or hepatic impairment on the pharmacokinetics of crizanlizumab-tmca is unknown. Drug Interaction Studies Hydroxyurea had no clinically meaningful effect on crizanlizumab-tmca pharmacokinetics in patients in clinical studies.

🧬 Pharmacodynamics 22 words ▾

12.2Pharmacodynamics ADAKVEO resulted in a dose-dependent P-selectin inhibition (measured ex vivo ) in patients with sickle cell disease and healthy volunteers.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES SUSTAIN The efficacy of ADAKVEO was evaluated in patients with sickle cell disease in SUSTAIN [NCT01895361], a 52-week, randomized, multicenter, placebo-controlled, double-blind study. A total of 198 patients with sickle cell disease, any genotype (HbSS, HbSC, HbS/beta 0 -thalassemia, HbS/beta + -thalassemia, and others), and a history of 2-10 VOCs in the previous 12 months were eligible for inclusion. Patients were randomized 1:1:1 to ADAKVEO 5 mg/kg (N = 67), ADAKVEO 2.5 mg/kg (N = 66), or placebo (N = 65) administered over a period of 30 minutes by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter for a treatment duration of 52 weeks.

Randomization was stratified by patients already receiving hydroxyurea (Y/N) and by the number of VOCs in the previous 12 months (2 to 4, 5 to 10). Patients received ADAKVEO (with or without hydroxyurea) and were allowed to receive occasional transfusions and pain medications [i.e., acetaminophen, NSAIDs, and opioids] on an as needed basis. Patients recruited in the study had complications associated with sickle cell disease and other comorbidities, including a history of acute chest syndrome (18%); pulmonary hypertension (8%); priapism (7%); psychiatric manifestations (25%), including depression and anxiety; hypertension (17%); cholelithiasis (17%).

Demographic and other baseline characteristics were similar among the treatment groups (see Table 3). Table 3: Demographics and Baseline Characteristics in SUSTAIN Study Abbreviation: VOCs, vasoocclusive crises. ADAKVEO 5 mg/kg (N = 67) Placebo (N = 65) Age (years) Median 29 26 Range 16, 63 16, 56 Gender, n (%) Male 32 (48%) 27 (42%) Female 35 (52%) 38 (59%) Ethnicity, n (%) Hispanic or Latino 20 (30%) 11 (17%) Not Hispanic or Latino 45 (67%) 53 (82%) Unknown 2 (3%) 1 (2%) Race Black or African American 60 (90%) 60 (92%) White 4 (6%) 3 (5%) Other 3 (5%) 2 (3%) Sickle cell disease genotype, n (%) HbSS 47 (70%) 47 (72%) HbSC 9 (13%) 8 (12%) HbS/beta 0 - thalassemia 3 (5%) 7 (11%) HbS/beta + - thalassemia 7 (10%) 1 (2%) Other 1 (2%) 2 (3%) Hydroxyurea use, n (%) Yes 42 (63%) 40 (62%) No 25 (37%) 25 (39%) Number of VOCs in previous 12 months, n (%) 2 to 4 42 (63%) 41 (63%) 5 to 10 25 (37%) 24 (37%) Efficacy was evaluated in the SUSTAIN study by the annual rate of VOCs leading to a healthcare visit.

A VOC leading to a healthcare visit was defined as an acute episode of pain with no cause other than a vasoocclusive event that required a medical facility visit and treatment with oral or parenteral opioids, or parenteral NSAIDs. Acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism (requiring a visit to a medical facility) were also considered VOCs. Patients with sickle cell disease who received ADAKVEO 5 mg/kg had a lower median annual rate of VOC compared to patients who received placebo (1.63 vs.

2.98) which was statistically significant (p = 0.010). Reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype and/or hydroxyurea use. Thirty-six percent (36%) of patients treated with ADAKVEO 5 mg/kg did not experience a VOC compared to 17% of placebo-treated patients.

The median time to first VOC from randomization was 4.1 months in the ADAKVEO 5 mg/kg arm compared to 1.4 months in the placebo. The main efficacy results of the pivotal study, SUSTAIN, are summarized in Table 4. Table 4: Efficacy Results From SUSTAIN Trial in Sickle Cell Disease a Abbreviations: HL, hodges-lehmann; VOCs, vasoocclusive crises. a VOCs were as assessed by an independent review committee. b Standard median. c HL median difference [95% confidence interval (CI)].

