Generic Name: lenalidomide (Oral route)
- Potential for Human Birth Defects:
- Lenalidomide is an analogue of thalidomide. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Females should be advised to avoid pregnancy while taking lenalidomide.
- Special prescribing requirements: Because of this potential toxicity and to avoid fetal exposure to lenalidomide, lenalidomide is only available under a special restricted distribution program. This program is called RevAssist(R). Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, lenalidomide must only be dispensed to patients who are registered and meet all the conditions of the RevAssist(R) program. Please see the following information for prescribers, female patients, and male patients about this restricted distribution program.
- RevAssist(R) Program Description:
- PRESCRIBERS: Lenalidomide can be prescribed only by licensed prescribers who are registered in the RevAssist(R) program and understand the potential risk of teratogenicity if lenalidomide is used during pregnancy. Effective contraception must be used by female patients of childbearing potential for at least 4 weeks before beginning lenalidomide therapy, during lenalidomide therapy, during dose interruptions and for 4 weeks following discontinuation of lenalidomide therapy. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or because the patient has been postmenopausal naturally for at least 24 consecutive months. Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method. Females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed. Sexually mature females who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal naturally for at least 24 consecutive months (ie, who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential.
- Before prescribing lenalidomide, females of childbearing potential should have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL). The first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing lenalidomide. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
- Male patients: It is not known whether lenalidomide is present in the semen of patients receiving the drug. Therefore, males receiving lenalidomide must always use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy.
- Once treatment has started and during dose interruptions, pregnancy testing for females of childbearing potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in ther pregnancy test or in her menstrual bleeding. Lenalidomide treatment must be discontinued during this evaluation.
- Pregnancy test results should be verified by the prescriber and the pharmacist prior to dispensing any prescription.
- If pregnancy does occur during lenalidomide treatment, lenalidomide must be discontinued immediately.
- Any suspected fetal exposure to lenalidomide should be reported to the FDA via the MedWatch number at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
- FEMALE PATIENTS: Lenalidomide should be used in females of childbearing potential only when the patient meets all of the following conditions (ie, she is unable to become pregnant while on lenalidomide therapy):
- she understands and can reliably carry out instructions.
- she is capable of complying with the mandatory contraceptive measures, pregnancy testing, patient registration, and patient survey as described in the RevAssist(R) program.
- she has received and understands both oral and written warnings of the potential risks of taking lenalidomide during pregnancy and of exposing a fetus to the drug.
- she has received both oral and written warnings of the risk of possible contraception failure and of the need to use two reliable forms of contraception simultaneously, unless continuous abstinence from heterosexual sexual contact is the chosen method. Sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (ie, who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential.
- she acknowledges, in writing, her understanding of these warnings and of the need for using two reliable methods of contraception for 4 weeks prior to beginning lenalidomide therapy, during lenalidomide therapy, during dose interruptions and for 4 weeks after discontinuation of lenalidomide therapy.
- she has had two negative pregnancy tests with a sensitivity of at least 50 mIU/mL, within 10 to 14 days and 24 hours prior to beginning therapy.
- if the patient is between 12 and 18 years of age, her parent or legal guardian must have read the educational materials and agreed to ensure compliance with the above.
- MALE PATIENTS: Lenalidomide should be used in sexually active males when the patient meets all of the following conditions:
- he understands and can reliably carry out instructions.
- he is capable of complying with the mandatory contraceptive measures that are appropriate for men, patient registration, and patient survey as described in the RevAssist(R) program.
- he has received and understands both oral and written warnings of the potential risks of taking lenalidomide and exposing a fetus to the drug.
- he has received both oral and written warnings of the risk of possible contraception failure and that it is unknown whether lenalidomide is present in semen. He has been instructed that he must always use a latex condom during any sexual contact with females of childbearing potential, even if he has undergone a successful vasectomy.
- he acknowledges, in writing, his understanding of these warnings and of the need to use a latex condom during any sexual contact with females of childbearing potential, even if he has undergone a successful vasectomy. Females of childbearing potential are considered to be sexually mature females who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal for at least 24 consecutive months (ie, who have had menses at any time in the preceding 24 consecutive months).
- if the patient is between 12 and 18 years of age, his parent or legal guardian must have read the educational material and agreed to ensure compliance with the above.
- Hematologic Toxicity (Neutropenia and Thrombocytopenia):
- This drug is associated with significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.
- Deep Venous Thrombosis and Pulmonary Embolism:
- This drug has demonstrated a significantly increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with lenalidomide combination therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with lenalidomide may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient's underlying risk factors.
- You can get the information about lenalidomide and the RevAssist(R) program on the internet at www.revlimid.com or by calling the manufacturer's toll free number 1-888-423-5436 .
