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Peginterferon Beta-1a

Medically reviewed by Drugs.com. Last updated on Aug 5, 2020.

Pronunciation

(peg inter FEER on BAY ta wun ay)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous [preservative free]:

Plegridy: 125 mcg/0.5 mL (0.5 mL) [contains mouse (murine) and/or hamster protein]

Plegridy Starter Pack: 63 mcg/0.5 mL & 94 mcg/0.5 mL (1 mL) [contains mouse (murine) and/or hamster protein]

Solution Prefilled Syringe, Subcutaneous:

Plegridy: 125 mcg/0.5 mL (0.5 mL) [contains mouse (murine) and/or hamster protein]

Plegridy Starter Pack: 63 mcg/0.5 mL & 94 mcg/0.5 mL (1 mL) [contains mouse (murine) and/or hamster protein]

Brand Names: U.S.

  • Plegridy
  • Plegridy Starter Pack

Pharmacologic Category

  • Biological Response Modulator
  • Interferon

Pharmacology

Interferon beta differs from the naturally occurring human protein by a single amino acid substitution and the lack of carbohydrate side chains; alters the expression and response to surface antigens and can enhance immune cell activities. Properties of interferon beta that modify biologic responses are mediated by cell surface receptor interactions; mechanism in the treatment of multiple sclerosis is unknown.

Distribution

Vd: 481 L

Metabolism

Not extensively metabolized in the liver

Excretion

Urine (major)

Time to Peak

1 to 1.5 days

Half-Life Elimination

~78 hours (multiple sclerosis patients)

Special Populations: Renal Function Impairment

Renal impairment can increase the Cmax and AUC for peginterferon beta-1a. The half-life was 53, 49, and 82 hours in patients with mild, moderate, and severe renal impairment, respectively.

Use: Labeled Indications

Multiple sclerosis, relapsing: Treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Contraindications

Hypersensitivity to natural or recombinant interferon beta or peginterferon, or any component of the formulation.

Documentation of allergenic cross-reactivity for interferons is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Current severe depression and/or suicidal ideation.

Dosing: Adult

Multiple sclerosis, relapsing: SubQ: Initial: 63 mcg on day 1; 94 mcg on day 15. Maintenance: 125 mcg every 14 days beginning on day 29. Note: Analgesics and/or antipyretics may help decrease flu-like symptoms during treatment.

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Allow prefilled syringe or pen to warm to room temperature (~30 minutes) prior to injection; do not use external heat sources (eg, hot water) to warm.

Administration

Subcutaneous: The first injection should be administered under the supervision of a health care professional.

Administer subcutaneously in the abdomen, back of the upper arm, or thigh; rotate injection sites; do not inject into area where skin is red, irritated, bruised or scarred.

Storage

Store in the closed original carton to protect from light, between 2°C and 8°C (36°F and 46°F). Do not freeze; discard if frozen.

If refrigeration is unavailable, may store between 2°C and 25°C (36°F and 77°F) for up to 30 days, protected from light. May remove from, and return to, a refrigerator if necessary. The total combined time out of refrigeration, within a temperature range of 2°C to 25°C (36°F to 77°F), should not exceed 30 days.

Drug Interactions

Cladribine: May enhance the adverse/toxic effect of Interferons (Beta). Specifically, the risk for lymphopenia may be increased. Avoid combination

Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Monitor therapy

Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Monitor therapy

Zidovudine: Interferons may enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (44%), chills (17%)

Dermatologic: Injection site pruritus (13%)

Local: Injection site reaction (66%; severe: 3%), erythema at injection site (62%), pain at injection site (15%)

Neuromuscular & skeletal: Myalgia (19%), asthenia (13%), arthralgia (11%)

Respiratory: Flu-like symptoms (47%)

Miscellaneous: Fever (45%)

1% to 10%:

Central nervous system: Increased body temperature (6%), pain (5%), hyperthermia (4%)

Dermatologic: Pruritus (4%), rash at injection site (2%)

Endocrine & metabolic: Increased serum ALT (6%; >5 x ULN: 2%), increased gamma-glutamyl transferase (3%)

Gastrointestinal: Nausea (9%), vomiting (5%)

Hematologic and oncologic: Decreased white blood cell count (<3 x 109/L: 7%)

Hepatic: Increased serum AST (4%)

Immunologic: Antibody development (to PEG: 7%; neutralizing antibodies <1%)

Local: Hematoma at injection site (3%), swelling at injection site (3%), warm sensation at injection site (3%)

<1%, postmarketing, and/or case reports: Angioedema, hepatic disease, increased serum transaminases (combined with increased serum bilirubin), severe neutropenia, severe thrombocytopenia, thrombotic microangiopathy tissue necrosis at injection site, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune disorders: Idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported. Consider discontinuing treatment in patients who develop a new autoimmune disorder.

