Administration: Oral

Dose:

• The recommended dose of APREMILAST is 30mg twice daily taken orally, morning and evening, approximately 12 hours apart, swallowed whole, with no food restrictions.
• To reduce risk of GI symptoms an initial titration over 5 days from 10mg daily on day 1 to 30mg twice daily on day 6 is recommended:
  • 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 in Severe Renal Impairment:
  • Recommended dose is 30 mg once daily.
  • For initial dosage titration, titrate using only morning schedule and skip afternoon doses.

Time to response: 8 weeks to 6 months

Indications: Psoriatic Arthritis.

Contraindications:

• Hypersensitivity to APREMILAST or any excipients in formulation.
• Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
• Pregnancy and breastfeeding.
• History of suicidal ideation/behaviour.

Monitoring: No blood monitoring is required.

Ensure:

• Adequate contraception whilst taking APREMILAST and for 3 days after stopping it.
• Use with strong cytochrome p450 enzyme inducers (e.g. RIFAMPICIN, PHENOBARBITAL, CARBAMAZEPINE, PHENYTOIN, St. John’s Wort) is not recommended because loss of efficacy may occur.

In the event of:

• Side effects such as diarrhoea, headache, nausea and upper respiratory tract infections are common in the first 2 weeks of treatment and tend to resolve over time with continued dosing. Initial reassurance is all that is required.
• Worsening or new psychiatric symptoms - stop APREMILAST.
• 5-10% weight loss – consider stopping drug particularly in those with low BMI.