Type:Tablet
Generic Name:Apremilast
Manufacturer:Labaid Pharmaceuticals Ltd.
Price:৳25.00
Active psoriatic arthritis, moderate to severe plaque psoriasis
To reduce risk of GI symptoms associated with initial therapy, titrate to recommended dose (30 mg PO BID) according to the dosage schedules listed above Can be administered without regard to meals Swallow tablet whole; do not crush, split, or chew
Active psoriatic arthritis, moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. To reduce risk of gastrointestinal symptoms, titrate to recommended dose of 30 mg twice daily according to the following schedule: 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 and thereafter: 30 mg twice daily Hepatic impairment: No dosage adjustment required
Severe renal impairment (CrCl <30 mL/min): Reduce dose to 30 mg PO qDay Mild-to-moderate renal impairment: No dosage adjustment required
Known hypersensitivity to apremilast.
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.
Apremilast is associated with an increase in adverse reactions of depression. Before using, evaluate patient for history of depression and/or suicidal thoughts or behavior. Weight decrease of 5-10% of body weight. Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of Apremilast. Lactation: Unknown if distributed in human breast milk; caution required
1-10% Diarrhea (7.7-9.3%),Nausea (7.4-8.9%),Headache (4.8-5.9%),Upper respiratory tract infection (0.6-3.9%),Vomiting (0.8-3.2%),Nasopharyngitis (0.2-2.6%),Upper abdominal pain (0.6-2%)
Pregnancy Available pharmacovigilance data use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but data are extremely limited Based on findings from animal reproduction studies, may increase the risk for fetal loss Lactation There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production Detected in the milk of lactating mice Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition
Coadministration with strong CYP inducers (eg, rifampin, carbamazepine, phenobarbital phenytoin) may occur and result in a loss of efficacy of apremilast; therefore, coadministration is not recommended.
