ANTIVIRAL
Ganciclovir
Ficha de consulta para farmacia hospitalaria: indicaciones, preparación, dilución, estabilidad y compatibilidad de ganciclovir, con la fuente oficial de cada dato.
También conocido como: Ganciclovir IV, Cymevene, Cytovene
Presentación
500 mg para infusión — documentado: Sagent (FDA)
| Producto de referencia | Titular | Vía | Fuente |
|---|---|---|---|
| ganciclovir | Sagent Pharmaceuticals | Intravenous | FDA (DailyMed) |
¿Para qué sirve ganciclovir? Indicaciones autorizadas
1 INDICATIONS AND USAGE Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease. ( 1.2 ) 1.1 Treatment of CMV Retinitis Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1 )] . 1.2 Prevention of CMV Disease in Transplant Recipients Ganciclovir Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies ( 14.2 )].
FDA (DailyMed) · ganciclovir · Indications and usage · texto original en inglés
Contraindicaciones de ganciclovir
4 CONTRAINDICATIONS Ganciclovir Injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. Hypersensitivity to ganciclovir or valganciclovir. ( 4 )
FDA (DailyMed) · ganciclovir · Contraindications · texto original en inglés
Ajuste en insuficiencia renal
Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Creatinina sérica · Diálisis / TRRC
( 2.1 ) Dosage in Adult Patients with Normal Renal Function Treatment of CMV retinitis ( 2.3 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
Adults with renal impairment: Adjust dosage based on creatinine clearance.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
All patients should be monitored for renal function before and during treatment with Ganciclovir Injection and dose should be adjusted as needed [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 )]. Patients with CMV retinitis should have frequent ophthalmological examinations during treatment with Ganciclovir Injection solution to monitor disease status and for other retinal abnormalities [see Adverse Reactions ( 6.1 )]. 2.3 Recommended Dosage for Treatment of CMV Retinitis in Adult Patients with Normal Renal Function Induction Dosage: The recommended initial dosage of Ganciclovir Injection for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
Following induction treatment, the recommended maintenance dosage of Ganciclovir Injection is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. 2.4 Recommended Dosage for the Prevention of CMV Disease in Adult Transplant Recipients with Normal Renal Function Induction Dosage: The recommended initial dosage of Ganciclovir Injection for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
Following induction, the recommended maintenance dosage of Ganciclovir Injection is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation. 2.5 Recommended Dosage in Adult Patients with Renal Impairment For patients with impairment of renal function, refer to Table 1 for recommended doses of Ganciclovir Injection for induction and maintenance dosage for treatment of CMV retinitis and prevention of CMV disease in transplant recipients. Carefully monitor serum creatinine or creatinine clearance before and during treatment to allow for dosage adjustments in patients with impaired renal function.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
Recommended Induction and Maintenance Dosage for Adult Patients with Renal Impairment * Creatinine clearance can be related to serum creatinine by the formulas given below. Creatinine Clearance* (mL/min) Ganciclovir Injection Induction Dose (mg/kg) Dosing Interval (hours) for Induction Ganciclovir Injection Maintenance Dose (mg/kg) Dosing Interval (hours) for Maintenance Greater than or equal to 70 5 12 5 24 50 to 69…
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglésLeer la sección completa
Recommended Induction and Maintenance Dosage for Adult Patients with Renal Impairment * Creatinine clearance can be related to serum creatinine by the formulas given below. Creatinine Clearance* (mL/min) Ganciclovir Injection Induction Dose (mg/kg) Dosing Interval (hours) for Induction Ganciclovir Injection Maintenance Dose (mg/kg) Dosing Interval (hours) for Maintenance Greater than or equal to 70 5 12 5 24 50 to 69 2.5 12 2.5 24 25 to 49 2.5 24 1.25 24 10 to 24 1.25 24 0.625 24 Less than 10 1.25 3 times per week, following hemodialysis 0.625 3 times per week, following hemodialysis Creatinine clearance for males = (140 - age [yrs]) (body wt [kg]) (72) (serum creatinine [mg/dL]) Creatinine clearance for females = 0.85 x male value Patients Undergoing Hemodialysis Induction dosing for Ganciclovir Injection in patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week; and maintenance dosing should not exceed 0.625 mg/kg 3 times per week following each hemodialysis session. Ganciclovir Injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50% [see Clinical Pharmacology ( 12.3 )] . 2.6 Preparation of Ganciclovir Injection Ganciclovir Injection solution must be diluted under the supervision of a healthcare provider and administered as intravenous infusion.
Dosage in Adult Patients with Normal Renal Function Treatment of CMV retinitis (• 2.3 ) | Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients (• 2.4 ) | Induction: 5…
FDA (DailyMed) · ganciclovir · Dosage and administration table · texto original en inglésLeer la sección completa
Dosage in Adult Patients with Normal Renal Function
Treatment of CMV retinitis (• 2.3 ) | Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week.
Prevention of CMV disease in transplant recipients (• 2.4 ) | Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily, 7 days per week, or 6 mg/kg once daily, 5 days per week until 100 to 120 days post- transplantation.
