About MDS
Different people find different ways of dealing with the diagnosis and treatment of MDS (myelodysplastic syndromes) helpful. You may decide to join a support group and share experiences with others who are going through similar experiences. Or you may decide you want to learn everything you can about the condition, so you can participate as fully as possible in your care and work with your healthcare provider to find the best course of treatment for you.
Here is a list of resources and organizations that provide reliable information and support for people affected by MDS and related conditions.
Celgene does not necessarily endorse the organizations listed here and does not influence the content found at these links. Clicking on any of these links requires you to leave REVLIMID.com.
American Cancer Society
1599 Clifton Road NE
Atlanta, GA 30329
(800) ACS-2345
www.cancer.org
The American Cancer Society (ACS) provides information and support to people with many different types of cancer and related disorders. Although MDS is not considered a cancer, in some cases it can develop into the blood cancer leukemia. The ACS web site has a detailed information section on MDS. You can also find it by typing "MDS" into the search box in the upper right-hand corner of the ACS web site's home page.
American Association of Blood Banks
(301) 907-6977
www.aabb.org
The American Association of Blood Banks (AABB) provides information about blood donations and transfusions for donors, recipients, and healthcare providers. On the AABB web site you'll find information about who should and who shouldn't donate blood, how blood is screened, the different types of blood and blood transfusions, and more. Click on "All About Blood" on the home page.
Aplastic Anemia & MDS International Foundation
P.O. Box 310
Churchton, MD 20733
(800) 747-2820
www.aamds.org
This non-profit foundation has been providing information and support for people with MDS and related conditions for over 20 years. Its web site provides detailed information about MDS as well as patient conferences, community events, and support groups around the country.
Leukemia & Lymphoma Society
1311 Mamaroneck Avenue
White Plains, NY 10605
(800) 955-4572
www.leukemia-lymphoma.org
The Leukemia & Lymphoma Society is dedicated to curing leukemia, lymphoma, and related disorders,
including MDS, through research, patient services, education, and advocacy. Its web site includes
a section on MDS as well as information about clinical trials and patient services around the country.
The Myelodysplastic Syndromes Foundation
P.O. Box 353
Crosswicks, NJ 08515
(800) MDS-0839
(609) 298-6746 (outside US)
www.mds-foundation.org
The MDS Foundation is a national organization dedicated to the prevention, treatment, and study of MDS. The foundation's web site includes detailed information about MDS for patients and healthcare providers, research updates, and referrals to MDS "Centers of Excellence" in the US and around the world.
National Cancer Institute
(800) 4-CANCER (422-6237)
TTY: 1-800-332-8615
www.nci.nih.gov
The National Cancer Institute (NCI) is a government organization that funds research and provides information about all types of cancer and related diseases, including MDS. The NCI web site includes a section on MDS as well as clinical trial listings.
Many of the organizations listed above provide free educational materials about MDS. You can download them directly from each organization's web site, or order them by contacting the organization.
The following are some of the free educational materials about MDS that you might find useful:
Myelodysplastic Syndromes Detailed Guide
You can view this publication on the American Cancer Society's web site (www.cancer.org) or download a PDF version of it.
Myelodysplastic Syndromes Basic Explanations
You'll be asked to register on the Aplastic Anemia & MDS International Foundation web site (www.aamds.org) in order to download a PDF of this excellent booklet. Other materials are also available on the web site or by mail once you register. Registration is free and takes less than a minute.
Myelodysplastic Syndromes
You can view this booklet on the Leukemia & Lymphoma Society's web site (www.leukemia-lymphoma.org), download a PDF version, or order a printed copy by e-mail.
Understanding Myelodysplastic Syndromes: A Patient Handbook
View a printable HTML version of this booklet on the MDS Foundation's web site, in the "Patient Information" section
(www.mds-foundation.org/patientinfo.htm).
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REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
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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.
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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).
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Special Prescribing Requirements
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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.
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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: REVLIMID® (lenalidomide) is substantially excreted by the kidney, so the risk of toxic reactions may be greater in patients with impaired renal function. 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.
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
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 lenalidomide. For other Grade 3 or 4 toxicities judged to be related to lenalidomide, hold treatment and restart at next lower dose level when toxicity has resolved to less than or equal to Grade 2.
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| Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS and the FDA-approved MEDICATION GUIDE. |
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