peginterferon alfa-2a: clinical use

Prescribing considerations

• Initiate through a physician experienced in the relevant haematological or hepatic condition.
• Assess psychiatric history, autoimmune disease, thyroid and glucose control, cardiovascular status, renal function, liver compensation and infection risk.
• Review safety information for medicines used in combination.
• Record product name and batch number for biological traceability.
• In children treated for viral hepatitis, consider possible growth inhibition and monitor development.

Contraindications and cautions

• Hypersensitivity to peginterferon alfa-2a, alfa interferons or an excipient
• History or presence of autoimmune disease
• Thyroid disease not controllable with conventional treatment
• Severe hepatic dysfunction or decompensated cirrhosis
• Severe unstable or uncontrolled cardiac disease
• Concomitant telbivudine
• Children under 3 years because the formulation contains benzyl alcohol
• Severe current or previous psychiatric illness in paediatric patients

Monitoring

• Full blood count, including neutrophils and platelets
• Liver enzymes and hepatic function
• Thyroid function and blood glucose
• Mood, behaviour and other neuropsychiatric symptoms
• Cardiovascular status where clinically relevant
• Visual symptoms and ophthalmic assessment when indicated
• Growth and weight in children and adolescents

Clinical pharmacology

A recombinant interferon alfa-2a linked to branched polyethylene glycol, with antiviral, immunomodulatory and antiproliferative activity and slower clearance than unmodified interferon alfa-2a.

Formulation and product differences

• The solution contains benzyl alcohol and polysorbate 80 and is essentially sodium-free.
• Each pre-filled syringe is single-use and supplied with a needle.
• Potency must not be directly compared with other pegylated or non-pegylated interferon products.

Injection

Route: Parenteral

Strengths: 90 micrograms, 135 micrograms, 180 micrograms