Sofra Tablet (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. 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 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. 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 by patients who have had allergic reactions to this drug or its ingredients. Women who are pregnant or breastfeeding should not take this medication. Patients with impaired renal function should use this medication with caution, and particularly those with severe renal impairment may require dosage adjustments. During treatment, gastrointestinal disturbances such as diarrhea, nausea, and vomiting may commonly occur, so if symptoms are severe, consultation with healthcare professionals is necessary. Weight loss may occur, so regular weight monitoring is advised, and if unexplained weight loss occurs, consultation with a doctor is required. This drug may affect mental health issues such as depression or insomnia, so if mood changes or suicidal thoughts occur, healthcare professionals must be notified immediately. When combined with other medications, the potential for drug interactions should be considered, especially when taken with specific antibiotics or anticonvulsants, as this may reduce the drug's efficacy. Women who are planning to become pregnant should consult a doctor before taking this medication, and effective contraception should be used during treatment. Safety in pediatric patients has not been established, so it should not be administered to children. Elderly patients may use this medication without special dosage adjustments, but caution should be exercised if significant gastrointestinal disturbances occur. No effects on driving or operating machinery have been reported during the use of this medication, but individual discretion is advised. In case of overdose, treatment according to symptoms is necessary, and the medication should be kept out of the reach of children. The medication should be stored in its original container, and it should not be transferred to another container arbitrarily.

Diarrhea

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. Proper storage helps to maintain the drug's effectiveness safely for an extended period.

Appearance

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

Package unit

Starter Pack - 4 Tablets/PTP [10mg], Starter Pack - 4 Tablets/PTP [20mg], Starter Pack - 19 Tablets/PTP [30mg], Bottle - 30 Tablets/Bottle [30mg], Bottle - 60 Tablets/Bottle [30mg]