Otezla 75 mg/1
apremilast · TABLET, FILM COATED · Amgen, Inc
Otezla is a tablet, film coated containing apremilast at 75 mg/1, taken oral. Manufactured by Amgen, Inc.
Key Facts
- Brand Name
- Otezla
- Generic Name
- apremilast
- NDC Code (Product)
55513-519- Manufacturer
- Amgen, Inc
- Strength
- 75 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA205437
- Drug Class
- Phosphodiesterase 4 Inhibitor [EPC]
- Marketing Start
- 08/31/2025
Recall History
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. 1.1 Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis. 1.2 Plaque Psoriasis OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA is indicated for the t…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION To reduce the risk of gastrointestinal symptoms, titrate to recommended dosage as follows: Adults with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease See Table 1 for the initial titration schedule. Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily ( 2.1 ) Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis See Table 2 for the initial titration schedule ( 2.1 ) For patients weighing 50 kg or more : Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily ( 2.1 ) For patients weighing 20 kg to less than 50 kg : Recommended maintenance dosage is OTEZLA 20 mg twice daily ( 2.1 ) Dosage in Patients with Severe Renal Impairment : Adult Patients : For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses. Recommended maintenance dosage is OTEZLA 30 mg once daily ( 2.3 ) Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis : For initial dosage titration, titrate usin…
Contraindications
4 CONTRAINDICATIONS 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) ] . Known hypersensitivity to apremilast or to any of the excipients in the formulation ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Strong CYP450 Inducers Co-administration with strong CYP450 inducers (such as rifampin) decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS 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) ] Psoriatic Arthritis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Behçet's Disease : The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rat…
Frequently Asked Questions
What is Otezla used for?
Otezla contains apremilast. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Otezla a controlled substance?
Otezla is not classified as a controlled substance by the DEA.
What is the generic name for Otezla?
The generic name for Otezla is apremilast. There are no other listed brand versions of apremilast.
What is the NDC code for Otezla 75 mg/1?
The NDC (National Drug Code) for Otezla 75 mg/1 is 55513-519, listed by Amgen, Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)