Event ADAKVEO, 5 mg/kg b (n = 67) Placebo b (n = 65) Treatment Difference Estimate c Annual rate of VOCs a 1.63

2.98HL = -1.01, (-2.00, 0.00) Annual rate of days hospitalized 4

6.87STAND The efficacy of two doses of ADAKVEO, with or without HU/HC, was evaluated, but not established, in the STAND trial [NCT… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 120 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with crizanlizumab-tmca. In the 26-week repeat-dose toxicity study, cynomolgus monkeys were administered crizanlizumab-tmca once every 4 weeks at doses up to 50 mg/kg (at least 13.1 times the human clinical exposure based on AUC in patients with sickle cell disease at 5 mg/kg once every 4 weeks). There were no adverse effects of crizanlizumab-tmca on male or female reproductive organs.

13.2Animal Toxicology and/or Pharmacology In the 26-week repeat-dose toxicity study, administration of crizanlizumab-tmca in cynomolgus monkeys at dose levels up to 50 mg/kg/dose once every 4 weeks resulted in inflammation of the vessels in multiple tissues in 2 out of 10 animals.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with crizanlizumab-tmca. In the 26-week repeat-dose toxicity study, cynomolgus monkeys were administered crizanlizumab-tmca once every 4 weeks at doses up to 50 mg/kg (at least 13.1 times the human clinical exposure based on AUC in patients with sickle cell disease at 5 mg/kg once every 4 weeks). There were no adverse effects of crizanlizumab-tmca on male or female reproductive organs.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 6/2024 PATIENT INFORMATION ADAKVEO ® (ah dak vee oh) (crizanlizumab-tmca) injection, for intravenous use What is the most important information I should know about ADAKVEO?

ADAKVEO may cause serious side effects, including: Infusion-related reactions. Infusion-related reactions may happen during or within 24 hours of receiving an infusion of ADAKVEO. Infusion-related reactions may cause pain in different areas of your body.

Your healthcare provider may slow down, temporarily stop, or completely stop your infusion with ADAKVEO if you have an infusion-related reaction. You may continue to receive ADAKVEO at a slower infusion rate and your healthcare provider may give you certain medicines before your infusion to lower your risk of getting an infusion-related reaction. Your healthcare provider should monitor you for signs and symptoms of infusion-related reactions and treat your symptoms as needed.

Tell your healthcare provider right away if you get any of the following signs or symptoms of an infusion-related reaction: pain in different areas of your body headache fever chills or shivering nausea vomiting diarrhea tiredness dizziness sweating hives itching shortness of breath or wheezing ADAKVEO may interfere with a certain blood test. Tell your healthcare providers that you are receiving ADAKVEO before having any blood tests. ADAKVEO may interfere with a laboratory test to measure your platelet counts.

See "What are possible side effects of ADAKVEO?" for more information about side effects. What is ADAKVEO? ADAKVEO is a prescription medicine used in people 16 years of age and older who have sickle cell disease to help reduce how often painful crises happen.

It is not known if ADAKVEO is safe and effective in children under 16 years of age. Before receiving ADAKVEO, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. ADAKVEO may harm your unborn baby.

Talk to your healthcare provider about the possible risk to your unborn baby if you take ADAKVEO during pregnancy. are breastfeeding or plan to breastfeed. It is not known if ADAKVEO passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment with ADAKVEO.

Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive ADAKVEO? Your healthcare provider will give you ADAKVEO as an infusion into your vein through an intravenous (IV) line over 30 minutes.

You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks. Your healthcare provider may also prescribe other treatments for you to take during treatment with ADAKVEO.

Do not stop receiving ADAKVEO unless your healthcare provider tells you to. If you miss an appointment for infusion, call your healthcare provider as soon as possible to reschedule. What are the possible side effects of ADAKVEO?

