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LIVTENCITY is a brand name for Maribavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LIVTENCITY (maribavir) is indicated for: Treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies. 1.1 Pediatrics Pediatrics (< 18 years): No data are available to Health Canada; therefore, Health…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • No human data are available to establish whether LIVTENCITY poses a risk to pregnancy outcomes. LIVTENCITY is not recommended during pregnancy or for people who could become pregnant, who are not using reliable contraception.
• LIVTENCITY was not studied in patients with CMV Central Nervous System (CNS) infection. Based on non-clinical data CNS penetration of maribavir is expected to be low compared to plasma levels. , meningo-encephalitis). If CMV CNS infection is suspected, coverage with another CMV anti-viral agent is recommended.
2 Recommended Dose and Dosage Adjustment The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg. Drug-Drug Interactions Consider the potential for drug-drug interactions prior to and during LIVTENCITY therapy (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
Frequently monitor immunosuppressant drug levels (including tacrolimus, cyclosporine, sirolimus and everolimus) throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the immunosuppressant dose, as needed.
LIVTENCITY has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A4 and/or P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse events (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
If LIVTENCITY is co-administered with carbamazepine, increase the dose of LIVTENCITY to 800 mg twice daily (see 9 DRUG INTERACTIONS). If LIVTENCITY is co-administered with phenytoin or phenobarbital, increase the dose of LIVTENCITY to 1,200 mg twice daily (see 9 DRUG INTERACTIONS).
Special Populations Elderly Patients No dose adjustment is required for patients over 65 years of age. Impaired Renal Function No dose adjustment of LIVTENCITY is needed for patients with mild (creatinine clearance 50 to 80 mL/minute), moderate (creatinine clearance 30 to <50 mL/minute) or severe (creatinine clearance <30 mL/minute) renal impairment.
Administration of LIVTENCITY in patients with end stage renal disease (ESRD) or patients on dialysis has not been studied (see 10 CLINICAL PHARMACOLOGY). Impaired Hepatic Function No dose adjustment of LIVTENCITY is needed for patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
and 9 DRUG INTERACTIONS). Frequently monitor immunosuppressant drug levels (including tacrolimus, cyclosporine, sirolimus and everolimus) throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the immunosuppressant dose, as needed.
LIVTENCITY has the potential to increase the drug concentrations of immunosuppressant drugs that are CYP3A4 and/or P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse events (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
If LIVTENCITY is co-administered with carbamazepine, increase the dose of LIVTENCITY to 800 mg twice daily (see 9 DRUG INTERACTIONS). If LIVTENCITY is co-administered with phenytoin or phenobarbital, increase the dose of LIVTENCITY to 1,200 mg twice daily (see 9 DRUG INTERACTIONS).
Special Populations Elderly Patients No dose adjustment is required for patients over 65 years of age. Impaired Renal Function No dose adjustment of LIVTENCITY is needed for patients with mild (creatinine clearance 50 to 80 mL/minute), moderate (creatinine clearance 30 to <50 mL/minute) or severe (creatinine clearance <30 mL/minute) renal impairment.
Administration of LIVTENCITY in patients with end stage renal disease (ESRD) or patients on dialysis has not been studied (see 10 CLINICAL PHARMACOLOGY). Impaired Hepatic Function No dose adjustment of LIVTENCITY is needed for patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
Administration of LIVTENCITY in patients with severe hepatic impairment (Child Pugh Class C) has not been studied (see 10 CLINICAL PHARMACOLOGY). Pediatric population The safety and efficacy of LIVTENCITY in patients below 18 years of age have not been established.
Health Canada has not authorized an indication for pediatric use. 4 Administration LIVTENCITY is intended for oral use only and can be taken with or without food. The immediate-release tablets can be taken as a whole tablet. 5 Missed Dose Instruct patients that if they miss a dose of LIVTENCITY and the next dose is due within the next 3 hours, they should skip the missed dose and continue with the regular schedule.
• LIVTENCITY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Co-administration of LIVTENCITY with ganciclovir or valganciclovir is contraindicated. LIVTENCITY may antagonize the antiviral effect of ganciclovir and valganciclovir by inhibiting human CMV UL97 serine/threonine kinase, which is required for activation/phosphorylation of ganciclovir and valganciclovir (see 9 DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Administration of LIVTENCITY in patients with severe hepatic impairment (Child Pugh Class C) has not been studied (see 10 CLINICAL PHARMACOLOGY). Pediatric population The safety and efficacy of LIVTENCITY in patients below 18 years of age have not been established.
Health Canada has not authorized an indication for pediatric use. 4 Administration LIVTENCITY is intended for oral use only and can be taken with or without food. The immediate-release tablets can be taken as a whole tablet. 5 Missed Dose Instruct patients that if they miss a dose of LIVTENCITY and the next dose is due within the next 3 hours, they should skip the missed dose and continue with the regular schedule.
Patients are not to double their next dose or take more than the prescribed dose.
Patients are not to double their next dose or take more than the prescribed dose. 5 OVERDOSAGE In Study 303, an accidental overdose of a single extra dose occurred in 1 LIVTENCITY-treated patient on Day 13 (1,200 mg total daily dose).
No adverse reactions were reported. In Study 202, patients were treated with up to 1,200 mg twice daily. The safety profile of higher doses were comparable to 400 mg twice daily. However, the highest dose was associated with a greater incidence of immunosuppressant drug level increase.
There is no known specific antidote for LIVTENCITY. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted. Due to the high plasma protein binding of LIVTENCITY, dialysis is unlikely to reduce plasma concentrations of LIVTENCITY significantly.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging LIVTENCITY tablets are available as blue, oval shaped convex film-coated tablets containing 200 mg of maribavir and debossed with “SHP” on one side and “620” on the other side.
Maribavir 200 mg tablets are supplied in a high-density polyethylene (HDPE) white square bottle with an induction seal and a child resistant cap. 7 WARNINGS AND PRECAUTIONS General Virologic Failure During Treatment and Recurrence Post-Treatment Virologic failure due to resistance can occur during and after treatment with LIVTENCITY.
Virologic recurrence during the post-treatment period usually occurred within 4-8 weeks after treatment discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir (see 15 MICROBIOLOGY).
Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or has a recurrence. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Tablet 200 mg Tablet core: Magnesium stearate, Microcrystalline cellulose, Sodium starch glycolate Film coating: FD & C Blue #1/Brilliant Blue FCF aluminum lake, Macrogol/polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide LIVTENCITY (maribavir) Page 7 of 30 Unclassified / Non classifié Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY for further information.
Infection/Immune Patients with CMV Central Nervous System (CNS) Infection LIVTENCITY was not studied in patients with CMV CNS infection. Based on non-clinical data, CNS penetration of maribavir is expected to be low compared to plasma levels.
, meningo-encephalitis). If CMV CNS infection is suspected, coverage with another CMV anti-viral agent is recommended. Drug Interactions Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions The concomitant use of LIVTENCITY and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to: • Possible clinically significant adverse reactions from greater exposure of concomitant medicinal products.
• Significant decrease of LIVTENCITY plasma concentrations which may lead to reduced therapeutic effect of LIVTENCITY and possible development of viral resistance. For steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations, see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS, Table 5.
Use with Immunosuppressant Drugs LIVTENCITY has the potential to increase the drug concentrations […]