Lenalidomid Medical Valley
Immunomodulatory Agent for Multiple Myeloma, MDS, and Lymphoma
Quick Facts About Lenalidomid Medical Valley
Key Takeaways About Lenalidomid Medical Valley
- Multi-cancer treatment: Lenalidomide is approved for multiple myeloma, MDS with del(5q), mantle cell lymphoma, and follicular lymphoma – making it one of the most versatile oncology drugs available
- Strict pregnancy prevention required: As a thalidomide analogue, lenalidomide is expected to cause severe birth defects. Both men and women must follow mandatory contraception protocols before, during, and after treatment
- Regular blood monitoring essential: Weekly blood tests are required during the first 8 weeks, then at least monthly, to monitor for dangerously low blood cell counts (neutropenia and thrombocytopenia)
- Increased blood clot risk: Lenalidomide significantly increases the risk of venous thromboembolism, particularly when combined with dexamethasone. Prophylactic anticoagulation is often prescribed
- Taken in treatment cycles: Lenalidomide is taken on specific days during 21- or 28-day cycles, with rest periods. Treatment duration varies by condition and response
What Is Lenalidomid Medical Valley and What Is It Used For?
Lenalidomid Medical Valley contains lenalidomide, an immunomodulatory drug (IMiD) that belongs to a class of medicines affecting the immune system. It is used in adults to treat multiple myeloma, myelodysplastic syndromes (MDS), mantle cell lymphoma (MCL), and follicular lymphoma (FL).
Lenalidomide is a potent immunomodulatory agent structurally related to thalidomide but with significantly improved efficacy and a different safety profile. It was first approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) and has since become a cornerstone in the treatment of several haematological malignancies. Lenalidomid Medical Valley is a generic formulation manufactured by Medical Valley Invest AB, containing the same active substance as the originator product Revlimid.
The drug exerts its effects through multiple complementary mechanisms: it directly inhibits the proliferation of malignant cells, prevents angiogenesis (the formation of new blood vessels that feed tumours), and stimulates the body's own immune defences – particularly T-cells and natural killer (NK) cells – to recognise and destroy cancer cells. At a molecular level, lenalidomide binds to cereblon, a component of the E3 ubiquitin ligase complex, leading to the degradation of key transcription factors (Ikaros and Aeros) that are essential for the survival of malignant cells.
Multiple Myeloma
Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. These cells normally produce antibodies that help fight infections, but in myeloma they become malignant and multiply uncontrollably. This can damage bones, impair kidney function, and suppress normal blood cell production. While multiple myeloma generally cannot be cured, modern treatment has dramatically improved survival, and lenalidomide plays a central role in several treatment settings.
Lenalidomid Medical Valley is used for multiple myeloma in three key settings:
- Maintenance therapy after stem cell transplant: Used alone to maintain remission and delay disease recurrence after autologous bone marrow transplantation
- Newly diagnosed patients not eligible for transplant: Used in combination with bortezomib, dexamethasone, melphalan, or prednisone depending on the treatment protocol
- Previously treated (relapsed/refractory) myeloma: Used together with dexamethasone in patients who have received at least one prior therapy
Clinical trials have demonstrated that lenalidomide-based regimens significantly improve progression-free survival and overall survival compared to standard chemotherapy. The FIRST trial showed that continuous lenalidomide plus dexamethasone was superior to melphalan-prednisone-thalidomide in transplant-ineligible patients, while the CALGB 100104 and IFM 2005-02 trials established lenalidomide maintenance as the standard of care after transplant.
Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes are a group of disorders in which the bone marrow produces abnormal blood cells that do not function properly. Patients with MDS often develop anaemia requiring regular blood transfusions. Lenalidomid Medical Valley is specifically indicated for MDS patients who have a chromosomal abnormality known as isolated deletion 5q [del(5q)], are transfusion-dependent, and have not responded adequately to other treatments.
In this specific genetic subtype, lenalidomide has demonstrated remarkable efficacy. The MDS-003 and MDS-004 clinical trials showed that approximately 67% of del(5q) MDS patients achieved transfusion independence with lenalidomide treatment, with many achieving complete cytogenetic remission. The drug selectively eliminates del(5q) clones through cereblon-mediated degradation of casein kinase 1 alpha (CK1α), a haploinsufficient gene in the del(5q) region.
