Presentation and Status in Health Basket
Film Coated Tablets
Initiation Pack: 27 (4 x 10 mg, 4 x 20 mg, 19 x 30 mg)
Film Coated Tablets
56 X 30 mg
Treatment should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Posology: The recommended dose of apremilast is 30 mg twice daily taken orally, morning and evening, approximately 12 hours apart, with no food restrictions. An initial titration schedule is required as shown in prescribing information. No re-titration is required after initial titration. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time. During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment. If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered. The patient’s response to treatment should be evaluated on a regular basis. Clinical experience beyond 52 weeks is not available.
Elderly patients: No dose adjustment is required for this patient population.
Patients with renal impairment: No dose adjustment is needed in patients with mild and moderate renal impairment. The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 (see prescribing information for full details) and the PM doses be skipped.
Patients with hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment.
Paediatric population: The safety and efficacy of apremilast in children aged 0 to 17 years have not been established. No data are available.
Method of administration: This product is for oral use. The film-coated tablets should be swallowed whole, and can be taken either with or without food.
For treatment of adult patients with active psoriatic arthritis. For patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Hypersensitivity to the active substance or to any of the excipients. Pregnancy.
Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Psychiatric disorders: Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression. The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.
Severe renal impairment: In patients with severe renal impairment dose should be reduced to 30 mg once daily.
Underweight patients: Patients who are underweight at the start of treatment should have their body weight monitored regularly. In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
The most commonly reported adverse reactions in Phase III clinical studies have been gastrointestinal (GI) disorders including diarrhoea and nausea. The other most commonly reported adverse reactions included upper respiratory tract infections, headache and tension headache. The most common adverse reactions leading to discontinuation during the first 16 weeks of treatment were diarrhea and nausea. The overall incidence of serious adverse reactions was low and did not indicate any specific system organ involvement.
See prescribing information for full details.
Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John’s Wort) with apremilast is not recommended. Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (Cmax) by approximately 72% and 43%, respectively. Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g. rifampicin) and may result in reduced clinical response. In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy. There was no clinically meaningful drug-drug interaction between ketoconazole and apremilast. Apremilast can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole. There was no pharmacokinetic drug-drug interaction between apremilast and methotrexate in psoriatic arthritis patients. Apremilast can be co-administered with methotrexate. There was no pharmacokinetic drug-drug interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate. Apremilast can be co-administered with oral contraceptives.
Pregnancy and Lactation
Pregnancy: There are limited data about the use of apremilast in pregnant women. Apremilast is contraindicated during pregnancy.
Lactation: Apremilast was detected in milk of lactating mice. It is not known whether apremilast, or its metabolites, are excreted in human milk. A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg BID) for 4.5 days without evidence of dose limiting toxicities. In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted. In the event of overdose, symptomatic and supportive care is advised.
Each 10 mg film-coated tablet contains 60 mg lactose monohydrate. Each 20 mg film-coated tablet contains 120 mg lactose monohydrate. Each 30 mg film-coated tablet contains 180 mg lactose monohydrate. Do not store above 30ºC.