Peginterferon Beta-1a

The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.

• PLEGRIDY 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.ICD-10: G35

• PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY [see Warnings and Precautions ( 5.3 )] .contraindicated

For subcutaneous or intramuscular use only ( 2.1 ) Recommended dose: 125 micrograms every 14 days ( 2.1 ) PLEGRIDY dose should be titrated, starting with 63 micrograms on day 1, 94 micrograms on day 15, and 125 micrograms (full dose) on day 29 ( 2.1 ) A healthcare professional should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe or intramuscular injections using the prefilled syringe ( 2.2 ) Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms ( 2.3 ) 2.1 Dosing Information PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM). Recommended Maintenance Dosage After initial titration (see Table 1 and Table 2 ), the recommended dosage of PLEGRIDY is 125 micrograms injected every 14 days. For subcutaneous injection: Patients may rotate injection sites between the abdomen, back of the upper arm, or thigh. For intramuscular injection: Patients may rotate injection sites between the left and right thighs. Treatment Initiation Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY. Switching between the subcutaneous and intramuscular routes of administration and vice versa has not been studied.

Hepatic injury: monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuation of PLEGRIDY if hepatic injury occurs ( 5.1 ) Depression and suicide: advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider; consider discontinuation of PLEGRIDY if depression occurs ( 5.2 ) Anaphylaxis and other allergic reactions: Discontinue PLEGRIDY if a serious allergic reaction occurs ( 5.3 ) Injection site reactions: Do not administer PLEGRIDY into affected area until fully healed; if multiple lesions occur, change injection site or discontinue PLEGRIDY until healing of skin lesions ( 5.4 ) Congestive heart failure: monitor patients with pre-existing significant cardiac disease for worsening of cardiac symptoms ( 5.5 ) Decreased peripheral blood counts: monitor complete blood counts ( 5.6 ) Thrombotic Microangiopathy: Cases of thrombotic microangiopathy have been reported with interferon beta products. Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur ( 5.7 ) Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY. Discontinue PLEGRIDY if PAH is diagnosed ( 5.8 ) Autoimmune disorders: consider discontinuation of PLEGRIDY if a new autoimmune disorder occurs ( 5.9 ) 5.1 Hepatic Injury Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, have been reported with interferon beta.

The following serious adverse reactions are discussed in more detail in other sections of labeling: Hepatic Injury [see Warnings and Precautions ( 5.1 )] Depression and Suicide [see Warnings and Precautions ( 5.2 )] Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.3 )] Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.4 )] Congestive Heart Failure [see Warnings and Precautions (Section 5.5 )] Decreased Peripheral Blood Counts [see Warnings and Precautions ( 5.6 )] Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] Autoimmune Disorders [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] The most common adverse reactions in clinical trials of subcutaneous PLEGRIDY (incidence ≥10% and at least 2% more frequent on PLEGRIDY than on placebo) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of PLEGRIDY cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

Pregnancy: Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal data ( 8.1 ) Severe Renal Impairment: monitor for adverse reactions ( 8.6 ) 8.1 Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data ). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion ( see 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 observational studies reporting on pregnancies exposed to interferon beta products did not identify an association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects.

Metabolism

After single-dose or multiple-dose subcutaneous administration of PLEGRIDY to healthy subjects, serum PLEGRIDY peak concentration (C max ) and total exposure over time (area under the curve, or AUC) increased in proportion to doses from 63 to 188 micrograms. PLEGRIDY did not accumulate in the serum after multiple doses of 125 micrograms every 14 days.

• Aug 15, 2014BLABLA125499Biogen Idec Inc

1. 1Influenza Like Illness1,45911%
2. 2Injection Site Erythema1,0588.2%
3. 3Multiple Sclerosis Relapse9697.5%
4. 4Fatigue7105.5%
5. 5Headache6124.7%
6. 6Pain6034.7%
7. 7Injection Site Reaction5784.5%
8. 8Device Malfunction5714.4%
9. 9Multiple Sclerosis5584.3%
10. 10Pyrexia5184.0%
11. 11Memory Impairment4703.6%
12. 12Malaise4633.6%
13. 13Drug Delivery System Malfunction4543.5%
14. 14Injection Site Pain4443.4%
15. 15Fall4353.4%

The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Peginterferon Beta-1a as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
  Active not recruiting · Observational · 1,178 enrolled · Biogen
  NCT05688436updated 2026-06-04
• An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
  Active not recruiting · Observational · 4 enrolled · Bayer
  NCT06053749updated 2026-05-18
• Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
  Active not recruiting · Interventional · 900 enrolled · Johns Hopkins University
  NCT03500328updated 2025-10-14
• A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
  Active not recruiting · Phase 3 · Interventional · 152 enrolled · Biogen
  NCT03958877updated 2025-09-11
• Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
  Active not recruiting · Phase 4 · Interventional · 800 enrolled · The Cleveland Clinic
  NCT03535298updated 2025-08-28
• Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
  Completed · Phase 1 · Interventional · 84 enrolled · Food and Drug Administration (FDA)
  NCT04183491updated 2024-04-22
• Plegridy Satisfaction Study in Participants
  Completed · Phase 4 · Interventional · 193 enrolled · Biogen
  NCT02587065updated 2023-08-31
• Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
  Terminated · Phase 2 · Interventional · 7 enrolled · Faron Pharmaceuticals Ltd
  NCT04860518updated 2023-07-21
• Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
  Terminated · Phase 3 · Interventional · 11 enrolled · Biogen
  NCT03870763updated 2023-06-15
• Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Biogen
  NCT04079088updated 2023-06-01

Frequently asked questions

How does Peginterferon Beta-1a work?

The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.

What is Peginterferon Beta-1a used for?

According to FDA labeling, Peginterferon Beta-1a carries indications including: PLEGRIDY 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Peginterferon Beta-1a?

Peginterferon Beta-1a is classified as Interferons, Interferon beta, Unknown Cellular or Molecular Interaction.

What are the brand names for Peginterferon Beta-1a?

Peginterferon Beta-1a is marketed under brand names including Plegridy.

What are the contraindications for Peginterferon Beta-1a?

Peginterferon Beta-1a labeling lists contraindications including: PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY [see Warnings and Precautions ( 5.3 )] .. Always consult the full prescribing information and a clinician.