Mantle Cell Lymphoma (MCL)
Mantle cell lymphoma is an aggressive form of non-Hodgkin lymphoma arising from B-lymphocytes in the mantle zone of lymph nodes. Lenalidomid Medical Valley is used as monotherapy in adult patients with relapsed or refractory MCL who have been previously treated with other agents. The MCL-001 (EMERGE) trial demonstrated an overall response rate of 28% in heavily pretreated patients, providing an important treatment option for this difficult-to-treat disease.
Follicular Lymphoma (FL)
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma that arises from B-lymphocytes. Lenalidomid Medical Valley is used in combination with rituximab (an anti-CD20 monoclonal antibody) for the treatment of previously treated follicular lymphoma in adults. The AUGMENT trial showed that the lenalidomide-rituximab combination (R2 regimen) significantly improved progression-free survival compared to rituximab alone in patients with relapsed or refractory indolent lymphoma.
Lenalidomide acts through multiple mechanisms: (1) it directly inhibits cancer cell proliferation and induces apoptosis, (2) it blocks the growth of new blood vessels (angiogenesis) that feed tumours, (3) it enhances immune cell activity, particularly T-cells and NK cells, to attack cancer cells, and (4) it modulates cytokine production to create an anti-tumour environment. This multi-pronged approach makes it effective across several different types of blood cancer.
What Should You Know Before Taking Lenalidomid Medical Valley?
Before starting lenalidomide, you must understand the strict pregnancy prevention requirements, as this drug causes severe birth defects. You should not take it if you are pregnant or could become pregnant without adequate contraception. Inform your doctor about all medical conditions, especially previous blood clots, infections, and liver or kidney problems.
Contraindications
You must not take Lenalidomid Medical Valley if any of the following apply:
- Pregnancy: Lenalidomide is expected to cause severe birth defects and must not be taken during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take this medicine
- Women of childbearing potential not using adequate contraception: You must follow the mandatory pregnancy prevention programme, including using at least one effective method of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping
- Allergy to lenalidomide or any of the other ingredients in this medicine (lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, and various iron oxides)
Lenalidomide is a thalidomide analogue. Thalidomide is known to cause severe, life-threatening birth defects. Lenalidomide is expected to produce the same types of defects. Women of childbearing potential must have a negative pregnancy test before starting treatment and must use effective contraception. Men taking lenalidomide must use condoms during treatment and for 7 days after the last dose, even if they have had a vasectomy. Do not donate blood during treatment or for 7 days after stopping.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Lenalidomid Medical Valley if you have or have had any of the following:
- Previous blood clots (thrombosis): You have an increased risk of developing blood clots in your veins and arteries during treatment. Your doctor may prescribe anticoagulant or antiplatelet therapy, especially when lenalidomide is combined with dexamethasone or other agents
- Signs of infection: Such as cough, fever, or sore throat. Lenalidomide can weaken your immune system and make you more susceptible to infections, including serious infections like pneumonia and sepsis
- Previous or current viral infections: Particularly hepatitis B, varicella zoster (shingles), or HIV. Lenalidomide treatment may cause reactivation of latent viruses. Your doctor should test you for hepatitis B before starting treatment
- Kidney problems: Lenalidomide is primarily excreted by the kidneys, and dose adjustments are necessary in patients with renal impairment. Your doctor will perform kidney function tests before and during treatment
- Heart attack, blood clots, or cardiovascular risk factors: Including smoking, high blood pressure, or high cholesterol levels. These factors increase the risk of thrombotic events during lenalidomide treatment
- Previous allergic reaction to thalidomide: Patients who have experienced rash, itching, swelling, dizziness, or breathing difficulties with thalidomide may be at higher risk of similar reactions with lenalidomide
- Previous severe skin reactions: Such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, or toxic epidermal necrolysis. These potentially life-threatening reactions have been reported with lenalidomide
Contact your doctor or nurse immediately during or after treatment if you experience any of the following: blurred vision, loss of vision, difficulty speaking, weakness in an arm or leg, changes in gait, numbness, or confusion – these may be signs of a serious brain condition called progressive multifocal leukoencephalopathy (PML). Also report immediately any shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or leg swelling, which may indicate pulmonary hypertension.
