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.
2 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. |
3 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. |
4 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.
5 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.
6 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.
7 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. |
8 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.
9 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.