Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
VALCYTE |
| Manufacturer |
|
Roche Laboratories |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Nucleoside analogue. |
| Generic Name |
|
Valganciclovir (as HCl) (prodrug of ganciclovir) 450mg; tabs. |
| Indications |
|
Treatment of AIDS-related cytomegalovirus (CMV) retinitis. Prevention of CMV disease in high risk recipients of kidney, heart, or kidney-pancreas transplant. |
| Children |
|
Not recommended. |
| Adults |
|
Take with food. Treatment: induction: 900mg twice daily for 21 days; maintenance: 900mg once daily. Prevention: 900mg once daily starting within 10 days of transplantation until 100 days post-op. Renal impairment (CrCl <60mL/min): reduce dose; see literature. Hemodialysis (CrCl <10mL/min): not recommended (use ganciclovir). |
| Contraindications |
|
Acyclovir or ganciclovir allergy. Absolute neutrophil count <500 cells/microliter, platelet count <25,000/microliter, or hemoglobin <8 g/dL. Pregnancy (Cat.C: teratogenic, embryotoxic, carcinogenic, aspermatogenesis in animals), nursing mothers: see literature. |
| Precautions |
|
Do not substitute on a mg-per-mg basis for ganciclovir. Avoid handling broken tabs. Reduce dose or discontinue if blood dyscrasias occur. Renal impairment. Cytopenia or cytopenic reactions to drugs, chemicals, irradiation. Monitor CBCs, platelets, ophthalmic, and renal function. Use effective contraception during (men and women) and for at least 90 days after treatment (men). Elderly. |
| Interactions |
|
Zidovudine increases anemia/neutropenia risk. Caution with nephrotoxic drugs (eg, cyclosporine, amphotericin B, mycophenolate). Monitor for toxicity with didanosine. Probenecid increases levels. Caution with drugs that inhibit replication of rapidly-dividing cells (eg, dapsone, pentamidine, antineoplastics). Avoid imipenem-cilastatin (seizures). |
| Adverse Reactions |
|
GI upset, fever, bone marrow depression, headache, insomnia, retinal detachment, peripheral neuropathy, paresthesia, aplastic anemia, bleeding, CNS effects, elevated serum creatinine, infections, tremor, hypertension. |
| How Supplied |
|
Tabs—60 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