Tests and Monitoring
Regular blood tests are essential during lenalidomide treatment because the drug can significantly reduce blood cell counts. Your doctor will order blood tests on the following schedule:
- Before treatment begins: Baseline blood counts, kidney function, liver function, and pregnancy test (if applicable)
- Weekly for the first 8 weeks: Complete blood count to monitor white blood cells, red blood cells, and platelets
- Monthly thereafter: Ongoing monitoring of blood counts and organ function
For patients with MDS, additional monitoring for signs of acute myeloid leukaemia (AML) progression is important. For MCL and FL patients, the monitoring schedule may vary slightly, with more frequent checks during the initial treatment cycles.
Pregnancy and Breastfeeding
For women taking lenalidomide: You must not take lenalidomide if you are pregnant, as it is expected to cause severe birth defects. If you are of childbearing age, you must use effective contraception for at least 4 weeks before treatment, throughout the entire treatment period, and for at least 4 weeks after stopping treatment. Pregnancy tests are required before each prescription, at least every 4 weeks during treatment, and at least 4 weeks after the last dose. If you become pregnant during treatment, stop the medication immediately and contact your doctor.
For men taking lenalidomide: Lenalidomide passes into semen. If your partner is pregnant or could become pregnant, you must use condoms during treatment and for at least 7 days after stopping, even if you have had a vasectomy. Do not donate semen during treatment or for 7 days after stopping. If your partner becomes pregnant while you are taking lenalidomide, inform your doctor immediately.
Breastfeeding: It is not known whether lenalidomide passes into breast milk. You must not breastfeed during treatment with lenalidomide.
Blood donation: You must not donate blood during treatment and for at least 7 days after the last dose.
Drug Interactions
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. Lenalidomide can affect the way other medicines work, and other medicines can affect how lenalidomide works. In particular, inform your doctor if you are using:
- Certain contraceptives: Including combined oral contraceptives, which may become less effective during lenalidomide treatment
- Cardiac medications: Such as digoxin, whose blood levels may increase with concurrent lenalidomide use
- Anticoagulants: Such as warfarin, which may require closer monitoring of your INR (clotting time)
Driving and Operating Machinery
Lenalidomide may cause dizziness, fatigue, drowsiness, vertigo, or blurred vision. Do not drive or operate machinery if you experience any of these effects. You are responsible for assessing whether you are fit to drive or perform tasks requiring alertness while taking this medication.
Lenalidomid Medical Valley capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) sodium per capsule, meaning it is essentially sodium-free.
How Does Lenalidomid Medical Valley Interact with Other Drugs?
Lenalidomide has clinically significant interactions with digoxin, warfarin, combined oral contraceptives, and erythropoiesis-stimulating agents. It is important to inform your doctor about all medications, supplements, and herbal products you are taking before starting treatment.
While lenalidomide undergoes limited hepatic metabolism and is primarily excreted renally, it can still interact with other medications through pharmacodynamic and pharmacokinetic mechanisms. Understanding these interactions is crucial for safe and effective treatment. The table below summarises the most important known drug interactions.
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Digoxin | Cardiac glycoside | Lenalidomide increases digoxin plasma levels by approximately 14% | Monitor digoxin levels; dose adjustment may be needed |
| Warfarin | Anticoagulant | Potential alteration of INR values; increased bleeding risk | Monitor INR frequently, especially during the first weeks of concurrent use |
| Combined oral contraceptives | Hormonal contraception | Reduced contraceptive efficacy possible | Use additional or alternative non-hormonal contraceptive methods |
| Erythropoiesis-stimulating agents (ESAs) | Haematopoietic agents | Increased risk of venous thromboembolism | Use with caution; ensure adequate thromboprophylaxis |
| Dexamethasone | Corticosteroid | Commonly used in combination; increases VTE risk | Standard combination; thromboprophylaxis recommended |
It is important to note that lenalidomide is not significantly metabolised by cytochrome P450 enzymes. Therefore, pharmacokinetic interactions mediated through CYP enzymes are unlikely. However, as lenalidomide is primarily eliminated through the kidneys, drugs that affect renal function may alter lenalidomide clearance. Patients with impaired renal function may require dose adjustments.
