Lenalidomide (Page 2 of 12)
2.3 Recommended Dosage for Mantle Cell Lymphoma
The recommended starting dose of lenalidomide capsules is 25 mg/day orally on Days 1 to 21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.
Treatment is continued, modified or discontinued based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During MCL Treatment
Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to lenalidomide capsules.
Platelet counts
Thrombocytopenia during treatment in MCL
When Platelets | Recommended Course |
Fall below 50,000/mcL | Interrupt lenalidomide capsules treatment and follow CBC weekly |
Return to at least 50,000/mcL | Resume lenalidomide capsules at 5 mg less than the previous dose. Do not dose below 5 mg daily |
Absolute Neutrophil counts (ANC)
Neutropenia during treatment in MCL
When Neutrophils | Recommended Course |
Fall below 1,000/mcL for at least 7 days OR Falls below 1,000/mcL with an associated temperature at least 38.5°C OR Falls below 500/mcL | Interrupt lenalidomide capsules treatment and follow CBC weekly |
Return to at least 1,000/mcL | Resume lenalidomide capsules at 5 mg less than the previous dose. Do not dose below 5 mg daily |
2.5 Dosage Modifications for Non-Hematologic Adverse Reactions
For non-hematologic Grade 3/4 toxicities judged to be related to lenalidomide capsules, hold treatment and restart at the physician’s discretion at next lower dose level when toxicity has resolved to Grade 2 or below.
Permanently discontinue lenalidomide capsules for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reactions [see Warnings and Precautions (5.9, 5.15)].
2.6 Recommended Dosage for Patients with Renal Impairment
The recommendations for dosing patients with renal impairment are shown in the following table [see Clinical Pharmacology (12.3)].
Renal Function (Cockcroft-Gault) | Dose in Lenalidomide Capsules Combination Therapy for MM and MCL | Dose in Lenalidomide Capsules for MDS |
CLcr 30 to 60 mL/min | 10 mg once daily | 5 mg once daily |
CLcr below 30 mL/min (not requiring dialysis) | 15 mg every other day | 2.5 mg once daily |
CLcr below 30 mL/min (requiring dialysis) | 5 mg once daily. On dialysis days, administer the dose following dialysis. | 2.5 mg once daily. On dialysis days, administer the dose following dialysis. |
Lenalidomide Capsules Combination Therapy for MM: For CLcr of 30 to 60 mL/min, consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose of lenalidomide without dose-limiting toxicity.
Lenalidomide Capsules Therapy for MCL and MDS: Base subsequent lenalidomide capsules dose increase or decrease on individual patient treatment tolerance [see Dosage and Administration (2.1 to 2.3)].
2.7 Administration
Advise patients to take lenalidomide capsules orally at about the same time each day, either with or without food. Advise patients to swallow lenalidomide capsules whole with water and not to open, break, or chew them.
3 DOSAGE FORMS AND STRENGTHS
Capsules:
- 5 mg white capsules printed with “NAT” on cap and “5mg” on body of the capsule in black ink.
- 10 mg white capsules printed with “NAT” on cap and “10mg” on body of the capsule in black ink.
- 15 mg white capsules printed with “NAT” on cap and “15mg” on body of the capsule in black ink.
- 25 mg white capsules printed with “NAT” on cap and “25mg” on body of the capsule in black ink.
4 CONTRAINDICATIONS
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)].
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
Lenalidomide is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes life-threatening human birth defects or embryo-fetal death [see Use in Specific Populations (8.1)]. An embryo-fetal development study in monkeys indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy, similar to birth defects observed in humans following exposure to thalidomide during pregnancy.
Lenalidomide capsules are only available through the Lenalidomide REMS program [see Warnings and Precautions (5.2)].
Females of Reproductive Potential
Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning lenalidomide capsules therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide capsules, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing lenalidomide therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles [see Use in Specific Populations (8.3)].
Males
Lenalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide capsules and for up to 4 weeks after discontinuing lenalidomide capsules, even if they have undergone a successful vasectomy. Male patients taking lenalidomide capsules must not donate sperm and for up to 4 weeks after discontinuing lenalidomide capsules [see Use in Specific Populations (8.3)].
Blood Donation
Patients must not donate blood during treatment with lenalidomide capsules and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to lenalidomide.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.