Home › NDC Lookup › Ingredients › Interferon Beta-1B › 50419-0524-05
📦image loading
(from DailyMed)

Betaseron interferon beta-1b Kit — NDC 50419-524-05 (Billing 50419-0524-05)

by Bayer HealthCare Pharmaceuticals Inc. · 5 CARTON in 1 BOX / 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE

This is a package of Betaseron interferon beta-1b Kit from Bayer HealthCare Pharmaceuticals Inc., marketed since Jul 2009 and currently FDA-listed.

NDC 50419-0524-05
🏷️ FDA NDC (as labeled) 50419-524-05 billing pads the product segment with a zero
This package
Contains1 kit in 1 carton * 1 mL in 1 vial, single-use * 1.2 mL in 1 syringe Pack sizes4 compare ↓
Also priced by: Part D plans $733.73/unit — full pricing hub ↓
Product page 50419-0524-35 Also comes in: 1 kit 50419-524-09 1 kit 50419-524-35 1 kit 50419-524-81
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 50419-524-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50419 labeler · 524 product · 05 package
Package marketed since
Aug 11, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5041952405 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50419-524-05
Product NDC 50419-524
11-digit billing NDC 50419052405
RxCUI 198360, 207059
Application # BLA103471
SPL Set ID 66311f74-0472-4fa3-848a-06002ca0def5
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-07-09
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 62403060506420
GPI class Betaseron
GCN Seq No 062602
GCN 98376
HICL code 008537
Ingredient (HICL) Interferon Beta-1B
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0E
Therapeutic class — specific (HIC3) Agents To Treat Multiple Sclerosis
AHFS code 90:04.12.00
AHFS class Interferons
FDB label name BETASERON 0.3 MG KIT
FDB brand name Betaseron
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062602
  • GCN: 98376
  • GPI-14 (Medi-Span): 62403060506420
  • HICL (First Databank): 008537
  • AHFS class code: 90:04.12.00
  • RxCUI (RxNorm): 198360
Why two NDCs? The FDA registers this code as 50419-524-05 — 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 → 50419-0524-05. 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 Interferon beta class.

Pharmacologic class Interferon beta
Drug family (ATC) Interferons
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 BETASERON 0.3 MG KIT Ingredient Interferon Beta-1B
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 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 · Q2 2026 $733.73 —
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
50419-0524-05 You're viewing this 5 CARTON in 1 BOX / 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE — — 2009-08-11 — Active
50419-0524-09 50419-524-09 1 CARTON in 1 BOX / 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE — — 2009-08-11 — Active
50419-0524-35 50419-524-35 Main listing 14 CARTON in 1 BOX / 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE $725.98 / ea — 2009-08-11 — Active
50419-0524-81 50419-524-81 14 CARTON in 1 BOX / 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE — — 2016-09-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 carton in 1 box / 1 kit in 1 carton * 1 ml in 1 vial, single-use * 1.2 ml in 1 syringe.
What NDC number is used to bill for this package of Betaseron interferon beta-1b Kit?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betaseronthis 50419-0524-05 Bayer 1 kit — — 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

🏛️
1993
First FDA approval
Jul 1993
📍
2026
Currently FDA-listed
33 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Betaseroninterferon beta-1b Extaviainterferon beta-1b
🔒 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.
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerBayer HealthCare Pharmaceuticals Inc.
FDA applicationBLA103471 (BLA)
Labeler code50419
First marketedJul 2009
Product typeHuman Prescription Drug
Portfolio62 products on file

More NDCs from Bayer HealthCare Pharmaceuticals Inc. labeler code 50419

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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

1 INDICATIONS AND USAGE BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • For subcutaneous use only ( 2.1 ) • The recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. ( 2.1 ) • Reconstitute lyophilized powder with supplied diluent ( 2.2 )

2.1Dosing Information The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six-week period to the recommended dose of 0.25 mg (1 mL) every other day (see Table 1 ). Table 1: Schedule for Dose Titration BETASERON Dose Dosed every other day, subcutaneously Percentage of recommended dose Volume Weeks 1-2 0.0625 mg 25% 0.25 mL Weeks 3-4 0.125 mg 50% 0.5 mL Weeks 5-6 0.1875 mg 75% 0.75 mL Week 7 and thereafter 0.25 mg 100% 1 mL If a dose of BETASERON is missed, then it should be taken as soon as the patient remembers or is able to take it.

The patient should not take BETASERON on two consecutive days. The next injection should be taken about 48 hours (two days) after that dose. If the patient accidentally takes more than their prescribed dose, or takes it on two consecutive days, they should be instructed to call their healthcare provider immediately.

