Omzara Tablets 100 mg (Momelotinib Hydrochloride Hydrate)

Adult dose

This medication should be administered orally at a dose of 200mg once daily. It may be taken with or without food. If a dose is missed, the scheduled dose should be taken the following day. 1. Dose modification Dose modification should be considered for hematologic and nonhematologic toxicities (Table 1). If the patient cannot tolerate this medication at a dose of 100mg once daily, discontinue treatment. Thrombocytopenia Baseline platelet count ≥100 × 109/L, platelet count 20 × 109/L to <50 × 109/L: Reduce the daily dose by 50mg from the last administered dose. Baseline platelet count ≥100 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to 50 × 109/L. Resume at a daily dose reduced by 50mg from the last administered dose.b Baseline platelet count ≥50 × 109/L to <100 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to 50 × 109/L. Resume at a daily dose reduced by 50mg from the last administered dose.b Baseline platelet count <50 × 109/L, platelet count <20 × 109/L: Temporarily interrupt treatment until the platelet count recovers to baseline. Resume at a daily dose reduced by 50mg from the last administered dose.b Neutropenia ANC <0.5 × 109/L: Temporarily interrupt treatment until ANC is ≥0.75 × 109/L. Resume at a daily dose reduced by 50mg from the last administered dose.b Hepatotoxicity (unless there is another clear cause) ALT and/or AST >5 × ULN (if abnormal at baseline, >5 × baseline) and/or total bilirubin >2 × ULN (if abnormal at baseline, >2 × baseline): Temporarily interrupt treatment until ALT and AST recover to ≤2 × ULN or baseline levels and total bilirubin recovers to ≤1.5 × ULN or baseline levels. Resume at a daily dose reduced by 50mg from the last administered dose.b If an increase in ALT or AST to >5 × ULN recurs, permanently discontinue this medication. Other nonhematologic toxicities Grade 3 or higher nonhematologic toxicityc Grade 2 or higher bleedingc Temporarily interrupt treatment until recovery to Grade 1 or lower or baseline levels. Resume at a daily dose reduced by 50mg from the last administered dose.b a Restart treatment or gradually increase the dose, as clinically appropriate, up to a maximum of 200mg once daily. b If the last administered dose was 100mg, treatment may be restarted at 100mg. 2. Patients with renal impairment No dose adjustment is required in patients with renal impairment (see Precautions for Use, ‘12.2. Pharmacokinetic Properties 5) Special Populations’). 3. Patients with hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. The recommended starting dose of this medication in patients with severe hepatic impairment (Child-Pugh class C) is 150mg once daily (see Precautions for Use, ‘12.2. Pharmacokinetic Properties 5) Special Populations’).

This medication should not be used in patients with known allergies to this drug or its ingredients. This medication contains lactose, so patients with a genetic disorder that affects lactose digestion should not take this medication. Common side effects may occur while taking this medication, including diarrhea, thrombocytopenia, nausea, headache, dizziness, fatigue, abdominal pain, and cough. Serious side effects such as significant reduction in platelet counts may occur, thus regular blood tests to monitor platelet levels are necessary. Due to increased risk of infection, patients should immediately notify healthcare personnel if they experience symptoms of infection, such as fever, cough, or diarrhea. Patients with chronic hepatitis B should consult with their physician before taking this medication and have their liver function and viral load periodically monitored during treatment. This medication may occasionally increase the risk of cardiovascular abnormalities or thrombosis, thus older adults and those at risk for cardiovascular disease should use it with caution. This medication can cause dizziness or visual disturbances that may affect the ability to drive or operate machinery, so caution is advised after taking it. This medication may interact with certain drugs, hence inform healthcare personnel if you are taking other medications. Women of childbearing potential should avoid pregnancy while taking this medication, and its effect on hormonal contraceptives may be reduced; therefore, additional contraceptive methods should be used. This medication can potentially harm a fetus, thus women who are pregnant or planning to become pregnant should consult with their physician before starting it. Breastfeeding women should avoid breastfeeding during and for at least one week after taking this medication. The safety and effectiveness of this medication in children and adolescents under 18 years old have not been established, so it is advisable not to use it in this age group. Older adults over 65 years of age or those with compromised renal or liver function may take this medication without special dosage adjustments, but should follow their physician's guidance based on their condition. In case of overdose, seek medical attention immediately for appropriate treatment, and consult healthcare professionals if abnormal symptoms occur. This medication should be stored in a safe place out of the reach of children and should not be transferred to other containers.

• Diarrhea
• thrombocytopenia
• nausea
• headache
• dizziness
• fatigue
• asthenia
• abdominal pain
• cough
• infection

This medication should be stored in a tightly closed container to protect against air and moisture, and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance

Brown circular film-coated tablets

Package unit

30 tablets/bottle