valganciclovir

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2 hr	12–24 hr

Contraindicated in:

Hypersensitivity to valganciclovir or ganciclovir;
Hemodialysis;
Undergoing liver transplantation;
OB:
Pregnancy
;
Lactation: Lactation.

Use Cautiously in:

Renal impairment (↓ dose if CCr <60 mL/min);
Pre-existing bone marrow depression
;
Previous or concurrent myelosuppressive drug therapy or radiation therapy
;
Rep:
Women of reproductive potential and men with female partners of reproductive potential
;
Pedi: Children <4 mo (safety and effectiveness not established);
Geri: Age-related ↓ in renal function requires dosage ↓ in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

GI: abdominal pain, diarrhea, nausea, vomiting

GU: ↓fertility, renal impairment

Hemat: anemia, APLASTIC ANEMIA, NEUTROPENIA, PANCYTOPENIA, THROMBOCYTOPENIA

Neuro: headache, insomnia, agitation, ataxia, confusion, dizziness, hallucinations, paresthesia, peripheral neuropathy, psychosis, sedation, SEIZURES

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

↑risk of hematologic toxicity with zidovudine.
Probenecid may ↑ levels and risk of toxicity.
Patients with renal impairment may experience accumulation of metabolites of mycophenolate.

Drug-Food:

Food ↑ absorption.

Route/Dosage ⬆ ⬇

Treatment of CMV Disease

PO (Adults ): Induction: 900 mg twice daily for 21 days; Maintenance treatment or patients with inactive CMV retinitis: 900 mg once daily.

Renal Impairment

(Adults ): CCr 40–59 mL/min: Induction: 450 mg twice daily for 21 days. Maintenance treatment or patients with inactive CMV retinitis: 450 mg once daily. CCr 25–39 mL/min: Induction: 450 mg once daily for 21 days. Maintenance treatment or patients with inactive CMV retinitis: 450 mg every 2 days. CCr 10–24 mL/min: Induction: 450 mg every 2 days for 21 days. Maintenance treatment or patients with inactive CMV retinitis: 450 mg twice weekly.

Prevention of CMV Disease in Transplant Patients

PO (Adults ): Kidney/pancreas or heart transplant: 900 mg once daily, starting 10 days prior to transplant and continued for 100 days after; Kidney transplant: 900 mg once daily, starting 10 days prior to transplant and continued for 200 days after.
PO (Children 4 mo–16 yr): Kidney transplant: Dose is based on body surface area (BSA) and CCr. Dose = 7 × BSA × CCr (see prescribing information for equations used for BSA and CCr); all calculated doses should be rounded to nearest 25 mg (max = 900 mg) and administered as oral solution; should be started 10 days prior to transplant and continued for 200 days after.
PO (Children 4 mo–16 yr): Heart transplant: Dose is based on BSA and CCr. Dose = 7 × BSA × CCr (see prescribing information for equations used for BSA and CCr); all calculated doses should be rounded to nearest 25 mg (max = 900 mg) and administered as oral solution; should be started 10 days prior to transplant and continued for 100 days after.

Renal Impairment

PO (Adults ): CCr 40–59 mL/min: 450 mg once daily; CCr 25–39 mL/min: 450 mg every 2 days; CCr 12–24 mL/min: 450 mg twice weekly.

Availability ⬆ ⬇

(Generic available)

Tablets: 450 mg
Oral solution tutti-frutti flavor: 50 mg/mL

Assessment ⬆ ⬇

Culture for CMV (urine, blood, throat) may be taken prior to administration. However, a negative CMV culture does not rule out CMV retinitis. Diagnosis of CMV retinitis should be determined by ophthalmoscopy prior to treatment with valganciclovir. If symptoms do not respond after several weeks, resistance to valganciclovir may have occurred. Ophthalmologic exams should be performed weekly during induction and every 2 wk during maintenance or more frequently if the macula or optic nerve is threatened. Progression of CMV retinitis may occur during or following valganciclovir treatment.
Assess for signs/symptoms of infection (fever, chills, flu-like symptoms, cough, hoarseness, lower back or side pain, sore throat, dysuria, hematuria, cellulitis, erythematous nonhealing wound). Notify health care provider if these symptoms occur.
Assess for bleeding (bleeding gums, bruising, petechiae, weakness, tachycardia, dyspnea, dizziness, pallor, fatigue, tarry stools, coffee ground emesis). Avoid IM injections and taking rectal temperatures. Apply pressure to venipuncture sites for 10 min.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy.
- May cause neutropenia, anemia, and thrombocytopenia. Monitor CBC with differential closely during therapy. Do not administer if ANC <500 cells/mm³, platelet count <25,000 cells/mm³, or hemoglobin <8 g/dL. Recovery begins within 3–7 days of discontinuation of therapy. Consider hematopoietic growth factor treatment in patients with severe leukopenia, neutropenia, anemia, or thrombocytopenia.
- Monitor BUN and serum creatinine at least once every 2 wk during therapy. May ↑ serum creatinine. Monitor renal function in children using a modified Schwartz formula for calculations of CrCl and consider changes in height and body weight.

Implementation ⬆ ⬇

Do not confuse valganciclovir with valacyclovir. Do not confuse Valcyte with Valtrex.
During administration and when preparing or handling tablets, wear double chemotherapy gloves, protective gown, and hair and shoe covers; optimally prepare in a ventilated control device. Respiratory (N95) protection and eye/face protection is needed if there is risk of patient vomiting or spitting up. Single chemotherapy gloves are appropriate if handling and administering intact tablets from a unit-dose package. Health care providers who are actively trying to conceive, who are pregnant or may become pregnant, and who are breastfeeding should avoid handling valganciclovir.
PO: Administer tablets and oral solution with food. Adults should take tablets, not oral solution. Handle valganciclovir tablets carefully. DNC: Do not break or crush. Avoid direct contact with broken or crushed tablets. If contact with the skin or mucous membranes occurs, wash thoroughly with soap and water and rinse eyes thoroughly with plain water.
- For oral solution, shake well prior to use. Use oral dispenser provided for accurate dose. Store oral solution in refrigerator for no longer than 49 days.

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of valganciclovir. Instruct patient to take with food, as directed. Take missed doses as soon as remembered, unless almost time for next dose; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Instruct patient on proper handling and to avoid direct contact of skin or mucous membranes with any broken or crushed tablet, powder for oral solution, or reconstituted oral solution. Keep valganciclovir out of children's reach.
Advise patient to maintain adequate hydration to avoid renal toxicity.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Regular blood counts and eye exams will be needed.
Inform patient that valganciclovir is not a cure for CMV retinitis. Progression of retinitis may continue in immunocompromised patients during and following therapy. Advise patients to have regular ophthalmic exams at least every 4–6 wk. Duration of therapy for CMV prevention is based on the duration and degree of immunosuppression.
May cause seizures, sedation, dizziness, ataxia, and/or confusion. Caution patient not to drive or do other activities requiring alertness until response to medication is known.
Advise patient to promptly report unexplained weight loss, persistent weakness and fatigue, swollen lymph nodes, abnormal bleeding, unusual pain or bruising, or new lumps to health care provider.
Advise patient to notify health care provider if fever; chills; sore throat; other signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep:
May cause fetal harm. Advise women of reproductive potential to use effective contraception during and for ≥30 days following therapy and to avoid breastfeeding. Advise men with female partners of reproductive potential to use a barrier method of contraception during and for ≥90 days following therapy. Advise patient to notify health care provider immediately if pregnancy is suspected. May cause temporary or permanent infertility in men and women.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