2.2Reconstitution of the Lyophilized Powder (a) Prior to reconstitution, verify that the vial containing lyophilized BETASERON is not cracked or damaged. Do not use cracked or damaged vials. (b) To reconstitute lyophilized BETASERON for injection, attach the pre-filled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the BETASERON vial using the vial adapter.

(c) Slowly inject 1.2 mL of diluent into the BETASERON vial. (d) Gently swirl the vial to dissolve the lyophilized powder completely; do not shake . Foaming may occur during reconstitution or if the vial is swirled or shaken too vigorously.

If foaming occurs, allow the vial to sit undisturbed until the foam settles. (e) 1 mL of reconstituted BETASERON solution contains 0.25 mg of interferon beta-1b. (f) After reconstitution, if not used immediately, refrigerate the reconstituted BETASERON solution at 35°F to 46°F (2°C to 8°C) and use within three hours.

Do not freeze .

2.3Important Administration Instructions (a) BETASERON is intended for use under the guidance and supervision of a physician. If patients or caregivers are to administer BETASERON, train them in the proper technique for self‐administering subcutaneous injections using the prefilled syringe or the optional injection device. The BETACONNECT autoinjector has three adjustable injection depth settings; the healthcare provider should determine the proper depth setting and injection technique.

Use only the syringes in the BETASERON packaging with the BETACONNECT autoinjector. The initial BETASERON injection should be performed under the supervision of an appropriately qualified healthcare provider. Users should demonstrate competency in all aspects of the BETASERON injection prior to independent use.

If a patient is to self‐administer BETASERON, the physical and cognitive ability of that patient to self‐administer and properly dispose of syringes should be assessed. Patients with severe neurological deficits should not self‐administer injections without assistance from a trained caregiver. Appropriate instruction for self‐injection or injection by another person should be provided to the patient or their caregiver, including careful review of the BETASERON Medication Guide, the prefilled syringe Instructions for Use, and the BETACONNECT autoinjector Instructions for Use that accompanies the product.

(b) Visually inspect the reconstituted BETASERON solution before use; discard if it contains particulate matter or is discolored. (c) Keeping the syringe and vial adapter in place, turn the assembly over so that the vial is on top. Withdraw the appropriate dose of BETASERON solution.

Remove the vial from the vial adapter before injecting BETASERON. (d) Use safe disposal procedures for nee… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 0.3 mg lyophilized powder in a single-dose vial for reconstitution. For injection: 0.3 mg of lyophilized powder in a single-dose vial for reconstitution ( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation. History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hepatic Injury: Monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing BETASERON if serious hepatic injury occurs. ( 5.1 , 5.11 ) • Anaphylaxis and Other Allergic Reactions: Discontinue if anaphylaxis occurs. ( 5.2 ) • Depression and Suicide: Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of BETASERON if depression occurs.

( 5.3 ) • Congestive Heart Failure (CHF): Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of BETASERON if worsening of CHF occurs. ( 5.4 ) • Injection Site Reactions Including Necrosis: Do not administer BETASERON into affected area until fully healed; if multiple lesions occur, change injection site or discontinue BETASERON until healing of skin lesions. ( 5.5 ) • Leukopenia: Monitor complete blood count.

( 5.6 , 5.12 ) • Thrombotic Microangiopathy: Cases of thrombotic microangiopathy (TMA) have been reported. Discontinue BETASERON if clinical symptoms and laboratory findings consistent with TMA occur and a relationship to BETASERON is suspected. ( 5.7 ) • Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including BETASERON.

Discontinue BETASERON if PAH is diagnosed. ( 5.8 ) • Flu-like Symptom Complex: Consider analgesics and/or antipyretics on injection days. ( 5.9 ) • Drug-induced Lupus Erythematosus: Cases of drug-induced lupus erythematosus have been reported.

Discontinue BETASERON if patients develop new characteristic signs and symptoms. ( 5.11 )

5.1Hepatic Injury Severe hepatic injury including cases of hepatic failure, some of which have been due to autoimmune hepatitis, has been rarely reported in patients taking BETASERON. In some cases, these events have occurred in the presence of other drugs or comorbid medical conditions that have been associated with hepatic injury. Consider the potential risk of BETASERON used in combination with known hepatotoxic drugs or other products (eg, alcohol) prior to BETASERON administration, or when adding new agents to the regimen of patients already on BETASERON.

Monitor patients for signs and symptoms of hepatic injury. Consider discontinuing BETASERON if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice. Asymptomatic elevation of serum transaminases is common in patients treated with BETASERON.

