Otezla Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis (1.1)Plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2)Oral ulcers associated with Behçet's Disease (1.3) Pediatric patients 6 years of age and older with: Active psoriatic arthritis (1.1)Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2) In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg.
What should I know before taking it?
OTEZLA/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Warnings and Precautions (5.1), see Adverse Reactions (6.1)].
What important warnings are listed?
Hypersensitivity: Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy (5.1) Diarrhea, Nausea, and Vomiting: Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting (5.2) Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other.
How is this medication usually taken?
OTEZLA is available as diamond-shaped, film-coated tablets in the following dosage strengths: 10-mg pink tablet engraved with "APR" on one side and "10" on the other side20-mg brown tablet engraved with "APR" on one side and "20" on the other side30-mg beige tablet engraved with "APR" on one side and "30" on the other side OTEZLA XR is available as 75 mg round, biconvex, pink, film-coated extended-release tablets with "APR 75" printed in black on one side and a hole or indentation on either side of the tablet, which may or may not be visible.
What side effects are listed?
The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1)] Diarrhea, Nausea, and Vomiting [see Warnings and Precautions (5.2)] Depression [see Warnings and Precautions (5.3)] Weight Decrease [see Warnings and Precautions (5.4)] Drug Interactions [see Warnings and Precautions (5.5)]
What interactions are listed?
Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA/OTEZLA XR. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA/OTEZLA XR is not recommended [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6b1f516-4972-4d82-bced-113e47b41cc5
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.