Table 1. Recommended Induction and Maintenance Dosage for Adult Patients with Renal Impairment * Creatinine clearance can be related to serum creatinine by the formulas given below.
Creatinine Clearance* (mL/min) | Ganciclovir Injection Induction Dose (mg/kg) | Dosing Interval (hours) for Induction | Ganciclovir Injection Maintenance Dose (mg/kg) | Dosing Interval (hours) for Maintenance
Greater than or equal to 70 | 5 | 12 | 5 | 24
50 to 69 | 2.5 | 12 | 2.5 | 24
25 to 49 | 2.5 | 24 | 1.25 | 24
10 to 24 | 1.25 | 24 | 0.625 | 24
Less than 10 | 1.25 | 3 times per week, following hemodialysis | 0.625 | 3 times per week, following hemodialysis
Creatinine clearance for males = | (140 - age [yrs]) (body wt [kg])
(72) (serum creatinine [mg/dL])
Creatinine clearance for females = 0.85 x male value
Data Human Data In a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valganciclovir (the prodrug of ganciclovir) for CMV prophylaxis for up to 200 days post-transplantation were compared to an untreated control group.
FDA (DailyMed) · ganciclovir · Use in specific populations · texto original en inglés
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Ganciclovir Injection is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because renal clearance decreases with…
FDA (DailyMed) · ganciclovir · Use in specific populations · texto original en inglésLeer la sección completa
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Ganciclovir Injection is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because renal clearance decreases with age, Ganciclovir Injection should be administered to elderly patients with special consideration of their renal status. Renal function should be monitored and dosage adjustments should be made accordingly [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.6 )] . 8.6 Renal Impairment Dose reduction is recommended when administering Ganciclovir Injection to patients with renal impairment [see Dosage and Administration ( 2.5 ), and Warnings and Precautions ( 5.2 )] . 8.7 Hepatic Impairment The safety and efficacy of Ganciclovir Injection have not been studied in patients with hepatic impairment.
Ajuste en insuficiencia hepática
Infusion Instructions: a) Based on patient weight, the appropriate volume of the solution (ganciclovir concentration 50 mg per mL) should be removed from the vial and added to an acceptable infusion fluid (typically 100 mL) for delivery over the course of 1 hour.
FDA (DailyMed) · ganciclovir · Dosage and administration · texto original en inglés
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
FDA (DailyMed) · ganciclovir · Use in specific populations · texto original en inglés
Renal function should be monitored and dosage adjustments should be made accordingly [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.6 )] . 8.6 Renal Impairment Dose reduction is recommended when administering Ganciclovir Injection to patients with renal impairment [see Dosage and Administration ( 2.5 ), and Warnings and Precautions ( 5.2 )] . 8.7 Hepatic Impairment The safety and efficacy of Ganciclovir Injection have not been studied in patients with hepatic impairment.
FDA (DailyMed) · ganciclovir · Use in specific populations · texto original en inglés
Reconstitución de ganciclovir
Según presentación (polvo: 10 mL de agua inyectable, 50 mg/mL). Usar guantes.
Dilución de ganciclovir
SF 0.9% u otro diluyente aceptado (≤10 mg/mL).
Administración de ganciclovir
Infusión IV a velocidad constante en 1 h. NUNCA IM ni SC (pH alto, irritación grave).
Estabilidad y periodo de validez
| Condición | Tiempo | Nota |
|---|---|---|
| Diluido, refrigerado (2–8 °C) | 24 h | No congelar. |
Compatibilidad de ganciclovir
Compatible con
- SF 0.9%
Conservación y protección de la luz
A 25 °C (15–30 °C).
Sin requerimiento especial.
Advertencias
- Manipular como medicamento peligroso (carcinogénico y mutagénico).
- Mielosupresión; ajustar dosis a la función renal.
- Convulsiones reportadas con imipenem-cilastatina.
Diferencias entre fuentes oficiales
- La búsqueda en AEMPS devolvió valganciclovir comprimidos (otro producto), que no se usó.
Fuentes
- FDA (DailyMed) · ganciclovirSagent Pharmaceuticals · Ganciclovir inyectable 500 mg · versión 2020-11-30
Interacciones de ganciclovir
8 medicamentos del catálogo con una interacción documentada en sus fichas oficiales. Abre cada una para ver el efecto, la recomendación y su fuente.
- DoxorubicinaMayor
- Imipenem / cilastatinaMayor
- Imipenem / cilastatina / relebactamMayor
- TacrolimusMayor
- VincristinaMayor
- ZidovudinaMayor
- Anfotericina BModerada
- Micofenolato de mofetiloModerada
Diagnósticos relacionados
Diagnósticos que la ficha técnica de ganciclovir menciona en sus indicaciones. Cada uno abre su definición y los demás medicamentos indicados.
Identificación
- SNOMED CT (VTM)
- 78025001
- RxNorm
- 4678
Información de consulta profesional extraída de las fichas técnicas y etiquetas oficiales citadas. Las condiciones de preparación, estabilidad y administración dependen del producto concreto: verifica el documento del producto que utilizas. No sustituye el criterio clínico ni la valoración del paciente.