Brand Name
Livtencity
Generic Name
Maribavir
View Brand Information FDA approval date: November 23, 2021
Classification: Cytomegalovirus pUL97 Kinase Inhibitor
Form: Tablet
What is Livtencity (Maribavir)?
LIVTENCITY is indicated for the treatment of adults and pediatric patients with post-transplant cytomegalovirus infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir or foscarnet [see Use in Specific Populations.
Approved To Treat
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Related Clinical Trials
Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
Summary: This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation). The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatmen...
Prospective, Non-interventional Study to Describe The Use of Maribavir and Its Effectiveness in Patients With Post-transplant Cytomegalovirus Infection/Disease in Line With Belgian Reimbursement Conditions (The MARIBEL Study)
Summary: Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. Maribavir is a medicine approved for treating CMV infection in adults after transplant. The main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after t...
A Phase 3, Open-label, Single-arm, Repeated-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)
Summary: The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit the...
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Brand Information
Livtencity (MARIBAVIR)
1INDICATIONS AND USAGE
LIVTENCITY is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet
2DOSAGE FORMS AND STRENGTHS
Tablet: 200 mg, blue, oval shaped convex tablet debossed with "SHP" on one side and "620" on the other side.
3CONTRAINDICATIONS
None.
4OVERDOSAGE
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.
5DESCRIPTION
LIVTENCITY tablets contain maribavir, a benzimidazole riboside CMV pUL97 protein kinase inhibitor. The chemical name of maribavir is 5,6-Dichloro-
The molecular formula for maribavir is C
Each 200 mg tablet for oral administration contains 200 mg maribavir and the following inactive ingredients: FD&C Blue #1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, titanium dioxide, and talc.
6HOW SUPPLIED/STORAGE AND HANDLING
Tablet: 200 mg, blue, oval shaped convex tablet debossed with "SHP" on one side and "620" on the other side. They are supplied as follows:
Bottles of 28 tablets with child-resistant caps (NDC 64764-800-28)
Bottles of 56 tablets with child-resistant caps (NDC 64764-800-56)
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients that LIVTENCITY may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication
8Instructions for Use
LIVTENCITY (liv-TEN-city)
This Instructions for Use contains information on how to prepare and give a dose of LIVTENCITY tablets by breaking apart (dispersing) or crushing in drinking water and taking by mouth;
Important information you need to know before preparing a dose of LIVTENCITY:
- You can break apart (disperse) the tablets in drinking water
- Do not mix LIVTENCITY with any liquid other than drinking water.
- LIVTENCITY tablets that have been dispersed in drinking water can be given through a Nasogastric (NG) or Orogastric (OG) tube (French size 10 or larger).
- You can prepare the mixture ahead of time and store at room temperature 68°F to 77°F (20°C to 25°C) for up to 8 hours.
Preparing a dose of LIVTENCITY by dispersing or crushing tablets and taking by mouth:
Gather the following supplies:
- small, clean container to place tablets and water in
- drinking water
Step 1: Choose a clean, flat work surface. Place all supplies on the work surface.
Step 2: Wash and dry your hands well.
Step 3: Get the prescribed number of LIVTENCITY tablets needed to prepare the dose.
Step 4: Place the LIVTENCITY tablets into the container.
Note: If you prefer, you can crush the tablets with a spoon before adding water.
Step 5: Add the amount of drinking water needed for your prescribed dose.
Step 6: Swirl the container gently to disperse the tablets in the water and swallow the mixture right away. The mixture will have a bitter taste.
Step 7: Rinse the container with 15 mL of drinking water and swallow the mixture.
Repeat Step 7. Check that no pieces of tablet are left in the container. Repeat Step 7 until no pieces remain.
Preparing and giving a dose of LIVTENCITY through a Nasogastric (NG) or Orogastric (OG) Tube:
Gather the following supplies:
- 50 mL or 60 mL syringe
- drinking water
Step 1: Remove the cap (if capped) and plunger out of a 50 mL or 60 mL syringe. Add 2 tablets into the syringe body and place the plunger back in the syringe.
Note: Only 2 tablets can be given through the NG or OG tube at a time.
Step 2: Withdraw 30 mL of drinking water into the syringe.
Step 3: Hold the syringe with the tip pointing upward. Pull the plunger back so there is some air space in the syringe. If there is a cap, place the cap back on the syringe. Shake the syringe well for about 30 to 45 seconds or until the tablets are completely dispersed. Be careful not to spill the contents of the syringe.
Step 4: Remove the cap (if capped) from the syringe again and attach the syringe to the NG or OG tube and give the mixture right away.
Step 5: Withdraw 15 mL of drinking water into the same syringe and flush through the NG or OG tube.
Repeat Step 5. Check that no pieces of tablet are left in the syringe. Repeat Step 5 until no pieces remain.
Note: If your prescribed dose is more than 2 tablets, Repeat Steps 1 through 5 until you give the full prescribed dose.
Storing LIVTENCITY:
- Store LIVTENCITY at room temperature 68°F to 77°F (20°C to 25°C).
Keep LIVTENCITY and all medicines out of the reach of children.
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LIVTENCITY
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
9PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton
NDC 64764-800-28
LIVTENCITY
Rx Only
For Oral Use
Takeda
