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Otezla

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Otezla

INDICATIONS

Psoriatic Arthritis

OTEZLA is indicated for the treatment of adult patients with active psoriatic arthritis.

DOSAGE AND ADMINISTRATION

Dosage In Psoriatic Arthritis

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
AM AM PM AM PM AM PM AM PM AM PM
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 Cockroft–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.

HOW SUPPLIED

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 code
Bottles of 60 30 mg 59572-630-06
Two week starter pack 13-tablet blister titration pack containing: 10 mg, 20 mg, and 30 mg tablets with an additional (14) 30 mg tablets 59572-630-27
28 count carton 2-30mg blister cards containing (14) 30 mg tablets 59572-630-28

Storage And Handling

Store tablets below 30 °C (86°F).

Manufactured for: Celgene Corporation, Summit, NJ 07901. Revised: 03/14

Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.

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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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