In controlled clinical trials, elevations of SGPT to greater than five times baseline value were reported in 12% of patients receiving BETASERON (compared to 4% on placebo), and increases of SGOT to greater than five times baseline value were reported in 4% of patients receiving BETASERON (compared to 1% on placebo), leading to dose-reduction or discontinuation of treatment in some patients [see Adverse Reactions ( 6.1 )] . Monitor liver function tests [see Warnings and Precautions ( 5.12 )].

5.2Anaphylaxis and Other Allergic Reactions Anaphylaxis has been reported as a rare complication of BETASERON use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria [see Adverse Reactions ( 6.1 )] . Discontinue BETASERON if anaphylaxis occurs.

5.3Depression and Suicide Depression and suicide have been reported to occur with increased frequency in patients receiving interferon beta products, including BETASERON. Advise patients to report any symptom of depression and/or suicidal ideation to their healthcare provider. If a patient develops depression, discontinuation of BETASERON therapy should be considered.

In randomized controlled clinical trials, there were three suicides and eight suicide attempts among the 1532 patients on BETASERON compared to one suicide and four suicide attempts among 965 patients on placebo.

5.4Congestive Heart Failure Monitor patients with pre-existing congestive heart… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more details in other sections of labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.2 )] • Depression and Suicide [see Warnings and Precautions ( 5.3 )] • Congestive Heart Failure [see Warnings and Precautions ( 5.4 )] • Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.5 )] • Leukopenia [see Warnings and Precautions ( 5.6 )] • Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] • Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] • Flu-like Symptom Complex [see Warnings and Precautions ( 5.9 )] • Seizures [see Warnings and Precautions ( 5.10 )] • Drug Induced Lupus Erythematosus [see Warnings and Precautions ( 5.11 )] In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on BETASERON than on placebo) were: injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals at 1-888-842-2937 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 and over varying lengths of time, adverse reaction rates observed in the clinical trials of BETASERON cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. Among 1407 patients with MS treated with BETASERON 0.25 mg every other day (including 1261 patients treated for greater than one year), the most commonly reported adverse reactions (at least 5% more frequent on BETASERON than on placebo) were injection site reaction, lymphopenia, flu-like symptoms, myalgia leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of BETASERON, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction symptom) were depression, flu-like symptom complex, injection site reactions, leukopenia, increased liver enzymes, asthenia, hypertonia, and myasthenia. Table 2 enumerates adverse reactions and laboratory abnormalities that occurred among patients treated with 0.25 mg of BETASERON every other day by subcutaneous injection in the pooled placebo-controlled trials (Study 1-4) at an incidence that was at least 2% more than that observed in the placebo-treated patients [see Clinical Studies ( 14 )] .

Table 2: Adverse Reactions and Laboratory Abnormalities in Patients with MS in Pooled Studies 1, 2, 3, and 4 Adverse Reaction Placebo (N=965) BETASERON (N=1407) Blood and lymphatic system disorders Lymphocytes count decreased (<1500/mm3) 66% 86% Absolute neutrophil count decreased (<1500/mm3) 5% 13% White blood cell count decreased (<3000/mm3) 4% 13% Lymphadenopathy 3% 6% Nervous system disorders Headache 43% 50% Insomnia 16% 21% Incoordination 15% 17% Vascular disorders Hypertension 4% 6% Respiratory, thoracic and mediastinal disorders Dyspnea 3% 6% Gastrointestinal disorders Abdominal pain 11% 16% Hepatobiliary disorders Alanine aminotransferase increased (SGPT > 5 times baseline) 4% 12% Aspartate aminotransferase increased (SGOT > 5 times baseline) 1% 4% Skin and subcutaneous tissue disorders Rash 15% 21% Skin disorder 8% 10% Musculoskeletal and connective tissue disorders Hypertonia 33% 40% Myalgia 14% 23% Renal and urinary disorders Urinary urgency 8% 11% Reproductive system and breast disorders Metrorrhagia 7% 9% Impotence 6% 8% General disorders and administration site conditions Injection site reaction "Injection site reaction" comprises all adverse reactions occur… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose ( see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data The majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects Animal Data When BETASERON (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related abortifacient effect was observed.

The low-effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m 2 ) basis. A no-effect dose for embryo-fetal developmental toxicity in rhesus monkeys was not established.

8.2Lactation Risk Summary There are no data on the presence of BETASERON in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BETASERON and any potential adverse effects on the breastfed child from BETASERON or from the underlying maternal condition.

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of BETASERON did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

🤰 Pregnancy 211 words ▾

8.1Pregnancy Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose ( see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data The majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects Animal Data When BETASERON (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related abortifacient effect was observed.

The low-effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m 2 ) basis. A no-effect dose for embryo-fetal developmental toxicity in rhesus monkeys was not established.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of BETASERON did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.

