valganciclovir

val-gan-SYE-kloe-veer

Therapeutic Classification: antivirals

REMS

Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
Prevention of CMV disease in kidney, kidney/pancreas and heart transplant patients at risk.

Valganciclovir is a prodrug, which is rapidly converted to ganciclovir by intestinal and hepatic enzymes. CMV virus converts ganciclovir to its active form (ganciclovir phosphate) inside host cell, where it inhibits viral DNA polymerase.

Therapeutic effects:

Antiviral effect directed preferentially against CMV-infected cells.

Absorption: 59.4% absorbed following oral administration, rapidly converted to ganciclovir.

Distribution: Widely distributed to tissues, including CSF.

Metabolism/Excretion: Rapidly converted to ganciclovir; ganciclovir is mostly excreted by the kidneys.

Half-Life: 4.1 hr (intracellular half-life of ganciclovir phosphate is 18 hr).

(ganciclovir plasma concentrations)

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

Contraindicated in:

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

Use Cautiously in:

Renal impairment (dosage ↓ recommended 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;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children 4 mo (safety and effectiveness not established);
Geri: Age-related in renal function requires dosage in older adults.

GI: abdominal pain, diarrhea, nausea, vomiting

GU: ↓fertility, renal impairment

Hemat: anemia, aplastic anemia, bone marrow depression, NEUTROPENIA, pancytopenia, THROMBOCYTOPENIA

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

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

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 and valganciclovir.

Food ↑ absorption.

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

CCr 40–59 mL/min
(Adults ): Induction: 450 mg twice daily for 21 days; Maintenance treatment or patients with inactive CMV retinitis: 450 mg once daily.

Renal Impairment

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

Renal Impairment

CCr 10–24 mL/min
(Adults ): 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.

(Generic available)

Tablets: 450 mg
Oral solutiontutti-frutti flavor: 50 mg/mL

Diagnosis of CMV retinitis should be determined by ophthalmoscopy prior to treatment with valganciclovir.
Culture for CMV (urine, blood, throat) may be taken prior to administration. However, a negative CMV culture does not rule out CMV retinitis. If symptoms do not respond after several wk, 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 ganciclovir treatment.
Assess for signs of infection (fever, chills, cough, hoarseness, lower back or side pain, sore throat, difficult or painful urination). Notify health care professional if these symptoms occur.
Assess for bleeding (bleeding gums, bruising, petechiae, or guaiac stools, urine, and 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 granulocytopenia, anemia, and thrombocytopenia. Monitor neutrophil and platelet count closely during therapy. Do not administer if absolute neutrophil count <500/mm³, platelet count <25,000/mm³, or Hgb <8 g/dL. Recovery begins within 3–7 days of discontinuation of therapy.
- Monitor BUN and serum creatinine at least once every 2 wk during therapy. May cause ↑ in serum creatinine.

Do not confuse valganciclovir with valacyclovir. Do not confuse Valcyte with Valtrex.
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.
- Oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient. Shake well prior to use. Use oral dispenser provided for accurate dose. Store oral solution in refrigerator for no longer than 49 days.

Instruct patient to take valganciclovir 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.
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 notify health care professional 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.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 30 days following therapy and to avoid breastfeeding. Advise males with female partners of reproductive potential to use a barrier method of contraception during and for at least 90 days following therapy. Advise patient to notify health care professional immediately if pregnancy is suspected. May cause temporary or permanent infertility.
Emphasize the importance of frequent follow-up exams to monitor blood counts.

Management of the symptoms of CMV retinitis in patients with AIDS.
Prevention of CMV disease in kidney, kidney/pancreas and heart transplant patients at risk.

