Otezla

OTEZLA- apremilast tablet, film coated
OTEZLA- apremilast
Amgen Inc

1 INDICATIONS AND USAGE

1.1 Psoriatic Arthritis

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

1.2 Plaque Psoriasis

OTEZLA is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

1.3 Oral Ulcers Associated with Behçet’s Disease

OTEZLA is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Psoriatic Arthritis, Plaque Psoriasis, and Behçet’s Disease

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

2.2 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 (8.6) and Clinical Pharmacology (12.3)]. 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.

3 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

4 CONTRAINDICATIONS

OTEZLA is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. Avoid the use of OTEZLA 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 and institute appropriate therapy.

5.2 Diarrhea, Nausea, and Vomiting

There have been reports of severe diarrhea, nausea, and vomiting 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. Patients who reduced dosage or discontinued OTEZLA generally improved quickly. Consider OTEZLA dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting.

5.3 Depression

Treatment with OTEZLA is associated with an increased incidence of depression. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with OTEZLA. Patients, their 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 if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur.

Psoriatic Arthritis: During the 0 to 16-week placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of subjects treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. During the clinical trials, 0.3% (4/1441) of subjects treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated subjects (0/495). Depression was reported as serious in 0.2% (3/1441) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1441) of subjects while receiving OTEZLA, compared to none in placebo treated subjects (0/495). In the clinical trials, 2 subjects who received placebo committed suicide compared to none in OTEZLA-treated subjects.

Plaque Psoriasis: During the 0 to 16-week placebo-controlled period of the 3 controlled clinical trials in subjects with moderate to severe plaque psoriasis, 1.3% (12/920) of subjects treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of subjects treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated subjects (0/506). Depression was reported as serious in 0.1% (1/1308) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of subjects while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated subjects. In the clinical trials, one subject treated with OTEZLA attempted suicide while one who received placebo committed suicide.

During the 0 to 16-week placebo-controlled period of the mild to moderate plaque psoriasis clinical trial, the incidence of subjects reporting depression was similar to what was observed in the moderate to severe plaque psoriasis trials.

Behçet’s Disease: During the placebo-controlled period of the phase 3 trial, 1% (1/104) of subjects treated with OTEZLA reported depression/depressed mood compared to 1% (1/103) treated with placebo. None of these reports of depression was serious or led to discontinuation from the trial. No instances of suicidal ideation or behavior were reported during the placebo-controlled period of the phase 3 trial in subjects treated with OTEZLA (0/104) or treated with placebo (0/103).

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