What Is the Correct Dosage of Lenalidomid Medical Valley?
The dosage of lenalidomide varies considerably depending on the condition being treated, whether it is used alone or in combination, and the patient's kidney function. Treatment is given in repeating cycles of 21 or 28 days. Only physicians experienced in treating these conditions should prescribe lenalidomide.
Always take this medicine exactly as your doctor has told you. The capsules should be swallowed whole with water – do not crush, open, or chew them. If powder from a broken capsule contacts the skin, wash the area immediately and thoroughly with soap and water. Take the capsules at approximately the same time each day, with or without food.
Multiple Myeloma – Maintenance After Transplant
Maintenance monotherapy
Starting dose: 10 mg once daily continuously on days 1–28 of each 28-day cycle. Treatment continues until disease progression or unacceptable toxicity. After 3 cycles of stable maintenance, the dose may be increased to 15 mg once daily if tolerated. Dose reductions are made for haematological toxicity.
Multiple Myeloma – Newly Diagnosed (Not Transplant-Eligible)
In combination with dexamethasone (Rd)
Lenalidomide: 25 mg once daily on days 1–21 of each 28-day cycle. Dexamethasone: 40 mg once on days 1, 8, 15, and 22. Treatment continues until disease progression. In patients aged 75 years or older, the starting dose of dexamethasone is reduced to 20 mg.
In combination with bortezomib and dexamethasone (VRd)
Lenalidomide: 25 mg once daily on days 1–14 of each 21-day cycle for cycles 1–8, followed by 25 mg on days 1–21 of 28-day cycles from cycle 9 onwards. This is combined with bortezomib and dexamethasone according to the treating physician's protocol.
In combination with melphalan and prednisone (MPR)
Lenalidomide: 10 mg once daily on days 1–21 of each 28-day cycle for up to 9 cycles, followed by lenalidomide maintenance at 10 mg on days 1–21 of each 28-day cycle.
Multiple Myeloma – Previously Treated
In combination with dexamethasone
Lenalidomide: 25 mg once daily on days 1–21 of each 28-day cycle. Dexamethasone: 40 mg once daily on days 1–4, 9–12, and 17–20 of each 28-day cycle for the first 4 cycles, then 40 mg on days 1–4 only from cycle 5 onwards. Treatment continues until disease progression or toxicity.
MDS with Deletion 5q
Monotherapy
Starting dose: 10 mg once daily on days 1–21 of each 28-day cycle. Dose adjustments are based on blood count results. Treatment continues as long as the patient benefits and tolerates the medicine.
Mantle Cell Lymphoma
Monotherapy
Starting dose: 25 mg once daily on days 1–21 of each 28-day cycle. Treatment continues until disease progression or unacceptable toxicity.
Follicular Lymphoma
In combination with rituximab
Lenalidomide: 20 mg once daily on days 1–21 of each 28-day cycle for up to 12 cycles. Rituximab: 375 mg/m² intravenously on day 1 of each 28-day cycle for cycles 1–12.
Dose Adjustments for Kidney Impairment
Since lenalidomide is primarily excreted by the kidneys, dose reductions are necessary for patients with impaired kidney function. Your doctor will determine the appropriate dose based on your creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR).
| Kidney Function (CrCl) | Starting Dose | Schedule |
|---|---|---|
| ≥ 50 mL/min (normal / mild impairment) | 25 mg (or standard dose) | Days 1–21 of 28-day cycle |
| 30–49 mL/min (moderate impairment) | 10 mg once daily | Days 1–21 of 28-day cycle |
| < 30 mL/min, not on dialysis | 15 mg every other day | Days 1–21 of 28-day cycle |
| < 30 mL/min, on dialysis | 5 mg once daily | Days 1–21 of 28-day cycle; on dialysis days, take dose after dialysis |
Missed Dose
If you forget to take Lenalidomid Medical Valley at the usual time:
- Less than 12 hours late: Take the capsule immediately
- More than 12 hours late: Do not take the missed capsule. Take the next capsule at your regular time the following day
Do not take a double dose to make up for a forgotten dose.