• Bone marrow suppression: May cause decreased peripheral blood cell counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Monitor CBC with differential and platelets; monitor patients for infections, bleeding, and symptoms of anemia. Patients with preexisting myelosuppression may need more intensive monitoring.

• Hepatic effects: Severe hepatic injury, including hepatitis, autoimmune hepatitis, and severe hepatic failure (rare) have been reported; asymptomatic elevation of hepatic transaminases has also been reported and has recurred upon rechallenge. Monitor for signs and symptoms of hepatic injury.

• Hypersensitivity: Anaphylaxis and other serious allergic reactions (eg, angioedema, urticaria) may occur (rare); discontinue therapy if a serious allergic reaction occurs and institute appropriate supportive therapy.

• Injection site reactions: Injection site reactions (eg, injection site erythema, pain, pruritus, edema, necrosis) can occur with subcutaneous use. If necrosis occurs at a single site, avoid administration near the affected area; if multiple lesions occur, discontinue until healing occurs.

• Neuropsychiatric disorders: Depression, suicidal ideation and suicide have been reported; monitor for symptoms of depression and suicidal ideation; consider discontinuing treatment with development of depression or other severe psychiatric symptoms.

• Thrombotic microangiopathy: Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS), has been reported (some fatal) with interferon beta products. Cases have been reported several weeks to years after initiating therapy. Monitor for new-onset hypertension, thrombocytopenia, renal impairment; discontinue use in patients who develop TMA and manage appropriately (Hunt 2014; Mahe 2013).

Disease-related concerns:

• Cardiovascular disease: Congestive heart failure (CHF), cardiomyopathy, and cardiomyopathy with CHF may occur in patients receiving interferon beta. Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of therapy.

• Renal impairment: Use with caution in severe renal impairment; increased drug exposure may occur; monitor for adverse reactions.

• Seizures: May cause seizures; use with caution in patients with a seizure disorder.

Dosage form specific issues:

• Product variability: Due to differences in dosage, patients should not change brands of interferon.

Monitoring Parameters

CBC with differential and platelets, transaminase levels; signs and symptoms of hepatic injury, hypersensitivity, infections, bleeding, new onset autoimmune disorders, psychiatric disorders (including depression and/or suicidal ideation), new onset/worsening cardiovascular disease; adverse reactions in patients with severe renal impairment (CrCl <30 mL/minute); injection site reactions; signs/symptoms of thrombotic microangiopathy (eg, new-onset hypertension, thrombocytopenia, renal impairment).

Reproductive Considerations

In general, disease modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy except in females at high risk of MS activity (AAN [Rae-Grant 2018]). Consider use of agents other than peginterferon beta-1a for females at high risk of disease reactivation who are planning a pregnancy. Delaying pregnancy is recommended for females with persistent high disease activity; when disease modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Pregnancy Considerations

Information related to the use of peginterferon beta-1a in pregnancy is limited (MacDonald 2018). Based on available data, an increased risk of major birth defects following maternal use of interferon beta products has not been observed; data related to low birth weight or miscarriage are inconsistent.

In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Data collection to monitor pregnancy and infant outcomes following exposure to peginterferon beta-1a is ongoing. Females exposed to peginterferon beta-1a during pregnancy are encouraged to enroll in the Plegridy pregnancy registry (866-810-1462 or https://www.plegridypregnancyregistry.com).

Patient Education

What is this drug used for?

• It is used to treat MS (multiple sclerosis).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flu-like symptoms

• Nausea

• Vomiting

• Muscle pain

• Joint pain

• Injection site irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome like bruising or bleeding; loss of strength and energy; dark urine or yellow skin; pale skin; change in amount of urine passed; vision changes; change in strength on one side is greater than the other, trouble speaking or thinking, change in balance; or fever

• Depression like thoughts of suicide, anxiety, agitation, irritability, panic attacks, mood changes, behavioral changes, or confusion

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin

• Thyroid problems like change in weight without trying, anxiety, feeling restless, feeling very weak, hair thinning, depression, neck swelling, trouble focusing, inability handling heat or cold, menstrual changes, tremors, or sweating

• Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out

• Seizures

• Sore throat

• Bruising

• Bleeding

• Severe loss of strength and energy

• Injection site skin breakdown, skin discoloration, swelling, or drainage of fluid

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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