WARNINGS AND PRECAUTIONS ( continued )
• Tumor Lysis Syndrome ( TLS ): TLS may occur in patients treated with POMALYST . Patients at risk are those with high tumor burden prior to treatment . These patients should be monitored closely and appropriate precautions taken .
ADVERSE REACTIONS
Nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction ( 99 %). The most common adverse reactions ( ≥15 %) included neutropenia ( 51.3 %), fatigue and asthenia ( 46.7 %), upper respiratory tract infection ( 31 %), thrombocytopenia ( 29.7 %), pyrexia ( 26.7 %), dyspnea ( 25.3 %), diarrhea ( 22 %), constipation ( 21.7 %), back pain ( 19.7 %), cough ( 20 %), pneumonia ( 19.3 %), bone pain ( 18 %), edema peripheral ( 17.3 %), peripheral neuropathy ( 17.3 %), muscle spasms ( 15.3 %), and nausea ( 15 %). Grade 3 or 4 adverse reactions ( ≥15 %) included neutropenia ( 48.3 %), thrombocytopenia ( 22 %), and pneumonia ( 15.7 %).
DRUG INTERACTIONS
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2 . Consider alternative treatments . If a strong CYP1A2 inhibitor must be used , reduce POMALYST dose by 50 %.
USE IN SPECIFIC POPULATIONS
• Pregnancy : See Boxed WARNINGS . If pregnancy does occur during treatment , immediately discontinue the drug and refer patient to an obstetrician / gynecologist experienced in reproductive toxicity for further evaluation and counseling . There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST . This registry is also used to understand the root cause for the pregnancy . Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436 .
• Lactation : There is no information regarding the presence of pomalidomide in human milk , the effects of POMALYST on the breastfed infant , or the effects of POMALYST on milk production . Pomalidomide was excreted in the milk of lactating rats . Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from POMALYST , advise a nursing woman to discontinue breastfeeding during treatment with POMALYST .
• Pediatric Use : Safety and effectiveness have not been established in pediatric patients .
• Geriatric Use : No dosage adjustment is required for POMALYST based on age . Patients > 65 years of age were more likely than patients ≤65 years of age to experience pneumonia .
• Renal Impairment : Reduce POMALYST dose by 25 % in patients with severe renal impairment requiring dialysis . Take dose of POMALYST following hemodialysis on hemodialysis days .
• Hepatic Impairment : Reduce POMALYST dose by 25 % in patients with mild to moderate hepatic impairment and 50 % in patients with severe hepatic impairment .
• Smoking Tobacco : Advise patients that smoking may reduce the efficacy of POMALYST . Cigarette smoking reduces the AUC of pomalidomide by 32 % by CYP1A2 induction .
Please see brief summary of full Prescribing Information , including Boxed WARNINGS , on the following pages .
REFERENCE : 1 . U . S . Department of Health and Human Services , Food and Drug Administration , Center for Drug Evaluation and Research , Center for Biologics Evaluation and Research . Guidance for industry : Clinical trial endpoints for the approval of cancer drugs and biologics . https :// www . fda . gov / RegulatoryInformation / Guidances / default . htm . Accessed April 13 , 2017 .
POMALYST is only available through a restricted distribution program , POMALYST REMS ® .
POMALYST ® , POMALYST REMS ® , and REVLIMID ® are registered trademarks of Celgene Corporation . © 2017 Celgene Corporation 06 / 17 US-POM170013a