ADAKVEO may cause serious side effects. See "What is the most important information I should know about ADAKVEO?" The most common side effects of ADAKVEO include: headache joint pain nausea back pain fatigue stomach pain fever diarrhea vomiting throat pain These are not all of the possible side effects of ADAKVEO. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of ADAKVEO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ADAKVEO that is written for health professionals. What are the ingredients in ADAKVEO?

Active ingredient:… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 18 words ▾

Dosage and Administration, Recommended Dosage ( 2.1 ) 6/2024 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 6/2024

📄 Package Label / Principal Display Panel 55 words ▾

PRINCIPAL DISPLAY PANEL NDC 0078-0883-61 Rx Only ADAKVEO ® (crizanlizumab-tmca) Injection 100 mg/10 mL (10 mg/mL) For intravenous infusion after dilution. 1 Single-Dose Vial. Discard Unused Portion. NOVARTIS PRINCIPAL DISPLAY PANEL NDC 0078-0883-61 Rx Only ADAKVEO® (crizanlizumab-tmca) Injection 100 mg/10 mL (10 mg/mL) For intravenous infusion after dilution. 1 Single-Dose Vial. Discard Unused Portion. NOVARTIS

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.4K
Units reimbursed last 4 qtrs
96.5K
Gross reimbursed last 4 qtrs
$22.66M
Avg / prescription
$6,613.68
Avg / unit
$234.90
Latest quarter Q1 2026
735Rx
Fee-for-service vs managed care ⓘ
27% FFS 73% MCO
Fee-for-service · 934 Rx Managed care · 2,492 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,132 units · 14.5 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,218 units · 37.5 per 100k residents WI Michigan: 1,930 units · 19.2 per 100k residents MI New York: 5,797 units · 29.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 380 units · 9.0 per 100k residents OR Nevada: 1,440 units · 45.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 4,026 units · 32.1 per 100k residents IL Indiana: 5,437 units · 79.2 per 100k residents IN Ohio: 2,400 units · 20.4 per 100k residents OH Pennsylvania: 940 units · 7.3 per 100k residents PA New Jersey: 5,664 units · 61.0 per 100k residents NJ Massachusetts: no data reported MA California: 2,552 units · 6.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 526 units · 11.6 per 100k residents KY West Virginia: no data reported WV Virginia: 5,285 units · 60.6 per 100k residents VA Maryland: 5,854 units · 94.7 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 2,672 units · 36.0 per 100k residents AZ New Mexico: no data reported NM Kansas: 1,490 units · 50.7 per 100k residents KS Arkansas: no data reported AR Tennessee: 699 units · 9.8 per 100k residents TN North Carolina: 3,444 units · 31.8 per 100k residents NC South Carolina: 500 units · 9.3 per 100k residents SC Delaware: 280 units · 27.2 per 100k residents DE Oklahoma: no data reported OK Louisiana: 3,564 units · 77.9 per 100k residents LA Mississippi: 280 units · 9.5 per 100k residents MS Alabama: 5,998 units · 117 per 100k residents AL Georgia: 3,628 units · 32.9 per 100k residents GA D.C.: 1,648 units · 243 per 100k residents DC Hawaii: no data reported HI Texas: 9,389 units · 30.8 per 100k residents TX Florida: 17,291 units · 76.5 per 100k residents FL
Units reimbursed · per 100k residents
6.5243
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 243 /100k
2 Alabama 117 /100k
3 Maryland 94.7 /100k
4 Indiana 79.2 /100k
5 Louisiana 77.9 /100k
6 Florida 76.5 /100k
7 New Jersey 61.0 /100k
8 Virginia 60.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Adakveo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Adakveo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.16M
Claims incl. refills
110
Beneficiaries
52
Spend / beneficiary
$22,384.81
Spend / claim
$10,581.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ADAKVEO (this brand).

Top reported reactions

Sickle Cell Anaemia With Crisis360
Pain352
Back Pain150
Infusion Related Reaction131
Arthralgia95
Pain In Extremity89
Chest Pain81

Age at onset

Neonate1
Adolescent5
Adult38

Reporter sex

1,389 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization570
Death55
Disabling27
Life-threatening23
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 426 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 Novartis Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novartis Pharmaceuticals Corporation 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0791 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00078-0876-01 · Novartis 00078-0897-78 · Novartis →
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.