Wansaiwei (Valganciclovir Hydrochloride Tablets) is an antiviral drug that belongs to the class of deoxyribonucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitors.

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: Thin film coated sheet.

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: Adjust the dose based on creatinine clearance rate (CrCl): the induction dose of CrCl at 40-59mL/min is reduced to 450mg twice daily, and the maintenance dose is 450mg once daily; The induction dose of CrCl25-39mL/min is 450mg once daily, and the maintenance dose is 450mg once every 2 days; The induction dose of CrCl10-24mL/min is 450mg once every 2 days, and the maintenance dose is 450mg twice a week; CrCl<10mL/min or contraindicated for hemodialysis patients.

6、 Medication precautions

1. Dietary impact: Must be taken with food to increase bioavailability.

2. Blood monitoring: Regular testing of blood routine (neutrophils, platelets, hemoglobin) and renal function is required.

3. Neurotoxicity: May cause dizziness or confusion, avoid driving or operating machinery.

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).

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).

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