Patient Medication Guide

Information for patients and caregivers:

MEDICATION GUIDE

REVLIMID^® (rev-li-mid)

(lenalidomide)

•	REVLIMID® is only for patients who understand and agree to all of the instructions in the REVASSIST® program.
•	REVLIMID® may cause serious side effects including:

1.	Possible birth defects (deformed babies) or death of an unborn baby. Female patients who are pregnant or who plan to become pregnant must not take REVLIMID®.
	REVLIMID® is similar to the medicine thalidomide (THALOMID®). We know thalidomide causes life-threatening birth defects. REVLIMID® has not been tested in pregnant women. REVLIMID® has harmed unborn animals in animal testing.
	Female patients must not get pregnant:

	It is not known if REVLIMID® passes into semen, so:

	If you get pregnant while taking REVLIMID®, stop taking it right away and call your healthcare provider. Female partners of males taking REVLIMID® should call their healthcare provider right away if they get pregnant. Healthcare providers and patients should report all cases of pregnancy to:

2.	Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID® causes low white blood cells and low platelets in most patients. You may need a blood transfusion or certain medicines if your blood counts drop too low. If you are being treated for del 5q myelodysplastic syndromes (MDS) your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID®, and at least monthly thereafter. If you are being treated for multiple myeloma, your blood counts should be checked every 2 weeks for the first 12 weeks and then at least monthly thereafter.
3.	An increased chance for blood clots in veins and in the lungs. Call your healthcare provider or get emergency medical care right away if you get the following signs or symptoms:

What is REVLIMID^® and what is it used for?

REVLIMID^® is a medicine taken by mouth to treat certain patients who have myelodysplastic syndromes (MDS). Patients with MDS have bone marrow that does not produce enough mature blood cells. This causes a lack of healthy blood cells that can function properly in the body. There are different types of MDS. REVLIMID^® is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. Patients with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.

REVLIMID^® is also used with dexamethasone to treat patients with multiple myeloma who have already had another treatment. Multiple myeloma is a cancer of plasma cells. Plasma cells are found in the bone marrow. Plasma cells produce a protein called antibodies. Some antibodies can attack and kill disease causing germs. Patients with this type of cancer may have low blood cell counts and immune problems giving them a higher chance for getting infections such as pneumonia. The bones can be affected leading to bone pain and breaks (fractures).

REVLIMID^® can only be:

•	prescribed by healthcare providers who are registered in the RevAssist® program
•	dispensed by a pharmacy that is registered in the RevAssist® program
•	given to patients who are registered in the RevAssist® program and who agree to do everything required in the program

REVLIMID^® has not been studied in children under 18 years of age.

Who should not take REVLIMID^®?

•	Do not take REVLIMID® if you are pregnant, plan to become pregnant, or become pregnant during REVLIMID® treatment. REVLIMID® may cause birth defects. See "What is the most important information I should know about REVLIMID®?"
•	Do not take REVLIMID® if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in REVLIMID®.

What should I tell my healthcare provider before taking REVLIMID^®?

Tell your healthcare provider about all of your medical conditions, including if you:

•	are pregnant or breastfeeding. REVLIMID® must not be used by women who are pregnant or breastfeeding.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. It is possible that REVLIMID^® and other medicines may affect each other causing serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID^®?

•	Take REVLIMID® exactly as prescribed. You must also follow all the instructions of the RevAssist® program. Before prescribing REVLIMID®, your healthcare provider will:

	•	explain the RevAssist® program to you
	•	have you sign the Patient-Physician Agreement Form

You will not be prescribed REVLIMID^® if you cannot agree to or follow all of the instructions of the RevAssist^® program.

You will get no more than a 28-day supply of REVLIMID^® at one time. This is to make sure you follow the RevAssist^® program.

•	Swallow REVLIMID® capsules whole with water once a day. Do not break, chew, or open your capsules.
•	If you miss a dose of REVLIMID®, take it as soon as you remember that day. If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take 2 doses at the same time.
•	If you take too much REVLIMID® or overdose, call your healthcare provider or poison control center right away.
•	You will have regular blood tests during your treatment with REVLIMID®. If you are being treated for del 5q myelodysplastic syndromes (MDS) you should have your blood tested every week during your first 8 weeks of treatment, and at least monthly after that. If you are being treated for multiple myeloma, your blood counts should be checked every two weeks for the first 12 weeks and then at least monthly after that. Your healthcare provider may adjust your dose of REVLIMID® or interrupt your treatment based on the results of your blood tests and on your general condition.
•	Female patients who can get pregnant will get regular pregnancy testing.

•	Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping REVLIMID®.
•	Male patients, even those who have had a vasectomy, must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant.

