Lenalidomide
Generic Name: lenalidomide
Brand Names:
Lenalidomide
11 DESCRIPTION Lenolidamide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro- 2H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder.
Overview
11 DESCRIPTION Lenolidamide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro- 2H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder.
Uses
1 INDICATIONS AND USAGE Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Mantle cell lymphoma (MCL) whose disease has relapsed orprogressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ).
Dosage
2 DOSAGE AND ADMINISTRATION MM combination therapy: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. ( 2.1 ). MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles ( 2.1 ). MDS: 10 mg once daily ( 2.2 ). MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles ( 2.3 ). FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles ( 2.4 ). Renal impairment: Adjust starting dose based on the creatinine clearance value ( 2.6 ). For concomitant therapy doses, see Full Prescribing Information ( 2.1 , 2.4 , 14.1 , 14.4 ).
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the prescribing information: Embryo-Fetal Toxicity [see Boxed Warning , Warnings and Precautions (5.1 , 5.2) ] Hematologic Toxicity [see Boxed Warning , Warnings and Precautions (5.3) ] Venous and Arterial Thromboembolism [see Boxed Warning , Warnings and Precautions (5.4) ] Increased Mortality in Patients with CLL [see Warnings and Precautions (5.5) ] Second Primary Malignancies [see Warnings and Precautions (5.6) ] Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Severe Cutaneous Reactions [see Warnings and Precautions...
Interactions
7 DRUG INTERACTIONS Digoxin: Monitor digoxin plasma levels periodically due to increased C max and AUC with concomitant lenalidomide therapy ( 7.1 ). Concomitant use of erythropoietin stimulating agents or estrogen containing therapies with lenolidamide may increase the risk of thrombosis ( 7.2 ). 7.1 Digoxin When digoxin was co-administered with multiple doses of lenalidomide capsules (10 mg/day) the digoxin C max and AUC inf were increased by 14%. Periodically monitor digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, during administration of lenalidomide capsules.
Warnings
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. 5 WARNINGS AND PRECAUTIONS Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with lenalidomide capsules ( 5.5 ). Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving lenalidomide capsules ( 5.6 ). Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.7 ). Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop lenalidomide capsules and evaluate if hepatotoxicity is suspected ( 5.8 ). Severe Cutaneous Reactions: Discontinue lenalidomide capsules for severe reactions ( 5.9 ). 4 CONTRAINDICATIONS • Pregnancy ( Boxed Warning , 4.1 , 5.1 , 8.1 ). • Demonstrated severe hypersensitivity to lenalidomide ( 4.2 , 5.9 , 5.15 ). 4.1 Pregnancy Lenalidomide capsules can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenolidamide during pregnancy as well as female partners of male patients who are exposed to lenolidamide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to lenolidamide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
Storage
16.2 Storage Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Lenalidomide used for?▼
1 INDICATIONS AND USAGE Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Mantle cell lymphoma (MCL) whose disease has relapsed orprogressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ).
What are the side effects of Lenalidomide?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the prescribing information: Embryo-Fetal Toxicity [see Boxed Warning , Warnings and Precautions (5.1 , 5.2) ] Hematologic Toxicity [see Boxed Warning , Warnings and Precautions (5.3) ] Venous and Arterial Thromboembolism [see Boxed Warning , Warnings and Precautions (5.4) ] Increased Mortality in Patients with CLL [see Warnings and Precautions (5.5) ] Second Primary Malignancies [see Warnings and Precautions (5.6) ] Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Severe Cutaneous Reactions [see Warnings and Precautions...
Can I take Lenalidomide during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenolidamide during pregnancy as well as female partners of male patients who are exposed to lenolidamide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to lenolidamide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
What are the important warnings for Lenalidomide?▼
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. 5 WARNINGS AND PRECAUTIONS Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with lenalidomide capsules ( 5.5 ). Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving lenalidomide capsules ( 5.6 ). Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.7 ). Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop lenalidomide capsules and evaluate if hepatotoxicity is suspected ( 5.8 ). Severe Cutaneous Reactions: Discontinue lenalidomide capsules for severe reactions ( 5.9 ). 4 CONTRAINDICATIONS • Pregnancy ( Boxed Warning , 4.1 , 5.1 , 8.1 ). • Demonstrated severe hypersensitivity to lenalidomide ( 4.2 , 5.9 , 5.15 ). 4.1 Pregnancy Lenalidomide capsules can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested.
Related Medications
Gallium Citrate Ga-67
gallium citrate ga-67
DESCRIPTION Gallium Citrate Ga 67 Injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. Each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of gallium Ga-67 on the calibration date as a complex formed from 8.3 nanograms gallium chloride Ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative.
Stannum 21x
stannum 21x
Use: Temporary relief of headache.
Culix Pipiens
culix pipiens
Dosage form: INJECTION, SOLUTION. Route: PERCUTANEOUS. Active ingredients: CULEX PIPIENS (.01 g/mL). Category: BLA.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.