Ganciclovir oral and injectable

Before taking ganciclovir, tell your doctor if you have

• had an allergic reaction to ganciclovir or acyclovir (Zovirax);

• kidney disease; or

• blood problems or low blood counts.

You may not be able to take ganciclovir, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Ganciclovir is in the FDA pregnancy category C. This means that it is not known whether ganciclovir will be harmful to an unborn baby. Ganciclovir has caused birth defects in animals, and it is generally not recommended for use during pregnancy. Women should use an effective form of birth control during treatment with ganciclovir. Also, men should use a form of barrier contraception (e.g., condom) during and for at least 90 days following treatment with ganciclovir.

It is not known whether ganciclovir passes into breast milk. Generally, breast-feeding should be avoided during treatment with ganciclovir. Do not take ganciclovir without first talking to your doctor if you are breast-feeding a baby.

Before taking ganciclovir, tell your doctor if you are taking any of the following drugs:

• zidovudine (Retrovir, AZT);

• didanosine (Videx);

• probenecid (Benemid); or

• imipenem-cilastatin (Primaxin).

You may not be able to take ganciclovir, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with ganciclovir. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Applies to ganciclovir: capsule, powder for solution

Along with its needed effects, ganciclovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking ganciclovir:

• Sore throat and fever
• unusual bleeding or bruising

• Mood or other mental changes
• nervousness
• pain at place of injection
• skin rash
• tremor
• unusual tiredness and weakness

• Decreased vision or any change in vision

Some side effects of ganciclovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• loss of appetite
• nausea and vomiting

Induction therapy:
5 mg/kg IV at a constant rate over 1 hour, every 12 hours for 14 to 21 days.

Maintenance:
IV: 5 mg/kg IV at a constant rate over 1 hour once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg 3 times a day or 500 mg 6 times a day (every 3 hours while awake) with food.

Patients who experience progression of CMV retinitis while receiving maintenance treatment should receive reinduction treatment.

Because ganciclovir capsules are associated with risk of more rapid rate of CMV retinitis progression, they should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions. Oral ganciclovir should not be used for induction.

Patients with advanced HIV: 1000 mg orally 3 times a day with food.

Transplant Recipients:
Initial: 5 mg/kg IV over 1 hour every 12 hours for 7 to 14 days
Maintenance:
IV: 5 mg/kg IV once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg orally 3 times a day with food.

No adjustment recommended

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

Due to the frequency of granulocytopenia and thrombocytopenia in patients receiving ganciclovir, it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/microL at the beginning of treatment. Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients.

Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia. Ganciclovir should not be administered in patients with severe neutropenia (ANC less than 500/microL) or severe thrombocytopenia (platelets less than 25,000/microL).

Do not administer ganciclovir IV solution by rapid or bolus IV injection. The recommended infusion rate should not be exceeded. The toxicity of ganciclovir IV may be increased as a result of excessive plasma levels.

IM or subcutaneous injection of reconstituted ganciclovir IV solution may result in severe tissue irritation due to its high pH (11).

Ganciclovir capsules should be taken with food for optimal bioavailability.