POMOLIDE

What it is

Pomalidomide is a thalidomide analogue. Pomolide is available as hard gelatin capsules containing 1 mg, 2 mg, 3 mg or 4 mg of pomalidomide. Pomalidomide is an immunomodulating agent.

Approved indications

— Treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide, in combination with bortezomib and dexamethasone. — Treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy, in combination with dexamethasone.

Dosing overview

The recommended starting dose of pomalidomide is 4 mg orally once daily. For the combination with bortezomib and dexamethasone, pomalidomide is given on Days 1–14 of each 21-day cycle. For the combination with dexamethasone alone, pomalidomide is given on Days 1–21 of repeated 28-day cycles until disease progression. To initiate treatment, the platelet count must be ≥50 × 10⁹/L and the neutrophil count must be ≥1.0 × 10⁹/L, with complete blood counts monitored weekly for the first 8 weeks and monthly thereafter.

Key safety warnings

Pomalidomide is a thalidomide analogue and thalidomide is a known human teratogen that causes severe life-threatening human birth defects; if pomalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking pomalidomide, during dose interruptions, and for 4 weeks after stopping the medicine. Pomolide is available under a restricted distribution program (Pregnancy Prevention Program), and only physicians and pharmacists registered with this program can prescribe and dispense the product; it must only be dispensed to patients who are registered and meet all the conditions of the program. Neutropenia was the most frequently reported Grade 3/4 hematologic adverse reaction in subjects with relapsed/refractory multiple myeloma; Grade 3 or 4 neutropenia occurred in 41.7% of patients who received pomalidomide plus low-dose dexamethasone. Patients must be monitored for hematologic toxicities, especially neutropenia, with complete blood counts monitored weekly for the first 8 weeks and monthly thereafter; dose modifications may be required and patients may require use of blood product support and/or growth factors. Patients receiving pomalidomide have developed venous thromboembolic events (VTE) reported as serious adverse events; anti-coagulation therapy (unless contraindicated) is recommended, and a decision to take prophylactic measures should be made carefully after an assessment of an individual patient's underlying risk factors. Angioedema, anaphylaxis and severe dermatologic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms have been reported; pomalidomide must be discontinued for angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous rash or if these reactions are suspected, and should not be resumed following discontinuation for these reactions. Interstitial lung disease and related events, including cases of pneumonitis, have been observed with pomalidomide; careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude interstitial lung disease, and pomalidomide should be interrupted pending investigation of these symptoms.

Contraindications

Pomolide is contraindicated in pregnancy; in females of childbearing potential and male patients unless all of the conditions of the Pregnancy Prevention Program have been met; and in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

Pomolide is listed on the PBS with authority required restriction for the 1 mg capsule at A$264.06 ex-manufacturer price, the 2 mg capsule at A$706.08 ex-manufacturer price, the 3 mg capsule at A$706.08 ex-manufacturer price, and the 4 mg capsule at A$941.43 ex-manufacturer price.

Regulatory history

Pomolide 1 mg, 2 mg, 3 mg and 4 mg hard gelatin capsules were first listed on the ARTG on 18 May 2021.