Lenalidomide, often sold under the brand name Revlimid, is an oral medication that belongs to a class of drugs called immunomodulatory agents. It has a variety of clinical applications, but is primarily used in the treatment of multiple myeloma and myelodysplastic syndromes.
Lenalidomide (Revlimid) is an immunomodulatory drug that is closely related to thalidomide. It is used in the treatment of patients with blood-related malignancies including multiple myeloma and lymphoma.
Lenalidomide Uses:
- Follicular lymphoma:
- It is used to treat formerly treated follicular lymphoma in adults in combination with rituximab product.
- Mantle cell lymphoma:
- Used to treat mantle cell lymphoma which has relapsed or advanced after 2 treatments, one of which consists of bortezomib.
- Marginal zone lymphoma:
- In adults, it is used to treat marginal zone lymphoma that has relapsed (in combination with rituximab).
- Multiple myeloma:
- In adults it is used to treat multiple myeloma in combination with dexamethasone; autologous hematopoietic stem cell transplantation followed by upkeep treatment.
- Myelodysplastic syndromes:
- In adults, it is used to treat transfusion-dependent anemia due to low or intermediate 1 risk myelodysplastic syndromes (MDS) associated with a deletion 5q (del 5q) cytogenetic abnormality with or without added cytogenetic anomalies.
- Limitations of use: It is not recommended in the treatment of CLL (outside clinical trials).
- Off Label Use of Lenalidomide in Adults:
- Multiple myeloma, newly detected.
- Prolonged lymphocytic leukemia, relapsed or stubborn.
- Systemic light chain amyloidosis
- Myelodysplastic syndrome without deletion 5q
- Diffuse large B-cell lymphoma relapsed or stubborn.
Lenalidomide (Revlimid) Dose in Adults:
Lenalidomide (Revlimid) Dose in the treatment of relapsed or refractory Chronic lymphocytic leukemia, (off-label):
Lenalidomide for Chronic Lymphocytic Leukemia (when other treatments haven't worked):
- How to Take It: Take lenalidomide by mouth (swallowing it).
- Dosage: Take 10 milligrams (mg) of lenalidomide once every day.
- When to Start: Start taking it on the 9th day of the treatment cycle. This is a repeating cycle of treatment.
- With What: Take lenalidomide along with another medicine called rituximab. Rituximab is given in cycles, too.
- Continuous Use: Keep taking lenalidomide and rituximab as long as your doctor tells you to, without stopping.
Lenalidomide (Revlimid) Dose in the treatment of relapsed or refractory diffuse large B-cell lymphoma (off-label):
Using Lenalidomide for Diffuse Large B-Cell Lymphoma (when other treatments haven't worked):
- How to Take It: Swallow lenalidomide, like a regular pill.
- Dosage: The amount you take is 25 milligrams (mg) each day.
- How Often: Take it daily for 21 days straight. After those 21 days, you take a break for 7 days. This whole 28-day period (21 days of taking the medicine followed by 7 days without) is considered one treatment cycle.
- Duration: Repeat this cycle for up to 1 year.
Lenalidomide (Revlimid) Dose in the treatment of Follicular lymphoma:
Using Lenalidomide for Follicular Lymphoma:
- How to Take It: Take lenalidomide like any regular pill by swallowing it.
- Dosage: Take 20 milligrams (mg) of it every day.
- How Often: Take the pill daily for 21 days in a row. Then, you won't take it for the next 7 days. This full 28 days (21 days on the pill and 7 days off) is one treatment round.
- With What: Also take another medicine called rituximab during this time.
- Duration: Repeat this 28-day treatment round up to 12 times in total.
Lenalidomide (Revlimid) Dose in the treatment of Mantle cell lymphoma:
Using Lenalidomide for Mantle Cell Lymphoma:
- How to Take It: Swallow lenalidomide like you would any pill.
- Dosage: Take 25 milligrams (mg) of it every day.
- How Often: Use the pill every day for 21 days straight. After these 21 days, take a break and don't use the pill for the next 7 days. This whole process (21 days taking the pill and 7 days not taking it) is one complete cycle.
- Duration: Keep doing this cycle until the lymphoma gets worse (progresses) or if the side effects become too much (unacceptable toxicity).
Lenalidomide (Revlimid) Dose in the treatment of Marginal zone lymphoma:
Using Lenalidomide for Marginal Zone Lymphoma:
- How to Take It: Take lenalidomide as you would any other pill, by swallowing it.
