Otezla(apremilast)
Otezla 14-Day 10/20/30 Starter Pack
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Otezla FAQs
Is there a pregnancy exposure registry for OTEZLA?Yes, there is a pregnancy exposure registry for OTEZLA that monitors pregnancy outcomes in women exposed to OTEZLA during pregnancy. For more information about the registry or to report a pregnancy while on OTEZLA, contact 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/otezla/.
What is the risk of major birth defects or adverse outcomes with OTEZLA use in pregnant women?Available pharmacovigilance data with OTEZLA use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but these data are extremely limited. Based on findings from animal reproduction studies, OTEZLA may increase the risk for fetal loss. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Pregnant women should consult with their healthcare provider and consider pregnancy planning and prevention.
What are the animal data on OTEZLA use in pregnancy?In embryo-fetal development studies, pregnant cynomolgus monkeys administered apremilast (OTEZLA) during organogenesis resulted in dose-related increases in abortion/embryo-fetal death at doses approximately 2.1-times the maximum recommended human therapeutic dose (MRHD) and greater. No abortifacient effects were observed at a dose approximately 1.4-times the MRHD. No teratogenic effects were observed in mice administered apremilast during organogenesis up to exposures 4.0-times the MRHD. Apremilast distributed across the placenta into the fetal compartment in mice and monkeys. Pregnant women should consult with their healthcare provider and consider pregnancy planning and prevention.
Is apremilast (OTEZLA) present in human milk?There are no data on the presence of apremilast in human milk. However, apremilast was detected in the milk of lactating mice. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OTEZLA and any potential adverse effects on the breastfed infant from OTEZLA or from the underlying maternal condition. Women should consult with their healthcare provider.
Is OTEZLA safe and effective for use in pediatric patients?No, the safety and effectiveness of OTEZLA in pediatric patients less than 18 years of age have not been established.
Is OTEZLA safe for use in geriatric patients?According to clinical trials, there were no overall differences in the safety profile of geriatric patients ≥ 65 years of age and younger adult patients < 65 years of age. However, because patients 65 years of age or older may be at a higher risk of complications such as volume depletion or hypotension from severe diarrhea, nausea, or vomiting, monitor geriatric patients closely for such complications.
Is dosage adjustment needed for OTEZLA in patients with renal impairment?While no dosage adjustment is needed in patients with mild or moderate renal impairment, the dosage of OTEZLA should be reduced to 30 mg once daily in patients with severe renal impairment.
Is dosage adjustment needed for OTEZLA in patients with hepatic impairment?No, dosage adjustment is not necessary for OTEZLA in patients with moderate or severe hepatic impairment.
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