12.2Pharmacodynamics Interferons (IFNs) are a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents. Three major types of interferons have been defined: type 1 (IFN-alpha, beta, epsilon, kappa and omega), type II (IFN–gamma) and type III (IFN-lambda). Interferon-beta is a member of the type I subset of interferons.

The type I interferons have considerably overlapping but also distinct biologic activities. The bioactivities of all IFNs, including IFN-beta, are induced via their binding to specific receptors on the membranes of human cells. Differences in the bioactivities induced by the three major subtypes of IFNs likely reflect differences in the signal transduction pathways induced by signaling through their cognate receptors.

Interferon beta-1b receptor binding induces the expression of proteins that are responsible for the pleiotropic bioactivities of interferon beta-1b. A number of these proteins (including neopterin, β2-microglobulin, MxA protein, and IL-10) have been measured in blood fractions from BETASERON-treated patients and BETASERON-treated healthy volunteers. Immunomodulatory effects of interferon beta-1b include the enhancement of suppressor T cell activity, reduction of pro-inflammatory cytokine production, down-regulation of antigen presentation, and inhibition of lymphocyte trafficking into the central nervous system.

It is not known if these effects play an important role in the observed clinical activity of BETASERON in multiple sclerosis (MS).

12.3Pharmacokinetics Because serum concentrations of interferon beta-1b are low or not detectable following subcutaneous administration of 0.25 mg or less of BETASERON, pharmacokinetic information in patients with MS receiving the recommended dose of BETASERON is not available. Following single and multiple daily subcutaneous administrations of 0.5 mg BETASERON to healthy volunteers (N=12), serum interferon beta-1b concentrations were generally below 100 IU/mL. Peak serum interferon beta-1b concentrations occurred between one to eight hours, with a mean peak serum interferon concentration of 40 IU/mL.

Bioavailability, based on a total dose of 0.5 mg BETASERON given as two subcutaneous injections at different sites, was approximately 50%. After intravenous administration of BETASERON (0.006 mg to 2 mg), similar pharmacokinetic profiles were obtained from healthy volunteers (N=12) and from patients with diseases other than MS (N=142). In patients receiving single intravenous doses up to 2 mg, increases in serum concentrations were dose proportional.

Mean serum clearance values ranged from 9.4 mL/min•kg-1 to 28.9 mL/min•kg-1 and were independent of dose. Mean terminal elimination half-life values ranged from 8 minutes to 4.3 hours and mean steady-state volume of distribution values ranged from

0.25 L/kg to

2.88L/kg. Three-times-a-week intravenous dosing for two weeks resulted in no accumulation of interferon beta-1b in sera of patients. Pharmacokinetic parameters after single and multiple intravenous doses of BETASERON were comparable.

Following every other day subcutaneous administration of 0.25 mg BETASERON in healthy volunteers, biologic response marker levels (neopterin, β2- microglobulin, MxA protein, and the immunosuppressive cytokine, IL-10) increased significantly above baseline six-twelve hours after the first BETASERON dose. Biologic response marker levels peaked between 40 and 124 hours and remained elevated above baseline throughout the seven-day (168-hour) study. The relationship between serum interferon beta-1b levels or induced biologic response marker levels and the clinical effects of interferon beta-1b in multiple sclerosis is unknown.

Drug Interaction Studies No formal drug interaction studies have been conducted with BETAS… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.

📦 How Supplied / Storage and Handling 154 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BETASERON is supplied as a lyophilized powder in a clear glass, single-dose vial (3 mL capacity). Each carton contains 5 single-dose cartons (NDC 50419-524-05) or 14 single-dose cartons (NDC 50419-524-35). Each single-dose carton contains: A single-dose vial containing 0.3 mg BETASERON (interferon beta-1b) A pre-filled single-dose syringe containing 1.2 mL diluent (Sodium Chloride, 0.54% solution) A vial adapter with a 30-gauge needle attached 2 alcohol prep pads The optional BETACONNECT autoinjector is not supplied with BETASERON, but is available for patients with a prescription for BETASERON by calling the BETAPLUS patient support program toll-free number at 1-800-788-1467.

16.2Stability and Storage BETASERON and the diluent are for single-dose only. Discard unused portions. The reconstituted product contains no preservative. Store BETASERON vials between 36°F to 86°F (2°C to 30°C). After reconstitution, if not used immediately, refrigerate the reconstituted solution and use within three hours. Do not freeze.

📋 Description 189 words ▾

11 DESCRIPTION Interferon beta-1b is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17.

Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of BETASERON is approximately 32 million international units (IU)/mg interferon beta-1b.

Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers.

