Valganvir S.K 50 mg/ml

/ K.S Kim International (SK-PHARMA)

Oral solution has not been tested against Valgancyclovir tablets and is therefore not considered as equivalent to Valgancyclovir tablets.
General Dosing Information
• It is recommended that adult patients should use Valganciclovir tablets, instead of Valganciclovir hydrochloride for oral solution.
• Solution should be taken with food.
• Solution must be prepared by the pharmacist prior to dispensing to the patient.
Adults
Treatment of CMV Retinitis:
• Induction: The recommended dosage is 900 mg (18 ml) taken orally twice a day for 21 days.
• Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dosage is 900 mg (18 ml) taken orally once a day.
Prevention of CMV Disease:
• For adult patients who have received a heart or kidney-pancreas transplant, the recommended dosage is 900 mg (18 ml) taken orally once a day starting within 10 days of transplantation until 100 days post-transplantation.
• For adult patients who have received a kidney transplant, the recommended dosage is 900 mg (18 ml) taken orally once a day starting within 10 days of transplantation until 200 days post-transplantation.
Pediatric Patients
Prevention of CMV Disease in Pediatric Kidney Transplant Patients: For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of post-transplantation until 200 days post-transplantation.
Prevention of CMV Disease in Pediatric Heart Transplant Patients: For pediatric heart transplant patients 1 month to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of transplantation until 100 days post-transplantation.
See prescribing information for full details.

Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis:  indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV Disease:  indicated for the prevention of CMV disease in kidney, heart, and kidney- pancreas transplant patients at high risk.
Pediatric Patients
Prevention of CMV Disease: indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk

Hypersensitivity to valganciclovir, ganciclovir or to any of the excipients

Hematologic Toxicity
Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir or ganciclovir. The drug should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL. Valganciclovir hydrochloride should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered.
Due to the frequency of neutropenia, anemia, and thrombocytopenia in patients receiving valganciclovir, complete blood counts with differential and platelet counts should be performed frequently, especially in infants, in patients with renal impairment, and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/μL at the beginning of treatment. Increased monitoring for cytopenias may be warranted if therapy with oral ganciclovir is changed to valganciclovir, because of increased plasma concentrations of ganciclovir after valganciclovir administration.
Acute Renal Failure
Acute renal failure may occur in:
* Elderly patients with or without reduced renal function. Caution should be exercised when administering valganciclovir to geriatric patients, and dosage reduction is recommended for those with impaired renal function.
* Patients receiving potential nephrotoxic drugs. Caution should be exercised when administering valganciclovir to patients receiving potential nephrotoxic drugs.
* Patients without adequate hydration. Adequate hydration should be maintained for all patients.
See prescribing information for full details.

The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with this medical product or valganciclovir tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
See prescribing information for full details.

In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for Valganciclovir. See prescribing information for full details.

Pregnancy: After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, Valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir. There are no available human data on use of Valganciclovir or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Advise pregnant women of the potential risk to the fetus.
Lactation: No data are available regarding the presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, the effects on the breastfed infant, or the effects on milk production. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. Advise nursing mothers that breastfeeding is not recommended during treatment with valganciclovir because of the potential for serious adverse events in nursing infants and because of the potential for transmission of HIV. Advise mothers not to breast-feed if they are receiving valganciclovir because of the potential for hematologic toxicity and cancer in nursing infants, and because HIV can be passed to the baby in breast milk.

Experience with Valganciclovir Hydrochloride Tablets: An overdose of valganciclovir hydrochloride could possibly result in increased renal toxicity . Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of valganciclovir hydrochloride. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered.
Reports of adverse reactions after overdoses with valganciclovir, some with fatal outcomes, have been received from clinical trials and during postmarketing experience. The majority of patients experienced one or more of the following adverse events:
Hematological toxicity: myelosuppression including pancytopenia, bone marrow failure, leukopenia, neutropenia, granulocytopenia
Hepatotoxicity: hepatitis, liver function disorder
Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine
Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting
Neurotoxicity: generalized tremor, seizure

Store dry powder below 25 °C.
Store constituted solution under refrigeration at 2° to 8°C for no longer than 49 days. Do not freeze.