Valcyte

NDC Code

0004- Genentech, Inc.
- 0004-0038- Valcyte
  - 0004-0038-22- 1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

0004- Genentech, Inc.
- 0004-0039- Valcyte
  - 0004-0039-09- 1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) > 100 mL in 1 BOTTLE, GLASS

0591- Actavis Pharma, Inc.
- 0591-2579- Valganciclovir hydrochloride for Oral
  - 0591-2579-20- 100 mL in 1 BOTTLE, GLASS (0591-2579-20)

0603- Par Pharmaceutical
- 0603-6330- Valganciclovir
  - 0603-6330-20- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20)

0904- Major Pharmaceuticals
- 0904-6796- Valganciclovir
  - 0904-6796-04- 30 BLISTER PACK in 1 CARTON (0904-6796-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6796- Valganciclovir
  - 0904-6796-10- 20 BLISTER PACK in 1 CARTON (0904-6796-10) > 1 TABLET, FILM COATED in 1 BLISTER PACK

16714- NorthStar Rx LLC
- 16714-765- Valganciclovir
  - 16714-765-01- 60 TABLET, FILM COATED in 1 BOTTLE (16714-765-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-832- Valganciclovir
  - 31722-832-31- 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-832- Valganciclovir
  - 31722-832-32- 10 TABLET, FILM COATED in 1 CARTON (31722-832-32)

31722- Camber Pharmaceuticals, Inc.
- 31722-832- Valganciclovir
  - 31722-832-60- 60 TABLET, FILM COATED in 1 BOTTLE (31722-832-60)

42291- AvKARE, Inc.
- 42291-875- Valganciclovir
  - 42291-875-60- 60 TABLET, FILM COATED in 1 BOTTLE (42291-875-60)

43598- Dr. Reddy's Laboratories Inc
- 43598-356- valganciclovir hydrochloride
  - 43598-356-30- 30 TABLET in 1 BOTTLE (43598-356-30)

43598- Dr. Reddy's Laboratories Inc
- 43598-356- valganciclovir hydrochloride
  - 43598-356-60- 60 TABLET in 1 BOTTLE (43598-356-60)

48433- Safecor Health, LLC
- 48433-124- Valganciclovir
  - 48433-124-10- 1 BLISTER PACK in 1 BOX (48433-124-10) > 100 TABLET, FILM COATED in 1 BLISTER PACK (48433-124-01)

50268- AvPAK
- 50268-787- Valganciclovir
  - 50268-787-12- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11)

55111- Dr. Reddy's Laboratories Limited
- 55111-762- Valganciclovir
  - 55111-762-05- 500 TABLET, FILM COATED in 1 BOTTLE (55111-762-05)

55111- Dr. Reddy's Laboratories Limited
- 55111-762- Valganciclovir
  - 55111-762-60- 60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60)

55111- Dr. Reddy's Laboratories Limited
- 55111-762- Valganciclovir
  - 55111-762-78- 10 BLISTER PACK in 1 CARTON (55111-762-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79)

60429- Golden State Medical Supply Inc.
- 60429-846- Valganciclovir
  - 60429-846-60- 60 TABLET, FILM COATED in 1 BOTTLE (60429-846-60)

63739- McKesson Corporation dba SKY Packaging
- 63739-357- VALGANCICLOVIR HYDROCHLORIDE
  - 63739-357-33- 3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-357-33) > 10 TABLET in 1 BLISTER PACK

65862- Aurobindo Pharma Limited
- 65862-753- VALGANCICLOVIR HYDROCHLORIDE
  - 65862-753-01- 100 TABLET in 1 BOTTLE (65862-753-01)

65862- Aurobindo Pharma Limited
- 65862-753- VALGANCICLOVIR HYDROCHLORIDE
  - 65862-753-05- 500 TABLET in 1 BOTTLE (65862-753-05)

65862- Aurobindo Pharma Limited
- 65862-753- VALGANCICLOVIR HYDROCHLORIDE
  - 65862-753-18- 180 TABLET in 1 BOTTLE (65862-753-18)

65862- Aurobindo Pharma Limited
- 65862-753- VALGANCICLOVIR HYDROCHLORIDE
  - 65862-753-60- 60 TABLET in 1 BOTTLE (65862-753-60)

65862- Aurobindo Pharma Limited
- 65862-753- VALGANCICLOVIR HYDROCHLORIDE
  - 65862-753-99- 1000 TABLET in 1 BOTTLE (65862-753-99)

68084- American Health Packaging
- 68084-965- Valganciclovir
  - 68084-965-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)

69097- Cipla USA Inc.
- 69097-277- Valganciclovir
  - 69097-277-03- 60 TABLET in 1 BOTTLE (69097-277-03)

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