TM Owner Bristol Myers Squibb
Revlimid 2.5mg Capsule
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Indications & Clinical Uses
- Revlimid 2.5 mg capsules contain lenalidomide, an immunomodulatory agent related to thalidomide, and are approved for adults with multiple myeloma, used in combination with dexamethasone or as maintenance therapy after autologous stem cell transplant; for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes with a deletion 5q cytogenetic abnormality; for relapsed or refractory mantle cell lymphoma after prior therapy including a proteasome inhibitor; and, in combination with rituximab, for previously treated follicular lymphoma or marginal zone lymphoma.
- Revlimid is not approved, and should not be used, for chronic lymphocytic leukaemia outside a controlled clinical trial because of an observed increase in deaths.
- It is prescribed by a haematologist or oncologist and taken by the patient at home, only ever through a restricted distribution programme.
Side Effects
- Very common reactions include diarrhoea, fatigue, low red blood cell count (anaemia), constipation, low white cell counts (neutropenia), muscle cramps, rash, peripheral swelling and trouble sleeping; low platelet counts (thrombocytopenia) are also frequent and increase bleeding risk.
- REVLIMID carries a BOXED WARNING covering three serious risks: embryo-fetal toxicity (Revlimid must never be used in pregnancy, as it can cause severe, life-threatening birth defects), significant hematologic toxicity with severe neutropenia and thrombocytopenia requiring regular blood counts, and an increased risk of blood clots in the veins and arteries (deep vein thrombosis, pulmonary embolism, heart attack and stroke).
- Other serious effects include liver injury, severe skin reactions such as Stevens-Johnson syndrome, tumour lysis syndrome, and a higher chance of developing second cancers.
- Report unusual bruising, bleeding, breathlessness, leg swelling or fever without delay.
Precautions & Warnings
- Because of the boxed warning risks, Revlimid is available only through the Lenalidomide REMS restricted distribution programme, which requires prescribers, pharmacies and patients to be certified and patients to complete regular pregnancy tests and counselling where relevant.
- Revlimid must never be used in pregnancy; patients who can become pregnant must use two reliable methods of contraception starting 4 weeks before treatment, throughout treatment (including dose interruptions) and for 4 weeks after stopping, and male patients must always use a condom during any sexual contact that could lead to pregnancy, both during and for some time after treatment, because lenalidomide passes into semen.
- Complete blood counts are checked regularly, and the dose is adjusted according to renal function and blood count results.
- Blood clot risk should be assessed, and thromboprophylaxis considered, especially in myeloma patients on combination therapy.
Avoid Interactions
- Combining Revlimid with erythropoiesis-stimulating agents (used to raise red blood cell counts) or with oestrogen-containing medicines, such as hormone replacement therapy or combined oral contraceptives, further raises the risk of blood clots, so these combinations need careful assessment.
- Digoxin levels can rise when taken with Revlimid, so digoxin blood levels should be monitored, particularly when starting or stopping treatment.
- Live vaccines should generally be avoided during treatment because of Revlimid's immune-modulating effects and the risk of infection in myelosuppressed patients.
- Warfarin and other blood-thinning medicines may interact and require closer monitoring of clotting tests.
- Because Revlimid is dispensed only through the REMS programme, no other person should ever take or share these capsules.
- Tell your healthcare provider and pharmacist about every medicine and supplement you use before and during treatment.
References
Frequently Asked Questions
Revlimid (lenalidomide) treats multiple myeloma, certain myelodysplastic syndromes with a deletion 5q change, and specific lymphomas (mantle cell, follicular and marginal zone) after prior therapy. It is often combined with dexamethasone or rituximab and is prescribed by a haematologist or oncologist.
Revlimid capsules are swallowed whole, once daily, usually at about the same time each day, with or without food. Do not open, break or chew them. Your dose and treatment cycle (days on and off) depend on your condition, so follow your haematologist's exact schedule.
Revlimid carries a boxed warning for three serious risks: severe birth defects if used in pregnancy, significant drops in blood cell counts, and an increased risk of dangerous blood clots including DVT, pulmonary embolism, heart attack and stroke. Regular blood tests and pregnancy prevention measures are required.
Never take Revlimid during pregnancy, and always use effective contraception as directed, since it can cause severe birth defects. Avoid oestrogen-containing medicines and live vaccines without medical advice, as these raise clot or infection risk. Never share your capsules - Revlimid is dispensed only through its REMS programme.
Because of its boxed-warning risks, Revlimid is available only through the Lenalidomide REMS, a restricted distribution programme. Prescribers, pharmacies and patients must be certified, and patients who can become pregnant must complete regular pregnancy tests before each prescription is filled.
Complete blood counts are checked weekly for the first two cycles, then at least monthly, since Revlimid can cause significant neutropenia and thrombocytopenia. Kidney function is also monitored, since your dose depends on it. Report unusual bruising, bleeding, infection signs or fatigue between scheduled tests.
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