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Valcyte

Brand: 瑞士罗氏
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Valcyte was developed by the Swiss pharmaceutical company Roche and was first approved for marketing in the United States in 2001. It was subsequently launched in Europe and many other countries and regions.

1. Drug name and main ingredients

1. Common name :Valganciclovirhydrochloride

2. Product name :Valcyte®

3. Dosage form :Film-coated tablet

4. Main ingredient : Each tablet contains 496.3 mg of valganciclovir hydrochloride (equivalent to 450 mg of valganciclovir). The excipients include microcrystalline cellulose, povidone K-30, cross-linked povidone and stearic acid. Film coat contains OpadryPink®.

2. Indications

Cytomegalovirus (CMV) retinitis : For the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

3. Specifications and characteristics

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

2. Characteristics : Pink convex oval film-coated tablet, with "VGC" engraved on one side and "450" ​​engraved on the other side.

4. Usage and dosage

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

2. Maintenance treatment : 900mg once a day, take with meals.

3. Treatment of missed doses : If you miss a dose and it is >4 hours before the next dose, you can take it again, otherwise skip it. No need to take additional doses after vomiting.

5. Dose adjustment (renal insufficiency)

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

2. CrCl40-59mL/min : Reduce the induction dose to 450 mg twice a day and the maintenance dose to 450 mg once a day.

3. CrCl25-39mL/min : The induction dose is 450 mg once a day, and the maintenance dose is 450 mg once every 2 days.

4. CrCl10-24mL/min : The induction dose is 450 mg once every 2 days, and the maintenance dose is 450 mg twice a week.

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

6. Medication Precautions

1. Effect of diet on : It needs to be taken with food to increase bioavailability.

2. Blood monitoring : During treatment, routine blood tests (neutrophils, platelets, hemoglobin) and renal function need to be tested regularly.

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

7. Medication for special groups

1. U200c for pregnant women: Disabled (animal experiments show teratogenicity).

2. Lactation : Breastfeeding is prohibited during treatment and for at least 1 week after the last dose.

3. Children : Safety has not been established.

4. Elderly : The dose needs to be adjusted according to renal function.

8. Adverse reactions

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

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

9. Contraindications

1. Those who are allergic to valganciclovir or cyclovir.

2. Absolute neutrophil count <500/μL or platelet count <25,000/μL.

10. Drug interactions

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

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

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

11. Storage method

1. Store in original packaging, protected 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 : CMV viral load and fundus examination need to be monitored regularly during treatment. Avoid taking it with aluminum/magnesium-containing antacids (need to be separated by 2 hours).