Revlimid

Pronunciation

Generic Name: lenalidomide (Oral route)

len-a-LID-oh-mide

Oral route(Capsule)

Fetal Risk: Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception. Lenalidomide is available only under a restricted distribution program called REVLIMID REMS(TM). Hematologic Toxicity: Lenalidomide can cause significant neutropenia and thrombocytopenia. For patients with del 5q myelodysplastic syndromes, monitor CBC weekly for the first 8 weeks of therapy and monthly thereafter. DVT and Pulmonary Embolism: Significantly increased risk of DVT and PE in patients with multiple myeloma receiving lenalidomide with dexamethasone .

Commonly used brand name(s)

In the U.S.

  • Revlimid

Available Dosage Forms:

  • Capsule

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). Patients with MDS may have very low red blood cell counts and require blood transfusions.

Lenalidomide is also used together with dexamethasone to treat multiple myeloma (plasma cell cancer) in patients who have received at least one previous treatment with another medicine.

Slideshow: Flashback: FDA Drug Approvals 2013

Lenalidomide is also used to treat mantle cell lymphoma (MCL) in patients who have been treated previously with bortezomib plus one additional medicine that did not work well.

This medicine is available only with your doctor's prescription and through a special restricted distribution program called the Revlimid® REMS 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:

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.

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.

Breast Feeding

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

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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Itraconazole

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

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:

  • Blood clotting problems or
  • Deep vein thrombosis (blood clot in leg), history of or
  • Liver disease or
  • Neutropenia (low number of white blood cells) or
  • Pulmonary embolism (blood clot in lung), history of or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infections.
  • Kidney disease, severe—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 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 first checking with your doctor.

It is very important that you understand the rules of the Revlimid® 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. 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 with water.

Take this medicine at the same time each day. This means 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, taken with water. 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, taken with water. 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:
      • Adults—At first, 25 milligrams (mg) once a day, taken with water. 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.

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 and 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.

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.

Women should take the necessary precautions to avoid pregnancy while taking lenalidomide. Begin 2 forms of reliable contraception 4 weeks before starting lenalidomide, and continue contraceptive measures during therapy and for 4 weeks after the last dose. Routine pregnancy tests are necessary with this medicine. Call your doctor or 1-888-668-2528 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 therapy and for 4 weeks after the last dose. Do not donate sperm while taking this medicine. Call your doctor or 1-888-668-2528 for emergency contraception information if you think your sexual partner may be pregnant.

Do not donate blood during therapy and for 1 month 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 the following symptoms: anxiety, chest pain, fainting, a fast heartbeat, sudden shortness of breath or troubled breathing, or pain, redness, or swelling in the arm or leg.

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.

Serious liver problems can occur with this medicine. Your doctor may order blood tests to monitor your liver. Check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

This medicine may increase your risk of getting certain cancers (eg, acute myelogenous leukemia, Hodgkin lymphoma). 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.

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.

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
  • 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
  • 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
Incidence not known
  • Anxiety
  • blistering, peeling, or loosening of the skin
  • clay-colored stools
  • dark-colored urine
  • depressed mood
  • diarrhea
  • difficulty having a bowel movement (stool)
  • dizziness or lightheadedness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • general feeling of tiredness or weakness
  • hair loss
  • headache
  • hoarseness or husky voice
  • itching
  • 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
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • slowed heartbeat
  • stomach pain, continuing
  • sudden shortness of breath or troubled breathing
  • sweating
  • swelling of the feet or lower legs
  • trouble sleeping
  • unpleasant breath odor
  • vomiting of blood
  • weight gain or 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
  • bruising
  • burning 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, stiffness, or twitching
  • pain or tenderness around the eyes and cheekbones
  • seizures
  • shivering
  • tender, swollen glands in the neck
  • trembling
  • trouble with concentrating
  • trouble with swallowing
  • unsteadiness or awkwardness
  • upper abdomen or stomach pain
  • voice changes
  • weakness in the arms, hands, legs, or feet

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.

See also: Side effects (in more detail)

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