- Dosage: Every day, take 20 milligrams (mg) of the medicine.
- How Often: Take this pill daily for 21 days in a row. After that, take a 7-day break without the pill. This entire period (21 days with the pill and 7 days without) is one treatment cycle.
- With What: During this treatment, you'll also take another medicine called rituximab.
- Duration: Do this 28-day treatment cycle for up to 12 times.
Lenalidomide (Revlimid) Dose in the treatment of Multiple myeloma:
Using Lenalidomide for Multiple Myeloma:
- How to Take It: Just like other pills, you swallow lenalidomide.
- Dosage: Every day, take 25 milligrams (mg) of lenalidomide.
- How Often: Use this pill daily for 21 days straight. Then, take a 7-day break without it. Together, these 28 days (21 days on the pill and 7 days off) make up one treatment cycle.
- With What: Also, during this treatment, you'll take another medicine called dexamethasone. If you're over 75 years old, your doctor might give you a smaller dose of dexamethasone.
- Duration:
- If you're not going for a specific type of bone marrow transplant (autologous stem cell transplantation), keep taking the medicine until the cancer worsens or if there are too many side effects.
- If you are eligible for this bone marrow transplant, doctors will start preparing for the transplant (a process called hematopoietic stem cell mobilization) within the first 4 cycles of taking lenalidomide.
Lenalidomide (Revlimid) Dose in the maintenance treatment of Multiple myeloma (following autologous stem cell transplant):
Using Lenalidomide as Maintenance for Multiple Myeloma After Bone Marrow Transplant:
- How to Take It: You swallow lenalidomide just like any other pill.
- Dosage:
- Standard Dose: Start with 10 milligrams (mg) every day.
- After Recovery: You begin taking this after your blood counts have recovered enough (when ANC is 1,000/mm or more and platelets are 75,000/mm or more).
- Dose Increase: If you're doing well with the medication after 3 cycles (each cycle is 28 days), your doctor might increase the dose to 15 mg daily.
- How Often & Duration:
- Keep taking the medicine until the cancer starts growing again or if the side effects are too much to handle.
An Alternate (Off-label) Dose Suggested:
- Dosage: 10 mg every day.
- How Often: Take the pill daily for 21 days straight, then have a 7-day break without the pill. Together, this is one 28-day cycle.
- Duration: Continue this 28-day cycle until the cancer returns (relapse).
Lenalidomide (Revlimid) Dose in the treatment of newly diagnosed Multiple myeloma (off-label combination):
Using Lenalidomide for Newly Diagnosed Multiple Myeloma (using different off-label combinations):
Combination with Daratumumab and Dexamethasone:
- Dosage: Take 25 milligrams (mg) of lenalidomide each day.
- How Often: Swallow the pill every day for 21 days, then take a 7-day break. This makes up one 28-day cycle.
- Duration: Continue this pattern until the cancer gets worse or if there are strong side effects.
Combination with Bortezomib and Dexamethasone:
- Dosage: Take 25 mg of lenalidomide daily.
- How Often: Use the pill each day for 14 days, then have a 7-day break. This whole process counts as one 21-day cycle.
- Duration: Repeat this 21-day cycle for 8 times.
Combination with Carfilzomib and Dexamethasone:
- Dosage: Again, it's 25 mg of lenalidomide every day.
- How Often: Take the pill daily for 21 days followed by a 7-day break. This is a 28-day cycle.
- Duration: Do this 28-day cycle up to 8 times.
Lenalidomide (Revlimid) Dose in the treatment of relapsed Multiple myeloma (off-label combinations):
Using Lenalidomide for Relapsed Multiple Myeloma (off-label combinations):
- Combination with Carfilzomib and Dexamethasone:
- Dosage: Take 25 milligrams (mg) of lenalidomide daily.
- How Often: Use the pill daily for 21 days, then take a 7-day break. This completes one 28-day cycle.
- Duration: Continue this pattern until the cancer worsens or if there are severe side effects.
- Combination with Daratumumab and Dexamethasone:
- Dosage: Again, it's 25 mg of lenalidomide daily.
- How Often: Take the pill daily for 21 days, then have a 7-day break. This makes up one 28-day cycle.
- Duration: Keep doing this cycle until the cancer worsens or if the side effects become too much.
Lenalidomide (Revlimid) Dose in the treatment of Myelodysplastic syndrome with deletion 5q:
Using Lenalidomide for Myelodysplastic Syndrome with Deletion 5q:
- How to Take It: Swallow lenalidomide like a regular pill.
