Drug Action
Pomalidomide is structurally related to thalidomide and has immunomodulatory properties and direct anti-myeloma tumoricidal activity.
PDF page 1035
Loading InternPractice…
Drug reference
Pomalidomide is structurally related to thalidomide and has immunomodulatory properties and direct anti-myeloma tumoricidal activity.
PDF page 1035
Treatment of relapsed and refractory multiple myeloma in patients who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and who have had disease progression during the last treatment (in combination with dexamethasone) ▶BY MOUTH ▶Adult: 4 mg once daily for 21 consecutive days of repeated 28–day cycles, for doses of dexamethasone and dose adjustment due to side effects—consult product literature
PDF page 1035
DUE TO INTERACTIONS ▶Manufacturer advises halve dose with concurrent use of potent inhibitors of CYP1A2 and ciprofloxacin.
PDF page 1035
Cardiac disease. cardiac risk factors. hepatitis B infection. high tumour burden—risk of tumour lysis syndrome. interstitial lung disease—discontinue if suspected. peripheral neuropathy CAUTIONS, FURTHER INFORMATION ▶Thromboembolism Risk factors for thromboembolism (such as smoking, hypertension, hyperlipidaemia) should be minimised. Thromboprophylaxis should be considered, particularly in patients with additional risk factors. ▶Second primary malignancy Patients should be carefully evaluated before and during treatment with pomalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated. ▶Hepatitis B infection The MHRA advises that those with a history of hepatitis B infection should be closely monitored for signs and symptoms of active infection throughout treatment; expert advice should be sought for patients who test positive for active infection.
PDF page 1035
Patient, prescriber, and supplying pharmacy must comply with a pregnancy prevention programme. Every prescription must be accompanied by a completed Prescription Authorisation Form.
PDF page 1036
NICE decisions ▶Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib (January 2017) NICE TA427 Pomalidomide (Imnovid ®), in combination with low-dose dexamethasone, is recommended as an option for treating multiple myeloma in adults at third or subsequent relapse (that is, after three previous treatments including both lenalidomide and bortezomib), only when the manufacturer provides pomalidomide with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta427
PDF page 1036
MHRA/CHM ADVICE (MAY 2016): RISK OF HEPATITIS B REACTIVATION An EU wide review has concluded that pomalidomide can cause hepatitis B reactivation; the MHRA recommends to establish hepatitis B virus status in all patients before initiation of treatment.
PDF page 1035
→Appendix 1: pomalidomide
PDF page 1036
▶Common or very common Anaemia. angioedema. appetite decreased. atrial fibrillation. cataract. Clostridioides difficile colitis. confusion. constipation. cough. decreased leucocytes. depression. diarrhoea. dizziness. dry mouth. dyspnoea. electrolyte imbalance. embolism and thrombosis. fall. fatigue. fever. gastrointestinal discomfort. haemorrhage. heart failure. hyperglycaemia. hypertension. hyperuricaemia. hypotension. increased risk of infection. insomnia. intracranial haemorrhage. level of consciousness decreased. muscle spasms. muscle weakness. myocardial infarction. nausea. neoplasms. Immune system and malignant disease neutropenia. oedema. pain. pancytopenia. paraesthesia. pelvic pain. peripheral neuropathy. renal impairment. respiratory disorders. sepsis. skin reactions. stomatitis. syncope. taste altered. thrombocytopenia. tremor. urinary retention. vertigo. vomiting. weight decreased ▶Uncommon Hepatitis. hyperbilirubinaemia. stroke. tumour lysis syndrome ▶Frequency not known Hepatitis B reactivation. severe cutaneous adverse reactions (SCARs)
PDF page 1036
For women of child- bearing potential, pregnancy must be excluded before starting treatment with pomalidomide (perform pregnancy test on initiation or within 3 days prior to initiation). Women must practise effective contraception at least 1 month before, during, and for at least 1 month after treatment, including during dose interruptions (oral combined hormonal contraceptives and copper-releasing intra-uterine devices not recommended) and men should use condoms during treatment, during dose interruption, and for at least 1 week after stopping if their partner is pregnant or is of childbearing potential and not using effective contraception. Patients, prescribers and pharmacists must comply with pregnancy prevention measures as specified in the manufacturer’s Pregnancy Prevention Programme.
PDF page 1036
Important: teratogenic risk.
PDF page 1036
Avoid—present in milk in animal studies.
PDF page 1036
Manufacturer advises caution (risk of increased exposure).
PDF page 1036
Manufacturer advises caution—no information available.
PDF page 1036
▶Maufacturer advises monitor full blood count before treatment, then every week for the first 8 weeks, then monthly thereafter (reduce dose or interrupt treatment if neutropenia or thrombocytopenia develop—consult product literature). ▶Manufacturer advises monitor for arterial or venous thromboembolism. ▶Manufacturer advises monitor for signs and symptoms of cardiac failure. ▶Manufacturer advises monitor for acute onset or unexplained worsening of respiratory symptoms. ▶Manufacturer advises monitor liver function for 6 months after initiation, then as clinically indicated.
PDF page 1036
There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 3, 25 EXCIPIENTS: May contain Propylene glycol ▶Imnovid (Celgene Ltd) A Pomalidomide 1 mg Imnovid 1mg capsules | 21 capsule P £8,884.00 Pomalidomide 2 mg Imnovid 2mg capsules | 21 capsule P £8,884.00 Pomalidomide 3 mg Imnovid 3mg capsules | 21 capsule P £8,884.00 Pomalidomide 4 mg Imnovid 4mg capsules | 21 capsule P £8,884.00
PDF page 1036
Patients and their carers should be made aware of the symptoms of thromboembolism and advised to report sudden breathlessness, chest pain, or swelling of a limb. Patients and their carers should be made aware of the symptoms of neutropenia and advised to seek medical advice if symptoms suggestive of neutropenia (such as fever, sore throat) or of thrombocytopenia (such as bleeding) develop. Conception and contraception Patient counselling is advised for pomalidomide capsules (pregnancy and contraception).
PDF page 1036
4 mg once daily for 21 consecutive days of
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1035