Valcyte was developed by Roche, a Swiss pharmaceutical company, and was first approved for market in the United States in 2001. It has since been launched in Europe and multiple other countries and regions.

1、 Drug name and main ingredients

1. Common name: Valganciclovir hydrochloride

2. Product Name: Valcyte ®

3. Dosage form: Film coated tablets

4. Main ingredients: Each tablet contains 496.3mg of valganciclovir hydrochloride (equivalent to 450mg of valganciclovir), and excipients include microcrystalline cellulose, polyvinylpyrrolidone K-30, cross-linked polyvinylpyrrolidone, and stearic acid. Film coating containing OpadyInk ®。

2、 Indications

Cytomegalovirus (CMV) retinitis: used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

3、 Specifications and characteristics

1. Specification: 450mg/tablet (calculated as valganciclovir).

2. Appearance: Pink convex elliptical thin film coating, with "VGC" engraved on one side and "450" engraved on the other side.

4、 Usage and dosage

1. Induction therapy: 900mg (2 tablets) taken twice daily with meals for 21 days.

2. Maintenance therapy: 900mg once daily, taken with meals.

3. Omission treatment: If missed and more than 4 hours before the next administration, it can be supplemented, otherwise it will be skipped. No need to take additional medication after vomiting.

5、 Dose adjustment (renal insufficiency)

1. Creatinine clearance rate (CrCl) ≥ 60mL/min: Maintain the original dose.

2. CrCl40-59mL/min: The induction dose is reduced to 450mg twice daily, and the maintenance dose is 450mg once daily.

3. CrCl25-39mL/min: Induction dose 450mg once daily, maintenance dose 450mg once every 2 days.

4. CrCl10-24mL/min: Induction dose 450mg once every 2 days, maintenance dose 450mg twice a week.

5. Hemodialysis patients (CrCl<10mL/min): contraindicated.

6、 Medication precautions

1. Dietary impact: It needs to be taken together with food to improve bioavailability.

2. Blood monitoring: During treatment, regular blood routine tests (neutrophils, platelets, hemoglobin) and renal function should be conducted.

3. Drug interactions: Avoid combination with strong CYP3A inhibitors (such as ketoconazole) or inducers (such as rifampicin).

7、 Medication for special populations

1. Pregnant women: prohibited (animal experiments show teratogenicity).

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and for at least one week after the last dose.

3. Children: Safety has not been established.

4. Elderly people: The dosage should be adjusted according to kidney function.

8、 Adverse reactions

1. Common (≥ 20%): diarrhea (41%), nausea (30%), fever (31%), neutropenia (27%), anemia (26%).

2. Serious reactions: Bone marrow suppression (19% neutrophils<500/μ L), retinal detachment (15%), acute kidney injury (3%).

9、 Contraindications

1. Individuals who are allergic to valganciclovir or ganciclovir.

2. Absolute neutrophil count<500/μ L or platelet count<25000/μ L.

10、 Drug interactions

1. Zidovudine: increases the risk of anemia and neutropenia.

2. Deoxyinosine: When used in combination, it can increase the AUC of Deoxyinosine by 111%.

3. Probenecid: can increase the blood concentration of ganciclovir by 53%.

11、 Storage method

1. Keep in original packaging, away from light and moisture.

2. Storage temperature: 25 ° C (short-term fluctuations of 15-30 ° C are allowed).

12、 Manufacturer

Original manufacturer: Roche Laboratories Inc.

Note: Regular monitoring of CMV viral load and fundus examination are required during treatment. Avoid taking with aluminum/magnesium antacids (with a 2-hour interval).

Valcyteinformation