- Dosage: You'll take 10 milligrams (mg) of lenalidomide every day.
- How Often: Take the pill once daily.
- Duration: You keep taking the medication until either the disease gets worse or if the side effects become too much to handle.
Lenalidomide (Revlimid) Dose in the treatment of Myelodysplastic syndrome, lower risk, without deletion 5q (off-label):
Using Lenalidomide for Myelodysplastic Syndrome, Lower Risk, Without Deletion 5q (off-label use):
- How to Take It: Just like other pills, you swallow lenalidomide.
- Dosage: Take 10 milligrams (mg) of lenalidomide each day.
- How Often: Use the pill once daily.
Lenalidomide (Revlimid) Dose in the treatment of Systemic light chain amyloidosis (off-label):
Using Lenalidomide for Systemic Light Chain Amyloidosis (off-label use):
- How to Take It: Take lenalidomide just like any other pill, by swallowing it.
- Dosage: Every day, take 15 milligrams (mg) of lenalidomide.
- How Often: Use the pill daily for 21 days in a row. Then, take a 7-day break without the pill. This makes up one 28-day cycle.
- With What: During this treatment, you'll also take another medicine called dexamethasone.
Use in Children:
Not indicated.
Pregnancy Risk Category: X
- Risks: Lenalidomide can cause serious birth defects or even death to an unborn baby, similar to thalidomide.
- Warning: Never use lenalidomide during pregnancy.
- Testing Before Treatment: Women who can have babies should get two negative pregnancy tests before starting lenalidomide.
- Contraception: Women capable of getting pregnant must:
- Use two methods of birth control or avoid having heterosexual sex entirely.
- Start this 4 weeks before taking lenalidomide, during treatment, any treatment breaks, and for 4 weeks after ending the treatment.
- Special Program: Lenalidomide is available only under a special program called Revlimid REMS due to these risks. Only women who can follow the program's rules should take the drug.
- Pregnancy Testing During Treatment: Women who can have babies must test for pregnancy:
- Before starting treatment.
- Every week for the first 4 weeks.
- Then, every 4 weeks (or every 2 weeks if their periods are irregular).
- For Men:
- Lenalidomide is also in men's semen.
- Men should use a condom during any sexual activity with women who can have babies. This includes those who've had a vasectomy.
- This should be done during treatment, during any treatment breaks, and for 4 weeks after ending treatment.
- Men shouldn't donate sperm during this time.
- If Pregnancy Happens:
- Stop taking lenalidomide immediately if you miss a period, have an abnormal pregnancy test, or unusual menstrual bleeding.
- See a specialist if pregnancy occurs while on the drug.
Use while breastfeeding
- It's unclear if lenalidomide passes into breast milk.
- There's a risk of serious side effects for a baby if it does.
- The company that makes the drug recommends not breastfeeding while taking lenalidomide.
Lenalidomide (Revlimid) Dose in Kidney Disease:
Follicular Lymphoma and Marginal Zone Lymphoma:
- CrCl >60 mL/minute: Regular dose, no change.
- CrCl 30 to 60 mL/minute: Start with 10 mg/day. If tolerated, increase to 15 mg/day after 2 cycles.
- CrCl <30 mL/minute (no dialysis): 5 mg/day.
- CrCl <30 mL/minute (with dialysis): 5 mg/day (take after dialysis on dialysis days).
Mantle Cell Lymphoma and Multiple Myeloma (with dexamethasone):
- CrCl >60 mL/minute: Regular dose, no change.
- CrCl 30 to 60 mL/minute: 10 mg/day. For multiple myeloma, possibly increase to 15 mg/day after 2 cycles if tolerated.
- CrCl <30 mL/minute (no dialysis): 15 mg every other day.
- CrCl <30 mL/minute (with dialysis): 5 mg/day (take after dialysis on dialysis days).
Myelodysplastic Syndrome and Multiple Myeloma (after stem cell transplant):
- CrCl >60 mL/minute: Regular dose, no change.
- CrCl 30 to 60 mL/minute: 5 mg/day.
- CrCl <30 mL/minute (no dialysis): 2.5 mg/day.
- CrCl <30 mL/minute (with dialysis): 2.5 mg/day (take after dialysis on dialysis days).
International Myeloma Working Group (IMWG) Recommendations for Multiple Myeloma:
- Use specific formulas (CKD-EPI or MDRD) to measure kidney function.
