maribavir

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

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.

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

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess for fever, fatigue, muscle aches, skin rash, and swollen glands.
Assess for resistance in patients not responding to treatment.

Lab Test Considerations:

Monitor CMV DNA levels and assess for resistance as clinically appropriate.

Implementation ⬆ ⬇

PO: Administer with or without food. Tablet may be taken whole or crushed to make a suspension. Suspension can be administered by mouth or through a nasogastric (NG) or orogastric (OG) tube (≥10 French). To prepare suspension, for 400-mg dose, crush two tablets and mix with 30 mL of water; for 800-mg dose, crush four tablets and mix with 60 mL of water; for 1200-mg dose, crush six tablets and mix with 90 mL of water. The suspension may be prepared ahead of time and stored at room temperature for up to 8 hr. After administering the initial suspension, rinse container with 15 mL of drinking water and administer contents; visually inspect container and repeat rinsing of container if particles remain.
- For NG/OG administration, remove the plunger from a 60-mL syringe, place 400-mg dose (two tablets) in syringe, and put plunger back in place. Draw up 30 mL of drinking water into syringe and pull back plunger further to allow air space in the syringe. Cap syringe and shake syringe well for 30–45 sec until tablets disperse completely; administer. Draw up 15 mL drinking water into the syringe and flush the OG/NG tube; repeat 15-mL flush one time and then a second time if any drug particles remain in syringe. If dose >400 mg, repeat all steps for each 400-mg dose increment.

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.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction of CMV DNA level.

US Brand Names ⬆ ⬇

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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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