Valcyte^®

valganciclovir hydrochloride

• On February 1, 2022, Cheplapharm Arzneimittel GmbH (“Cheplapharm”) signed an agreement with F. Hoffmann-La Roche Ltd. to acquire the worldwide rights to Valcyte^® (valganciclovir hydrochloride). Under the terms of the agreement, Cheplapharm will receive product rights for Valcyte^® in certain countries worldwide including the USA.

  Beginning April 4, 2023, please direct any clinical product questions to Cheplapharm’s US partner, H2 Pharma, by phone at 1 (334) 647-1947.

  Who should I contact if I have side effect concerns or have an adverse event to report on the product?

  Beginning April 4, 2023, you may contact Cheplapharm’s US partner, H2 Pharma, by phone at 1-866-946-3864 or by email: [email protected] if you have side effect concerns or you would like to report an adverse event. You may also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Indication

Adult Patients:

VALCYTE (valganciclovir hydrochloride) is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

Pediatric Patients:

VALCYTE is 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.

Adult patients should use Valcyte tablets, not Valcyte for oral solution. VALCYTE for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient.

Important Safety Information Including Boxed WARNINGS

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS

• Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anemia have been reported in patients treated with VALCYTE

• Impairment of Fertility: Based on animal data and limited human data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis and suppression of fertility in females

• Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans

• Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE has the potential to cause cancers in humans

CONTRAINDICATION

VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation.

WARNINGS AND PRECAUTIONS:

• Hematologic toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anemia have occurred with the use of VALCYTE or ganciclovir. Avoid VALCYTE use if absolute neutrophil count is less than 500 cells/mL, platelet count is less than 25,000/mL, or hemoglobin is less than 8 g/dL. Use with caution in pre-existing cytopenias and when receiving myelosuppressive drugs or irradiation. Monitor with frequent testing of platelet and complete blood counts. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors and or the interruption of therapy is recommended. Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia. Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with AIDS. Severe thrombocytopenia may be associated with potentially life-threatening bleeding.
• Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function. Adequate hydration should be maintained for all patients.
• Impairment of fertility: Based on animal studies and limited human data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis, and may cause suppression of fertility in females. Advise patients that fertility may be impaired with use of VALCYTE.
• Fetal toxicity: Based on animal studies, VALCYTE may cause fetal harm. Pregnancy should be avoided in female patients taking VALCYTE and in females with male partners taking VALCYTE. Females of reproductive potential should be advised of the potential risk to the fetus and use effective contraception during and following treatment and males should practice barrier contraception during and following treatment.
• Mutagenicity and carcinogenicity: Based on animal studies, VALCYTE is potentially mutagenic and carcinogenic.

POTENTIAL DRUG INTERACTIONS:

• Toxicity may be enhanced when VALCYTE is co-administered with other drugs known to be myelosuppressive or associated with renal impairment; these drugs should only be considered for concomitant use with valganciclovir if the potential benefits outweigh the potential risks.
  • Zidovudine: Potential to cause neutropenia and anemia. Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels.
  • Probenecid: May increase ganciclovir levels. Monitor for evidence of ganciclovir toxicity.
  • Mycophenolate mofetil (MMF): Based on increased risk, patients should be monitored for hematological and renal toxicity.
  • Didanosine: May increase didanosine concentrations. Monitor for didanosine toxicity (e.g. pancreatitis).
• Cross hypersensitivity: Due to the similarity of the chemical structure of ganciclovir and that of acyclovir and valacyclovir, a cross-hypersensitivity reaction between these drugs is possible. Caution should therefore be used when prescribing VALCYTE to patients with known hypersensitivity to acyclovir or penciclovir, or to their prodrugs, valacyclovir or famciclovir.

ADVERSE REACTIONS:

Adult Patients: The most common adverse reactions and laboratory abnormalities reported in at least one indication by ≥20% of adult patients are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting

Pediatric Patients: The most common adverse reactions and laboratory abnormalities reported in ≥20% of pediatric solid organ transplant recipients are diarrhea, pyrexia, hypertension, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

Please see accompanying full Prescribing information, including Boxed WARNINGS, for additional important safety information