- CrCl ≥60 mL/minute: 25 mg/day.
- CrCl 30 to 59 mL/minute: 10 mg/day, possibly 15 mg/day if no toxicity.
- CrCl 15 to 29 mL/minute: 15 mg every other day or adjust to 10 mg/day.
- CrCl <15 mL/minute: 5 mg/day.
- ESRD on dialysis: 5 mg/day.
For patients undergoing hemodialysis, about 30% of the drug is removed in a 4-hour session.
Dose in Liver disease:
Manufacturer's Labeling: The manufacturer's information doesn't include specific dosage adjustments for lenalidomide based on liver function because it hasn't been studied or provided.
Hepatic Metabolism: Lenalidomide doesn't go through significant processing in the liver.
May vary based on the indication.
Common Side Effects of Lenalidomide (Revlimid):
- Cardiovascular:
- Peripheral Edema
- Central Nervous System:
- Fatigue
- Dizziness
- Headache
- Paresthesia
- Dermatologic:
- Pruritus
- Skin Rash
- Xeroderma
- Endocrine & Metabolic:
- Weight Loss
- Hypokalemia
- Gastrointestinal:
- Diarrhea
- Nausea
- Constipation
- Gastroenteritis
- Decreased Appetite
- Abdominal Pain
- Vomiting
- Genitourinary:
- Urinary Tract Infection
- Hematologic & Oncologic:
- Thrombocytopenia
- Neutropenia
- Leukopenia
- Anemia
- Infection:
- Influenza
- Neuromuscular & Skeletal:
- Muscle Spasm
- Asthenia
- Arthralgia
- Back Pain
- Muscle Cramps
- Limb Pain
- Respiratory:
- Bronchitis
- Nasopharyngitis
- Cough
- Pneumonia
- Dyspnea
- Pharyngitis
- Epistaxis
- Upper Respiratory Tract Infection
- Rhinitis
- Sinusitis
- Miscellaneous:
- Fever
Less Common Side Effects Of Lenalidomide (Revlimid):
- Cardiovascular:
- Edema
- Hypotension
- Hypertension
- Chest Pain
- Palpitations
- Deep Vein Thrombosis
- Pulmonary Embolism
- Cardiac Failure
- Central Nervous System:
- Insomnia
- Peripheral Neuropathy
- Hypoesthesia
- Pain
- Myasthenia
- Rigors
- Chills
- Lethargy
- Vertigo
- Dermatologic:
- Night Sweats
- Diaphoresis
- Ecchymoses
- Erythema Of Skin
- Cellulitis
- Endocrine & Metabolic:
- Dehydration
- Hypothyroidism
- Hypomagnesemia
- Hypocalcemia
- Hyponatremia
- Gastrointestinal:
- Anorexia
- Upper Abdominal Pain
- Xerostomia
- Dysgeusia
- Loose Stools
- Oral Herpes Simplex Infection
- Genitourinary:
- Dysuria
- Urolithiasis
- Hematologic & Oncologic:
- Tumor Flare
- Bruise
- Lymphocytopenia
- Febrile Neutropenia
- Pancytopenia
- Squamous Cell Carcinoma Of Skin
- Granulocytopenia
- Myelodysplastic Syndrome
- Hepatic:
- Increased Serum Alanine Aminotransferase
- Hyperbilirubinemia
- Hypersensitivity:
- Hypersensitivity Reaction
- Infection:
- Herpes Zoster Infection
- Infection
- Sepsis
- Bacteremia
- Neuromuscular & Skeletal:
- Myalgia
- Swelling Of Extremities
- Musculoskeletal Pain
- Renal:
- Renal Failure Syndrome
- Respiratory:
- Oropharyngeal Pain
- Dyspnea On Exertion
- Pleural Effusion
- Rhinorrhea
- Pulmonary Infection
- Hypoxia
- Respiratory Distress
- Respiratory Tract Infection
- Miscellaneous:
- Physical Health Deterioration
- Troponin Increased In Blood Specimen
Frequency of side effects not defined:
- Cardiovascular:
- Acute Myocardial Infarction
- Angina Pectoris
- Arterial Thromboembolism
- Atrial Fibrillation (Including Exacerbation)
- Bradycardia
- Cardiac Disorder (Aortic Disorder)
- Cardiogenic Shock
- Cardiomyopathy
- Cerebral Infarction
- Cerebrovascular Accident
- Ischemia
- Ischemic Heart Disease
- Septic Shock
- Subarachnoid Hemorrhage
- Superficial Thrombophlebitis
- Supraventricular Cardiac Arrhythmia
- Supraventricular Tachycardia