Lenalidomide may cause human birth defects, hematological toxicity (neutropenia and thrombocytopenia), deep vein thrombosis (DVT), and pulmonary embolism (PE). Lenalidomide is an analogue of thalidomide, a known human teratogen that causes severe life-threatening human birth defects. If taken during pregnancy, lenalidomide may cause birth defects or death to an unborn baby. Avoid pregnancy due to potential toxicity and to avoid fetal exposure. Lenalidomide is only available under a special restricted distribution program called RevAssist(R). Lenalidomide is associated with significant neutropenia and thrombocytopenia in patients with del 5q myelodysplastic syndromes. CBC should be monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction and the use of blood product support and/or growth factors. There is an increased risk of DVT and PE in patients with multiple myeloma who receive lenalidomide. Observe patients for signs and symptoms of thromboembolism .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Modulator
Uses For Revlimid
Lenalidomide is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS) called 5q MDS. Patients with this type of MDS may have very low red blood cell counts and require blood transfusions.
Lenalidomide is also used in combination with dexamathasone to treat multiple myeloma (plasma cell cancer) in patients who have received at least one prior therapy.
This medicine is available only under a special restricted distribution program called RevAssist® program.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, lenalidomide is used in certain patients with the following medical condition:
- Multiple myeloma, first-line treatment, in combination with dexamethasone (treatment of bone marrow cancer; used together with dexamethasone).
Before Using Revlimid
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of lenalidomide in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenalidomide in the elderly.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Neutropenia (low white blood cells) or
- Thrombocytopenia (low platelets)—Use with caution. May make these conditions worse.
- Infection—May decrease your ability to fight infections.
- Kidney disease, severe—May increase the amount of lenalidomide in your body and increase the risk of side effects.
- Liver disease—Use caution as studies have not been done.
- Multiple myeloma—May increase your risk for serious side effects.
Proper Use of Revlimid
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.
It is very important that you understand the requirements of the RevAssist® program, and become familiar with the RevAssist® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting lenalidomide therapy. .
You should take the necessary precautions to avoid pregnancy while taking lenalidomide. Use one highly effective form of birth control plus an additional effective form of birth control at the same time, if abstinence is not the chosen method. Begin this 4 weeks before starting lenalidomide and continue it for 4 weeks after stopping the medication.
There is a telephone survey and patient registry that you must participate in while taking lenalidomide. Ask your doctor or pharmacist if you have any questions about what you need to do.
Swallow the capsule whole, do not break, chew, or open it.
It is important that you have blood tests at regular intervals. Keep all appointments with your doctor for the tests.
It is important that you have pregnancy tests at regular intervals.
Male patients, even those who have had a vasectomy, must use a latex condom during sexual contact with a female patient.
Male patients: Do not donate semen or sperm while taking lenalidomide.
Do not donate blood while taking lenalidomide.
You should not share this medication with anyone, even if someone else has similar symptoms.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For anemia in patients with myelodysplastic syndrome:
- Adults—10 milligrams (mg) once a day, taken with water. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma:
- Adults—25 milligrams (mg) once a day, taken with water. This medicine may be taken together with dexamethasone. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Revlimid
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.
Your doctor will want to see you every 4 weeks for pregnancy tests if you have a regular menstrual cycle, and every 2 weeks if you have an irregular cycle.
Call your doctor or 1-888-688-2528 for emergency contraception information if you think you are pregnant or, for males, if you think that your sexual partner may be pregnant.
Seek medical attention if you develop any shortness of breath, chest pain, or arm or leg swelling.
Do not breastfeed while you are using this medicine.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
Revlimid Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- decreased urine
- difficult or labored breathing
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- unusual bleeding or bruising
- unusual tiredness or weakness
- dizziness or lightheadedness
- fast heartbeat
- pain, redness, or swelling in the arm or leg
- sudden shortness of breath or troubled breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abnormal or decreased touch sensation
- back pain
- bloody nose
- blurred vision
- body aches or pain
- burning while urinating
- burning, numbness, tingling, or painful sensations
- change in taste
- cough-producing mucus
- depressed mood
- difficulty having a bowel movement (stool)
- difficulty with moving
- dry skin and hair
- dryness or soreness of the throat
- ear congestion
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- feeling sad or empty
- feeling unusually cold
- flushing, redness of the skin
- hair loss
- hoarseness or husky voice
- itching skin
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- lack or loss of strength
- large, flat, blue or purplish patches in the skin
- loose stools
- loss of appetite
- loss of interest or pleasure
- loss of taste
- loss of voice
- muscle aching
- muscle spasms, stiffness, or twitching
- nasal congestion
- night sweats
- pain in the arms or legs
- pain in joints
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- runny nose
- stomach pain
- stuffy or runny nose
- sweating increased
- swelling of the hands, ankles, feet, or lower legs
- swollen joints
- tender, swollen glands in the neck
- trouble with concentrating
- trouble with sleeping
- trouble with swallowing
- troubled breathing with exertion
- unable to sleep
- unsteadiness or awkwardness
- unusually warm skin
- upper abdomen or stomach pain
- voice changes
- weakness in the arms, hands, legs, or feet
- weight gain
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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- Revlimid Prescribing Information (FDA)
- Revlimid MedFacts Consumer Leaflet (Wolters Kluwer)
- Revlimid Consumer Overview
- Lenalidomide Professional Patient Advice (Wolters Kluwer)