POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Safety profile of POMALYST® (pomalidomide) + dex + EMPLICITI® (elotuzumab) and POMALYST + dex alone.1,2

*For adverse reactions, criteria were met for all grades.
Low discontinuation rates due to adverse reactions were observed in both POMALYST + dex + EMPLICITI (5%) and POMALYST + dex alone (1.8%)1
- 43% of patients in the POMALYST + dex + EMPLICITI arm experienced a heart rate of <60 bpm vs 22% of patients in the POMALYST + dex arm. 23% of patients in the POMALYST + dex + EMPLICITI arm experienced a heart rate of ≥100 bpm vs 24% of patients in the POMALYST + dex arm
- The overall incidence of serious adverse reactions was 22% in patients treated with POMALYST + dex + EMPLICITI and in 15% of patients treated with POMALYST + dex
- The most frequent serious adverse reactions were pneumonia (13% vs 11%) and respiratory tract infection (7% vs 3.6%); in the POMALYST + dex + EMPLICITI vs POMALYST + dex arm, respectively
- 65% of patients treated in either arm experienced infections of any grade
- Grade 3/4 infections were reported in 13% of patients treated with POMALYST + dex + EMPLICITI vs 22% of patients treated with POMALYST + dex
- Infusion reactions were reported in 3.3% of patients treated with POMALYST + dex + EMPLICITI
- Median treatment duration was 9 cycles of POMALYST + dex + EMPLICITI vs 5 cycles for POMALYST + dex, with a minimum follow-up of 9.1 months
Important Safety Information for POMALYST and EMPLICITI
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%), fatigue and asthenia (47%), upper respiratory tract infection (31%), thrombocytopenia (30%), pyrexia (27%), dyspnea (25%), diarrhea (22%), constipation (22%), back pain (20%), cough (20%), pneumonia (19%), bone pain (18%), edema peripheral (17%), peripheral neuropathy (17%), muscle spasms (15%), 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%), thrombocytopenia (22%), and pneumonia (16%).
Serious adverse reactions in the EMPLICITI ELOQUENT-3 trial were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).
The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).
DRUG INTERACTIONS FOR POMALYST
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg.
USE IN SPECIFIC POPULATIONS
- Pregnancy: See Boxed WARNINGS for POMALYST: 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, a Bristol Myers Squibb company, at 1-888-423-5436.
- Pregnancy and EMPLICITI Use: There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major defects and miscarriage.
- Lactation: There is no information regarding the presence of pomalidomide or elotuzumab in human milk, the effects of POMALYST or EMPLICITI on the breastfed child, or the effects of POMALYST or EMPLICITI 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 or POMALYST in combination with EMPLICITI.
- 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: For patients with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily. Take dose of POMALYST following hemodialysis on hemodialysis days.
- Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce POMALYST dosage to 3 mg orally daily and to 2 mg orally daily in patients with severe hepatic impairment.
- Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction.
elo, elotuzumab; MM, multiple myeloma; PI, proteasome inhibitor.
References: 1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2. Dimopolous MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-1822. 3. POMALYST [package insert]. Summit, NJ: Celgene Corp.