- Tachyarrhythmia
- Thrombosis
- Transient Ischemic Attacks
- Venous Thromboembolism
- Ventricular Dysfunction
- Central Nervous System:
- Abnormal Gait
- Aphasia
- Cerebellar Infarction
- Confusion
- Depression
- Dysarthria
- Falling
- Impaired Consciousness
- Migraine
- Spinal Cord Compression
- Dermatologic:
- Erythema Multiforme
- Erythematous Rash
- Exfoliative Dermatitis
- Follicular Rash
- Macular Eruption
- Maculopapular Rash
- Papular Rash
- Pruritic Rash
- Pustular Rash
- Sweet's Syndrome
- Endocrine & Metabolic:
- Gout
- Gouty Arthritis
- Graves' Disease
- Hypernatremia
- Hypoglycemia
- Gastrointestinal:
- Biliary Obstruction
- Cholecystitis (May Be Acute)
- Clostridioides Difficile Associated Diarrhea
- Clostridioides Difficile Colitis
- Colonic Polyps
- Diverticulitis Of The Gastrointestinal Tract
- Dysphagia
- Gastritis
- Gastrointestinal Hemorrhage
- Gastrointestinal Pain
- Gastrointestinal Reflux Disease
- Infection Of Mouth
- Inguinal Hernia (Obstructive)
- Intestinal Obstruction (Small Intestine)
- Intestinal Perforation
- Irritable Bowel Syndrome
- Ischemic Colitis
- Lower Abdominal Pain
- Melena
- Pancreatitis
- Genitourinary:
- Abscess Of Rectum And/Or Peri-Rectal Area
- Azotemia
- Hematuria
- Pelvic Pain
- Urinary Tract Infection With Sepsis
- Hematologic & Oncologic:
- Acquired Blood Coagulation Disorder
- Acute Leukemia
- Basal Cell Carcinoma Of Skin
- Bone Marrow Depression
- Bronchogenic Carcinoma
- Decreased Hemoglobin
- Hemolysis
- Hemolytic Anemia
- Malignant Lymphoma
- Malignant Neoplasm Of Lung
- Myeloid Leukemia (Acute)
- Postprocedural Hemorrhage
- Progression Of Cancer
- Prostate Carcinoma
- Rectal Hemorrhage
- Splenic Infarction
- Warm Antibody Immunohemolytic Anemia
- Hepatic:
- Abnormal Hepatic Function Tests (May Be Transient)
- Hepatic Failure
- Hypersensitivity:
- Transfusion Reaction
- Infection:
- Fungal Infection
- Herpes Virus Infection
- Kidney Infection
- Localized Infection
- Pseudomonas Infection
- Staphylococcal Infection
- Local:
- Catheter Infection
- Neuromuscular & Skeletal:
- Arthritis (Including Exacerbation)
- Bone Fracture (Femur, Femoral Neck, Pelvis, Hip, Rib, Spinal Compression)
- Calcium Pyrophosphate Deposition Disease
- Neck Pain
- Otic:
- Otic Infection
- Renal:
- Acute Renal Failure
- Increased Serum Creatinine
- Respiratory:
- Acute Sinusitis
- Chronic Obstructive Pulmonary Disease (Includes Exacerbation)
- Interstitial Pulmonary Disease
- Lobar Pneumonia
- Pulmonary Edema
- Pulmonary Infiltrates
- Respiratory Failure
- Wheezing
- Miscellaneous:
- Accidental Injury (Traffic Accident)
- Mass (Renal)
- Nodule
Contraindication to Lenalidomide (Revlimid):
- If you've had a strong allergic reaction to lenalidomide or any part of the medicine. This can be reactions like severe skin rashes (like Stevens-Johnson syndrome or toxic epidermal necrolysis) or severe swelling (angioedema).
- If you're pregnant.
In Canada, there are additional reasons:
- If you're a patient with Myelodysplastic syndrome (MDS) and your platelet count is less than 50,000/mm.
- If you've had an allergic reaction to related drugs like thalidomide or pomalidomide.
- If you're a woman who can become pregnant.
- If you're breastfeeding.
- If you're a man and you can't or won't follow required birth control measures.
Warnings and precautions
Suppression of bone marrow: [US Boxed Warning]
- Lenalidomide can affect your bone marrow, leading to reduced blood cell counts.
