ASH Clinical News FINAL_ACN_3.14_FULL_ISSUE_DIGITAL | Page 75

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