Lyophilized BETASERON is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution). Albumin (Human) USP and Mannitol, USP (15 mg each/vial) are added as stabilizers.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients to carefully read the supplied BETASERON Medication Guide and caution patients not to change the BETASERON dose or schedule of administration without medical consultation. Instruction on Self-Injection Technique and Procedures Provide appropriate instruction for reconstitution of BETASERON and methods of self-injection, including careful review of the BETASERON Medication Guide.

Instruct patients in the use of aseptic technique when administering BETASERON. Tell patients not to re-use needles or syringes and instruct patients on safe disposal procedures. Advise patients of the importance of rotating areas of injection with each dose, to minimize the likelihood of severe injection site reactions, including necrosis or localized infection [see Medication Guide] .

Hepatic Injury Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of BETASERON. Inform patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their healthcare provider [see Warnings and Precautions ( 5.1 )] . Anaphylaxis and Other Allergic Reactions Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur [see Warnings and Precautions ( 5.2 )] .

Depression and Suicide Advise patients that depression and suicidal ideation have been reported during the use of BETASERON. Inform patients of the symptoms of depression or suicidal ideation, and instruct patients to report them immediately to their healthcare provider [see Warnings and Precautions ( 5.3 )] . Congestive Heart Failure Advise patients that worsening of pre-existing congestive heart failure have been reported in patients using BETASERON.

Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their healthcare provider [see Warnings and Precautions ( 5.4 )] . Injection Site Reactions Including Necrosis Advise patients that injection site reactions occur in most patients treated with BETASERON, and that injection site necrosis may occur at one or multiple sites. Instruct patients to promptly report any break in the skin, which may be associated with blue-black discoloration, swelling, or drainage of fluid from the injection site, prior to continuing their BETASERON therapy [see Warnings and Precautions ( 5.5 )] .

Pulmonary Arterial Hypertension Inform patients that PAH has occurred in patients treated with interferon beta products, including BETASERON. Instruct patients to promptly report any new symptoms such as new or increasing fatigue or shortness of breath to their healthcare provider [see Warnings and Precautions (5.8)]. Flu-like Symptom Complex Inform patients that flu-like symptoms are common following initiation of therapy with BETASERON, and that concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with BETASERON use [see Warnings and Precautions ( 5.9 ) and Dosage and Administration ( 2.4 )] .

Seizures Instruct patients to report seizures immediately to their healthcare provider [see Warnings and Precautions ( 5.10 )] . Pregnancy Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant [see Use in Specific Populations ( 8.1 )].

💬 Medication Guide ~3 min read ▾

Medication Guide Medication Guide BETASERON (bay-ta-seer-on) interferon beta-1b (in-ter-feer-on beta-one-be) What is the most important information I should know about BETASERON? BETASERON can cause serious side effects, including: • liver problems including liver failure. Symptoms of liver problems may include: • yellowing of your eyes • itchy skin • nausea or vomiting • feeling very tired • flu-like symptoms • bruising easily or bleeding problems Your healthcare provider will do blood tests to check for these problems while you take BETASERON. • serious allergic reactions.

Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps. • depression or suicidal thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • new or worse depression • new or worse anxiety • trouble sleeping (insomnia) • acting aggressive, being angry, or violent • acting on dangerous impulses • hallucinations • other unusual changes in behavior or mood What is BETASERON?

BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is similar to certain interferon proteins that are produced in the body. It is not known if BETASERON is safe and effective in children.

Who should not take BETASERON? Do not take BETASERON if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. See the end of this leaflet for a complete list of ingredients in BETASERON.

What should I tell my healthcare provider before taking BETASERON? Before you take BETASERON, tell your healthcare provider if you: • have or have had depression (sinking feeling or sadness), anxiety (feeling uneasy, nervous, or fearful for no reason) or trouble sleeping • have or have had liver problems • have or have had blood problems such as bleeding or bruising easily, low red blood cells (anemia) or low white blood cells • have or have had seizures • have or have had heart problems • are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed.

It is not known if BETASERON passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take BETASERON? • See the Instructions for Use at the end of this Medication Guide for complete information on how to use BETASERON. • BETASERON is given by injection under your skin (subcutaneous injection) every other day. • Take BETASERON exactly as your healthcare provider tells you to take it. • If your healthcare provider feels that you or someone else may give you the injections then you or the other person should be trained by your healthcare provider in how to give an injection. • Do not try to give yourself or have another person give you injections until you or both of you understand and are comfortable with how to prepare your dose and give the injection. • You may be started on a lower dose when you first start taking BETASERON.

Your healthcare provider will tell you what dose of BETASERON to use. • Your healthcare provider may change your dose of BETASERON. You should not change your dose without talking to your healthcare provider. • If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Your next injection should be taken about 48 hours (2 days) after that dose.

