POTENTIAL FOR HUMAN BIRTH DEFECTS
WARNING: 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.
PLEASE SEE THE FOLLOWING INFORMATION FOR PRESCRIBERS, FEMALE PATIENTS, AND MALE PATIENTS ABOUT THIS RESTRICTED DISTRIBUTION PROGRAM.
RevAssist® PROGRAM DESCRIPTION
REVLIMID® (lenalidomide) can be prescribed only by licensed prescribers who are registered in the RevAssist® 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 REVLIMID® (lenalidomide) therapy, during REVLIMID® (lenalidomide) therapy, during dose interruptions and for 4 weeks following discontinuation of REVLIMID® (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 (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential.
Before prescribing REVLIMID® (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 10–14 days, and the second test within 24 hours prior to prescribing REVLIMID® (lenalidomide). A prescription for REVLIMID® (lenalidomide) for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
Male Patients: It is not known whether lenalidomide is present in the semen of patients receiving the drug. Therefore, males receiving REVLIMID® (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 her pregnancy test or in her menstrual bleeding. REVLIMID® (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 REVLIMID® (lenalidomide) treatment, REVLIMID® (lenalidomide) must be discontinued immediately.
Any suspected fetal exposure to REVLIMID® (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.
REVLIMID® (lenalidomide) should be used in females of childbearing potential only when the patient MEETS ALL OF THE FOLLOWING CONDITIONS (i.e., 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® 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 (i.e., who have had menses at some time in the preceding 24 consecutive months), or had a bilateral oophorectomy 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 10-14 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.
REVLIMID® (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® 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 (i.e., 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 materials 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. (See DOSAGE AND ADMINISTRATION)
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 1-888-423-5436.
5 mg, 10 mg, 15 mg and 25 mg capsules
REVLIMID®(lenalidomide), a thalidomide analogue, is an immunomodulatory agent with anti-angiogenic and anti-neoplastic properties.
REVLIMID® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Media Articles Related to Revlimid (Lenalidomide)
Effect of follow-up of MGUS on survival in patients with multiple myeloma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.03.09]
Patients with multiple myeloma (MM) appear to have better survival if they are found to have monoclonal gammopathy of undetermined significance (MGUS) first, the state that precedes MM and which is...
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Published Studies Related to Revlimid (Lenalidomide)
Single-dose pharmacokinetics of lenalidomide in healthy volunteers: dose
proportionality, food effect, and racial sensitivity. 
food effect, and racial sensitivity... CONCLUSION: Lenalidomide displayed linear pharmacokinetics from doses 5-400Â mg in
Lenalidomide after stem-cell transplantation for multiple myeloma. 
transplantation in patients with multiple myeloma... CONCLUSIONS: Lenalidomide maintenance therapy, initiated at day 100 after
Adjusting for patient crossover in clinical trials using external data: a case study of lenalidomide for advanced multiple myeloma. [2011.07]
OBJECTIVES: In some trials, particularly in oncology, patients whose disease progresses under the comparator treatment are crossed over into the experimental arm. This unplanned crossover can introduce bias in analyses because patients who crossover likely have a different prognosis than those who do not cross over; for instance, sicker patients not responding to standard therapy or those expected to benefit the most may be selectively chosen to receive the experimental treatment. Standard statistical methods cannot adequately correct for this bias. We describe an approach designed to minimize the impact of crossover, and illustrate this by using data from two randomized trials in multiple myeloma (MM)... CONCLUSION: The calibration method described here is simple to implement, provided that suitable data are available; it can be implemented with other types of endpoints in any therapeutic area. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. [2011.02]
BACKGROUND: In two randomized phase III trials (MM-009 and MM-010), lenalidomide plus dexamethasone significantly prolonged time to progression and overall survival (OS) in patients with relapsed/refractory multiple myeloma compared with dexamethasone alone. In both trials the treatment was continued until disease progression or unacceptable toxicity. We conducted a subanalysis to determine if continuing therapy after achieving>/=partial response (PR) improved survival... CONCLUSION: Continued lenalidomide treatment until disease progression after achievement of >/=PR is associated with a significant survival advantage when controlling for patient characteristics. These findings should be confirmed in a prospectively designed trial.
Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232). [2010.12.23]
The Southwest Oncology Group conducted a randomized trial comparing lenalidomide (LEN) plus dexamethasone (DEX; n = 97) to placebo (PLC) plus DEX (n = 95) in newly diagnosed myeloma. Three 35-day induction cycles applied DEX 40 mg/day on days 1 to 4, 9 to 12, and 17 to 20 together with LEN 25 mg/day for 28 days or PLC...
Clinical Trials Related to Revlimid (Lenalidomide)
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma [Terminated]
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days
1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will
commence once the MTD is established, additional subjects will be enrolled and receive oral
lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease
progression is documented.
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer [Terminated]
Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days
1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on
study until documention of disease progression.
A Study of Revlimid for Treatment of Non-Hodgkin's Lymphoma [Active, not recruiting]
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day
cycle. Treatment will continue until disease progression, or unacceptable adverse events
Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkinâ€™s Lymphoma [Completed]
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle.
Treatment will continue until for up to 52 weeks or until disease progression, subjects who
achieve a CR will receive an additional 2 cycles of treatment prior to discontinuation.
Subjects will be followed for progression free survival following discontinuation from the
Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL) [Active, not recruiting]
The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to
control CLL in patients who have already received standard therapy. The safety of
lenalidomide will also be studied.
Reports of Suspected Revlimid (Lenalidomide) Side Effects
Multiple Myeloma (982),
Platelet Count Decreased (519),
Thrombocytopenia (449), more >>
Page last updated: 2015-03-09