Pronunciation:

le-na-LID-oh-mide

Brand Names:

• Revlimid

Dosage Forms:

• Capsule

Warnings:

• POTENTIAL FOR HUMAN BIRTH DEFECTS
  • Lenalidomide is an analogue of thalidomide. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Females should be advised to avoid pregnancy while taking lenalidomide.
  • SPECIAL PRESCRIBING REQUIREMENTS: Because of this potential toxicity and to avoid fetal exposure to lenalidomide, lenalidomide is only available under a special restricted distribution program. This program is called RevAssist(SM). Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, lenalidomide must only be dispensed to patients who are registered and meet all the conditions of the the RevAssist(SM) program. Please see the following information for prescribers, female patients, and male patients about this restricted distribution program.
  • REVASSIST(SM) PROGRAM DESCRIPTION
  • PRESCRIBERS: Lenalidomide can be prescribed only by licensed prescribers who are registered in the RevAssist(SM) program and understand the potential risk of teratogenicity if lenalidomide is used during pregnancy. Effective contraception must be used by female patients of childbearing potential for at least 4 weeks before beginning lenalidomide therapy, during lenalidomide therapy, during dose interruptions and for 4 weeks following discontinuation of lenalidomide therapy. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or because the patient has been postmenopausal naturally for at least 24 consecutive months. Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method. Females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed. Sexually mature females who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal naturally for at least 24 consecutive months (ie, who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential.
  • Before prescribing lenalidomide, FEMALES of childbearing potential should have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL). The first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing lenalidomide. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
  • For MALE patients, it is not known whether lenalidomide is present in the semen of patients receiving the drug. Therefore, males receiving lenalidomide must always use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy.
  • Once treatment has started and during dose interruptions, pregnancy testing for females of childbearing potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in ther pregnancy test or in her menstrual bleeding. Lenalidomide treatment must be discontinued during this evaluation.
  • Pregnancy test results should be verified by the prescriber and the pharmacist prior to dispensing any prescription.
  • If pregnancy does occur during lenalidomide treatment, lenalidomide must be discontinued immediately.
  • Any suspected fetal exposure to lenalidomide should be reported to the FDA via the MedWatch number at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
  • FEMALE PATIENTS: Lenalidomide should be used in females of childbearing potential only when the patient meets all of the following conditions (ie, she is unable to become pregnant while on lenalidomide therapy):
  • she understands and can reliably carry out instructions.
  • she is capable of complying with the mandatory contraceptive measures, pregnancy testing, patient registration, and patient survey as described in the RevAssist(SM) program.
  • she has received and understands both oral and written warnings of the potential risks of taking lenalidomide during pregnancy and of exposing a fetus to the drug.
  • she has received both oral and written warnings of the risk of possible contraception failure and of the need to use two reliable forms of contraception simultaneously, unless continuous abstinence from heterosexual sexual contact is the chosen method. Sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (ie, who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential.
  • she acknowledges, in writing, her understanding of these warnings and of the need for using two reliable methods of contraception for 4 weeks prior to beginning lenalidomide therapy, during lenalidomide therapy, during dose interruptions and for 4 weeks after discontinuation of lenalidomide therapy.
  • she has had two negative pregnancy tests with a sensitivity of at least 50 mIU/mL, within 10 to 14 days and 24 hours prior to beginning therapy.
  • if the patient is between 12 and 18 years of age, her parent or legal guardian must have read the educational materials and agreed to ensure compliance with the above.
  • MALE PATIENTS: Lenalidomide should be used in sexually active males when the PATIENT MEETS ALL OF THE FOLLOWING CONDITIONS:
  • he understands and can reliably carry out instructions.
  • he is capable of complying with the mandatory contraceptive measures that are appropriate for men, patient registration, and patient survey as described in the RevAssist(SM) program.
  • he has received and understands both oral and written warnings of the potential risks of taking lenalidomide and exposing a fetus to the drug.
  • he has received both oral and written warnings of the risk of possible contraception failure and that it is unknown whether lenalidomide is present in semen. He has been instructed that he must always use a latex condom during any sexual contact with females of childbearing potential, even if he has undergone a successful vasectomy.
  • he acknowledges, in writing, his understanding of these warnings and of the need to use a latex condom during any sexual contact with females of childbearing potential, even if he has undergone a successful vasectomy. Females of childbearing potential are considered to be sexually mature females who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal for at least 24 consecutive months (ie, who have had menses at any time in the preceding 24 consecutive months).
  • if the patient is between 12 and 18 years of age, his parent or legal guardian must have read the educational material and agreed to ensure compliance with the above.
• HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)
  • This drug is associated with 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 .
• DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM
  • This drug has demonstrated a significantly increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with lenalidomide combination therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with lenalidomide may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient's underlying risk factors
• You can get the information about lenalidomide and the RevAssist(SM) program on the internet at www.revlimid.com or by calling the manufacturer's toll free number 1-888-423-5436 .

Potential for human birth defects, hematological toxicity (neutropenia and thrombocytopenia), deep vein thrombosis (DVT), and pulmonary embolism (PE). Lenalidomide is an analogue of thalidomide, a known human teratogen that causes severe life-threatening human birth defects. If taken during pregnancy, it may cause birth defects or death to an unborn baby. Avoid pregnancy due to potential toxicity and to avoid fetal exposure. Lenalidomide is only available under a special restricted distribution program called RevAssist(SM). Associated with significant neutropenia and thrombocytopenia in patients with del 5q myelodysplastic syndromes. CBC should be monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. May require dose interruption and/or reduction and the use of blood product support and/or growth factors. Increased risk of DVT and PE in patients with multiple myeloma. Observe for signs and symptoms of thromboembolism .

Classifications:

Therapeutic—

Immune Modulator

Uses of This Medicine:

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 .

This medicine is available only with your doctor's prescription .

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 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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of lenalidomide in children with use in other age groups .

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults .

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.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Kidney disease—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 .

Proper Use of This Medicine:

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 .

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—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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 This Medicine:

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.

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 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 hands, feet, or lips

painful or difficult urination

pale skin

pinpoint red spots on skin

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

tightness in chest

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

Frequency not known

Anxiety

dizziness or light-headedness

fainting

fast heartbeat

pain, redness, or swelling in 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 in moving

discouragement

drowsiness

dry skin and hair

dryness or soreness of throat

ear congestion

fast, irregular, pounding, or racing heartbeat or pulse

feeling sad or empty

feeling unusually cold

flushing, redness of skin

hair loss

headache

hoarseness or husky voice

irritability

itching skin

itching, pain, redness, swelling, tenderness, or warmth on 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 pain or stiffness

muscle spasms or twitching

nasal congestion

nervousness

night sweats

pain

pain in arms or legs

pain in joints

pain or tenderness around eyes and cheekbones

pounding in the ears

rash

runny nose

seizures

shivering

sleeplessness

slow or fast heartbeat

sneezing

stomach pain

stuffy or runny nose

sweating increased

swelling of hands, ankles, feet, or lower legs

swollen joints

tender, swollen glands in neck

tiredness

trembling

trouble concentrating

trouble sleeping

trouble swallowing

troubled breathing with exertion

unable to sleep

unsteadiness or awkwardness

unusually warm skin

upper abdomen 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.