Do not take BETASERON on 2 consecutive days. If you acciden… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Because serum concentrations of interferon beta-1b are low or not detectable following subcutaneous administration of 0.25 mg or less of BETASERON, pharmacokinetic information in patients with MS receiving the recommended dose of BETASERON is not available. Following single and multiple daily subcutaneous administrations of 0.5 mg BETASERON to healthy volunteers (N=12), serum interferon beta-1b concentrations were generally below 100 IU/mL. Peak serum interferon beta-1b concentrations occurred between one to eight hours, with a mean peak serum interferon concentration of 40 IU/mL.

Bioavailability, based on a total dose of 0.5 mg BETASERON given as two subcutaneous injections at different sites, was approximately 50%. After intravenous administration of BETASERON (0.006 mg to 2 mg), similar pharmacokinetic profiles were obtained from healthy volunteers (N=12) and from patients with diseases other than MS (N=142). In patients receiving single intravenous doses up to 2 mg, increases in serum concentrations were dose proportional.

Mean serum clearance values ranged from 9.4 mL/min•kg-1 to 28.9 mL/min•kg-1 and were independent of dose. Mean terminal elimination half-life values ranged from 8 minutes to 4.3 hours and mean steady-state volume of distribution values ranged from

0.25 L/kg to

2.88L/kg. Three-times-a-week intravenous dosing for two weeks resulted in no accumulation of interferon beta-1b in sera of patients. Pharmacokinetic parameters after single and multiple intravenous doses of BETASERON were comparable.

Following every other day subcutaneous administration of 0.25 mg BETASERON in healthy volunteers, biologic response marker levels (neopterin, β2- microglobulin, MxA protein, and the immunosuppressive cytokine, IL-10) increased significantly above baseline six-twelve hours after the first BETASERON dose. Biologic response marker levels peaked between 40 and 124 hours and remained elevated above baseline throughout the seven-day (168-hour) study. The relationship between serum interferon beta-1b levels or induced biologic response marker levels and the clinical effects of interferon beta-1b in multiple sclerosis is unknown.

Drug Interaction Studies No formal drug interaction studies have been conducted with BETASERON.

🧬 Pharmacodynamics 216 words ▾

12.2Pharmacodynamics Interferons (IFNs) are a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents. Three major types of interferons have been defined: type 1 (IFN-alpha, beta, epsilon, kappa and omega), type II (IFN–gamma) and type III (IFN-lambda). Interferon-beta is a member of the type I subset of interferons.

The type I interferons have considerably overlapping but also distinct biologic activities. The bioactivities of all IFNs, including IFN-beta, are induced via their binding to specific receptors on the membranes of human cells. Differences in the bioactivities induced by the three major subtypes of IFNs likely reflect differences in the signal transduction pathways induced by signaling through their cognate receptors.

Interferon beta-1b receptor binding induces the expression of proteins that are responsible for the pleiotropic bioactivities of interferon beta-1b. A number of these proteins (including neopterin, β2-microglobulin, MxA protein, and IL-10) have been measured in blood fractions from BETASERON-treated patients and BETASERON-treated healthy volunteers. Immunomodulatory effects of interferon beta-1b include the enhancement of suppressor T cell activity, reduction of pro-inflammatory cytokine production, down-regulation of antigen presentation, and inhibition of lymphocyte trafficking into the central nervous system.

It is not known if these effects play an important role in the observed clinical activity of BETASERON in multiple sclerosis (MS).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The clinical effects of BETASERON were studied in four randomized, multicenter, double-blind, placebo-controlled studies in patients with multiple sclerosis (Studies 1, 2, 3, and 4). Patients with Relapsing-Remitting Multiple Sclerosis The effectiveness of BETASERON in relapsing-remitting MS (RRMS) was evaluated in a double-blind, multiclinic, randomized, parallel, placebo controlled clinical study of two years duration (Study 1). The study enrolled MS patients, aged 18 to 50, who were ambulatory [Kurtzke Expanded Disability Status Scale (EDSS) of ≤ 5.5 – score 5.5 is ambulatory for 100 meters, disability precludes full daily activities], exhibited a relapsing-remitting clinical course, met Poser's criteria for clinically definite and/or laboratory supported definite MS and had experienced at least two exacerbations over two years preceding the trial without exacerbation in the preceding month.

The EDSS score is a method of quantifying disability in patients with MS and ranges from 0 (normal neurologic exam) to 10 (death due to MS). Patients who had received prior immunosuppressant therapy were excluded. An exacerbation was defined as the appearance of a new clinical sign/symptom or the clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persisted for a minimum of 24 hours.

