Revlimid

Revlimid 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. Revlimid is also used in combination with dexamethasone to treat multiple myelomas (plasma cell cancer).

Revlimid 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 RevlimidВ® 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.

Before using Revlimid, you must know all about the risks and complications associated with it. 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

Information about this lenalidomide-oral-routePregnancy 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.

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): 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 decreases 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 usage of Revlimid requires strict adherence to your doctor’s orders. 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 RevlimidВ® 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 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. Your doctor may adjust your dose as needed.
• Children: Use and dose must be determined by your doctor.

For mantle cell lymphoma:

• Adults: t 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 myelomas 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.

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.

Before using Revlimid, there are some precautions you must take. It is very important that your doctor checks 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.

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 or vomiting,
• pain or discomfort in the arms, jaw, back, or neck,
• shortness of breath, or sweating.

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.

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,
• 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,
• unusual tiredness or weakness.

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.

As with many medications, there are several potential side effects associated with Revlimid. 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

Less common:

• Chest discomfort
• confusion difficulty with speaking
• double vision
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• pain or discomfort in the arms, jaw, back or neck
• slow speech
• sweating

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
• the general feeling of tiredness or weakness
• hair loss
• hoarseness or husky voice
• itching or rash 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 sudden shortness of breath or troubled breathing
• 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
• the 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 concentrating
• trouble 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.