Otebel 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 medicine should not be used by individuals who have had allergic reactions to this medicine or any of its ingredients. Women who are pregnant or breastfeeding should also not take this medicine. This medicine contains lactose, so it should not be administered to patients with lactose intolerance or specific genetic metabolic disorders. Caution is especially advised for patients with impaired kidney function, and dosage may need to be adjusted if necessary. Diarrhea, nausea, headache, and upper respiratory infections are possible side effects, and if symptoms are severe, consult a doctor. Patients over 65 years of age may experience more severe gastrointestinal side effects, so caution is needed. Weight loss may occur, so regular weight checks are necessary, and unexplained weight loss should be discussed with healthcare professionals. Symptoms of depression or mood changes may occur, so patients with a history of depression or suicidal thoughts should thoroughly consult with healthcare providers before using this medicine. This medicine may interact with certain other medications, so inform healthcare professionals if taking other medications. Women planning to become pregnant should consult a doctor before taking this medicine and use effective contraception during treatment. The safety and efficacy of this medicine in pediatric patients have not been confirmed, so children should not use this medicine. When storing this medicine, keep it out of reach of children and store it in its original container.

• Diarrhea
• nausea
• upper respiratory infection
• headache
• nasopharyngitis
• tension headache
• vomiting
• fatigue
• dyspepsia
• hypertension

This medicine should be stored in a sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

30mg: dark pink diamond-shaped film-coated tablet, 20mg: brown diamond-shaped film-coated tablet, 10mg: pink diamond-shaped film-coated tablet

Package unit

Starter pack - 27 tablets/box [10mg 4 tablets/PTP, 20mg 4 tablets/PTP, 30mg 5 tablets/PTP, 30mg 14 tablets/PTP], maintenance dose - 56 tablets/box [30mg 14 tablets/PTP x 4]