Valganciclovir
والگانسیکلوویر
🦠 Antiinfectives For Systemic UseOral anti-CMV antiviral
Market / country: 🇺🇸 USA
Valcyte (US)
🧮 Dose calculator
Cytomegalovirus (CMV) — retinitis and transplant prophylaxis · Regimen source: FDA Valcyte · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to valganciclovir or ganciclovir. FDA Valcyte · 4
Warnings
- • Boxed warning: haematological toxicity, impaired fertility, fetal toxicity, mutagenesis and carcinogenesis. FDA Valcyte · Boxed Warning
Renal adjustment
- • eGFR < 60: CrCl <60: reduce per Table 2; haemodialysis: no recommendation. FDA Valcyte · 2.5
Formulations
- 450 mg tablet — tablet 🇺🇸 USA FDA Valcyte · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Valcyte · Boxed Warning
“Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ].”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Valcyte · 8.2
“Advise nursing mothers that breastfeeding is not recommended during treatment with VALCYTE because of the potential for serious adverse events in nursing infants and because of the potential for transmission of HIV [see Boxed Warning , Warnings and Precautions (5.1 , 5.3 , 5.4 , 5.5) , Nonclinical Toxicology (13.1) ] .”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Valcyte · 8.4
“The safety and efficacy of VALCYTE for oral solution and tablets have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Valcyte · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Valcyte · 8.3
“Contraception Females Because of the mutagenic and teratogenic potential of VALCYTE, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with VALCYTE [see Dosage and Administration (2.6) , Warnings and Precautions (5.4 , 5.5) …”
🔗 Reference links
- FDA (approval record)NDA021304
- DailyMed (FDA label)FDA Valcyte
- MedlinePlus (NIH)Valganciclovir
- WHO ATC/DDDJ05AB14
- Darooyab (Iran)Valganciclovir
🇮🇷 Registered in Iran Darooyab · G-1212/Valganciclovir
Dosage forms with Iranian generic codes, per Darooyab.
- 19085 · VALGANCICLOVIR 250MG/5ML SYRUP · شربت والگانسیکلوویر ۲۵۰ میلیگرم / ۵ میلیلیتر
- 04768 · VALGANCICLOVIR 450MG TAB · قرص والگانسیکلوویر ۴۵۰ میلیگرم
- 50776 · VALGANCICLOVIR (AS HYDROCHLORIDE) POWDER, FOR SOLUTION ORAL 50 mg/1mL 12 g · محلول خوراکی والگانسیکلوویر (معادل هیدروکلراید) ۵۰ میلیگرم / ۱ میلیلیتر ۱۲ گرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Valcyte · 3FDA Valcyte · 2.2FDA Valcyte · 2.1FDA Valcyte · 2.3FDA Valcyte · 4FDA Valcyte · Boxed WarningFDA Valcyte · 2.5FDA Valcyte · SPL approval / marketing categoryFDA Valcyte · 8.2FDA Valcyte · 8.4FDA Valcyte · 8.5FDA Valcyte · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1212/Valganciclovir
- Clinical review⚠ Unverified