GANCICLOVIR-AFT POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL [SIN17325P]

Product Info

GANCICLOVIR-AFT POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL

[SIN17325P]

Indication

2.1 THERAPEUTIC INDICATIONS

Ganciclovir-AFT vials are indicated for the prevention and treatment of life- or sight-threatening cytomegalovirus (CMV) disease in immunocompromised individuals.

The benefits of Ganciclovir-AFT for CMV prevention in patients with HIV may be limited.

Dosing

2.2 DOSE AND METHOD OF ADMINISTRATION

General

Ganciclovir-AFT must be reconstituted and diluted under the supervision of a healthcare professional and administered as an intravenous infusion (see section 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Caution: Ganciclovir-AFT must only be administered by IV infusion over 1 hour, preferably via a plastic cannula, into a vein with adequate blood flow (intramuscular or subcutaneous injection may result in severe tissue irritation due to the high pH (~ 11) of ganciclovir solution. Do not administer by rapid or bolus IV injection because the resulting excessive plasma levels may increase the toxicity of Ganciclovir-AFT (see section 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The recommended dosage, frequency, or infusion rates should not be exceeded.

STANDARD DOSAGE FOR TREATMENT OF CMV DISEASE

Dosage for patients with normal renal function

Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 14–21 days.

Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given. 5 mg/kg given as an IV infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.

The duration of maintenance treatment should be determined on an individual basis.

STANDARD DOSAGE FOR PREVENTION OF CMV DISEASE USING PRE-EMPTIVE THERAPY

Dosage for patients with normal renal function

Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 7–14 days.

Maintenance treatment: 5 mg/kg given as an IV infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.

The duration of maintenance treatment is based on the risk of CMV disease and should be determined on an individual basis.

Special dosage instructions

Pediatric Patients

Safety and efficacy of ganciclovir in pediatrics have not been established, including use for the treatment of congenital or neonatal CMV infections. The use of Ganciclovir-AFT in children warrants extreme caution due to the potential for long-term carcinogenicity and reproductive toxicity. The benefits of treatment should outweigh the risks (see section 3.2.5 Pharmacokinetics in Special Populations, Pediatric Population – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients

No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Ganciclovir-AFT should be administered to geriatric patients with special consideration of their renal status (see Table 1 and section 3.2.5 Pharmacokinetics in Special Populations, Geriatric population – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

For patients with renal impairment, the dose of Ganciclovir-AFT should be modified as shown in the table below.

Estimated creatinine clearance can be related to serum creatinine by the following formulae:

For females = 0.85 x male value

As dosage modifications are recommended in patients with renal impairment, serum creatinine or estimated creatinine-clearance levels should be monitored carefully.

Hepatic impairment

The safety and efficacy of Ganciclovir-AFT have not been studied in patients with hepatic impairment (see section 3.2.5 Pharmacokinetics in Special Populations, Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

2.3 CONTRAINDICATIONS

Ganciclovir-AFT is contraindicated in patients with hypersensitivity to ganciclovir, valganciclovir or to any of the excipients.