POMALYST

What it is

Pomalidomide Sandoz is available as capsules in strengths of 1 mg, 2 mg, 3 mg and 4 mg. 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

For pomalidomide in combination with bortezomib and dexamethasone, the recommended starting dose is 4 mg orally once daily on Days 1–14 for each 21-day cycle. For pomalidomide in combination with dexamethasone, the recommended starting dose is 4 mg per day taken orally on Days 1–21 of repeated 28-day cycles until disease progression. To initiate a cycle of pomalidomide, the platelet count must be ≥50 × 10⁹/L and the neutrophil count must be ≥1.0 × 10⁹/L. Complete blood counts should be 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 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. Pomalidomide is available under a restricted distribution Pregnancy Prevention Program; only physicians and pharmacists registered with this program can prescribe and dispense the product, and 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 haematologic adverse reaction in subjects with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia. Patients should be monitored for haematologic toxicities, especially neutropenia, with complete blood counts monitored weekly for the first 8 weeks and monthly thereafter. Patients receiving pomalidomide have developed venous thromboembolic events reported as serious adverse events; anti-coagulation therapy (unless contraindicated) is recommended such as aspirin, warfarin, heparin or clopidogrel. 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 Stevens–Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms is 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 acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude interstitial lung disease, pomalidomide should be interrupted pending investigation of these symptoms and if interstitial lung disease is confirmed, appropriate treatment should be initiated, and pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks. Cases of progressive multifocal leukoencephalopathy, including fatal cases, have been reported with pomalidomide in combination with immunosuppressive therapy including dexamethasone, reported several months to several years after starting treatment; physicians should consider progressive multifocal leukoencephalopathy in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms, and if progressive multifocal leukoencephalopathy is suspected, further pomalidomide dosing must be suspended until progressive multifocal leukoencephalopathy has been excluded, and if confirmed, pomalidomide must be permanently discontinued.

Contraindications

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

PBS listing

Pomalidomide (POMALYST) is registered on the ARTG in 1 mg, 2 mg, 3 mg and 4 mg capsule strengths, first listed 2014-07-01. In November 2017, the PBAC recommended an amendment to allow pomalidomide to be used in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma in patients who have received at least two prior therapies, including lenalidomide and bortezomib. In July 2023, the PBAC recommended pomalidomide for relapsed/refractory multiple myeloma. Specific PBS strength listings, item numbers, restriction type and ex-manufacturer pricing are not available in the provided sources.

Regulatory history

Pomalidomide Sandoz (POMALYST) was first registered on the ARTG on 1 July 2014, with registrations for 1 mg, 2 mg, 3 mg and 4 mg capsule strengths under licence category RE (restricted evaluation). In November 2017, the PBAC recommended an amendment to the PBS listing to allow pomalidomide to be used in combination with dexamethasone for patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib. In July 2023, the PBAC recommended pomalidomide for relapsed/refractory multiple myeloma.