- This can be severe, especially in certain conditions.
- Your doctor will need to check your blood counts regularly, possibly weekly at the start and then less often, to watch for any problems.
- If needed, they might adjust the dose or the timing of your treatment, and you might require additional support or growth factors to help your blood counts.
- Keep an eye out for signs of infection, bleeding, or bruising as well, as these could be related to the effects of the medication.
CNS effects
- Lenalidomide might make you feel dizzy or tired.
- If you're taking it, be careful when doing activities where you need to be alert, like driving or using machinery.
Dermatologic reactions
- Lenalidomide can cause severe skin problems.
- These include reactions like Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and another serious condition called DRESS which can affect the skin and other parts of the body.
- These reactions can be life-threatening.
- DRESS might show up as a skin rash, fever, swollen glands, and problems with organs like the liver or lungs.
- If you get a serious rash or any of these reactions, the medicine might need to be paused, changed, or even stopped.
- If you've had a severe rash from a related drug, thalidomide, you shouldn't take lenalidomide.
Hepatotoxicity
- Taking lenalidomide, especially with another drug called dexamethasone, can seriously harm the liver.
- In some cases, this has even led to death.
- This damage can show up in different ways in the liver.
- If you already have liver issues, are taking certain other medications, or had high liver enzyme levels before starting the drug, you might be at higher risk.
- It's crucial to keep a close watch on liver function while on this treatment.
- If tests show your liver isn't working right, the medicine might need to be paused.
- If things go back to normal, the treatment could possibly restart, but maybe at a lower dose.
Hypersensitivity
- Some people taking lenalidomide have had severe allergic reactions, like swelling (angioedema) or even life-threatening reactions called anaphylaxis.
- If you experience these, you should stop taking the medicine permanently.
Secondary malignancy
- Taking lenalidomide, especially when used for treating MDS and multiple myeloma, can increase the risk of developing other cancers.
- These could be blood-related cancers like AML and MDS, solid tumors, or skin cancers that aren't melanoma.
- The risk might be even higher when lenalidomide is combined with a certain type of chemotherapy drug known as an alkylating agent.
- Regular check-ups are essential to catch any new cancers early.
Thromboembolic Events: [US Boxed Warning]
- Lenalidomide, especially when taken with dexamethasone for multiple myeloma, can increase the risk of blood clots in both arteries and veins.
- This means there's a higher chance of getting deep vein clots (DVT), lung clots (PE), heart attacks, or strokes.
- Look out for signs like shortness of breath, chest pain, or swelling in the arms or legs.
- If you notice these, seek medical attention quickly.
- To reduce the risk, doctors often recommend medicines to prevent clots.
- The best prevention method depends on the patient's risk factors.
- Expert guidelines suggest using either aspirin or a specific type of blood thinner for patients with lower risks.
- For those with higher risks, a stronger blood thinner is recommended.
- Other medicines like those boosting red blood cells (ESAs) or estrogen can increase the clot risk even more.
- So, it's essential to use them carefully, especially if you have other risk factors like high cholesterol, high blood pressure, or if you smoke.
- Each patient's plan to prevent clots should be tailored to their individual situation and overall treatment plan.
Thyroid disorders
- aking lenalidomide can affect your thyroid, leading to either underactivity (hypothyroidism) or overactivity (hyperthyroidism) of the thyroid gland.
- Before starting the medicine, and then at regular intervals during treatment, it's a good idea to check how well your thyroid is working.
TumorFlare:
- When some people with chronic lymphocytic leukemia (CLL) or certain lymphomas take lenalidomide, their tumors can temporarily get worse before getting better.
- This is called "tumor flare".
- Symptoms might include a low fever, pain, skin rash, or swollen and tender lymph nodes.
- For people with certain types of lymphoma, it can look like the disease is getting worse.
- This flare mostly happens in the first treatment cycle.
- If you have a flare, your doctor might treat it with things like corticosteroids, painkillers, or anti-inflammatory drugs.
- In some cases, you might need to pause your lenalidomide treatment.
TumourThe lysis syndrome
- Tumor lysis syndrome is a serious condition where broken down tumor cells release their contents into the bloodstream.
- This has happened in some people taking lenalidomide, and it can be deadly.
- If you have a lot of tumor cells (high tumor burden), you're at higher risk.
- Signs include high uric acid levels in the blood.