•	Do not get pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®. See "What is the most important information I should know about REVLIMID®?"
•	Do not breastfeed while taking REVLIMID®. We do not know if REVLIMID® passes into your milk and harms your baby.
•	Do not share REVLIMID® with other people. It may cause birth defects and other serious problems.
•	Do not give blood while you take REVLIMID® and for 4 weeks after stopping REVLIMID®. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID® and may be born with birth defects.
•	Male patients should not donate sperm while taking REVLIMID® and for 4 weeks after stopping REVLIMID®. If a female who is trying to become pregnant gets your sperm, her baby may be exposed to REVLIMID® and may be born with birth defects.

•	REVLIMID® may cause serious side effects including:

	•	birth defects
	•	low white blood cells and platelets
	•	blood clots in veins and in the lungs

See "What is the most important information I should know about REVLIMID^®?"

Other common side effects of REVLIMID^® are:

	•	diarrhea
	•	itching
	•	rash
	•	tiredness

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with REVLIMID^®. Ask your healthcare provider or pharmacist for more information.

How should I store REVLIMID^®?

Store REVLIMID^® at room temperature, 59° to 86°F (15° to 30° C).

Keep REVLIMID^® and all medicines out of the reach of children.

General information about the safe and effective use of REVLIMID^®

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not take REVLIMID^® for conditions for which it was not prescribed. Do not give REVLIMID^® to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide provides a summary of the most important information about REVLIMID^®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about REVLIMID^® that is written for health professionals. You can also call 1-888-423-5436 or visit www.REVLIMID.com.

What are the ingredients in REVLIMID^®?

REVLIMID^® (lenalidomide) capsules contain 5 mg, 10 mg, 15 mg or 25 mg of lenalidomide and are available as gelatin capsules for oral administration.

The inactive ingredients of REVLIMID^® capsules are: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

The 5 mg and 25 mg capsule shells contain gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink.

Manufactured for Celgene Corporation

Summit, NJ 07901

This Medication Guide has been approved by the US Food and Drug Administration.

Important Safety Information

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

REVLIMID® (lenalidomide) is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

WARNINGS: 1. 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 REVLIMID® (lenalidomide). Special Prescribing Requirements BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO REVLIMID® (lenalidomide), REVLIMID® (lenalidomide) IS ONLY AVAILABLE UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED "RevAssist®". UNDER THIS PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM CAN PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, REVLIMID® (lenalidomide) MUST ONLY BE DISPENSED TO PATIENTS WHO ARE REGISTERED AND MEET ALL THE CONDITIONS OF THE RevAssist® PROGRAM. 2. 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. (SEE DOSAGE AND ADMINISTRATION) 3. 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 REVLIMID® (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 REVLIMID® (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 REVLIMID® (lenalidomide) and the RevAssist® program on the Internet at www.REVLIMID.com or by calling the manufacturer's toll-free number at 1-888-423-5436.

ADDITIONAL WARNINGS: HEMATOLOGIC TOXICITY Multiple Myeloma In the pooled multiple myeloma studies, Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of REVLIMID® (lenalidomide) and dexamethasone than in patients treated with dexamethasone alone. Patients on therapy should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter. Patients may require dose interruption and/or dose reduction. CONTRAINDICATIONS: Hypersensitivity: REVLIMID® (lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components. PRECAUTIONS: Renal impairment: Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID® (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe (CLcr < 60 mL/min) renal impairment and in patients on dialysis. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function. Nursing mothers: It is not known whether REVLIMID® (lenalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. ADVERSE REACTIONS: Multiple Myeloma In the REVLIMID® (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID® (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID® (lenalidomide)/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3/4 adverse events were more frequent in MM patients who received the combination of REVLIMID® (lenalidomide)/dexamethasone compared to placebo/dexamethasone. Other adverse events reported in multiple myeloma patients (REVLIMID® (lenalidomide)/dexamethasone vs dexamethasone/placebo): constipation (39% vs 19%), fatigue (38% vs 37%), insomnia (32% vs 37%), muscle cramp (30% vs 21%), diarrhea (29% vs 25%), neutropenia (28% vs 5%), anemia (24% vs 17%), asthenia (23% vs 25%), pyrexia (23% vs 19%), nausea (22% vs 19%), headache (21% vs 21%), peripheral edema (21% vs 19%), dizziness (21% vs 15%), dyspnea (20% vs 15%), tremor (20% vs 7%), decreased weight (18% vs 14%), thrombocytopenia (17% vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia (15% vs 14%), and muscle weakness (15% vs 15%). Myelodysplastic Syndromes Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events observed in the del 5q MDS population. Other adverse reactions reported in del 5q MDS patients (REVLIMID® (lenalidomide)): diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), and pharyngitis (16%). DOSAGE AND ADMINISTRATION: Dosing is continued or modified based upon clinical and laboratory findings. Dosing modifications are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID® (lenalidomide). For other Grade 3 or 4 toxicities judged to be related to REVLIMID® (lenalidomide), hold treatment and restart at next lower dose level when toxicity has resolved to less than or equal to Grade 2.

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS.

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