Adult: In patients previously treated with at least 2 other treatment regimens including lenalidomide and a proteasome inhibitor (e.g. bortezomib) and with disease progression within 60 days of the last completed therapy: Initially, 4 mg once daily in combination with dexamethasone for 21 days of a 28-day cycle, continue until disease progression or unacceptable toxicity. Initiate therapy if ANC is ≥500 cells/mm3 and platelet count of ≥50,000 cells/mm3. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
Adult: After failure of highly active antiretroviral therapy (HAART) or in patients with Kaposi's sarcoma who are HIV-negative: Initially, 5 mg once daily for 21 days of a 28-day cycle, continue until disease progression or unacceptable toxicity. Initiate therapy if ANC is ≥1,000/mm3 and platelet count of ≥75,000/mm3. Continue HAART treatment in patients with AIDS-related Kaposi's sarcoma. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
Special Patient Group
Patients taking potent CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine, enoxacin): Reduce the dose of pomalidomide by 50%.
Renal Impairment
Multiple myeloma:
Severe (requiring haemodialysis): Initially, 3 mg once daily, given after haemodialysis.
AIDS-related Kaposi's sarcoma; Kaposi's sarcoma:
Severe (requiring haemodialysis): Initially, 4 mg once daily, given after haemodialysis.
Hepatic Impairment
Multiple myeloma:
Mild or moderate (Child-Pugh class A or B): Initially, 3 mg once daily. Severe (Child-Pugh class C): Initially, 2 mg once daily.
AIDS-related Kaposi's sarcoma; Kaposi's sarcoma:
Mild, moderate or severe (Child-Pugh class A, B or C): Initially, 3 mg once daily.
Contraindications
Severe hypersensitivity (e.g. anaphylaxis, angioedema). Women of childbearing potential and male patients who are not compliant with the required contraceptive measures. Pregnancy.
Special Precautions
Patient with risk factors and history of thromboembolism or cardiac disease, at risk of tumour lysis syndrome (e.g. with high tumour burden), history of hepatitis B infection. Smokers. Hepatic and severe renal impairment. Lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. angioedema, anaphylaxis); thromboembolic events (e.g. DVT, pulmonary embolism, MI, stroke); bone marrow suppression (e.g. anaemia, neutropenia, thrombocytopenia); ILD and related events (e.g. pneumonia, pneumonitis); peripheral and sensory neuropathy; secondary malignancies (e.g. acute myelogenous leukaemia, non-melanoma skin cancer); tumour lysis syndrome; cardiac events (e.g. pulmonary oedema, CHF, atrial fibrillation); hypothyroidism, dizziness, confusion; ALT and bilirubin elevation; hepatitis B reactivation. Blood and lymphatic system disorders: Leucopenia. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, abdominal pain, gastrointestinal haemorrhage. General disorders and administration site conditions: Fatigue, pyrexia, chills, asthenia, peripheral oedema. Infections and infestations: URTI, bronchitis, UTI, sepsis. Investigations: Increased serum creatinine, weight loss. Metabolism and nutrition disorders: Decreased appetite, hyperglycaemia, hypercalcaemia, hyperkalaemia, hypokalaemia, hyponatraemia. Musculoskeletal and connective tissue disorders: Back pain, limb pain, bone pain, arthralgia, muscle spasms, musculoskeletal chest pain. Nervous system disorders: Headache, tremor, myasthenia, syncope. Psychiatric disorders: Insomnia, anxiety, depression. Renal and urinary disorders: Renal failure syndrome, urinary retention. Reproductive system and breast disorders: Pelvic pain. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, epistaxis, oropharyngeal pain. Skin and subcutaneous tissue disorders: Rash, pruritus, hyperhidrosis, night sweats, xeroderma. Vascular disorders: Hypotension. Potentially Fatal: Severe cutaneous reactions (e.g. Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], drug reaction with eosinophilia and systemic symptoms [DRESS]); hepatic failure, progressive multifocal leukoencephalopathy.
This drug may cause dizziness or confusion, if affected, do not drive or operate machinery. Avoid donating blood during treatment and for at least 1 month following treatment cessation. Women of childbearing potential must use proven birth control methods during therapy (including dose interruption) and for 4 weeks after stopping the treatment. Men should use condoms and avoid donating semen or sperm during treatment (including dose interruption) and for at least 7 days following treatment cessation. Women of childbearing potential or who are pregnant should not handle the blister or capsule.
Monitoring Parameters
Evaluate pregnancy 10-14 days and 24 hours prior to treatment initiation, weekly during the 1st month then every 2 weeks or monthly thereafter for patients with irregular and regular menstrual cycles, respectively, and at least 1 month following discontinuation of therapy. Perform HBV screening including HBsAg, hepatitis B (HB) core antibody, total Ig or IgG, and antibody to HBsAg before starting or at the beginning of therapy. Monitor CBC (with differential and platelet count) weekly for the 1st 8 weeks of therapy and monthly or as indicated thereafter; renal function (e.g. serum creatinine, creatine clearance); thyroid function (at baseline and every 2-3 months during treatment), and LFTs (monthly). Assess for signs and symptoms of hypersensitivity or dermatologic reactions, ILD, tumour lysis syndrome, neuropathy, and thromboembolism (e.g. chest pain, shortness of breath, arm or leg swelling).
Drug Interactions
Increased exposure with strong CYP1A2 inhibitor (e.g. fluvoxamine, ciprofloxacin) that may enhance risk for toxicities.
Food Interaction
Food, particularly high-fat and high-caloric meal, decreases the rate and extent of absorption.
Action
Description: Mechanism of Action: Pomalidomide is a thalidomide analogue with immunomodulatory, antiangiogenic, and direct anti-myeloma tumouricidal properties. It inhibits the production of proinflammatory cytokines such as tumour necrosis factor-α (TNF-α) and interleukin (IL)-6, and IL-12; enhances T cell- and natural killer (NK) cell-mediated immunity; and blocks the migration and adhesion of endothelial cells resulting in the prevention of angiogenesis. Additionally, it also induces cell cycle arrest and apoptosis leading to the inhibition of growth and proliferation of haematopoietic tumour cells, including lenalidomide-resistant multiple myeloma cell lines. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Food, particularly high-fat and high-caloric meal, decreases the rate and extent of absorption. Time to peak plasma concentration: 2-3 hours. Distribution: Distributed into the semen (approx 67%). Plasma protein binding: 12-44%. Metabolism: Metabolised in the liver via hydroxylation and subsequent glucuronidation or hydrolysis mainly by CYP1A2 and CYP3A4, and to a lesser extent by CYP2C19 and CYP2D6. Excretion: Mainly via urine (73%; 2% as unchanged drug); faeces (15%; 8% as unchanged drug). Elimination half-life: Approx 7.5 hours (patient with multiple myeloma); approx 9.5 hours (healthy individual).
Chemical Structure
Pomalidomide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 134780, Pomalidomide. https://pubchem.ncbi.nlm.nih.gov/compound/Pomalidomide. Accessed Feb. 22, 2024.
Storage
Store between 20-25°C. This is a cytotoxic drug, follow applicable procedures for receiving, handling, administration, and disposal.
Sign Out