Heart Failure:
- According to the American Heart Association, lenalidomide can cause heart problems or make existing heart issues worse.
- Specifically, it might directly harm the heart muscle or make a weak heart work even harder, which can lead to heart failure.
- If you're taking lenalidomide and feel any heart-related symptoms.
Mantle cell lymphoma
- In a study on people taking lenalidomide for mantle cell lymphoma, there were more deaths early on in the treatment (within 20 weeks).
- Those at higher risk had a lot of cancer cells, a high MIPI score (which helps predict how the disease might progress), and a high white blood cell count (above 10,000/mm) when they started the treatment.
Multiple myeloma
- In studies of patients with multiple myeloma, there were more deaths when they were treated with a combination of pembrolizumab (a type of immune therapy), a thalidomide-related drug (like lenalidomide or pomalidomide), and dexamethasone.
- Some of the reasons for death included severe heart issues, severe skin reactions like Stevens-Johnson syndrome, infections, organ failure, and even suicide.
- Because of these risks, using pembrolizumab with thalidomide-related drugs and dexamethasone isn't officially approved for treating multiple myeloma.
- If considering this treatment, it should only be done as part of a research study.
Renal impairment
- If you have kidney problems, be cautious when taking lenalidomide.
- Your body might not clear the drug as fast, which means it can stay in your system longer and increase the chance of side effects.
- If you have moderate to severe kidney problems or are on dialysis, you'll likely need a different starting dose.
Stem cell mobilization
- Taking lenalidomide for 4 or more cycles might reduce the number of specific cells (CD34+ cells) collected for personal use in stem cell transplants.
- If you're planning to have such a transplant and are on lenalidomide, it's crucial to coordinate with a transplant center.
- This will help make sure you get the most cells when they're collected.
- If lenalidomide affects your cell collection, other drugs like cyclophosphamide with G-CSF or G-CSF with a special kind of inhibitor (like plerixafor) might be used to help.
Lenalidomide: Drug Interaction
Bisphosphonate Derivatives |
Angiogenesis Inhibitors (Systemic) may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. |
Chloramphenicol (Ophthalmic) |
May enhance the adverse/toxic effect of Myelosuppressive Agents. |
CloZAPine |
Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. |
Coccidioides immitis Skin Test |
Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. |
Denosumab |
May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. |
Digoxin |
Lenalidomide may increase the serum concentration of Digoxin. |
Erythropoiesis-Stimulating Agents |
May enhance the thrombogenic effect of Lenalidomide. |
Estrogen Derivatives |
May enhance the thrombogenic effect of Lenalidomide. |
Mesalamine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
Ocrelizumab |
May enhance the immunosuppressive effect of Immunosuppressants. |
Pidotimod |
Immunosuppressants may diminish the therapeutic effect of Pidotimod. |
Promazine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
Siponimod |
Immunosuppressants may enhance the immunosuppressive effect of Siponimod. |
Smallpox and Monkeypox Vaccine (Live) |
Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). |
Tertomotide |
Immunosuppressants may diminish the therapeutic effect of Tertomotide. |
Trastuzumab |
May enhance the neutropenic effect of Immunosuppressants. |
Risk Factor D (Consider therapy modification) |
|
Baricitinib |
Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. |
Deferiprone |
|
DexAMETHasone (Systemic) |
May enhance the thrombogenic effect of Lenalidomide. |
Echinacea |
May diminish the therapeutic effect of Immunosuppressants. |
Fingolimod |
Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). |
Leflunomide |
Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. |
Nivolumab |
Immunosuppressants may diminish the therapeutic effect of Nivolumab. |
Roflumilast |
May enhance the immunosuppressive effect of Immunosuppressants. |
Sipuleucel-T |
Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. |
Tofacitinib |
Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. |
Vaccines (Inactivated) |
Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. |
Risk Factor X (Avoid combination) |
|
Abatacept |
Anti-TNF Agents may enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. |
Anakinra |
Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. |
BCG (Intravesical) |
Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). |
BCG (Intravesical) |
Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). |
Canakinumab |
Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. |
Certolizumab Pegol |
Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. |
Cladribine |
May enhance the immunosuppressive effect of Immunosuppressants. |
Cladribine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
Dipyrone |
May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased |
Natalizumab |
Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. |
Pembrolizumab |
May enhance the adverse/toxic effect of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. |
Pimecrolimus |
May enhance the adverse/toxic effect of Immunosuppressants. |
Rilonacept |
Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. |
Tacrolimus (Topical) |
May enhance the adverse/toxic effect of Immunosuppressants. |
Tocilizumab |
May enhance the immunosuppressive effect of Anti-TNF Agents. |
Upadacitinib |
Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. |
Vaccines (Live) |
Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). |
Vedolizumab |
Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. |
Monitoring parameters:
Blood Tests:
- Mantle Cell Lymphoma (MCL):
- Weekly for the first cycle.
