Drug Guide
Peginterferon Alfa-2a
Classification
Therapeutic: Antiviral and immunomodulator
Pharmacological: Interferon, recombinant
FDA Approved Indications
- Chronic hepatitis B virus infection
- Chronic hepatitis C virus infection (in combination with other agents)
Mechanism of Action
Peginterferon Alfa-2a enhances the immune response against viral-infected cells and inhibits viral replication by modulating the immune system and interfering with viral gene expression and replication.
Dosage and Administration
Adult: Usually 180 mcg once weekly by subcutaneous injection. Dosage may vary based on condition and patient response.
Pediatric: Not typically recommended for children.
Geriatric: Use with caution; adjust dose based on tolerability and response.
Renal Impairment: Adjust dose if necessary; monitor renal function.
Hepatic Impairment: Use with caution; hepatic function should be monitored.
Pharmacokinetics
Absorption: Once weekly subcutaneous injection with peak levels in 24-48 hours.
Distribution: Distributed into tissues; large volume of distribution.
Metabolism: Metabolized by proteolytic enzymes; not extensively processed by liver enzymes.
Excretion: Primarily excreted via kidneys.
Half Life: Approximately 40-60 hours.
Contraindications
- Hypersensitivity to peginterferon alfa-2a or any component of the formulation.
- Autoimmune hepatitis.
- Decompensated liver disease.
Precautions
- Monitor for autoimmune disorders.
- Use with caution in patients with psychiatric disorders, cardiac disease, or hematologic abnormalities.
- Pregnancy category C; should only be used if clearly needed during pregnancy; effective contraception recommended during therapy and for 6 months after.
Adverse Reactions - Common
- Flu-like symptoms (fever, chills, myalgia) (Very common)
- Fatigue (Common)
- Headache (Common)
- Nausea and vomiting (Common)
- Bone marrow suppression (neutropenia, thrombocytopenia, anemia) (Common)
Adverse Reactions - Serious
- Neuropsychiatric effects (depression, suicidal ideation) (Uncommon)
- Autoimmune disorders (thyroiditis, autoimmune hepatitis) (Uncommon)
- Severe neuropsychiatric symptoms or depression leading to discontinuation (Uncommon)
- Allergic reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Ribavirin, other myelosuppressants, other immunomodulators.
Drug-Food Interactions
- Limited data; generally no significant food interactions.
Drug-Herb Interactions
- Potential interactions with herbal supplements affecting immune function; consult with healthcare provider.
Nursing Implications
Assessment: Baseline complete blood count, hepatic function, mental health status, and screening for autoimmune disorders.
Diagnoses:
- Risk for infection due to myelosuppression
- Risk for depression or suicidal ideation
Implementation: Administer subcutaneously as prescribed; monitor blood counts, liver function, and mental health throughout therapy.
Evaluation: Assess for efficacy of viral suppression, monitor adverse effects, and adjust dosage as necessary.
Patient/Family Teaching
- Report flu-like symptoms, depression, suicidal thoughts, or unusual bleeding.
- Use contraceptives during treatment and for 6 months after.
- Adherence to injection schedule is essential for effectiveness.
- Avoid pregnancy during therapy and for 6 months afterward.
Special Considerations
Black Box Warnings:
- Neuropsychiatric effects, including depression and suicidality.
- Hepatitis B reactivation in patients with HBV infection undergoing treatment for hepatitis C.
Genetic Factors: Genetic polymorphisms can influence response to therapy.
Lab Test Interference: Can cause transient decreases in blood counts and liver enzymes, monitor regularly.
Overdose Management
Signs/Symptoms: Flu-like symptoms, hematologic abnormalities, neuropsychiatric symptoms.
Treatment: Supportive care; no specific antidote. Discontinue drug and provide symptomatic treatment as needed.
Storage and Handling
Storage: Store refrigerated at 2-8°C (36-46°F). Do not freeze.
Stability: Stable until the expiration date on the label when stored properly.