Wansaiwei is a precursor drug of ganciclovir, which rapidly converts into ganciclovir in the body after oral administration, and has high bioavailability, making it easy to take for a long time.

1、 Drug name

1. Common name: Valganciclovir

2. Product Name: Wansaiwei/Calcyte

2、 Indications

1. Adult patients:

Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Prevent CMV disease in high-risk (donor CMV serum positive/recipient CMV serum negative, i.e. D+/R -) kidney, heart, and kidney pancreas transplant patients.

2. Pediatric patients (within a specific age range):

Prevent CMV disease in high-risk pediatric kidney transplant patients (4 months to 16 years old) and heart transplant patients (1 month to 16 years old).

3、 Specifications and characteristics

Tablets: 450 milligrams.

4、 Main components

1. Active ingredient: Valganciclovir hydrochloride.

2. Tablet excipients: Microcrystalline cellulose, polyvinylpyrrolidone K-30, cross-linked polyvinylpyrrolidone, stearic acid, and OpadryPink ® Film coating.

5、 Usage and dosage

1. Administration principle: The tablets and oral solution of this product should be taken together with food. Adult patients should use tablets. Tablets must not be broken or crushed.

2. Adult dose (for individuals with normal renal function):

CMV retinitis treatment: Induction period: 900 milligrams (two tablets 450 milligrams), twice daily, lasting for 21 days. Maintenance period: 900 milligrams, once daily.

Prevention of CMV disease (after transplantation): Heart or kidney pancreas transplantation: 900 milligrams, once daily, starting within 10 days after transplantation and continuing until 100 days after transplantation. Kidney transplantation: 900 milligrams, once daily, starting within 10 days after transplantation and continuing until 200 days after transplantation.

3. Pediatric dose (prevention of CMV disease): Based on body surface area and creatinine clearance rate calculated using the modified Schwartz formula, the daily dose is calculated using a specific formula (7 × BSA × CrCl). Kidney transplant patients should take medication for 200 days after transplantation, and heart transplant patients should take medication for 100 days after transplantation. The calculated dose should be rounded to the nearest 25 milligrams increment, with a maximum dose not exceeding 900 milligrams. Oral solution is the preferred dosage form.

6、 Dose adjustment

1. Adult patients with renal insufficiency: The dosage must be adjusted according to creatinine clearance rate. For those with creatinine clearance rate greater than or equal to 60 milliliters per minute, the induction dose is 900 milligrams twice daily, and the maintenance/prevention dose is 900 milligrams once daily; As the creatinine clearance rate decreases, the dose needs to be reduced accordingly (for example, for 40-59 milliliters per minute, the induction dose is 450 milligrams twice daily, and the maintenance/prevention dose is 450 milligrams once daily); Adult patients with creatinine clearance rates below 10 milliliters per minute or undergoing hemodialysis are not recommended to use this product tablet.

2. Pediatric patients: The dose calculation formula already includes creatinine clearance rate, so the calculation itself takes into account renal function factors. Regular monitoring of serum creatinine levels is required, and dosage should be adjusted according to changes in height and weight.

7、 Medication precautions

1. Medication time: It must be taken together with food to improve bioavailability.

2. Omission: Not specified, usually if missed, it should be taken as soon as possible, but if it is close to the next medication time, there is no need to take it again, and the medication should not be doubled. Specific medical advice should be followed.

3. Vomiting: Not specified. If vomiting occurs shortly after taking the medication, it is recommended to consult a doctor to see if additional medication is needed.

4. Others: Caution should be exercised when handling tablets, oral solution powders, and prepared solutions to avoid direct contact with the skin or mucous membranes. If contact occurs, thoroughly wash the skin with soap and water, or rinse the eyes with clean water. This product should be handled and disposed of in accordance with the guidelines for anti-tumor drugs.

8、 Medication for special populations

1. Pregnant women: Based on animal data, this product has a potential risk of causing fetal malformations. It should be avoided during pregnancy. Women with fertility should take effective contraceptive measures during the medication period and at least 30 days after the last dose.

2. Breastfeeding women: breastfeeding is not recommended. Due to the possibility of serious adverse reactions to nursing infants caused by medication, and the risk of HIV transmission from HIV infected mothers during breastfeeding.

3. Men and women with reproductive potential: Women need to use effective contraception. Men should use condoms during medication and for at least 90 days after the last dose. This product may cause temporary or permanent infertility.

4. Elderly patients: The dosage should be carefully selected, usually starting from the lower end of the dosage range, and adjusted considering the renal function status.

5. Liver injury patients: No research has been conducted, safety and efficacy are unknown.

6. Pediatric patients: Only approved for the prevention of CMV disease in kidney and heart transplant patients within a specific age range. It is not applicable to prevent liver transplantation, kidney/heart transplantation less than a specific age, pediatric AIDS patients with CMV retinitis, and infants with congenital CMV infection.

9、 Adverse reactions

1. Common adverse reactions (in adults): including diarrhea, fever, fatigue, nausea, tremors, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infections, and vomiting.

2. Common adverse reactions (pediatric): including diarrhea, fever, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

3. Serious adverse reactions: hematological toxicity (such as severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure), acute kidney failure, fertility impairment, fetal toxicity, mutagens, and carcinogenicity.

10、 Contraindications

1. Patients with a history of clinically significant hypersensitivity reactions (such as allergic reactions) to valganciclovir, ganciclovir, or any component of this product are contraindicated.

11、 Drug interactions

1. Imipenem cilastatin: Not recommended for combination as there have been reports of causing systemic epileptic seizures.

2. Cyclosporine or amphotericin B: Co administration may increase the risk of nephrotoxicity, and renal function should be monitored.

3. Mycophenolate mofetil: Co administration may increase the risk of hematological and renal toxicity, and relevant toxicity should be monitored.

4. Other drugs related to bone marrow suppression or nephrotoxicity: Co administration may lead to increased toxicity, and should only be considered when potential benefits outweigh risks.

5. Didanosine: may increase the concentration of didanosine, and its toxicity should be monitored (such as pancreatitis).

6. Probenecid: may increase the concentration of ganciclovir, and evidence of ganciclovir toxicity should be monitored.

12、 Storage method

Tablets: Store at 20 ° C to 25 ° C, allowing fluctuations between 15 ° C to 30 ° C.

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