NHSL Guidelines
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.