Otemila Tablets (Apremilast)

Adult dose

Treatment with this medication should be initiated by a specialist experienced in the diagnosis and treatment of psoriatic arthritis and psoriasis. To reduce gastrointestinal adverse reactions caused by this medication, follow the schedule in Table 1 below during initial administration. The maintenance dose of this medication is 30 mg orally twice daily, approximately 12 hours apart. When restarting treatment after the initial administration, it may be administered without gradually increasing the dose. Table 1. Dosage and administration schedule for initial administration Day 1: 10 mg in the morning Day 2: 10 mg in the morning, 10 mg in the evening Day 3: 10 mg in the morning, 20 mg in the evening Day 4: 20 mg in the morning, 20 mg in the evening Day 5: 20 mg in the morning, 30 mg in the evening Day 6 onward: 30 mg in the morning, 30 mg in the evening This medication may be taken with or without food. Swallow it whole without chewing; do not crush or split it. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Patients with renal impairment No dosage adjustment is necessary for patients with mild or moderate renal impairment. Data in patients with moderate renal impairment are limited. For patients with severe renal impairment (creatinine clearance of 30ml/min or less, calculated using the Cockcroft-Gault equation), reduce the dose to 30 mg once daily. For initial administration in patients with severe renal impairment, gradual dose escalation is recommended using only the morning dose schedule specified in Table 1 and omitting the evening doses. Assessment of renal function is recommended before administering this medication. Patients with hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment.

This medication should not be used in patients who have had a hypersensitivity reaction to this drug or its ingredients. Pregnant or breastfeeding women should not take this medication. Patients with impaired kidney function should use this medication with caution, and particularly those with severe renal impairment may require dose adjustments. Gastrointestinal symptoms such as diarrhea, nausea, and vomiting may commonly occur during treatment, so caution is needed, and severe symptoms should be discussed with a healthcare professional. Weight loss may occur, so regular weight checks are recommended, and if unexplained weight loss occurs, consultation with healthcare professionals is advised. Mental health issues such as depression or suicidal thoughts may arise, so any mood changes should be promptly reported to healthcare professionals, and attention should be paid. There may be interactions when used with other medications, so it is important to inform healthcare professionals of any other medications being taken. In particular, it is advisable not to combine this with strong CYP3A4 enzyme inducers. Women planning to become pregnant should consult with healthcare professionals before administration, and effective contraceptive methods should be used during treatment. The safety and efficacy in pediatric patients have not been established, so it is not recommended for use. No specific dose adjustment is required for the elderly, but caution is necessary due to the increased risk of complications if gastrointestinal symptoms occur. In the case of overdose, treatment should be symptomatic and the medication should not be stopped or doses changed arbitrarily. This medication should be kept out of the reach of children and stored in its original container.

Diarrhea

This medication should be stored tightly closed to protect it from air and moisture. The appropriate storage temperature is between 1 degree to 30 degrees Celsius at room temperature. It should be placed in a location that is neither too hot nor too cold to maintain the efficacy of the drug.

Appearance

10mg: Pink rhombus-shaped film-coated tablet 20mg: Brown rhombus-shaped film-coated tablet 30mg: Light purple rhombus-shaped film-coated tablet

Package unit

Starter Pack - 4 tablets/PITP[10mg], Starter Pack - 4 tablets/PITP[20mg], Starter Pack - 19 tablets/PITP[30mg], 30mg - 30 tablets/bottle[30mg], 30mg - 60 tablets/bottle[30mg]