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Peginterferon Beta-1a

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:

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
  • Immunomodulator, Systemic
  • 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: Treatment of patients with relapsing forms of multiple sclerosis

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.

Dosing: Adult

Multiple sclerosis: 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.

Missed doses: Canadian labeling:

≥7 days until next scheduled dose: Administer dose immediately then continue with next scheduled dose

<7 days until next scheduled dose: Administer dose then begin new 2 week dosing schedule starting from day missed dose is administered

Do not administer 2 doses within 7 days of each other

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

US labeling: There are no dosage adjustments provided in the manufacturer's labeling; use with caution in severe renal impairment (CrCl <30 mL/minute).

Canadian labeling:

Mild to severe impairment: No dosage adjustment necessary.

End-stage renal disease (ESRD): No dosage adjustment necessary.

Hemodialysis: Partially removed (~24%) by hemodialysis

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

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: 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

Theophylline Derivatives: Interferons may decrease the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. 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% (Limited to important or life-threatening): Angioedema, hepatic disease, 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).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Until information is available, consideration should be given to discontinuing treatment prior to pregnancy (Buraga 2014; Coyle 2012; Houtchens 2013; Lu 2013).

A pregnancy registry has been established to monitor outcomes of women exposed to peginterferon beta-1a during pregnancy (866-810-1462 or https://www.plegridypregnancyregistry.com/).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flu-like symptoms, nausea, vomiting, muscle pain, or joint pain. Have patient report immediately to prescriber signs of infection, signs of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (bruising or bleeding; feeling very tired or weak; dark urine or yellow skin or eyes; pale skin; change in the 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), signs of depression (suicidal ideation, anxiety, emotional instability, or illogical thinking), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any bleeding that is very bad or that will not stop), signs of thyroid problems (change in weight without trying, feeling nervous and excitable, feeling restless, feeling very weak, hair thinning, low mood (depression), neck swelling, not able to focus, not able to handle heat or cold, period (menstrual) changes, shakiness, or sweating), shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, arrhythmia, seizures, passing out, severe dizziness, severe loss of strength and energy, or severe injection site edema, skin discoloration, or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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