Big Bear VALSYDX Valganciclovir 450mg

Product Information

• Product name: VALSYDX Valganciclovir 450mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Valganciclovir
• Current strength: 450mg
• SKU: BB-ITEM-15
• Site category: other cancer

Product Summary

VALSYDX Valganciclovir 450mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Valganciclovir is the active ingredient used for this product page. Public prescribing information for Valganciclovir was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Valganciclovir is an antiviral drug with activity against CMV .

Reference Indications

Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk.

Reference Dosage and Administration

Taken with food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir for oral solution . Impairment of Fertility: Based on animal data and limited human data, valganciclovir for oral solution may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females . Fetal Toxicity: Based on animal data, valganciclovir for oral solution has the potential to cause birth defects in humans . Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir for oral solution has the potential to cause cancers in humans .

Common Adverse Reactions and Monitoring

Mutagenesis and Carcinogenesis . Valganciclovir, a prodrug of ganciclovir, is rapidly converted to ganciclovir after oral administration. The frequencies of neutropenia (ANC less than 500/μL) were 11% for patients receiving valganciclovir tablets compared with 13% for patients receiving intravenous ganciclovir. Anemia (Hgb less than 8 g/dL) occurred in 8% of patients in each group. Other laboratory abnormalities occurred with similar frequencies in the two groups. Approximately 252 (68%) of these patients received valganciclovir tablets for more than nine months (maximum duration was 36 months).

Drug Interactions and Special Populations

Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug. Cyclosporine or amphotericin B Unknown Monitor renal function when valganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine . Mycophenolate mofetil (MMF) ↔ Ganciclovir (in patients with normal renal function) ↔ MMF (in patients with normal renal function) Based on increased risk, patients should be monitored for hematological and renal toxicity.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Valganciclovir hydrochloride for Oral public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.