PLEGRIDY

What it is

PLEGRIDY is peginterferon beta-1a available as a single pre-filled syringe containing 0.5 mL of solution containing 63 micrograms, 94 micrograms, or 125 micrograms of peginterferon beta-1a. The glass syringe is contained within a single-use, disposable, injection device (pre-filled pen). PLEGRIDY is interferon beta-1a conjugated to a single, linear 20 kDa methoxy poly(ethylene glycol) molecule to the alpha-amino group of the N-terminal amino acid residue.

Approved indications

— Treatment of relapsing forms of Multiple Sclerosis (MS)

Dosing overview

The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 2 weeks. It is generally recommended that patients start treatment with 63 micrograms at dose 1 (day 0), increasing to 94 micrograms at dose 2 (day 14), reaching the full dose of 125 micrograms by dose 3 (day 28) and continuing with the full dose (125 micrograms) every 14 days (2 weeks) thereafter. 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 interferon treatment.

Key safety warnings

Hepatic injury, including elevated serum hepatic transaminase levels, hepatitis, and autoimmune hepatitis, and rare cases of severe hepatic failure, has been reported with interferon beta. Elevations in hepatic enzymes, noninfectious hepatitis and hepatic injury have been observed with the use of PLEGRIDY. Patients should be monitored for signs of hepatic injury. Withdrawal of treatment with PLEGRIDY should be considered if hepatic transaminase levels significantly increase or if they are associated with clinical symptoms such as jaundice. Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products, including PLEGRIDY. PAH has occurred in patients treated with interferon beta products in the absence of other contributory factors. Many of the reported cases required hospitalisation, including one case with interferon beta in which the patient underwent a lung transplant. PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnoea, new or increasing fatigue) should be assessed for PAH. If alternative aetiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated. Depression and suicidal ideation have been reported to occur with increased frequency in patients receiving interferon beta. Patients treated with PLEGRIDY should be advised to report immediately any symptoms of depression and/or suicidal ideation to their prescribing physician. Patients exhibiting depression should be monitored closely during therapy with PLEGRIDY and treated appropriately. If a patient develops depression or other severe psychiatric symptoms, cessation of PLEGRIDY therapy should be considered. Serious hypersensitivity reactions, including cases of anaphylaxis, have been reported as a rare complication of treatment with interferon beta, including PLEGRIDY. Patients should be advised to discontinue PLEGRIDY and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity. Treatment should not be restarted. Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta. Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with PLEGRIDY. Patients should be monitored for symptoms or signs of decreased peripheral blood counts.

Contraindications

PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of the formulation. The initiation of treatment is contraindicated during pregnancy, and in patients with current severe depression and/or suicidal ideation.

PBS listing

PLEGRIDY 125 micrograms in 0.5 mL as a single use injection pen is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$555.47. A pack containing single use injection pens of 63 micrograms and 94 micrograms in 0.5 mL is also listed with streamlined restriction at an ex-manufacturer price of A$555.47.

Regulatory history

PLEGRIDY was first registered on the ARTG on 10 November 2014 in four variants: 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen titration pack, 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled syringe titration pack, 125 microgram/0.5 mL solution for injection pre-filled syringe, and 125 microgram/0.5 mL solution for injection pre-filled pen.