Medical Editor: John P. Cunha, DO, FACOEP
What Is Livtencity?
Livtencity (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.
What Are Side Effects of Livtencity?
Livtencity may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat, and
- severe dizziness
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Livtencity include:
- taste disturbance,
- nausea,
- diarrhea,
- vomiting, and
- fatigue.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Livtencity
The recommended dosage of Livtencity in adults and pediatric patients (12 years of age and older and weighing at least 35 kg) is 400 mg (two 200 mg tablets) taken orally twice daily with or without food.
Livtencity In Children
The recommended dosing regimen of Livtencity in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults.
The safety and effectiveness of Livtencity have not been established in children younger than 12 years of age.
What Drugs, Substances, or Supplements Interact with Livtencity?
Livtencity may interact with other medicines such as:
- valganciclovir/ganciclovir,
- strong CYP3A4 inducers,
- drugs that are sensitive substrates of CYP3A, P-gp, and BCRP,
- digoxin,
- certain anticonvulsants,
- rifabutin and rifampin,
- St. John’s wort,
- rosuvastatin, and
- immunosuppressants.
Livtencity During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Livtencity; it is unknown how it might affect a fetus. It is unknown if Livtencity passes into breast milk. Consult your doctor before breastfeeding.Additional Information
Our Livtencity (maribavir) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Bowel regularity means a bowel movement every day. See AnswerSIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of LIVTENCITY was evaluated in one Phase 3 multi-center, randomized, open-label, active-control trial in which 352 adult transplant recipients were randomized, and treated with LIVTENCITY (N=234) or Investigator-Assigned Treatment (IAT) consisting of monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator (N=116) for up to 8-weeks following a diagnosis of CMV infection/disease refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir. The mean treatment durations (SD) for LIVTENCITY and IAT were 48.6 (± 13.82) and 31.2 (± 16.91) days, respectively. The most common adverse events occurring in more than 10% of subjects receiving LIVTENCITY are outlined in Table 2.
Table 2: Adverse Events (All Grades) Reported in >10% of Subjects in the LIVTENCITY Group in Trial 303
| ADVERSE EVENT | LIVTENCITY N = 234 (%) |
IATa N=116 (%) |
| Taste disturbanceb | 46 | 4 |
| Nausea | 21 | 22 |
| Diarrhea | 19 | 21 |
| Vomiting | 14 | 16 |
| Fatigue | 12 | 9 |
| a IAT (Investigator-Assigned Treatment) included monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator b taste disturbance includes the following reported preferred terms: ageusia, dysgeusia, hypogeusia and taste disorder |
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Similar proportions of subjects experienced serious adverse events (38% in the LIVTENCITY group and 37% in the IAT group). The most common serious adverse event in both treatment groups occurred in the Infections and Infestations System Organ Class (SOC) (23% in the LIVTENCITY group and 15% in the IAT group) with CMV infection and disease being the most common in both groups.
A higher proportion of subjects in the IAT group discontinued study medication due to an adverse event compared to the LIVTENCITY group (32% in the IAT group versus 13% in the LIVTENCITY group). The most commonly reported causes that led to study drug discontinuation were neutropenia (9%) and acute kidney injury (5%) in the IAT group and dysgeusia, diarrhea, nausea, and recurrence of underlying disease (each reported at 1%) in the LIVTENCITY group.
Taste disturbance occurred in 46% of subjects treated with LIVTENCITY. These events rarely led to discontinuation of LIVTENCITY (1%) and, for 37% of the subjects, these events resolved while on therapy (median duration 43 days; range 7 to 59 days). For the subjects with ongoing taste disturbance after drug discontinuation, resolution occurred in 89%. In subjects with resolution of symptoms after drug discontinuation, the median duration of symptoms off treatment was 6 days (range 2 to 85 days).
Laboratory Abnormalities
Selected laboratory abnormalities reported in subjects with refractory (with or without genotypic resistance) CMV infections in Trial 303 are presented in Table 3.
Table 3: Selected Laboratory Abnormalities Reported in Trial 303
| Laboratory Parameter | LIVTENCITY N=234 n (%) |
IAT N=116 n (%) |
| Neutrophils (cells /μL) | ||
| <500 | 4 (2) | 4 (3) |
| ≥500 to <750 | 7 (3) | 7 (6) |
| ≥750 to <1,000 | 10 (4) | 6 (5) |
| Hemoglobin (g/dL) | ||
| <6.5 | 3 (1) | 1 (1) |
| ≥6.5 to <8.0 | 34 (15) | 23 (20) |
| ≥8.0 to <9.5 | 76 (32) | 33 (28) |
| Platelets (cells /μL) | ||
| <25,000 | 11 (5) | 6 (5) |
| ≥25,000 to <50,000 | 27 (12) | 10 (9) |
| ≥50,000 to <100,000 | 41 (18) | 20 (17) |
| Creatinine (mg/dL) | ||
| >2.5 | 16 (7) | 12 (10) |
| >1.5 to ≤2.5 | 78 (33) | 29 (25) |
DRUG INTERACTIONS
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 and Microbiology].
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 for selected anticonvulsants [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS].
Potential For LIVTENCITY To Affect Other Drugs
Maribavir is a weak inhibitor of CYP3A4, and an inhibitor of P-gp and breast cancer resistance protein (BCRP). Co-administration of LIVTENCITY with drugs that are sensitive substrates of CYP3A, P-gp and BCRP 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 and CLINICAL PHARMACOLOGY].
Table 4: Established and Other Potentially Significant Drug Interactionsa
| Concomitant Drug Class: Drug Name | Effect on Concentration | Clinical Comments |
| Antiarrhythmics | ||
| Digoxinb | ