About MDS
Regardless of the treatment you receive, if you have MDS (myelodysplastic syndromes) there are things you can do to improve the way you feel and to keep yourself as healthy as possible. These may include changes in your diet, as well as lifestyle changes that can help you lower the risks of infection and bleeding that can be caused by low blood counts.
Vitamins and supplements: adding vitamins and supplements to your diet can help restore important nutrients to your body and improve your ability to fight infection. At the same time, there are some vitamins and herbal supplements that might actually make your condition worse.
Because of the possible risks involved, it is extremely important that you discuss any vitamins or supplements you may be taking-or considering taking-with your healthcare provider.
Neutropenic diet: some people with MDS have low levels of white blood cells called neutrophils. If you have this condition, called "neutropenia," you are at a higher risk for infection. Your healthcare provider may advise you to follow a special "neutropenic diet," which involves avoiding foods that can expose you to bacterial contamination. Some examples of food you should avoid are:
- Anything from an open salad bar
- Fresh fruit that has not been washed and peeled
- Cooked food that has been allowed to cool without refrigeration
Talk to your healthcare provider about whether this type of diet may be right for you.
Always avoid using alcohol and tobacco: these substances can weaken your body and cause treatment complications.
If you have a reduced number of white blood cells as a result of MDS or treatment for the disease, you have a higher risk for infections. Learning to recognize early warning signs of an infection is important so that you can receive treatment promptly. If you experience any symptoms of an infection, contact your healthcare provider immediately.
Common signs of infection:
- Fever above 100°F (38°C)
- Shaking chills
- Persistent cough
- Diarrhea lasting more than 48 hours
- Painful urination
- Extreme fatigue and weakness
Prevent infections from getting worse by:
- Washing hands thoroughly
- Keeping good hygiene (showering daily, cleaning after using the bathroom)
- Practicing safe sex
Things to avoid:
- Crowded places, especially at busy times (malls, theaters)
- Close contact with people who are obviously ill
- Smoking
- Alcohol
If you have a reduced number of platelets (thrombocytopenia) as a result of MDS or its treatment, you are at an increased risk for bleeding. With bleeding, and an impaired ability to stop bleeding, the body is much slower to heal wounds, which can also lead to a greater risk of infection. (See the section above on how to protect yourself against infections.)
An important way of dealing with low platelet counts is learning to recognize the signs of bleeding and how to reduce the risk.
Common signs of low platelet counts (thrombocytopenia):
- Nosebleeds
- Easy bruising
- Bleeding that does not stop easily
- Tiny red lesions (most commonly on the ankles, chest, and soft palate)
- Blood in the urine or stool
- Bleeding gums
Reduce the risk of bleeding by:
- Using a soft toothbrush and stopping flossing if there is increased bleeding after flossing-check with your healthcare provider before going to the dentist
- Blowing your nose gently
What to avoid:
- Taking aspirin or aspirin-containing medicines
- Cuts (use gloves when gardening, use caution with kitchen knives, consider an electric razor)
- Contact sports
What to do if you bleed:
- If you experience increased bleeding, put pressure on the site with a clean towel for several minutes
- If the bleeding does not stop, contact your healthcare provider immediately
- If you observe blood in your stool or urine, contact your healthcare provider immediately
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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