Aprima Tablet is manufactured by Incepta Pharmaceuticals Limited. Aprima Tablet contains 30 mg Apremilast. It is Disease-modifying antirheumatic drugs (DMARDs) class drug.
Aprima is an inhibitor of phosphodiesterase 4 (PDE4) enzyme specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism by which Aprima exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.
Aprima is used for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
|Therapeutic Class:||Disease-modifying antirheumatic drugs (DMARDs)|
|Manufacturer:||Incepta Pharmaceuticals Limited|
|Last Updated:||November 19, 2020 at 6:15 pm|
Table Of contents
Aprima contains Apremilast 30 mg. Aprima Dosage:
The recommended initial dosage titration of Aprima 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. Aprima 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 and thereafter: 30 mg twice daily
Dosage adjustment in patients with severe renal impairment
Aprima dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Aprima be titrated using only the morning schedule and the evening doses be skipped.
The most frequently occurring side effects of Aprima are nausea, diarrhea, and headache.
Other less frequent side effects are upper respiratory tract infection, vomiting, nasopharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.
Treatment with Aprima is associated with an increase in adverse reactions of depression. 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 Aprima if such events occur.
During the controlled period of the studies in psoriatic arthritis, weight decrease between 5%-10% of body weight was reported in 10% of subjects treated with Aprima 30 mg twice daily compared to 3.3% treated with placebo.
Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Aprima.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Aprima is not recommended.
Pregnancy Lactation use
Pregnancy: Pregnancy Category C.
Nursing mothers: It is not known whether Aprima or its metabolites are present in human milk; however Aprima was detected in milk of lactating mice. Caution should be exercised when Aprima is administered to a nursing woman.
Usage in Pediatric Patients
The safety and effectiveness of Aprima in pediatric patients less than18 years of age have not been established.
Aprima is contraindicated in patients with a known hypersensitivity to Aprima or to any of the excipients in the formulation.
Use in Paediatric patient: The safety and effectiveness of Aprima in paediatric patients less than 18 years of age have not been established.
Interaction with other Medicine
Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of Aprima. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with Aprima is not recommended.
Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.