Patients selected for study were randomized to treatment with either placebo (N=123), 0.05 mg of BETASERON (N=125), or 0.25 mg of BETASERON (N=124) self-administered subcutaneously every other day. Outcome based on the 372 randomized patients was evaluated after two years. Patients who required more than three 28-day courses of corticosteroids were removed from the study.

Minor analgesics (acetaminophen, codeine), antidepressants, and oral baclofen were allowed ad libitum, but chronic nonsteroidal anti-inflammatory drug (NSAID) use was not allowed. The primary protocol-defined outcome measures were 1) frequency of exacerbations per patient and 2) proportion of exacerbation free patients. A number of secondary clinical and magnetic resonance imaging (MRI) measures were also employed.

All patients underwent annual T2 MRI imaging and a subset of 52 patients at one site had MRIs performed every six weeks for assessment of new or expanding lesions. The study results are shown in Table 3 . Table 3: Two-Year RRMS Study Results of Primary and Secondary Clinical Outcomes (Study 1) Efficacy Parameters Treatment Groups Statistical Comparisons p-value Primary End Points Placebo (N=123) BETASERON 0.05 mg (N=125) BETASERON 0.25 mg (N=124) Placebo vs 0.05 mg 0.05 mg vs 0.25 mg Placebo vs 0.25 mg Annual exacerbation rate 1.31 1.14 0.9 0.005 0.113 0.0001 Proportion of exacerbation-free patients 14 exacerbation free patients (0 from placebo, six from 0.05 mg, and eight from 0.25 mg) dropped out of the study before completing six months of therapy.

These patients are excluded from this analysis. 16% 18% 25% 0.609 0.288 0.094 Exacerbation frequency per patient 0 1 2 3 4 > 5 20% 32% 20% 15% 15% 21% 22% 31% 28% 15% 7% 16% 29% 39% 17% 14% 9% 8% 0.151 0.077 0.001 Secondary Endpoints Sequelae and Functional Neurologic Status, both required by protocol, were not analyzed individually but are included as a function of the EDSS. Median number of months to first on-study exacerbation 5 6 9 0.299 0.097

0.01Rate of moderate or severe exacerbations per year 0.47 0.29 0.23 0.02 0.257 0.001 Mean number of moderate or severe exacerbation days per patient 44 33 20 0.229 0.064 0.001 Mean change in EDSS score EDSS scores range from 1-10, with higher scores reflecting greater disability. at endpoint 0.21 0.21 -0.07 0.995 0.108 0.144 Mean change in Scripps score Scripps neurologic rating scores range from 0-100, with smaller scores reflecting greater disability. at endpoint -0.53 -0.5 0.66 0.641 0.051 0.126 Median duration in days per exacerbation 36 33 36 ND ND = Not done.

ND ND % change in mean MRI lesion area at endpoint 21.4%… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 143 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis BETASERON has not been tested for its carcinogenic potential in animals. Mutagenesis BETASERON was not genotoxic in the in vitro Ames bacterial test or the in vitro chromosomal aberration assay in human peripheral blood lymphocytes. BETASERON treatment of mouse BALBc-3T3 cells did not result in increased transformation frequency in an in vitro model of tumor transformation.

Impairment of Fertility Administration of BETASERON (doses of up to 0.33 mg/kg/day) to normally cycling female rhesus monkeys had no apparent adverse effects on either menstrual cycle duration or associated hormonal profiles (progesterone and estradiol) when administered over three consecutive menstrual cycles. The highest dose tested is approximately 30 times the recommended human dose of 0.25 mg on a body surface area (mg/m2) basis. The potential for other effects on fertility or reproductive performance was not evaluated.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 140 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis BETASERON has not been tested for its carcinogenic potential in animals. Mutagenesis BETASERON was not genotoxic in the in vitro Ames bacterial test or the in vitro chromosomal aberration assay in human peripheral blood lymphocytes. BETASERON treatment of mouse BALBc-3T3 cells did not result in increased transformation frequency in an in vitro model of tumor transformation.

Impairment of Fertility Administration of BETASERON (doses of up to 0.33 mg/kg/day) to normally cycling female rhesus monkeys had no apparent adverse effects on either menstrual cycle duration or associated hormonal profiles (progesterone and estradiol) when administered over three consecutive menstrual cycles. The highest dose tested is approximately 30 times the recommended human dose of 0.25 mg on a body surface area (mg/m2) basis. The potential for other effects on fertility or reproductive performance was not evaluated.

