- Indications and Usage Post-Transplant CMV: Indicated for the treatment of compositionally refractory cytomegalovirus (CMV) infection or disease in adult and pediatric patients 12 years of age and older weighing at least 35 kg. Refractory is defined as persistent infection or disease despite at least one prior course of anti-CMV therapy (e.g., ganciclovir, valganciclovir, cidofovir, or foscarnet).
- Dosage and Administration Recommended Dosage: 400 mg taken orally twice daily. The duration of therapy should be individualized based on clinical response (typically 8 weeks). Administration: Can be swallowed whole or crushed, administered with or without food. Dose Adjustments for CYP3A4 Inducers: With carbamazepine: Increase to 800 mg twice daily. With phenytoin or phenobarbital: Increase to 1200 mg twice daily. Do not use with strong inducers like rifampin. Missed Dose: If missed, skip if the next dose is due within 3 hours; do not double the dose.
- Mechanism of Action Kinase Inhibition: Maribavir selectively inhibits the CMV protein kinase UL97. Viral Replication Blockade: By inhibiting UL97, maribavir prevents the necessary phosphorylation of viral immediate-early proteins and the activation of ganciclovir. This blocks the initiation of viral DNA replication and assembly.
- Safety and Warnings Anorexia/Cachexia: Galactose intolerance is a contraindication; the drug may cause vomiting, which can exacerbate dehydration or nutritional status in transplant patients. Neutropenia: Hematologic abnormalities, including neutropenia, anemia, and thrombocytopenia, may occur. Resistance: Viral mutations in the UL97 gene can lead to therapeutic failure and recurrence. CMV DNA levels and resistance should be monitored closely if response is poor.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Dysgeusia (taste disturbance), nausea, vomiting, diarrhea, fatigue, and hypertension. Taste disturbance is reported in nearly half of patients. Clinical Research: A pivotal Phase 3 randomized, double-blind trial demonstrated that maribavir resulted in a significantly higher overall response rate compared to optimal available therapy in refractory CMV cases.
- Drug Interactions Ganciclovir/Valganciclovir: Concomitant use is not recommended. Maribavir inhibits UL97 and antagonizes the phosphorylation required to activate ganciclovir/valganciclovir, reducing their antiviral efficacy. CYP3A4 Substrates: Maribavir is a weak inhibitor of CYP3A4 and a potent inhibitor of P-gp and BCRP. It can increase plasma concentrations of sensitive substrates, particularly calcineurin inhibitors (e.g., tacrolimus, cyclosporine) and mTOR inhibitors (e.g., sirolimus, everolimus), requiring frequent monitoring and dose adjustment.
- Pharmaceutical Information Chemical Composition: Active ingredient: Maribavir. Appearance: Dark blue, oval, film-coated tablets. Storage: Store at 20°C to 25°C (68°F to 77°F).
Yitaizhi Maribavir Tablets
Brand Name:抑泰之 ®（Yitaizhi®）
Generic Name: Maribavir
Strength: 0.2 g (200 mg) per tablet, 56 tablets per bottle, 1 bottle per box
Manufacturer: Takeda Ireland Limited
Marketing Authorization Holder: Takeda Pharma A/S
Approval Date in China: December 21, 2023
Registration Number:国药准字 HJ20230162
Storage: Store tightly sealed at temperature below 30°C, protect from light and moisture. Refer to the full package insert for detailed storage specifications.
Price&Cost:Contact Us now for the best price of Maribavir（Yitaizhi）
Only logged in customers who have purchased this product may leave a review.
Reviews
There are no reviews yet.