Pomarza Adverse Reactions

Summary of the safety profile: Pomalidomide in combination with bortezomib and dexamethasone: The most commonly reported blood and lymphatic system disorders were neutropenia, thrombocytopenia and anaemia. The most frequently reported adverse reaction was peripheral sensory neuropathy. The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia, thrombocytopenia and anaemia. The most commonly reported serious adverse reaction was pneumonia.
Other serious adverse reactions reported included pyrexia, lower respiratory tract infection, pulmonary embolism, influenza, and acute kidney injury.
Pomalidomide in combination with dexamethasone: The most commonly reported adverse reactions have been blood and lymphatic system disorders including anaemia, neutropenia and thrombocytopenia; in general disorders and administration site conditions including fatigue, pyrexia and oedema peripheral; and in infections and infestations including pneumonia. Peripheral neuropathy adverse reactions were reported and venous embolic or thrombotic (VTE) adverse reactions were reported. The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia, anaemia and thrombocytopenia; in infections and infestations including pneumonia; and in general disorders and administration site conditions including fatigue, pyrexia and oedema peripheral. The most commonly reported serious adverse reaction was pneumonia. Other serious adverse reactions reported included febrile neutropenia, neutropenia, thrombocytopenia and VTE adverse reactions.
Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Tabulated list of adverse reactions: Pomalidomide in combination with bortezomib and dexamethasone: The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Frequencies for Pom+Btz+Dex (any grade) are defined in accordance with current guidance, as: very common, common and uncommon. (See Tables 7a and 7b.)

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Tabulated list of adverse reactions: Pomalidomide in combination with dexamethasone: The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed as follows in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone treatment and from post-marketing data. Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined in accordance with current guidance, as: very common, common and uncommon. (See Table 8.)

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Tabulated list of post-marketing adverse reactions: In addition to the above adverse reactions identified, the following Table 9 is derived from data gathered from post-marketing surveillance.
Frequencies are defined in accordance with current guidance, as: very common, common, uncommon and not known. (See Table 9.)

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Description of selected adverse reactions: Teratogenicity: Pomalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see Use in Pregnancy & Lactation). If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see Precautions).
Neutropenia and thrombocytopenia: In patients receiving combination therapy with pomalidomide, neutropenia occurred in patients.
Neutropenia did not lead to pomalidomide discontinuation in any patient and was infrequently serious.
Febrile neutropenia (FN) was reported in patients and was serious (see Dosage & Administration and Precautions).
In patients receiving combination therapy with pomalidomide, thrombocytopenia occurred in patients.
Thrombocytopenia was Grade 3 or 4 in patients, led to pomalidomide discontinuation and was serious (see Dosage & Administration and Precautions).
Neutropenia and thrombocytopenia tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Infection: Infection was the most common non haematological toxicity.
In patients receiving combination therapy with pomalidomide in, infection occurred in patients (Grade 3 or 4). Upper respiratory tract infection and pneumonia were the most frequently occurring infections. Fatal infections (Grade 5) occurred in patients. Infections led to pomalidomide discontinuation in patients.
Thromboembolic events: Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all patients. Anticoagulation therapy (unless contraindicated) is recommended (see Precautions).
In patients receiving combination therapy with pomalidomide, venous thromboembolic events (VTE) occurred in patients (Grade 3 or 4). VTE was reported as serious in patients, no fatal reactions were reported, and VTE was associated with pomalidomide discontinuation in patients.
Peripheral neuropathy: Pomalidomide in combination with bortezomib and dexamethasone: Patients with ongoing peripheral neuropathy ≥Grade 2 with pain within 14 days prior to randomisation were excluded from treatment. Peripheral neuropathy occurred in patients (Grade 3; Grade 4). The patients experiencing peripheral neuropathy had a history of neuropathy at baseline. Peripheral neuropathy led to discontinuation of bortezomib in patients, pomalidomide in patients and dexamethasone in patients, respectively. Refer also to the bortezomib SmPC.
Pomalidomide in combination with dexamethasone: Patients with ongoing peripheral neuropathy ≥Grade 2 were excluded from treatment. Peripheral neuropathy occurred in patients (Grade 3 or 4). No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in patients (see Precautions).
Haemorrhage: Haemorrhagic disorders have been reported with pomalidomide, especially in patients with risk factors such as concomitant medicinal products that increase susceptibility to bleeding. Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Allergic reactions and severe skin reactions: Angioedema, anaphylactic reaction and severe cutaneous reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide. Patients with a history of severe rash associated with lenalidomide or thalidomide should not receive pomalidomide (see Precautions).
Paediatric population: Adverse reactions reported in paediatric patients (aged 4 to 18 years) with recurrent or progressive brain tumours were consistent with the known pomalidomide safety profile in adult patients (see Pharmacology: Pharmacodynamics under Actions).