Overdose
If you take more lenalidomide than prescribed, or if a child accidentally takes this medicine, contact your doctor or go to the nearest emergency department immediately. There is no specific antidote for lenalidomide overdose. Treatment is supportive and symptomatic.
Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blisters or capsules. Gloves should be removed carefully to prevent skin exposure, placed in a resealable polyethylene bag, and disposed of according to local regulations. Hands should be washed thoroughly with soap and water afterwards. Women who are or suspect they may be pregnant should not handle the blisters or capsules.
What Are the Side Effects of Lenalidomid Medical Valley?
Like all medicines, lenalidomide can cause side effects, although not everyone gets them. Some side effects can be serious and require immediate medical attention, including severe allergic reactions, blood clots, and dangerously low blood cell counts. Regular blood monitoring is essential during treatment.
Hives, rash, swelling of the eyes, mouth or face, difficulty breathing, or itching – these may be signs of serious allergic reactions (angioedema or anaphylaxis). Also seek emergency care for widespread skin rash with skin loss (Stevens-Johnson syndrome or toxic epidermal necrolysis) or widespread rash with high fever, elevated liver enzymes, and enlarged lymph nodes (DRESS syndrome).
Tell your doctor immediately if you notice fever, chills, sore throat, cough, mouth ulcers, or other signs of infection (including sepsis); bleeding or bruising without injury; chest pain or leg pain; shortness of breath; or bone pain, muscle weakness, confusion, or fatigue that may be due to high calcium levels.
Very Common Side Effects
- Anaemia (low red blood cells) causing tiredness and weakness
- Neutropenia (low white blood cells) increasing infection risk
- Thrombocytopenia (low platelets) increasing bleeding risk
- Skin rash, itching
- Muscle cramps, muscle weakness, muscle and bone pain, joint pain, back pain
- General swelling including swelling of arms and legs (oedema)
- Weakness, fatigue, fever and flu-like symptoms
- Numbness, tingling, or burning sensation in skin (peripheral neuropathy)
- Decreased appetite, altered taste
- Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn
- Low potassium, calcium, and/or sodium levels in blood
- Lower than normal thyroid function (hypothyroidism)
- Leg pain or chest pain (possible signs of blood clots)
- Infections of all types, including sinusitis, pneumonia, and upper respiratory tract infections
- Shortness of breath, blurred vision, cataract
- Kidney problems, abnormal liver values
- Raised blood sugar levels, headache, nosebleed
- Depression, mood changes, insomnia, dry skin, cough
- Dehydration, weight loss
Common Side Effects
- Haemolytic anaemia (breakdown of red blood cells)
- Certain types of skin tumour
- Bleeding from gums, stomach, or intestines
- High blood pressure, slow or fast or irregular heartbeat
- Darker skin, bruising, skin swelling filled with blood
- Increased uric acid in blood, increased sweating, night sweats
- Difficulty swallowing, sore throat, hoarseness
- Shortness of breath when lying down (possible heart failure)
- Stroke, fainting, dizziness, temporary loss of consciousness
- Chest pain radiating to arms, neck, jaw (possible heart attack)
- Muscle weakness, lack of energy, neck or chest pain
- Slow or blocked bile flow from liver
- Liver damage, impaired balance, difficulty moving, deafness, tinnitus
- Nerve pain, thirst, confusion, toothache, falls
Uncommon Side Effects
- Intracranial bleeding
- Circulatory problems, loss of vision
- Decreased libido
- Fanconi syndrome (kidney disorder with bone pain and weakness)
- Jaundice, liver failure
- Colitis, appendicitis
- Renal tubular necrosis (kidney cell damage)
- Changes in skin colour, sun sensitivity
- Tumour lysis syndrome (metabolic complications from dying cancer cells)
- Pulmonary hypertension (raised blood pressure in lung vessels)
Rare / Unknown Frequency
- Pancreatitis (sudden or worsening upper abdominal/back pain with nausea and fever)
- Interstitial lung disease (wheezing, shortness of breath, dry cough)
- Rhabdomyolysis (muscle breakdown leading to kidney problems)
- Leukocytoclastic vasculitis (inflamed small blood vessels with joint pain and fever)
- Gastrointestinal perforation (breakdown of stomach or intestinal wall)
- Viral infections including herpes zoster (shingles) and hepatitis B reactivation
- Solid organ transplant rejection
It is important to note that a small proportion of patients may develop other types of cancer (secondary malignancies) during lenalidomide treatment. Your doctor should carefully evaluate the benefits and risks when prescribing this medication.
