Pronunciation:

len-a-LID-oh-mide

Brand Names:

• Revlimid

Dosage Forms:

• Capsule

Warnings:

Embryo-Fetal Toxicity, Hematologic Toxicity, and Venous and Arterial ThromboembolismEmbryo-Fetal ToxicityDo not use lenalidomide during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide treatment. To avoid embryo-fetal exposure to lenalidomide, lenalidomide is only available through a restricted distribution program, the Lenalidomide REMS programInformation about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the manufacturer’s toll-free number 1-888-423-5436Hematologic Toxicity (Neutropenia and Thrombocytopenia)Lenalidomide can cause 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.Venous and Arterial ThromboembolismLenalidomide has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with lenalidomide and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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 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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.