ganciclovir

Contraindicated in:

Hypersensitivity to ganciclovir or acyclovir;
Bone marrow depression or immunosuppression or thrombocytopenia (do not administer if absolute neutrophil count [ANC] <500/mm³, hemoglobin <8 g/dL, or platelet count <25,000/mm³)
;
OB:
Ganciclovir is not the preferred systemic therapy during pregnancy
;
Lactation: Lactation.

Use Cautiously in:

Renal impairment (dose ↓ required if CCr <80 mL/min);
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Geri: Dose ↓ recommended in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, edema, hypertension, hypotension

Derm: alopecia, photosensitivity, pruritus, rash, urticaria

Endo: hypoglycemia

GI: ↑liver enzymes, abdominal pain, GI BLEEDING, nausea, vomiting

GU:

↓fertility

gonadal suppression

, hematuria, renal impairment

Hemat:

neutropenia

, THROMBOCYTOPENIA, ANEMIA, eosinophilia

Local: pain/phlebitis at IV site

Neuro: abnormal dreams, ataxia, confusion, dizziness, drowsiness, headache, malaise, nervousness, SEIZURES, tremor

Resp: dyspnea

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

Toxicity may be ↑ by probenecid.
↑risk of seizures with imipenem/cilastatin; concurrent use not recommended.
Concurrent use of cyclosporine or amphotericin B↑ risk of nephrotoxicity.
↑risk of nephrotoxicity and hematological toxicity with mycophenolate mofetil.
Concurrent use with dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine, or zidovudine↑ risk of nephrotoxicity and myelosuppression.

Availability ⬆ ⬇

(Generic available)

Lyophilized powder for injection: 500 mg/vial
Solution for injection: 50 mg/mL
Premixed infusion: 500 mg/250 mL

Route/Dosage ⬆ ⬇

IV (Adults and Children >3 mo): Induction: 5 mg/kg every 12 hr for 14–21 days. Maintenance regimen: 5 mg/kg/day or 6 mg/kg for 5 days of each wk. If progression occurs, ↑ to every 12 hr regimen. Prevention: 5 mg/kg every 12 hr for 7–14 days; then 5 mg/kg/day or 6 mg/kg for 5 days of each wk.
IV (Neonates ): Congenital CMV infection: 12 mg/kg/day divided every 12 hr for 6 wk.

Renal Impairment

IV (Adults and Children ): Induction: CCr 50–69 mL/min: 2.5 mg/kg/dose every 12 hr; CCr 25–49 mL/min: 2.5 mg/kg/dose every 24 hr; CCr 10–24 mL/min: 1.25 mg/kg/dose every 24 hr; CCr <10 mL/min: 1.25 mg/kg 3 times/wk after hemodialysis. Maintenance: CCr 50–69 mL/min: 2.5 mg/kg/dose every 24 hr; CCr 25–49 mL/min: 1.25 mg/kg/dose every 24 hr; CCr 10–24 mL/min: 0.625 mg/kg/dose every 24 hr; CCr <10 mL/min: 0.625 mg/kg 3 times/wk after hemodialysis.

Action ⬆ ⬇

CMV converts ganciclovir to its active form (ganciclovir phosphate) inside the host cell, where it inhibits viral DNA polymerase.

Therapeutic effects:

Antiviral effect directed preferentially against CMV-infected cells.

Classifications ⬆ ⬇

Therapeutic Classification: antivirals

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed; enters CSF.

Protein Binding: 1–2%.

Metabolism/Excretion: 90% excreted unchanged by the kidneys.

Half-Life: Adults: 2.9 hr; Children 9 mo–12 yr: 2.4 ±0.7 hr; Neonates: 2.4 hr (↑ in renal impairment).

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(antiviral levels)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	12–24 hr

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of ganciclovir. Do not stop receiving drug without consulting health care provider. If an appointment is missed, contact health care provider as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Inform patient that ganciclovir is not a cure for CMV retinitis. Progression of retinitis may continue in immunocompromised patients during and after therapy. Advise patients to have regular ophthalmic exams at least every 6 wk. Duration of therapy for CMV prevention is based on the duration and degree of immunosuppression.
Emphasize the importance of frequent follow-up exams to monitor blood counts.
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 a nonhormonal method of contraception during therapy and for ≥30 days after last dose and to avoid breastfeeding during therapy. Advise men to use condoms during and for ≥90 days after therapy. May ↓ fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9299- Ganciclovir
  - 0143-9299-10- 10 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)

12806- F. Hoffmann-La Roche Ltd
- 12806-6941-
  - 12806-6941-2- 28 kg in 1 DRUM (12806-6941-2)

12869- Corden Pharma Colorado, Inc.
- 12869-803-
  - 12869-803-01- 50 kg in 1 DRUM (12869-803-01)

24208- Bausch & Lomb Incorporated
- 24208-535- ZIRGAN
  - 24208-535-15- 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR

24208- Bausch & Lomb Incorporated
- 24208-535- ZIRGAN
  - 24208-535-35- 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR

25021- Sagent Pharmaceuticals
- 25021-185- ganciclovir
  - 25021-185-10- 25 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL

42023- Endo USA, Inc.
- 42023-173- Ganciclovir
  - 42023-173-25- 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

46014- Excella GmbH Co. KG
- 46014-1054-
  - 46014-1054-0- 50 kg in 1 BOX (46014-1054-0)

51754- EXELA PHARMA SCIENCES, LLC
- 51754-2500- GANCICLOVIR
  51754-2500-1- 250 mL in 1 BAG (51754-2500-1)

51754- EXELA PHARMA SCIENCES, LLC
- 51754-2500- GANCICLOVIR
  - 51754-2500-3- 10 BAG in 1 POUCH (51754-2500-3) / 250 mL in 1 BAG

51817- Pharmascience Inc.
- 51817-171- Ganciclovir
  - 51817-171-01- 25 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIAL

51817- Pharmascience Inc.
- 51817-171- Ganciclovir
  - 51817-171-02- 1 VIAL in 1 CARTON (51817-171-02) / 10 mL in 1 VIAL

59651- Aurobindo Pharma Limited
- 59651-108-
  - 59651-108-37- 50 kg in 1 DRUM (59651-108-37)

63323- Fresenius Kabi USA, LLC
- 63323-315- Ganciclovir
  63323-315-10- 25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)

63323- Fresenius Kabi USA, LLC
- 63323-315- Ganciclovir
  - 63323-315-94- 25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41)

70436- Slate Run Pharmaceuticals, LLC
- 70436-089- ganciclovir
  - 70436-089-55- 25 VIAL in 1 CARTON (70436-089-55) / 10 mL in 1 VIAL

70436- Slate Run Pharmaceuticals, LLC
- 70436-231- ganciclovir sodium
  - 70436-231-55- 25 VIAL in 1 CARTON (70436-231-55) / 10 mL in 1 VIAL

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Indications ⬇

Contraind./Precautions ⬆ ⬇