How Should You Store Lenalidomid Medical Valley?
Store Lenalidomid Medical Valley out of the sight and reach of children. No special storage conditions are required. Do not use the capsules after the expiry date printed on the blister and carton.
Keep this medicine out of the sight and reach of children at all times. Given the potential for severe birth defects, it is especially important that this medicine is stored securely and cannot be accessed by pregnant women or children.
Do not use Lenalidomid Medical Valley after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month. There are no special storage requirements – store at room temperature.
Do not use this medicine if the packaging is damaged or shows signs of tampering. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment and prevent accidental exposure.
What Does Lenalidomid Medical Valley Contain?
The active substance is lenalidomide, available in hard capsules at seven strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. The capsules contain lactose and are colour-coded for easy identification.
Each hard capsule contains lenalidomide as the active ingredient. The inactive ingredients (excipients) are the same across all strengths:
- Capsule contents: Lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate
- Capsule shell: Gelatin, titanium dioxide (E 171), and various iron oxides (E 172) and colorants depending on the strength
- Printing ink: Shellac, propylene glycol (E 1520), black iron oxide (E 172), and potassium hydroxide
| Strength | Capsule Appearance | Imprint |
|---|---|---|
| 2.5 mg | Dark blue cap / light orange body, size 4 (14–15 mm) | LP / 637 |
| 5 mg | Green cap / light brown body, size 2 (18–19 mm) | LP / 638 |
| 7.5 mg | Purple cap / pink body, size 1 (19–20 mm) | LP / 643 |
| 10 mg | Yellow cap / grey body, size 0 (21–22 mm) | LP / 639 |
| 15 mg | Brown cap / grey body, size 2 (18–19 mm) | LP / 640 |
| 20 mg | Dark red cap / light grey body, size 1 (19–20 mm) | LP / 641 |
| 25 mg | White cap / white body, size 0 (21–22 mm) | LP / 642 |
All capsules are filled with white powder. Lenalidomid Medical Valley is available in PVC/PCTFE/aluminium blisters. Pack sizes include 7, 21, or 7 × 1 capsules (perforated unit-dose blisters). Not all pack sizes may be marketed in every country.
The marketing authorisation holder is Medical Valley Invest AB, Sweden. The medicine is manufactured by Pharmadox Healthcare Ltd. (Malta) and Adalvo Ltd. (Malta).
Frequently Asked Questions About Lenalidomid Medical Valley
Lenalidomid Medical Valley contains the active substance lenalidomide and is used to treat four types of blood cancer in adults: multiple myeloma (as maintenance after transplant, or in combination with other medicines for newly diagnosed or previously treated patients), myelodysplastic syndromes (MDS) with a specific chromosomal abnormality called deletion 5q, mantle cell lymphoma (MCL) that has been previously treated, and follicular lymphoma (FL) in combination with rituximab. It is an immunomodulatory agent that works by stimulating the immune system, stopping cancer cell growth, and preventing tumour blood vessel formation.
Lenalidomide is a structural analogue of thalidomide, a drug that was responsible for thousands of severe birth defects in the 1950s and 1960s. Lenalidomide is expected to cause the same types of devastating defects if taken during pregnancy. To prevent any possibility of foetal exposure, both male and female patients must follow strict contraception rules. Women must use effective contraception for 4 weeks before, during, and 4 weeks after treatment, with regular pregnancy tests. Men must use condoms throughout treatment and for 7 days after, as lenalidomide is present in semen. Blood donation is also prohibited during and for 7 days after treatment.
