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LINAMIDE (LENALIDOMIDE) 25MG CAPSULES 18`S

Ksh 9,749

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What is this medicine and what is it used for?

Lenalidomide is an immunomodulatory drug (IMiD) that exerts its anti-cancer activity through multiple mechanisms: it activates the E3 ubiquitin ligase cereblon (CRBN), leading to selective degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3) in myeloma and lymphoma cells; enhances T-cell and NK-cell immune responses against cancer cells; inhibits tumour neoangiogenesis (blood vessel formation); and has direct anti-proliferative and pro-apoptotic effects.

Lenalidomide is used to treat adults with:

       Multiple myeloma (MM) — as combination therapy (with dexamethasone, bortezomib, or daratumumab) at various stages including newly diagnosed and relapsed/refractory disease; and as maintenance therapy after autologous stem cell transplant (ASCT).

       Myelodysplastic syndromes (MDS) — specifically transfusion-dependent anaemia due to low/intermediate-1 risk MDS associated with deletion 5q cytogenetic abnormality.

       Mantle cell lymphoma (MCL) — relapsed/refractory, after prior treatment.

       Follicular lymphoma (FL) — in combination with rituximab.

How to take this medicine

Take capsules orally once daily on days 1–21 of a 28-day cycle (for MM/MDS), or continuously (for some protocols). Swallow whole — do not open, crush, or chew (teratogenic powder hazard). Take with or without food at the same time each day.

Doses vary by indication, renal function, and tolerability: typical MM maintenance 10–25 mg/day; MDS 10 mg/day. Your haematologist prescribes the exact dose and schedule.

CRITICAL SAFETY PROGRAMME — LENALIDOMIDE (REMS/PREGNANCY PREVENTION):

Lenalidomide is a THALIDOMIDE ANALOGUE — it is TERATOGENIC and causes severe birth defects (limb and organ malformations) and foetal death.

ALL patients (male and female) must be enrolled in a mandatory pregnancy prevention programme before receiving any prescription.

FEMALES of childbearing potential: must use TWO highly effective contraceptive methods simultaneously starting 4 weeks before, during, and for 4 weeks after the last dose. Pregnancy tests required monthly.

MALES: must use condoms during treatment and for 4 weeks after the last dose — even if vasectomised. Must not donate sperm during treatment.

Do NOT donate blood during treatment or for 4 weeks after the last dose — recipients could include pregnant women.

DISPENSING: Pharmacists must verify the REMS/pregnancy prevention enrolment before dispensing. No more than a one-cycle supply should be dispensed at a time.

Possible side effects

Frequency

Side Effect

What to Do

Very Common (>10%)

Neutropenia / thrombocytopenia (dose-limiting)

CBC before each cycle; dose adjustment per protocol. Febrile neutropenia = emergency.

Very Common (>10%)

Venous thromboembolism (DVT, PE)

Thromboprophylaxis (aspirin, LMWH, or warfarin depending on risk) is mandatory during lenalidomide treatment.

Very Common (>10%)

Fatigue

Rest; assess for anaemia.

Very Common (>10%)

Diarrhoea / constipation

Hydration; loperamide or lactulose as indicated.

Very Common (>10%)

Muscle cramps

Hydration; magnesium supplementation may help.

Common (1–10%)

Peripheral neuropathy

Report tingling/numbness — dose reduction if Grade 2+.

Common (1–10%)

Rash

Assess severity; antihistamines for mild rash; stop if severe.

Common (1–10%)

Second primary malignancies (second cancers)

Risk increased with long-term lenalidomide; regular screening.

Seek help urgently

Symptoms of DVT (leg pain/swelling) or PE (sudden breathlessness, chest pain)

Seek emergency medical care.

Contraindications

Lenalidomide is absolutely contraindicated in: pregnancy; women of childbearing potential not using two reliable contraceptive methods; patients not enrolled in the mandatory REMS/pregnancy prevention programme; and known hypersensitivity.

Use with caution in: renal impairment — dose must be adjusted based on creatinine clearance (CrCl 30–60: 10 mg/day; CrCl <30: 7.5 mg/day; dialysis: 5 mg 3x/week post-dialysis). Hepatic impairment: no specific dose adjustment — use with caution.

Drug interactions

       Erythropoiesis-stimulating agents (ESAs) and hormone replacement therapy: increase VTE risk — avoid if possible.

       Digoxin: lenalidomide increases digoxin levels by ~14% — monitor digoxin levels.

       Warfarin: INR monitoring required — lenalidomide has complex anticoagulant interactions.

       Dexamethasone (standard combination partner): increases VTE risk — mandatory thromboprophylaxis.

Storage

Store below 30°C. Original capsule blister. Keep out of reach of children. Do not open or crush. Return any unused capsules to the pharmacy immediately — never discard in household waste.

Prescription requirement

PRESCRIPTION ONLY MEDICINE (POM) — Specialist haematologist/oncologist. MANDATORY REMS/PREGNANCY PREVENTION PROGRAMME enrolment for all patients before first dispensing.

Monitoring: CBC and differential before each cycle and during treatment; renal function; thrombosis signs; second primary malignancy screening.

Guidance for patients & caregivers

Lenalidomide is a powerful anti-cancer medicine for blood cancers, but it carries serious risks that require strict safety measures. The pregnancy prevention programme is absolutely non-negotiable — birth defects with thalidomide analogues are severe and irreversible.

VTE (blood clot in leg or lung) is common with lenalidomide, especially in combination with dexamethasone. You will be prescribed a blood thinner (aspirin, heparin injection, or warfarin) — take it consistently. Report any leg pain, swelling, sudden breathlessness, or chest pain immediately.

Do not share lenalidomide with anyone. Do not donate blood while taking it or for 4 weeks after stopping.

Pharmacist & prescriber notes

Ledomide and Linamide are branded generics of lenalidomide (Revlimid). Confirm the specific strength and pack size carefully at dispensing — 10 mg (21 caps) is typically for MDS and some myeloma maintenance protocols; 25 mg (28 caps) is the standard MM combination dose. Renal dose adjustment is critical — confirm CrCl at every dispensing cycle.

All pharmacists dispensing lenalidomide must be trained in and compliant with the applicable REMS (US) or Pregnancy Prevention Programme (EU) — confirm enrolment status before each supply.

Thromboprophylaxis stratification: aspirin 75–100 mg/day for low-risk patients; LMWH or warfarin (INR 2–3) for high-risk (prior VTE, immobility, or combined with high-dose dexamethasone).

10  Frequently asked questions

I am a male patient — why do I need to use contraception?

Lenalidomide is present in semen. Condom use prevents a female partner from being exposed to the drug through sexual contact. This applies even if you or your partner are not planning pregnancy.

What is VTE and why is blood clot prevention so important?

VTE (venous thromboembolism — DVT or PE) is a known serious risk with lenalidomide, especially combined with dexamethasone. Without preventive anticoagulation, the risk can be 10–26% in some protocols. Your prescribed blood thinner reduces this risk significantly — do not stop it without your haematologist's advice.

What happens to unused capsules?

Return all unused capsules to the pharmacy immediately. Never dispose of them in household waste or flush them — they are teratogenic and must be disposed of safely.

Can I have vaccinations?

Inactivated vaccines (flu, pneumococcal, and COVID-19) are generally safe and recommended. Live vaccines should generally be avoided during treatment. Discuss with your haematologist.

What is a 'second primary malignancy'?

Lenalidomide (like other IMiDs) may slightly increase the lifetime risk of developing a second cancer. Regular screening and follow-up with your haematologist are important to detect any new malignancy early.

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