Lenalidomide

Lenalidomide

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
  • Chills
  • Convulsions
  • 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 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
  • Wheezing

Incidence not known

  • Anxiety
  • Dizziness or lightheadedness
  • Fainting
  • 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
  • Bruising
  • Burning while urinating
  • Burning, numbness, tingling, or painful sensations
  • Change in taste
  • Constipation
  • Contusion
  • Cough-producing mucus
  • Depressed mood
  • Diarrhea
  • Difficulty having a bowel movement (stool)
  • Difficulty with moving
  • Discouragement
  • Drowsiness
  • 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
  • Headache
  • Hoarseness or husky voice
  • Irritability
  • 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
  • Nervousness
  • Night sweats
  • Pain
  • Pain in the arms or legs
  • Pain in joints
  • Pain or tenderness around the eyes and cheekbones
  • Pounding in the ears
  • Rash
  • Runny nose
  • Seizures
  • Shivering
  • Sleeplessness
  • Sneezing
  • 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
  • Tiredness
  • Trembling
  • 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
  • Vomiting
  • 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.

Precautions

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.

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 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.

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—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.

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.

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.

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.

Pregnancy

Pregnancy Category Explanation
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.

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:

  • 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.

Description

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).

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