Maribavir
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From MedlinePlus, U.S. National Library of Medicine
Cytomegalovirus pUL97 Kinase Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Administration Instructions The immediate-release tablets can be taken as whole, dispersed or crushed tablets by mouth, or as dispersed tablets through a nasogastric or orogastric tube (French size 10 or larger). The suspension may be prepared ahead of time and stored at room temperature for up to 8 hours. Administration of Dispersed Tablets or Crushed Tablets by Mouth Place the appropriate number of tablets for the prescribed dose into a suitable container.
If desired, the tablets may be crushed. Add the appropriate volume of drinking water (other liquids have not been tested) to make a suspension (see Table 1 below) . [See table below.] Swirl the container gently to keep the particles from settling, and administer the suspension before it settles. The mixture will have a bitter taste.
Rinse the container with 15 mL of drinking water and administer the rinse water. Repeat Step 3. Visually confirm that no particles are left in the container. If particles remain, repeat Step 3. Administration of Dispersed Tablets through a Nasogastric (NG) or Orogastric (OG) Tube Remove the cap (if applicable) and plunger out of a 50 or 60 mL catheter-tip compatible syringe or equivalent.
Add two tablets into the syringe body and place the plunger back in the syringe. Only two tablets can be administered via NG or OG tube at a time. Draw 30 mL of drinking water (other liquids have not been tested) into the syringe and hold the syringe with the tip pointing upward. Pull the plunger further to a higher volume position to have some air space in the syringe.
Place the cap back on the syringe (if applicable). Shake the syringe well (careful not to spill the contents) for about 30 to 45 seconds or until the tablets are completely dispersed. Once the tablets are completely dispersed in the syringe, remove the cap from the syringe again (if applicable) and attach the syringe to the NG or OG tube and administer the dispersion before it settles.
Draw 15 mL of water using the same syringe and flush through the same NG or OG tube. Repeat Step 4 and make sure no particles are left in the syringe by visual inspection. If particles remain, repeat Step 4. For doses of 800 mg (four 200 mg tablets) and 1,200 mg (six 200 mg tablets) [see Dosage and Administration (2.2 , 2.3) ] , repeat Steps 1-5 until prescribed dose is reached.
The same syringe, NG or OG tube can be used.
| Recommended Dosage | Number of 200 mg Tablets | Volume of Drinking Water |
|---|---|---|
| 400 mg | Two | 30 mL |
| 800 mg | Four | 60 mL |
| 1,200 mg | Six | 90 mL |
Drug interactions
Check maribavir against a medication listLabel text (10 paragraphs)
Refer to the full prescribing information for important drug interactions with LIVTENCITY. ( 5.1 , 5.3 , 7 ) Coadministration with strong CYP3A4 inducers is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). When coadministered with the moderate CYP3A4 inducers rifabutin (antimycobacterial) or phenobarbital (anticonvulsant), a dose adjustment is recommended. ( 2.2 , 2.3 , 7.3 )
7.1 Reduced Antiviral Activity When Coadministered with Ganciclovir or Valganciclovir LIVTENCITY is not recommended to be coadministered with valganciclovir/ganciclovir (vGCV/GCV). LIVTENCITY may antagonize the antiviral activity of ganciclovir and valganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir [see Warnings and Precautions (5.1) and Microbiology (12.4) ] .
7.2 Potential for Other Drugs to Affect LIVTENCITY Maribavir is a substrate of CYP3A4. Coadministration of LIVTENCITY with strong inducers of CYP3A4 is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). With the moderate CYP3A4 inducers, rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2 , 2.3) and Drug Interactions (7.3) ] . For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined.
7.3 Potential for LIVTENCITY to Affect Other Drugs Maribavir is an inhibitor of P-gp and breast cancer resistance protein (BCRP). Coadministration of LIVTENCITY with drugs that are substrates of P-gp and/or BCRP where minimal concentration changes may lead to serious adverse events may result in a clinically relevant increase in plasma concentrations of these substrates (see Table 4 ) .
Table 4 provides a list of established or potentially clinically significant drug interactions, based on either clinical drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or decrease in efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] . Table 4: Established and Other Potentially Significant Drug Interactions This table is not all inclusive. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comments ↓=decrease, ↑=increase.
Antiarrhythmics Digoxin The interaction between LIVTENCITY and the concomitant drug was evaluated in a clinical study [see Clinical Pharmacology (12.3) ] . ↑ Digoxin Use caution when LIVTENCITY and digoxin are coadministered. Monitor serum digoxin concentrations. The dose of digoxin may need to be reduced when coadministered with LIVTENCITY. Refer to the respective prescribing information. Anticonvulsants Carbamazepine ↓ Maribavir A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when coadministered with carbamazepine. Phenobarbital ↓ Maribavir A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when coadministration with phenobarbital.
Phenytoin ↓ Maribavir A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when coadministration with phenytoin. Antimycobacterials Rifabutin ↓ Maribavir A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when coadministered with rifabutin. Rifampin ↓ Maribavir Coadministration of LIVTENCITY and rifampin is not recommended due to potential for a decrease in efficacy of LIVTENCITY. Herbal Products St. John's wort ↓ Maribavir Coadministration of LIVTENCITY and St. John's wort is not recommended due to potential for a decrease in efficacy of LIVTENCITY.
HMG-CoA Reductase Inhibitors Rosuvastatin ↑ Rosuvastatin The patient should be closely monitored for rosuvastatin-related events, especially the occurrence of myopathy and rhabdomyolysis. Immunosuppressants Cyclosporine ↑ Cyclosporine Frequently monitor cyclosporine levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as needed. Everolimus ↑ Everolimus Frequently monitor everolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as needed.
Sirolimus ↑ Sirolimus Frequently monitor sirolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as needed. Tacrolimus ↑ Tacrolimus Frequently monitor tacrolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as needed.
7.4 Drugs without Clinically Significant Interactions with LIVTENCITY No clinically significant interactions were observed in clinical drug-drug interaction studies of LIVTENCITY and ketoconazole, antacid, caffeine, warfarin, voriconazole, dextromethorphan, or midazolam [see Clinical Pharmacology (12.3) ] .
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary No adequate human data are available to establish whether LIVTENCITY poses a risk to pregnancy outcomes. In animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (RHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data In a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. Females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (GD) 17, while males were dosed 29 days prior to mating and throughout mating. A decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the RHD). Intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day.
Maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the RHD. No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD. In the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to post-natal day (PND) 21.
A delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day. In addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. No effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the RHD). No effects on number of offspring, proportion of males, number of live pups, or survival to PND 4 were observed at any dose in the offspring born to the second generation.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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