Oteria 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. The maintenance dose of this medication is 30mg 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: 10mg in the morning Day 2: 10mg in the morning, 10mg in the evening Day 3: 10mg in the morning, 20mg in the evening Day 4: 20mg in the morning, 20mg in the evening Day 5: 20mg in the morning, 30mg in the evening Day 6 onward: 30mg in the morning, 30mg 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 30mg 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 drug should not be used in patients who have an allergy to this drug or any of its components or who have experienced hypersensitivity reactions. Women who are pregnant or nursing should not take this drug, and women planning to become pregnant should also avoid taking it. This drug contains lactose and should not be administered to patients with genetic disorders such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Patients with impaired kidney function should use this drug with caution and follow medical advice closely. Gastrointestinal disorders such as diarrhea, nausea, and vomiting may occur frequently while taking this drug, and if these symptoms worsen, the patient should immediately inform medical personnel. Additionally, this drug may cause weight loss, so regular weight monitoring is necessary, and a doctor should be consulted if unexplained weight loss occurs. Mental health issues such as depression or insomnia may also arise, so if mood changes or suicidal thoughts occur, medical personnel should be informed immediately. This drug may interact with other medications, so if the patient is taking other medications, they must inform their doctor or pharmacist. Caution is especially needed as the effectiveness of this drug may be reduced when combined with certain drugs. Use in pediatric patients is not recommended due to the lack of established safety and efficacy. Patients aged 65 years and older can use this drug without special dosage adjustments, but care should be taken regarding side effects. The impact of this drug on driving or operating machinery is not known; therefore, caution is advised according to symptoms. In case of overdose, immediate medical attention should be sought, and symptomatic treatment will be given based on symptoms. Finally, this drug should be stored out of the reach of children and kept safely in its original container.

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

This drug should be stored in a tightly closed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

10mg : Pink rhomboid film-coated tablets 20mg : Brown rhomboid film-coated tablets 30mg : Light brown rhomboid film-coated tablets

Package unit

Starter pack - 4 tablets/PTP[10mg], Starter pack - 4 tablets/PTP[20mg], Starter pack - 19 tablets/PTP[30mg], 30mg - 28 tablets/PTP[14 tablets/PTP x 2], 30mg - 56 tablets/PTP[14 tablets/PTP x 4]