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DOSAGE AND ADMINISTRATION
Dosage In Psoriatic Arthritis And Psoriasis
The recommended initial dosage titration of OTEZLA from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.
OTEZLA can be administered without regard to meals. Do not crush, split, or chew the tablets.
Table 1: Dosage Titration Schedule
|Day 1||Day 2||Day 3||Day 4||Day 5||Day 6 & thereafter|
|10 mg||10 mg||10 mg||10 mg||20 mg||20 mg||20 mg||20 mg||30 mg||30 mg||30 mg|
Dosage Adjustment In Patients With Severe Renal Impairment
OTEZLA dosage should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance (CLcr) of less than 30 mL per minute estimated by the Cockcroft–Gault equation) [see Use in Specific Populations and CLINICAL PHARMACOLOGY]. For initial dosage titration in this group, it is recommended that OTEZLA be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.
Dosage Forms And Strengths
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 side
- 20-mg brown tablet engraved with “APR” on one side and “20” on the other side
- 30-mg beige tablet engraved with “APR” on one side and “30” on the other side.
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 side; 20-mg brown tablet engraved with “APR” on one side and “20” on the other side; 30-mg beige tablet engraved with “APR” on one side and “30” on the other side.
Tablets are supplied in the following strengths and package configurations:
|Package configuration||Tablet strength||NDC number|
|Bottles of 60||30 mg||59572-631-06|
|Two-week starter pack||13-tablet blister titration pack containing: (4) 10-mg, (4) 20-mg, and (5) 30-mg tablets with an additional (14) 30-mg tablets||59572-630-27|
|28-count carton||Two 30-mg blister cards containing (14) 30-mg tablets||59572-631-28|
|28-day starter pack||13-tablet blister titration pack containing: (4) 10-mg, (4) 20-mg, and (5) 30-mg tablets with an additional (42) 30-mg tablets||59572-632-55|
Storage And Handling
Store tablets below 30°C (86°F).
Manufactured for: Celgene Corporation, Summit, NJ 07901. Revised: Dec 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/1/2016
Additional Otezla Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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