hils Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) Interrupt REVLIMID treatment
Return to ≥500/mcL Resume REVLIMID at 5 mg daily
When Neutrophils Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C) Interrupt REVLIMID treatment
Return to ≥500/mcL Resume REVLIMID at 5 mg every other day
Table 2: Starting Dose Adjustment for Renal Impairment in Myelodysplastic Syndromes (Days 1 – 28 of each 28 day cycle) Category Renal Function
(Cockcroft-Gault) Dose
Moderate Renal
Impairment CLcr 30-60 mL/min 5 mg
Every 24 hours
Severe Renal
Impairment CLcr < 30 mL/min (not requiring dialysis) 5 mg
Every 48 hours
End Stage Renal
Disease CLcr < 30 mL/min (requiring dialysis) 5 mg
3 times a week following each dialysis
3DOSAGE FORMS AND STRENGTHS
REVLIMID 5 mg, 10 mg, 15 mg and 25 mg capsules will be supplied through the RevAssist program
REVLIMID is available in the following capsule strengths:
5 mg: White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink 10 mg: Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink 15 mg: Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink 25 mg: White opaque capsules imprinted “REV” on one half and “25 mg” on the other half in black ink
4CONTRAINDICATIONS
4.1Pregnancy
REVLIMID may cause fetal harm when administered to a pregnant woman. 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 pregnant women and women capable of becoming pregnant [see Boxed Warning]. Females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, including at least one highly effective method (e.g., hormonal contraception, tubal ligation, IUD or partner’s vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to initiating treatment with REVLIMID, during therapy, during therapy delay, and continuing for 4 weeks following discontinuation of REVLIMID therapy. If hormonal or IUD contraception is medically contraindicated, two other effective or highly effective methods may be used.
Females of childbearing potential being treated with REVLIMID must have pregnancy testing (sensitivity of at least 50 mIU/mL). The first test should be performed within 10-14 days and the second test within 24 hours prior to beginning REVLIMID therapy and then weekly during the first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling must be performed if a patient misses her period or if there is any abnormality in menstrual bleeding. If pregnancy occurs, REV
