Description
Lenalidomide is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS). Patients with MDS may have very low red blood cell counts and require blood transfusions.
Lenalidomide is also used in combination with dexamethasone to treat multiple myeloma (plasma cell cancer). It is also used as maintenance treatment in patients with multiple myeloma after an autologous hematopoietic stem cell transplant (stem cell transplant that uses your own stem cells).
Lenalidomide is also used to treat mantle cell lymphoma (MCL) in patients who have been treated previously with bortezomib and one additional medicine that did not work well.
Lenalidomide is also used together with rituximab to treat previously treated follicular lymphoma (FL) and marginal zone lymphoma (MZL).
This medicine is available only under a restricted distribution program called the Lenalidomide REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Capsule
Before Using
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:
Allergies
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenalidomide in the elderly. However, elderly patients are more likely to have blood clotting problems, heart rhythm problem (eg, atrial fibrillation), and kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Digoxin
Other Interactions
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:
- Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
- Heart attack, recent or
- Liver disease or
- Neutropenia (low number of white blood cells) or
- Stroke, history of or
- Thrombocytopenia (low number of platelets) or
- Thyroid problems—Use with caution. May make these conditions worse.
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Hypertension (high blood pressure) or
- Smoking—May increase risk for more serious side effects.
- Infection—May decrease your body's ability to fight infections.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Lactose-intolerance—This medicine contains lactose, which can make this condition worse.
Proper Use
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 first checking with your doctor.
It is very important that you understand the rules of the Lenalidomide REMS program. Read the patient Medication Guide. Ask your doctor or pharmacist if you have any questions. You might be asked to sign a form to show that you understand the information.
Swallow the capsule whole with water. Do not break, chew, or open it. If you accidentally open the capsule and have contact with the powder, wash your skin with soap and clear water. If the medicine gets into your eyes, nose, or mouth, rinse them well with water.
Take this medicine at the same way each day. Take it at the same time and take it consistently, either with or without food.
Dosing
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—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For follicular lymphoma or marginal zone lymphoma:
- Adults—At first, 20 milligrams (mg) once a day. This medicine is taken on Days 1 to 21 of repeated 28-day cycles for up to 12 cycles. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For mantle cell lymphoma:
- Adults—At first, 25 milligrams (mg) once a day. This medicine is taken on Days 1 to 21 of repeated 28-day cycles. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma after stem cell transplant:
- Adults—At first, 10 milligrams (mg) once a day. This medicine is taken on Days 1 to 28 of repeated 28-day cycles. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma in combination with dexamethasone:
- Adults—At first, 25 milligrams (mg) once a day. This medicine is taken on Days 1 to 21 of repeated 28-day cycles. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For anemia in patients with myelodysplastic syndrome:
Missed Dose
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.
If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can, then take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your regular time, skip the missed dose and take your next dose at the normal time.
Storage
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.
Return unused capsules to your doctor or pharmacist.
Precautions
It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.
Women should take the necessary precautions to avoid pregnancy while using lenalidomide. Begin 2 forms of reliable contraception 4 weeks before starting lenalidomide. Continue contraceptive measures during treatment and for at least 4 weeks after the last dose. Routine pregnancy tests are necessary with this medicine. Call your doctor for emergency contraception information if you think you are pregnant.
Men, even those who have had a vasectomy, must prevent pregnancy in their sexual partners during treatment with this medicine and for at least 4 weeks after the last dose. Do not donate sperm while using this medicine. Call your doctor for emergency contraception information if you think your sexual partner may be pregnant.
Do not donate blood during treatment and for at least 4 weeks after the last dose.
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.
This medicine may increase your risk of having blood clots. Check with your doctor right away if you have anxiety, chest pain, fainting, a fast heartbeat, trouble breathing, or pain, redness, or swelling in the arm or leg.
This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, high cholesterol, or if you smoke. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea, vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, or trouble breathing.
Do not receive pembrolizumab together with dexamethasone and lenalidomide or similar medicines if you have multiple myeloma.
Serious liver problems can occur with this medicine. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow skin or eyes.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are using this medicine.
Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. 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.
This medicine may increase your risk of getting certain cancers (eg, acute myelogenous leukemia, myelodysplastic syndrome). Talk to your doctor if you have concerns about this risk.
This medicine may cause a tumor flare reaction. Tell your doctor if you have swollen and painful lymph nodes, a mild fever, pain, or a rash.
This medicine may cause a serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or trouble swallowing after using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain or tightness
- chills
- cough
- decreased urine
- difficult or labored breathing
- dry mouth
- fever
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Burning or stinging of the skin
- chest discomfort
- confusion
- difficulty with speaking
- dilated neck veins
- double vision
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular breathing
- pain or discomfort in the arms, jaw, back or neck
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- slow speech
- sweating
- swelling of the face, fingers, feet, or lower legs
- weight gain
Incidence not known
- Anxiety
- blistering, peeling, or loosening of the skin
- clay-colored stools
- dark urine
- depressed mood
- diarrhea
- difficulty having a bowel movement
- difficulty swallowing
- dizziness or lightheadedness
- dry skin and hair
- fainting
- fast heartbeat
- feeling cold
- general feeling of tiredness or weakness
- hair loss
- hives, itching, skin rash
- hoarseness or husky voice
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle cramps and stiffness
- pain, redness, or swelling in the arm or leg
- red skin lesions, often with a purple center
- red, irritated eyes
- sensitivity to heat
- slowed heartbeat
- stomach pain, continuing
- swelling of the feet or lower legs
- trouble sleeping
- trouble breathing
- unpleasant breath odor
- vomiting of blood
- weight loss
- yellow eyes or skin
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
- bloody nose
- blurred vision
- body aches or pain
- burning feeling while urinating
- burning, numbness, tingling, or painful sensations
- change in taste
- cough-producing mucus
- difficulty with moving
- drowsiness or tiredness
- ear congestion
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- flushing or redness of the skin
- increased sweating or night sweats
- irritability
- 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 interest or pleasure
- muscle spasms or twitching
- pain or tenderness around the eyes and cheekbones
- shivering
- tender, swollen glands in the neck
- trembling
- trouble concentrating
- unsteadiness or awkwardness
- upper abdomen or stomach pain
- voice changes
- weakness in the arms, hands, legs, or feet
Incidence not known
- Feeling of constant movement of self or surroundings
- sensation of spinning
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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