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SANDOZ LENALIDOMIDE is a brand name for Lenalidomide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Sandoz Lenalidomide (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. Approval for this indication is…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Recommended Starting Dose Adjustment for Renal Impairment: Myelodysplastic Syndromes: Since lenalidomide is primarily excreted unchanged by the kidney, starting dose adjustment is recommended in patients with renal insufficiency in order to maintain an effective and safe level of Sandoz Lenalidomide.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. A Sandoz Lenalidomide starting dose adjustment should be considered for patients with CrCL < 60 mL/min. Serious Warnings and Precautions Sandoz Lenalidomide (lenalidomide) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
• Potential for human birth defects, stillbirths, and spontaneous abortions (see 7 WARNINGS AND PRECAUTIONS, Females of Child-Bearing Potential and Male patients). • Neutropenia and Thrombocytopenia (see 7 WARNINGS AND PRECAUTIONS, Hematologic, 8 ADVERSE REACTIONS and 4 DOSAGE AND ADMINISTRATION).
• Venous and arterial thromboembolism: Increased risk of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Myocardial Infarction (MI), and Cerebrovascular Events (see 7 WARNINGS AND PRECAUTIONS, Venous and Arterial Thromboembolism).
Antithrombotic prophylaxis is recommended. • Hepatotoxicity, including fatal cases (see 7 WARNINGS AND PRECAUTIONS, Hepatic). • Anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Immune) Available only under a controlled distribution program called RevAid® Sandoz Lenalidomide Page 7 of 102 The recommendations for initial starting doses of Sandoz Lenalidomide for patients with MDS are as follows: Renal Function (CrCL) Myelodysplastic Syndromes Dose Mild Renal Impairment (90 > CrCL ≥ 60 mL/min) 10 mg (Normal Dose) Every 24 hours Moderate Renal Impairment (30 ≤ CrCL < 60 mL/min) 5 mg Every 24 hours Severe Renal Impairment (CrCL < 30 mL/min, not requiring dialysis) 5 mg Every 48 hours End Stage Renal Disease (CrCL < 30 mL/min, requiring dialysis) 5 mg 3 times a week following each dialysis Multiple Myeloma: Since lenalidomide is primarily excreted unchanged by the kidney, starting dose adjustment is recommended in patients with renal insufficiency in order to maintain an effective and safe level of Sandoz Lenalidomide.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. A Sandoz Lenalidomide starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of Sandoz Lenalidomide for patients with MM are as follows while maintaining a 21 out of 28 day treatment cycle: Renal Function (CrCL) Multiple Myeloma Dose Mild Renal Impairment (90 > CrCL ≥ 60 mL/min) 25 mg (Normal Dose) Every 24 hours Moderate Renal Impairment (30 ≤ CrCL < 60 mL/min) 10 mga Every 24 hours Severe Renal Impairment (CrCL < 30 mL/min, not requiring dialysis) 15 mg Every 48 hours End Stage Renal Disease (CrCL < 30 mL/min, requiring dialysis) 5 mg Once daily.
, Clinical Trial Adverse Reactions). 1 Dosing Considerations Recommended Starting Dose Adjustment for Renal Impairment: Myelodysplastic Syndromes: Since lenalidomide is primarily excreted unchanged by the kidney, starting dose adjustment is recommended in patients with renal insufficiency in order to maintain an effective and safe level of Sandoz Lenalidomide.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. A Sandoz Lenalidomide starting dose adjustment should be considered for patients with CrCL < 60 mL/min. Serious Warnings and Precautions Sandoz Lenalidomide (lenalidomide) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
• Potential for human birth defects, stillbirths, and spontaneous abortions (see 7 WARNINGS AND PRECAUTIONS, Females of Child-Bearing Potential and Male patients). • Neutropenia and Thrombocytopenia (see 7 WARNINGS AND PRECAUTIONS, Hematologic, 8 ADVERSE REACTIONS and 4 DOSAGE AND ADMINISTRATION).
• Venous and arterial thromboembolism: Increased risk of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Myocardial Infarction (MI), and Cerebrovascular Events (see 7 WARNINGS AND PRECAUTIONS, Venous and Arterial Thromboembolism).
