Valganciclovir

والگان‌سیکلوویر

⚠ Unverified

🦠 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

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🛡️ Safety & information

Contraindications

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

👥 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) …”

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