Cytomegalovirus Infection Treatments
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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.
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Related Clinical Trials
Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Patients With Refractory Cytomegalovirus Infection Following Allo-HSCT: a Prospective, Multicenter, Randomized, Controlled Clinical Trial
Summary: To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet
Summary: The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment with maribavir. Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms, the recurrence rate of CMV infection after treatm...
Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis
Summary: The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis). In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not imp...
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Brand Information
Livtencity (MARIBAVIR)
1INDICATIONS AND USAGE
LIVTENCITY
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.
For more information, go to
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LIVTENCITY and
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
10PRINCIPAL DISPLAY PANEL - 200 mg Bottle Carton
NDC 64764-800-56
LIVTENCITY
Rx Only
For Oral Use
Takeda
