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APO-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: • APO-LENALIDOMIDE (lenalidomide capsules) 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…
Verbatim from this product's HC label. Tap a section to expand.
). • 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/Biliary/Pancreatic). APO-LENALIDOMIDE (Lenalidomide capsules) Page 6 of 110 • Anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Immune) Available only under a controlled distribution program called ApoSecure™.
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 APO-LENALIDOMIDE.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. An APO-LENALIDOMIDE starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of APO-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 APO-LENALIDOMIDE.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. An APO-LENALIDOMIDE starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of APO-LENALIDOMIDE for patients with MM are as follows while maintaining a 21 out of 28 day treatment cycle: APO-LENALIDOMIDE (Lenalidomide capsules) Page 7 of 110 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.
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/Biliary/Pancreatic). APO-LENALIDOMIDE (Lenalidomide capsules) Page 6 of 110 • Anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Immune) Available only under a controlled distribution program called ApoSecure™.
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 APO-LENALIDOMIDE.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. An APO-LENALIDOMIDE starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of APO-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 APO-LENALIDOMIDE.
No dose adjustments are required for patients with CrCL ≥ 60 mL/min. An APO-LENALIDOMIDE starting dose adjustment should be considered for patients with CrCL < 60 mL/min. The recommendations for initial starting doses of APO-LENALIDOMIDE for patients with MM are as follows while maintaining a 21 out of 28 day treatment cycle: APO-LENALIDOMIDE (Lenalidomide capsules) Page 7 of 110 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.
, Immune 04/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...................................................................................................................
2 Geriatrics.................................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
12 5 OVERDOSAGE ............................................................................................................. 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 13 7 WARNINGS AND PRECAUTIONS ..................................................................................
• APO-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.
• APO-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 lenalidomide capsules 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.
Other brands of Lenalidomide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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).
Myelodysplastic Syndromes:
Recommended Starting Dose The recommended starting dose of APO-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 APO-LENALIDOMIDE treatment.
After initiation of APO-LENALIDOMIDE therapy, subsequent APO-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 to 468 days), and the median duration of the first dose interruption was 22 days (mean, 31 days; range, 2 to 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 to 568 days) and the median duration of the second dose interruption was 23 days (mean, 35 days; range, 2 to 295 days).
0) (see 14 CLINICAL TRIALS).
APO-LENALIDOMIDE (Lenalidomide capsules) Page 8 of 110 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 APO-LENALIDOMIDE treatment Return to ≥50,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily If baseline <100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt APO-LENALIDOMIDE treatment If baseline ≥60,000/mcL and returns to ≥50,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily If baseline <60,000/mcL and returns to ≥30,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily 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 APO-LENALIDOMIDE treatment Return to ≥30,000/mcL (without hemostatic failure) Resume APO-LENALIDOMIDE at 5 mg daily MDS patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows: If thrombocytopenia develops during treatment at 5 mg daily When Platelets Recommended Course <30,000/mcL or <50,000/mcL with platelet transfusions Interrupt APO-LENALIDOMIDE treatment Return to ≥30,000/mcL (without hemostatic failure) Resume APO-LENALIDOMIDE at 5 mg every other day Neutropenia: MDS patients who are dosed initially […]
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).
Myelodysplastic Syndromes:
Recommended Starting Dose The recommended starting dose of APO-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 APO-LENALIDOMIDE treatment.
After initiation of APO-LENALIDOMIDE therapy, subsequent APO-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 to 468 days), and the median duration of the first dose interruption was 22 days (mean, 31 days; range, 2 to 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 to 568 days) and the median duration of the second dose interruption was 23 days (mean, 35 days; range, 2 to 295 days).
0) (see 14 CLINICAL TRIALS).
APO-LENALIDOMIDE (Lenalidomide capsules) Page 8 of 110 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 APO-LENALIDOMIDE treatment Return to ≥50,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily If baseline <100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt APO-LENALIDOMIDE treatment If baseline ≥60,000/mcL and returns to ≥50,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily If baseline <60,000/mcL and returns to ≥30,000/mcL Resume APO-LENALIDOMIDE at 5 mg daily 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 APO-LENALIDOMIDE treatment Return to ≥30,000/mcL (without hemostatic failure) Resume APO-LENALIDOMIDE at 5 mg daily MDS patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows: If thrombocytopenia develops during treatment at 5 mg daily When Platelets Recommended Course <30,000/mcL or <50,000/mcL with platelet transfusions Interrupt APO-LENALIDOMIDE treatment Return to ≥30,000/mcL (without hemostatic failure) Resume APO-LENALIDOMIDE at 5 mg every other day Neutropenia: MDS […]
1 Special Populations .................................................................................................. 1 Pregnant Women ....................................................................................................
2 Breast-feeding......................................................................................................... 3 Pediatrics ................................................................................................................
4 Geriatrics.................................................................................................................. 24 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions........................................................
5 Post-Market Adverse Reactions .............................................................................. 52 9 DRUG INTERACTIONS ..................................................................................................
2 Drug Interactions Overview ..................................................................................... 3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 55 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics.................................................................................................. 3 Pharmacokinetics.....................................................................................................
56 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 60 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 60 PART II: SCIENTIFIC INFORMATION ......................................................................................
61 13 PHARMACEUTICAL INFORMATION .............................................................................. 61 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trials by Indication ...................................................................................... 2 Comparative Bioavailability Studies ........................................................................ 79 15 MICROBIOLOGY ..........................................................................................................
79 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 80 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................................... 84 PATIENT MEDICATION INFORMATION .................................................................................
85 PATIENT MEDICATION INFORMATION […]