Antithrombotic prophylaxis is recommended. • Hepatotoxicity, including fatal cases (see 7 WARNINGS AND PRECAUTIONS, Hepatic). • Anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Immune) Available only under a controlled distribution program called RevAid® Sandoz Lenalidomide Page 7 of 102 The recommendations for initial starting doses of Sandoz Lenalidomide for patients with MDS are as follows: Renal Function (CrCL) Myelodysplastic Syndromes Dose Mild Renal Impairment (90 > CrCL ≥ 60 mL/min) 10 mg (Normal Dose) Every 24 hours Moderate Renal Impairment (30 ≤ CrCL < 60 mL/min) 5 mg Every 24 hours Severe Renal Impairment (CrCL < 30 mL/min, not requiring dialysis) 5 mg Every 48 hours End Stage Renal Disease (CrCL < 30 mL/min, requiring dialysis) 5 mg 3 times a week following each dialysis Multiple Myeloma: Since lenalidomide is primarily excreted unchanged by the kidney, starting dose adjustment is recommended in patients with renal insufficiency in order to maintain an effective and safe level of Sandoz Lenalidomide.
, Increased Mortality in Patients with CLL).
Distribution restrictions:
Sandoz Lenalidomide is only available through a controlled distribution program called RevAid®. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, Sandoz Lenalidomide can only be dispensed to patients who are registered and meet all the conditions of the RevAid® program.
ca. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): Lenalidomide has been used in clinical trials in subjects up to 95 years of age.
The majority were ≥ 65 years of age. No effect of age on the clinical efficacy was observed in the Phase 3 clinical trials. 4 Geriatrics). 1 Dosing Considerations). Sandoz Lenalidomide Page 5 of 102 2 CONTRAINDICATIONS • Sandoz Lenalidomide (lenalidomide) is contraindicated in patients who are hypersensitive to it or to thalidomide, pomalidomide or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Sandoz Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant (see 7 WARNINGS AND PRECAUTIONS). Lenalidomide is structurally related to thalidomide, a known human teratogen that causes severe and life- threatening birth defects.
Lenalidomide induced malformations in monkeys similar to those described with thalidomide. If lenalidomide is taken during pregnancy, it may cause severe birth defects or death to the fetus (see 7 WARNINGS AND PRECAUTIONS). Females of Child-Bearing Potential may be treated with Sandoz Lenalidomide provided that adequate contraception, with two simultaneous effective methods of contraception, is used to prevent fetal exposure to the drug.
• Sandoz Lenalidomide (lenalidomide) is contraindicated in patients who are hypersensitive to it or to thalidomide, pomalidomide or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Sandoz Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant (see 7 WARNINGS AND PRECAUTIONS). Lenalidomide is structurally related to thalidomide, a known human teratogen that causes severe and life- threatening birth defects.
Lenalidomide induced malformations in monkeys similar to those described with thalidomide. If lenalidomide is taken during pregnancy, it may cause severe birth defects or death to the fetus (see 7 WARNINGS AND PRECAUTIONS). Females of Child-Bearing Potential may be treated with Sandoz Lenalidomide provided that adequate contraception, with two simultaneous effective methods of contraception, is used to prevent fetal exposure to the drug.
The choice of the two simultaneously effective contraceptive methods will necessitate a risk/benefit discussion between the patient and a qualified physician experienced in the use of contraceptive methods (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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On dialysis days the dose should be administered following dialysis aThe dose may be escalated to 15 mg every 24 hours after 2 cycles if patient is not responding to treatment and is tolerating the drug. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS).
Sandoz Lenalidomide Page 8 of 102 Myelodysplastic Syndromes:
Recommended Starting Dose The recommended starting dose of Sandoz Lenalidomide for MDS patients is 10 mg daily for the first 21 days of repeated 28-day cycles. Dosing is continued or modified based upon clinical and laboratory findings.
Patients without at least a minor erythroid response within 4 months of therapy initiation demonstrated by at least a 50% reduction in transfusion requirements or, if not transfused, a 1 g/dL rise in hemoglobin, should discontinue Sandoz Lenalidomide treatment.
After initiation of Sandoz Lenalidomide therapy, subsequent Sandoz Lenalidomide dose modification should be based on individual patient treatment tolerance, as described below. 8%) of the 148 patients; the median time to the first dose reduction or interruption was 22 days (mean, 48 days; range, 2-468 days), and the median duration of the first dose interruption was 22 days (mean, 31 days; range, 2-331 days).
3%) of the 148 patients. The median interval between the first and second dose reduction or interruption was 71 days (mean, 117 days; range, 15-568 days) and the median duration of the second dose interruption was 23 days (mean, 35 days; range, 2-295 days).