Regular blood tests are essential because lenalidomide can significantly reduce blood cell counts. For multiple myeloma and MDS patients, blood counts are checked before treatment, then weekly for the first 8 weeks, and at least monthly thereafter. For MCL patients, tests are performed weekly for the first 8 weeks (2 cycles), then every two weeks for cycles 3–4, and monthly from then on. For FL patients, tests are weekly for the first 3 weeks (1 cycle), then every two weeks for cycles 2–4, and monthly thereafter. Your doctor may also monitor liver function, kidney function, and thyroid function at regular intervals.
Yes, lenalidomide significantly increases the risk of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism. This risk is particularly elevated when lenalidomide is combined with dexamethasone, erythropoiesis-stimulating agents, or other chemotherapy drugs. Your doctor will likely prescribe prophylactic anticoagulant or antiplatelet therapy, particularly during the first few months of treatment. You should report any leg pain, swelling, chest pain, or sudden shortness of breath to your doctor immediately, as these may be signs of a blood clot.
Lenalidomid Medical Valley is a generic formulation of lenalidomide, while Revlimid is the original (brand-name) product developed by Bristol-Myers Squibb (originally Celgene). Both contain the same active substance (lenalidomide) at the same strengths and have been shown to be bioequivalent, meaning they are absorbed and work in the body in the same way. Lenalidomid Medical Valley has been approved by the European Medicines Agency (EMA) based on demonstrated pharmaceutical equivalence and bioequivalence with the reference product. The main difference is the manufacturer and the price, with generic formulations typically being more affordable.
The duration of treatment depends on the condition being treated and how well you respond. For multiple myeloma maintenance after transplant, treatment often continues for years until disease progression or unacceptable side effects. For newly diagnosed myeloma not eligible for transplant, treatment with lenalidomide and dexamethasone typically continues until progression. For MDS, treatment continues as long as the patient benefits. For MCL, treatment continues until progression. For follicular lymphoma, the standard protocol is up to 12 cycles (approximately 12 months) of lenalidomide in combination with rituximab. Your doctor will regularly assess whether you should continue treatment.
References
- European Medicines Agency (EMA). Lenalidomide – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed December 2025. [Evidence Level: Regulatory]
- Dimopoulos MA, et al. "Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma." New England Journal of Medicine. 2007;357(21):2123–2132. doi:10.1056/NEJMoa070594. [Evidence Level: 1A]
- Benboubker L, et al. "Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma (FIRST trial)." New England Journal of Medicine. 2014;371(10):906–917. doi:10.1056/NEJMoa1402551. [Evidence Level: 1A]
- McCarthy PL, et al. "Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis." Journal of Clinical Oncology. 2017;35(29):3279–3289. doi:10.1200/JCO.2017.72.6679. [Evidence Level: 1A]
- List A, et al. "Lenalidomide in the Myelodysplastic Syndrome with Chromosome 5q Deletion (MDS-004)." New England Journal of Medicine. 2006;355(14):1456–1465. doi:10.1056/NEJMoa061292. [Evidence Level: 1A]
- Leonard JP, et al. "AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma." Journal of Clinical Oncology. 2019;37(14):1188–1199. doi:10.1200/JCO.19.00010. [Evidence Level: 1A]
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 2.2025. Available at: www.nccn.org. [Evidence Level: Guideline]
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. [Evidence Level: Guideline]
- National Institute for Health and Care Excellence (NICE). Technology Appraisals: Lenalidomide for multiple myeloma and MDS. Available at: www.nice.org.uk. [Evidence Level: Guideline]
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in haematology, oncology, and clinical pharmacology. All content follows the GRADE evidence framework and is based on peer-reviewed research, international guidelines (EMA, FDA, WHO, NCCN, NICE), and current best clinical practice.
iMedic Medical Editorial Team – specialists in haematology and oncology with clinical experience in myeloma and lymphoma treatment.
iMedic Medical Review Board – independent panel of physicians ensuring accuracy according to international guidelines and current evidence.
Last medical review:
Evidence level: 1A – Based on systematic reviews and randomised controlled trials
Conflict of interest: None. iMedic receives no pharmaceutical industry funding.