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  • Revlimid
    / Neopharm Scientific


    Active Ingredient
    Lenalidomide 2.5, 5, 7.5, 10, 15, 20, 25 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    21 x 5 mg

    partial basket chart 23426 18443, 18461

    Hard Capsules

    21 x 10 mg

    partial basket chart 23430 18462, 18444

    Hard Capsules

    21 x 15 mg

    partial basket chart 83866 18463

    Hard Capsules

    21 x 25 mg

    partial basket chart 83867 18464

    Related information


    Dosage

    Myelodysplastic syndromes: The recommended starting dose is 10 mg daily with water. Patients should not break, chew or open the capsules. Dosing is continued or modified based upon clinical and laboratory findings. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug 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.
    Dose adjustments during treatment: Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted. See prescribing information for full details.
    Multiple myeloma: The recommended starting dose of is 25 mg/day with water administered as a single 25 mg capsule on Days 1-21 of repeated 28-day cycles. Patients should not break, chew or open the capsules. The recommended dose of dexamethasone is 40 mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg/day orally on Days 1-4 every 28 days. Dosing is continued or modified based upon clinical and laboratory findings. The effect of substituting lesser strengths of lenalidomide to achieve a 25 mg capsule dose is unknown. Dose adjustments during treatment: Dose modification guidelines, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide.
    See prescribing information for full details.


    Indications

    Treatment of transfusion-dependent anemia due to low-or immediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. In combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one prior therapy.


    Contra-Indications

    Pregnancy category X: Pregnant women and women capable of becoming pregnant. Lenalidomide is an analog of thalidomide, a known human theratogen that causes severe life threatening human birth defects. If taken during pregnancy, it may cause birth defects or death to an unborn baby. When there is no alternative, females of childbearing potential may be treated proved adequate precautions are taken to avoid pregancy. For detailed contraindications, see prescribing information.


    Special Precautions

    This drug is associated with significant neutropenia and thrombocytopenia. This drug has demonstrated a significantly increased risk of deep venous thrombosis and pulmonary embolism in patients with multiple myeloma who were treated with lenalidomide combination therapy. Patients and and physicians are advised to be observant for the signs and symptoms of thromboembolism.No formal studies have been conducted in patients with renal impairment. This drug is known to be excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
    Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.


    Side Effects

    Thrombocytopenia, neutropenia, anemia. Pruritus, rash, dry skin. Diarrhea, constipation, nausea. Nasopharyngitis, cough, dyspnea, pharyngitis, epstaxis. Fatigue, pyrexia, peripheral edema. Arthralgia, back pain, muscle cramp. Dizziness, headache.


    Drug interactions

    Lenalidomide is neither metabolized by nor inhibits or induces the cytochrome P450 pathway suggesting that it is not likely to cause or be subject to P450-based metabolic drug interactions in man. Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone.


    Pregnancy and Lactation

    REVLIMID can cause fetal harm when administered to a pregnant woman. REVLIMID is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women. However, in an animal study, lenalidomide  caused thalidomide-type limb defects in monkey offspring. If this drug is used during pregnancy, or if the patient becomes pregnant  while taking this drug, the patient should be apprised of the potential hazard to a fetus. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an  obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure to REVLIMID must be reported to the attending physician and Neopharm. In an embryofetal developmental toxicity study in monkeys, teratogenicity, including thalidomide-like limb defects, occurred in offspring when pregnant monkeys received oral lenalidomide  during organogenesis at doses approximately 0.17 times the maximum recommended human dose (MRHD) of 25 mg, based on body  surface area. Similar studies in pregnant rabbits and rats at 20 times and 200 times the MRHD respectively, produced embryolethality  in rabbits and no adverse reproductive effects in rats. In another study, pregnant rats received lenalidomide from organogenesis through lactation, some delay in sexual maturation occurred in male offspring. As with thalidomide, the rat model may not adequately  address the full spectrum of potential human embryofetal developmental effects for lenalidomide.  Females of childbearing potential must use effective means of contraception for 28 days before therapy, during lenalidomide therapy and dose interruptions, and for 28 days following discontinuation of lenalidomide therapy, or continually abstain from reproductive heterosexual sexual intercourse. Because of the increased risk of VTE in patients with multiple myeloma taking lenalidomide and dexamethasone, and to a lesser extent patients with MDS taking lenalidomide monotherapy, and because there is an increased risk of  VTE in patients taking combined oral contraceptive pills, physicians should discuss the risk/benefit of contraceptive methods with their patients.
    Nursing Mothers:  It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from lenalidomide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


    Overdose

    There is no specific experience in the management of lenalidomide overdose in patients; although in dose-ranging studies, some patients were exposed to up to 150 mg and in single-dose studies, some patients were exposed to up to 400 mg. In studies, the dose-limiting toxicity was essentially hematological. In the event of overdose, supportive care is advised.


    Manufacturer
    Celgene International SARL, Switzerland
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