0) (see 14 CLINICAL TRIALS).
Thrombocytopenia:
MDS patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as indicated in the following tables. If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily If baseline ≥100,000/mcL When Platelets Recommended Course Fall to <50,000/mcL Interrupt Sandoz Lenalidomide treatment Return to ≥50,000/mcL Resume Sandoz Lenalidomide at 5 mg daily If baseline <100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt Sandoz Lenalidomide treatment If baseline ≥60,000/mcL and returns to ≥50,000/mcL Resume Sandoz Lenalidomide at 5 mg daily If baseline <60,000/mcL and returns to Resume Sandoz Lenalidomide at 5 mg daily Sandoz Lenalidomide Page 9 of 102 ≥30,000/mcL If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily When Platelets Recommended Course <30,000/mcL or <50,000/mcL with platelet transfusions Interrupt Sandoz Lenalidomide treatment Return to ≥30,000/mcL (without hemostatic failure) Resume Sandoz Lenalidomide at 5 mg daily MDS patients who experience […]
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. A Sandoz Lenalidomide starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of Sandoz Lenalidomide for patients with MM are as follows while maintaining a 21 out of 28 day treatment cycle: Renal Function (CrCL) Multiple Myeloma Dose Mild Renal Impairment (90 > CrCL ≥ 60 mL/min) 25 mg (Normal Dose) Every 24 hours Moderate Renal Impairment (30 ≤ CrCL < 60 mL/min) 10 mga Every 24 hours Severe Renal Impairment (CrCL < 30 mL/min, not requiring dialysis) 15 mg Every 48 hours End Stage Renal Disease (CrCL < 30 mL/min, requiring dialysis) 5 mg Once daily.
On dialysis days the dose should be administered following dialysis aThe dose may be escalated to 15 mg every 24 hours after 2 cycles if patient is not responding to treatment and is tolerating the drug. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS).
Sandoz Lenalidomide Page 8 of 102 Myelodysplastic Syndromes:
Recommended Starting Dose The recommended starting dose of Sandoz Lenalidomide for MDS patients is 10 mg daily for the first 21 days of repeated 28-day cycles. Dosing is continued or modified based upon clinical and laboratory findings.
Patients without at least a minor erythroid response within 4 months of therapy initiation demonstrated by at least a 50% reduction in transfusion requirements or, if not transfused, a 1 g/dL rise in hemoglobin, should discontinue Sandoz Lenalidomide treatment.
After initiation of Sandoz Lenalidomide therapy, subsequent Sandoz Lenalidomide dose modification should be based on individual patient treatment tolerance, as described below. 8%) of the 148 patients; the median time to the first dose reduction or interruption was 22 days (mean, 48 days; range, 2-468 days), and the median duration of the first dose interruption was 22 days (mean, 31 days; range, 2-331 days).
3%) of the 148 patients. The median interval between the first and second dose reduction or interruption was 71 days (mean, 117 days; range, 15-568 days) and the median duration of the second dose interruption was 23 days (mean, 35 days; range, 2-295 days).
0) (see 14 CLINICAL TRIALS).
Thrombocytopenia:
MDS patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as indicated in the following tables. If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily If baseline ≥100,000/mcL When Platelets Recommended Course Fall to <50,000/mcL Interrupt Sandoz Lenalidomide treatment Return to ≥50,000/mcL Resume Sandoz Lenalidomide at 5 mg daily If baseline <100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt Sandoz Lenalidomide treatment If baseline ≥60,000/mcL and returns to ≥50,000/mcL Resume Sandoz Lenalidomide at 5 mg daily If baseline <60,000/mcL and returns to Resume Sandoz Lenalidomide at 5 mg daily Sandoz Lenalidomide Page 9 of 102 ≥30,000/mcL If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily When Platelets Recommended Course <30,000/mcL or <50,000/mcL with platelet transfusions Interrupt Sandoz […]
The choice of the two simultaneously effective contraceptive methods will necessitate a risk/benefit discussion between the patient and a qualified physician experienced in the use of contraceptive methods (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
• Breast feeding women. • Male patients unable to follow or comply with the required contraceptive measures (see 7 WARNINGS AND PRECAUTIONS, Male Patients). • Sandoz Lenalidomide treatment should not be started in MDS patients whose platelet levels are less than 50 x 109/L (see