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Important Safety Information (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
The most common adverse reactions for POMALYST
(≥30%) included fatigue and asthenia, neutropenia,
anemia, constipation, nausea, diarrhea, dyspnea,
upper-respiratory tract infections, back pain,
and pyrexia.
In the phase III trial, nearly all patients treated with
POMALYST + low-dose dex experienced at least one
adverse reaction (99%). Adverse reactions (≥15% in the
POMALYST + low-dose dex arm and ≥2% higher than
control) 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% in the POMALYST +
low-dose dex arm and ≥1% higher than control) 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 child, 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 a breastfed child from
POMALYST, advise women not to breastfeed 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. Guidance for Industry. Food and Drug
Administration, US Department of Health and Human
Services. 2007. 2. POMALYST [package insert]. Summit, NJ:
Celgene Corp; 2018. 3. Data on file. Celgene Corp; 2018.
POMALYST ® , POMALYST REMS ® , and REVLIMID ®
are registered trademarks of Celgene Corporation.
© 2018 Celgene Corporation
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US-POM-18-0163