Indications
Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Dosage & Administration
The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown below. 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. Apremilast can be administered without regard to meals.Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily
Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.
Interaction
Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Apremilast.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Apremilast is not recommended.
Contraindications
Apremilast is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.
Side Effects
The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.
Pregnancy & Lactation
Pregnancy Category C. It is not known whether Apremilast or its metabolites are present in human milk; however, Apremilast was detected in milk of lactating mice. Caution should be exercised when Apremilast is administered to a nursing woman.
Reviews
There are no reviews yet.