LENALIDOMIDE 10 mg/1
LENALIDOMIDE · CAPSULE · Camber Pharmaceuticals, Inc.
LENALIDOMIDE is a capsule containing lenalidomide at 10 mg/1, taken oral. Manufactured by Camber Pharmaceuticals, Inc..
Key Facts
- Brand Name
- LENALIDOMIDE
- Generic Name
- LENALIDOMIDE
- NDC Code (Product)
31722-259- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 10 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212414
- Drug Class
- Thalidomide Analog [EPC]
- Marketing Start
- 05/11/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Lenalidomide is 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 or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Limitations of Use: Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ). 1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide capsules are indicat…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION MM combination therapy: 25 mg once daily orally on Days 1 to 21 of repeated 28-day cycles. ( 2.1 ). MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1 to 28 of repeated 28-day cycles ( 2.1 ). MDS: 10 mg once daily ( 2.2 ). MCL: 25 mg once daily orally on Days 1 to 21 of repeated 28-day cycles ( 2.3 ). FL or MZL: 20 mg once daily orally on Days 1 to 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 ). 2.1 Recommended Dosage for Multiple Myeloma Lenalidomide Capsules Combination Therapy The recommended starting dose of lenalidomide capsules is 25 mg orally once daily on Days 1 to 21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies ( 14.1 )] . Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto…
Contraindications
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. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see Boxed Warning ] . 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 risk to a fetus [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Special Populations ( 8.1 , 8.3 )] . 4.2 Severe Hypersensitivity Reactions Lenalidomide capsules are contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see Warnings and Precautions ( 5.9 , 5.15 )] .
Drug Interactions
7 DRUG INTERACTIONS Digoxin: Monitor digoxin plasma levels periodically due to increased C max and AUC with concomitant lenalidomide capsules therapy ( 7.1 ). Concomitant use of erythropoietin stimulating agents or estrogen containing therapies with lenalidomide capsules 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. 7.2 Concomitant Therapies That May Increase the Risk of Thrombosis Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving lenalidomide [see Warnings and Precautions ( 5.4 )] . 7.3 Warfarin Co-administration of multiple doses of lenalidomide capsules (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S…
Adverse Reactions
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 ( 5.9 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.10 )] Tumor Flare Reactions [see Warnings and Precautions ( 5.11 )] Impaired Stem Cell Mobilization [see Warnings and Precautions ( 5.12 )] Thyroid Disorders [see Warnings and Precautions ( 5.13 )] Early Mortality in Patients with MCL [see Warnings and Precautions ( 5.14 )] Hypersensitivity [see Warnings and Precautions ( 5.15…
Frequently Asked Questions
What is LENALIDOMIDE used for?
LENALIDOMIDE contains LENALIDOMIDE. It is a capsule taken oral. Consult your doctor for specific uses.
Is LENALIDOMIDE a controlled substance?
LENALIDOMIDE is not classified as a controlled substance by the DEA.
What is the generic name for LENALIDOMIDE?
The generic name for LENALIDOMIDE is LENALIDOMIDE. There are 6 other brand versions of LENALIDOMIDE.
What is the NDC code for LENALIDOMIDE 10 mg/1?
The NDC (National Drug Code) for LENALIDOMIDE 10 mg/1 is 31722-259, listed by Camber Pharmaceuticals, Inc..