Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who
are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
IMPORTANT SAFETY INFORMATION
- Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any
of the excipients in the formulation
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the
use of Otezla. Most events occurred within the first few weeks of treatment. In some cases patients were
hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting.
Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact
their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of
depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla.
Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of
depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such
- Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical
trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was
reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated
patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2%
(1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed
- Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During
clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with
placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none
in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed
suicide compared to none on Otezla
- Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the
clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo.
No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with
- Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight
loss, and consider discontinuation of Otezla
- Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and
in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients
treated with Otezla compared to 1% (3/382) of patients treated with placebo
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking
Otezla and in 3.3% (16/495) of patients taking placebo
- Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla
and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a
strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme
inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended
- Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6),
nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla
and in 3.3% (16/495) of patients taking placebo
- Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a
frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%,
placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection
(11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory
tract infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of
fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a
pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects
of apremilast on the breastfed infant, or the effects of the drug on milk production. 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 child from Otezla or from the underlying maternal condition
- Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine
clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing
Please click here for Full Prescribing Information.