- Every 2 weeks during cycles 2 to 4.
- Monthly thereafter.
- Myelodysplastic Syndromes (MDS):
- Weekly for the first 8 weeks.
- Monthly after that.
- Multiple Myeloma:
- Weekly for the first 2 cycles.
- Every 2 weeks during the third cycle.
- Monthly thereafter.
- Follicular and Marginal Zone Lymphoma:
- Weekly for the first 3 weeks of cycle 1.
- Every 2 weeks during cycles 2 to 4.
- Monthly thereafter.
Other Tests:
- Serum creatinine (kidney function).
- Liver function tests.
- Thyroid function tests: Check TSH at the start, then every 2-3 months during treatment.
- ECG: Only when needed based on symptoms or doctor's recommendation.
Symptoms to Watch For:
- Signs of infection (especially if white blood cell counts are low).
- New cancers.
- Blood clots.
- Skin reactions.
- Rapid breakdown of tumor cells (tumor lysis syndrome).
- Sudden worsening of the tumor (tumor flare reaction).
For Women Who Can Get Pregnant:
- Take a pregnancy test:
- 10-14 days before starting the drug.
- 24 hours before starting the drug.
- Weekly during the first month of treatment.
- Every 2-4 weeks after that, and continue until 4 weeks after stopping the drug.
General Monitoring:
- Keep track to ensure the patient is taking the medicine as prescribed (adherence monitoring).
How to administer Lenalidomide (Revlimid)?
- Timing:
- Take it around the same time every day.
- Use water to help swallow it.
- Food:
- You can take it with or without food.
- How to Swallow:
- Swallow the capsule whole.
- Don't break, open, or chew it.
If You Miss a Dose:
- If it's been less than 12 hours since your usual dosing time, go ahead and take the missed dose.
- If it's been more than 12 hours since you were supposed to take it, skip that day's dose. Continue with your regular schedule the next day.
- Don't double up. Never take two doses at once to make up for a missed one.
Mechanism of action of Lenalidomide (Revlimid):
How Lenalidomide Works:
1. Multiple Actions:
- Lenalidomide is versatile and works against cancer in several ways.
2. Controlling Inflammation:
- It helps control inflammation by reducing the release of certain chemicals (like tumor necrosis factor-alpha) that can worsen inflammation.
3. Boosting Immunity:
- The drug strengthens the body's immune response. It boosts the activity of certain immune cells (T cells) making them release chemicals that help fight off diseases.
4. Stopping Blood Vessel Growth:
- Tumors need blood vessels to grow. Lenalidomide slows down the process by which tumors get their own blood supply.
5. Stopping Tumor Growth:
- The drug prevents the growth of certain cancer cells (like myeloma, lymphoma, and myelodysplastic cells) by causing them to pause and ultimately die.
6. Enhancing Other Treatments:
- When combined with a drug called rituximab, lenalidomide helps increase the destruction of certain cancer cells and can even make the cancer cells more prone to death.
In simple terms, lenalidomide helps the body's own defense system fight the cancer better and prevents the cancer from growing and spreading.
Absorption:
- The body absorbs lenalidomide quickly after you take it.
Protein Binding:
- About 30% of lenalidomide binds to proteins in the blood.
Half-life:
- It takes about 3 to 5 hours for the amount of lenalidomide in the body to reduce by half.
Peak in Blood:
- For patients with MDS or myeloma, the highest amount of lenalidomide in the blood is seen between 0.5 to 6 hours after taking it.
How it Leaves the Body:
- The body gets rid of lenalidomide mainly through urine. About 82% is removed this way, and it's mostly unchanged when it leaves the body.
Hemodialysis Effect:
- If a patient is on hemodialysis (a procedure to clean the blood), about 30% of the lenalidomide in their body can be removed in a 4-hour session. For patients on hemodialysis, the body clears the drug much slower (an 80% decrease) compared to people without kidney problems.
International Brand Names of Lenalidomide:
- Revlimid
- Immunomide
- Ladevina
- Lenangio
- Linamide
Lenalidomide Brand Names in Pakistan:
Update soon.