Uses of Aprima: - Plaque psoriasis Active psoriatic arthritis, moderate to severe plaque psoriasis Known hypersensitivity to apremilast.

Disease-modifying antirheumatic drugs (DMARDs)

Apremilast is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.

How to use Apremilast: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Apremilast may be taken with or without food, but it is better to take it at a fixed time. Administration: 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 Adult Dose: 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 Renal Dose: Severe renal impairment (CrCl <30 mL/min): Reduce dose to 30 mg PO qDay Mild-to-moderate renal impairment: No dosage adjustment required

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.

Known hypersensitivity to apremilast.

Common - Diarrhea - Nausea - Vomiting 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 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.

Precaution: 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

Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.

Disease-modifying antirheumatic drugs (DMARDs)

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.

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