l pills, injections, patch or implants) and a partner’s vasectomy. Additional effective contraceptive methods include latex condom, diaphragm and cervical cap. Patient must be instructed to immediately stop taking REVLIMID and contact her doctor if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant. The patient understands that if her doctor is not available, she can call 1-888-668-2528 for information on emergency contraception [see Use in Specific Populations (8.1)].
REVLIMID treatment should only be initiated in a female not of childbearing potential if she confirms that she is not now pregnant, nor of childbearing potential as she has been postmenopausal naturally for at least 24 months (been through the change of life); or she has had a hysterectomy or bilateral oophorectomy. The patient or guardian certifies that a prepubertal female child is not now pregnant, nor is of childbearing potential as menstruation has not yet begun, and/or the child will not be engaging in heterosexual sexual contact for at least 4 weeks before REVLIMID therapy, during therapy, during therapy interruption and for at least 4 weeks after stopping REVLIMID therapy.
REVLIMID treatment should only be initiated in men who agree to either completely abstain from sexual contact with women who are pregnant or able to become pregnant, or use a latex condom every time he engages in any sexual contact with women who are pregnant or may become pregnant. The patient should inform his doctor if he has had unprotected sexual contact with a woman who can become pregnant. He understands that if his doctor is not available, he can call 1-888-668-2528 for information on emergency contraception.
17.2 Hematologic Toxicity
REVLIMID is associated with significant neutropenia and thrombocytopenia [see Boxed Warnings and Warnings and Precautions (5.2)]
17.3Deep Vein Thrombosis and Pulmonary Embolism
REVLIMID/dexamethasone has demonstrated significant increased risk of DVT and PE in patients with multiple myeloma [see Boxed Warnings and Warning and Precautions (5.3)]
REVLIMID®, RevAssist®, and THALOMID® are registered trademarks of Celgene Corporation.
U.S. Pat. Nos. 5,635,517; 6,045,501; 6,281,230; 6,315,720; 6,555,554; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 7,119,106; 7,189,740; 7,465,800
©2005-2010 Celgene Corporation, All Rights Reserved.
RevPlyPI.010/MG.010 10/10
17.4MEDICATION GUIDE
MEDICATION GUIDE
REVLIMID®(rev-li-mid)
(lenalidomide)
Capsules
Read the Medication Guide that comes with REVLIMID before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about REVLIMID?
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the RevAssist® program.
REVLIMID may cause serious side effects including:
Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide (THALOMID®). We know thalidomide can cause seve
