maribavir

REMS

Post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Virologic failure due to resistance may occur during and after treatment; may also lead to cross-resistance to ganciclovir or valganciclovir;
End-stage renal disease;
Severe hepatic impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <12 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea, nausea, vomiting

GU: ↑serum creatinine

Hemat: anemia, thrombocytopenia, neutropenia

Neuro: fatigue, taste disturbance

Interactions ⬆ ⬇

Drug-drug:

May ↓ the antiviral activity of ganciclovir or valganciclovir; concurrent use not recommended.
CYP3A4 inducers, including carbamazepine, phenytoin, phenobarbital, rifabutin, and rifampin, may ↓ levels and effectiveness; ↑ maribavir dose when used with carbamazepine, phenobarbital, phenytoin, or rifabutin. Concurrent use with all other strong or moderate CYP3A4 inducers not recommended.
May ↑ levels and risk of toxicity of CYP3A4 substrates, including cyclosporine, everolimus, sirolimus, and tacrolimus; closely follow levels of these immunosuppressants.
May ↑ levels and risk of toxicity of P-glycoprotein substrates, including digoxin; monitor digoxin levels closely.
May ↑ levels and risk of toxicity of breast cancer resistance protein substrates, including rosuvastatin.

Drug-Natural Products:

St. John's wort may ↓ levels and effectiveness; concurrent use not recommended.

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥12 yr and ≥35 kg): 400 mg twice daily. Concurrent use with carbamazepine or rifabutin: 800 mg twice daily. Concurrent use with phenytoin or phenobarbital: 1200 mg twice daily

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a benzimidazole riboside antiviral that competitively inhibits the protein kinase activity of human CMV enzyme pUL97, resulting in inhibition of the phosphorylation of proteins.

Therapeutic effects:

Reduction of CMV DNA level.

Classifications ⬆ ⬇

Therapeutic Classification: antivirals

Pharmacologic Classification: kinase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP3A4 isoenzyme with some contribution from the CYP1A2 isoenzyme. 61% excreted in urine (<2% as unchanged drug), with 14% excreted in the feces (5% as unchanged drug).

Half-Life: 4.3 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–3 hr	12 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Advise to take as directed. If a dose is missed, take as soon as remembered. If it is close to the time for next dose, skip the missed dose and go back to the normal time. Do not take two doses at the same time or extra doses.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient of signs of kidney problems (unable to pass urine, change in how much urine is passed, blood in the urine, big weight gain).
Advise patient to notify health care professional if fever, chills, or sore throat; any unexplained bruising or bleeding; or significant tiredness or weakness occur.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or expected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

58567- CARBOGEN AMCIS AG
- 58567-106-
  - 58567-106-25- 25 kg in 1 DRUM (58567-106-25)

64764- Takeda Pharmaceuticals America, Inc.
- 64764-800- Livtencity
  - 64764-800-28- 1 BOTTLE in 1 CARTON (64764-800-28) / 28 TABLET, COATED in 1 BOTTLE

64764- Takeda Pharmaceuticals America, Inc.
- 64764-800- Livtencity
  - 64764-800-56- 1 BOTTLE in 1 CARTON (64764-800-56) / 56 TABLET, COATED in 1 BOTTLE

72640- MSN Life Sciences Private Limited
- 72640-039-
  - 72640-039-01- 50 kg in 1 DRUM (72640-039-01)

82708- HOSTER LABS PRIVATE LIMITED
- 82708-0010-
  - 82708-0010-1- 1 kg in 1 DRUM (82708-0010-1)

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Indications ⬇