REVLIMID
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Package(a):
CAPSULES: 21 x 5 mg.
Dosage(a):
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.
Prescribing Restrictions:
Package(b):
CAPSULES: 21 x 10 mg.
Dosage(b):
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.
Prescribing Restrictions:
Package(c):
CAPSULES: 21 x 15 mg.
Dosage(c):
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.
Prescribing Restrictions:
Package(d):
CAPSULES: 21 x 25 mg.
Dosage(d):
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.
Prescribing Restrictions:
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.
Pregnancy and lactation: A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks. The test should ensure that the patient is not pregnant when she starts treatment. Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis. If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
The following can be considered to be examples of suitable methods of contraception: Implant, levonorgestrel-releasing intrauterine system (IUS), medroxyprogesterone acetate depot, tubal sterilisation, sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses, ovulation inhibitory progesterone-only pills (i.e., desogestrel). Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above. The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone. If pregnancy does occur during treatment, the drug should be immediately discontinued. Under these conditions, the patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialized or experienced in teratology for evaluation or advice. For male patients taking lenalidomide, there is no clinical data available on the presence of lenalidomide in human semen. Therefore male patients taking lenalidomide should use condoms if their partner is of childbearing potential and has no contraception. Use in 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.
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.
