Aprila 30 mg (Tablet)

Indications

• Treatment of adult patients with active psoriatic arthritis
• Treatment of moderate to severe plaque psoriasis
• Candidates for phototherapy or systemic therapy

Pharmacology

• Apremilast is a small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4)
• Increases intracellular levels of cAMP
• Inhibits production of multiple proinflammatory mediators

Dosage & Administration

• Initial dosage titration from Day 1 to Day 5
• Recommended maintenance dosage of 30 mg twice daily
• Reduction of gastrointestinal symptoms associated with initial therapy

Interaction

• Co-administration of strong cytochrome P450 enzyme inducer Rifampin reduces systemic exposure of Aprila
• Not recommended with cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital, Carbamazepine, Phenytoin)

Contraindications

• Known hypersensitivity to Apremilast or any of the excipients

Side Effects

• Frequently occurring side effects: nausea, diarrhea, headache
• Less frequent side effects: upper respiratory tract infection, vomiting, nasopharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia

Pregnancy & Lactation

• Pregnancy Category C
• Caution during nursing

Precautions & Warnings

• Associated with increase in adverse reactions of depression
• Alert for emergence or worsening of depression, suicidal thoughts or other mood changes
• Evaluation of risks and benefits if such events occur
• Weight decrease between 5-10% of body weight reported

Use in Special Populations

• Safety and effectiveness in paediatric patients less than 18 years not established

Therapeutic Class

• Disease-modifying antirheumatic drugs (DMARDs)

Storage Conditions

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

Related Brands

• Arsenor 10 mg (Tablet) - beacon-pharmaceuticals-plc
• Arsenor 30 mg (Tablet) - beacon-pharmaceuticals-plc