📖 Instructions for Use ~3 min read ▾

Instructions for Use BETASERON (bay-ta-seer-on) interferon beta-1b (in-ter-feer-on beta-one-be) Read the Instructions for Use that come with your BETASERON before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Before you use BETASERON for the first time, make sure your healthcare provider shows you the right way to use it. Supplies needed for your BETASERON Injection (See Figure A). • 1 single-dose carton containing: o A vial of BETASERON o A pre-filled diluent syringe o A vial adapter with a 30-gauge needle attached (in the blister pack) o 2 alcohol prep pads Step 1: Preparing for Your BETASERON Injection • Place the supplies you will need on a clean, flat surface in a well-lit area. • Check the expiration date on the single-dose carton to make sure that it has not expired.

Do not use it if the medication has expired. • Wash your hands thoroughly with soap and water. • Open the single-dose carton and take out all the contents. Make sure the blister pack containing the vial adapter is sealed. Check to make sure the plastic cap on the pre-filled diluent syringe is firmly attached. • Remove the tray from the single-dose carton and place it on a flat surface. • Place the BETASERON vial in the well (vial holder) and place the pre-filled diluent syringe in the U-shaped trough (See Figure B).

Step 2: Mixing BETASERON • Remove the BETASERON vial from the well (vial holder) and take the cap off the vial. • Place the vial back into the well (vial holder). • Use an alcohol prep pad to clean the top of the vial. Move the alcohol prep pad in 1 direction. Leave the alcohol prep pad on top of the vial. • Peel the label off the blister pack with the vial adapter in it.

The vial adapter is sterile. Do not remove or touch the vial adapter. • Remove the alcohol prep pad from the top of the BETASERON vial. Pick up the vial adapter in the blister pack.

Turn over the blister pack keeping the vial adapter inside. Put the adapter on top of the BETASERON vial. Push down on the adapter until it pierces the rubber top of the BETASERON vial and snaps in place (See Figure C) .

Remove the blister packaging from the vial adapter. • Twist the plastic cap from the pre-filled diluent syringe. Throw away the plastic cap (See Figure D) . • Keep the vial adapter attached to the vial and remove the vial from the well (vial holder). Be careful not to pull the vial adapter off the top of the vial. • Connect the pre-filled diluent syringe to the vial adapter by turning clockwise until resistance is felt and the attachment is secure.

This forms the syringe assembly (See Figure E). • Slowly push the plunger of the pre-filled diluent syringe all the way in. This will transfer all of the liquid from the syringe into the BETASERON vial (See Figure F) . The plunger may return to its original position after you release it. • Gently swirl the vial to completely dissolve the white powder of BETASERON.

Do not shake. Shaking and even gentle mixing can cause foaming of the medicine. If there is foam, let the vial sit until the foam settles before using it. • After the powder dissolves, look closely at the solution in the vial.

Do not use the solution if it is cloudy or contains particles. It should be clear and colorless. • Do not use cracked or damaged BETASERON vials. If your vial is cracked or damaged, get a new single-dose carton containing a BETASERON vial, pre-filled diluent syringe, vial adapter and 2 alcohol prep pads.

Repeat the steps to prepare your BETASERON dose. • Contact BETAPLUS, the BETASERON patient support program, at 1-800-788-1467 to obtain a replacement product. Step 3: Preparing the Injection You have completed the steps to prepare your BETASERON and are ready for the injection. The injection should be given immediately after mixing and allowing any foam in the solution to settle.

If you must wait to give… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 76 words ▾

The principal display panel is a representative example and may not reflect the most current label. NDC 50419-524-01 Rx only BETASERON (interferon beta-1b) For injection 0.3 mg per vial For subcutaneous injection No U.S. standard of potency Single use carton Contains: • 1 single-use vial for reconstitution • 1 pre-filled single-use sodium chloride 0.54% solution diluent syringe • 1 vial adapter with a 30 gauge needle attached • 2 alcohol prep pads Figure Betaseron Single-Use PDP

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 kit50419-0524-35 557 Rx · $5,371,244
1 kit this page50419-0524-05 No Medicaid data
1 kit50419-0524-09 No Medicaid data
1 kit50419-0524-81 No Medicaid data
Drug total (last 4 qtrs): 557 Rx · 7,907 units · $5,371,244 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Betaseron — 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 Betaseron. 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
$18.79M
Claims incl. refills
1.8K
Beneficiaries
699
Spend / beneficiary
$26,886.36
Spend / claim
$10,666.04
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.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 Bayer HealthCare Pharmaceuticals 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 3 other package presentations of this same product, including 1 kit (50419-0524-09), 1 kit (50419-0524-35), 1 kit (50419-0524-81). 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?
Bayer HealthCare Pharmaceuticals 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.
← 50419-0491-04 · Bayer 50419-0540-01 · Bayer →
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.