Pomalidomide


Concise Prescribing Info
Indications/Uses
Multiple myeloma.
Dosage/Direction for Use
Adult : PO Combined with dexamethasone: Initial: 4 mg once daily for 21 days of a 28-day cycle.
Dosage Details
Oral
Multiple myeloma
Adult: In combination with dexamethasone, in patient previously treated with at least 2 other treatment regimens including lenalidomide and bortezomib and with disease progression within 60 days of the last completed therapy: Initially, 4 mg once daily for 21 days of a 28-day cycle, continue until disease progression and modify dose according to toxicity. Initiate therapy if absolute neutrophil count (ANC) ≥500 cells/mm3, platelet count ≥50,000 cells/mm3. Interrupt dosing if ANC <500 cells/mm3 (or ANC <1,000 cells/mm3 with fever ≥38.5°C), platelet count <25,000 cells/mm3, then resume at 3 mg once daily after values recover. For each subsequent fall (ANC <500 cells/mm3 and platelet count <25,000 cells/mm3), and other grade 3 or 4 toxicities, interrupt dosing until values recover and resume at 1 mg less than the previous dose. If toxicities still occur at 1 mg once daily dosing, discontinue treatment.
Special Patient Group
Patients taking potent CYP1A2 inhibitors: Reduce dose by 50%.
Renal Impairment
Severe (including patients on haemodialysis): 3 mg once daily, given after haemodialysis.
Hepatic Impairment
Mild or moderate (Child-Pugh class A or B): 3 mg once daily. Severe (Child-Pugh class C): 2 mg once daily.
Contraindications
Pregnancy.
Special Precautions
Patient with risk factors for thromboembolism, history of serious hypersensitivity reactions, cardiac disease or cardiac risk factors, high tumour burden, history of hepatitis B infection. Smokers. Hepatic and severe renal impairment. Lactation.
Adverse Reactions
Significant: Interstitial lung disease (e.g. pneumonia), bone marrow suppression (e.g. anaemia, neutropenia, thrombocytopenia, leucopenia), pyrexia, dizziness, confusion, hypersensitivity reactions (e.g. angioedema, severe dermatologic reactions), peripheral sensory neuropathy, secondary malignancies (e.g. acute myelogenous leukaemia), thromboembolic events (e.g. DVT, pulmonary embolism), tumour lysis syndrome (TLS), pulmonary oedema, congestive cardiac failure, reactivation of hepatitis B.
Gastrointestinal disorders: Diarrhoea, nausea, constipation, vomiting, oropharyngeal pain.
General disorders and administration site conditions: Fatigue, weakness, fever, hyperhidrosis, chills.
Infections and infestations: Sepsis, herpes zoster.
Investigations: Increased serum bilirubin, creatinine, weight loss.
Metabolism and nutrition disorders: Peripheral oedema, dehydration, decreased appetite, hypercalcaemia, hypo/hyperkalaemia, hyperglycaemia, hyponatraemia, hyperuricaemia.
Musculoskeletal and connective tissue disorders: Back pain, musculoskeletal chest pain, muscle spasms, arthralgia, myasthenia, musculoskeletal and limb pain, ostealgia.
Nervous system disorders: Dizziness, tremor, headache.
Psychiatric disorders: Insomnia, anxiety, confusion.
Renal and urinary disorders: Renal impairment, UTI.
Reproductive system and breast disorders: Pelvic pain.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, epistaxis, bronchitis, nasopharyngitis, upper respiratory tract infection, bronchopneumonia.
Skin and subcutaneous tissue disorders: Rash, dry skin, pruritus.
Potentially Fatal: Hepatic failure.
Patient Counseling Information
Avoid blood donation during therapy and for at least 1 month following drug discontinuation. This drug may cause dizziness and confusion, if affected, do not drive or operate machinery.
MonitoringParameters
Perform pregnancy test prior to initiation, weekly during the 1st month then monthly thereafter, and at least 1 month after discontinuation of therapy. Monitor CBC weekly for the 1st 8 weeks of therapy and monthly thereafter; renal function, thyroid function at baseline and every 2-3 months during treatment, LFT monthly. Monitor for signs and symptoms of TLS, neuropathy, thromboembolism.
Drug Interactions
Increased serum concentration with strong CYP1A2 (e.g. fluvoxamine) and CYP3A4 inhibitors (e.g. ciprofloxacin, ketoconazole).
Food Interaction
Delayed absorption with high-fat and high-caloric meals.
Action
Description: Pomalidomide is a thalidomide analogue with immunomodulatory and direct anti-myeloma tumouricidal activity. The exact mechanism of action has not been fully understood but it is thought to inhibit production of proinflammatory cytokines tumour necrosis factor-α (TNF-α), and angiogenesis; enhance T cell- and natural killer (NK) cell-mediated immunity; inhibit proliferation and induce apoptosis of tumour cells.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Food, particularly high-fat and high-caloric meal, decreases rate and extent of absorption. Time to peak plasma concentration: 2-3 hours.
Distribution: Distributed into the semen (approx 67%). Apparent volume of distribution: 62-138 L. 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 patient).
Chemical Structure

Chemical Structure Image
Pomalidomide

Source: National Center for Biotechnology Information. PubChem Database. Pomalidomide, CID=134780, https://pubchem.ncbi.nlm.nih.gov/compound/Pomalidomide (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C.
This is a cytotoxic drug, avoid contact w/ skin or mucous membranes by wearing gloves and protective equipment. Wash hands before and after handling. Pregnant staff should not handle this product. Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L04AX06 - pomalidomide ; Belongs to the class of other immunosuppressants.
References
Anon. Pomalidomide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/01/2018.

Buckingham R (ed). Pomalidomide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/01/2018.

Joint Formulary Committee. Pomalidomide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/01/2018.

Pomalyst Capsule (Celgene Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 31/01/2018.

Disclaimer: This information is independently developed by MIMS based on Pomalidomide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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