Cresembal Capsule 100 mg (Isavuconazonium sulfate)

Adult dose

1. Loading dose The recommended loading dose is 2 capsules (equivalent to 200 mg of isavuconazole) every 8 hours during the first 48 hours (a total of 6 doses). 2. Maintenance dose The recommended maintenance dose begins 12-24 hours after the last loading dose and is 2 capsules (equivalent to 200 mg of isavuconazole) once daily. The duration of treatment should be determined according to clinical response. For long-term treatment exceeding 6 months, the benefits and risks should be carefully considered. 3. Switching to isavuconazole injection This medicine is also available as an injection containing 200 mg of isavuconazole. Because oral bioavailability is high (98%), switching between intravenous and oral administration is appropriate when clinically necessary. 4. Renal impairment No dose adjustment is required in patients with renal impairment, including those with end-stage renal disease. 5. Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh class A and B). This medicine has not been studied in patients with severe hepatic impairment (Child-Pugh class C). 6. Method of administration This medicine may be taken with or without food. Swallow this medicine whole. Do not chew, crush, dissolve, or open the capsules.

This medicine should not be used in patients with known allergies to certain ingredients. Additionally, it should be avoided in combination with certain potent drugs as it may alter drug concentration. It is also advisable not to use this medication if there is a family history of heart rhythm diseases. Regular liver function and blood tests should be conducted while using this medication, and any issues related to the liver should be reported to healthcare professionals immediately. If severe skin reactions occur, discontinue use and seek medical attention right away. Symptoms such as confusion, drowsiness, or dizziness may occur when driving or operating machinery, so caution is advised. This medication can interact with various other drugs, so it is essential to inform healthcare professionals about any other medications being taken. Its use during pregnancy or breastfeeding is not recommended and especially should be avoided while breastfeeding. The safety and efficacy of this drug have not been sufficiently established for children under 18 years old. Patients with impaired kidney or liver function also require special attention, and it is not recommended for patients with severe liver dysfunction. There are no specific antidotes for overdose; therefore, appropriate treatment must be received based on symptoms, and it is not removed by hemodialysis. This medication should be kept out of reach of children and stored in its original container.

• Elevated liver function tests
• nausea
• vomiting
• shortness of breath
• abdominal pain
• diarrhea
• injection site reactions
• headache
• hypokalemia
• rash

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is important to keep it at a cool temperature below 25 degrees Celsius. Proper storage can help maintain the effectiveness of the drug for a long time.

Appearance

A hard capsule with a white upper part and a reddish-brown lower part containing a white-yellow powder that may have some lumps.

Package unit

7 capsules/blister [x2]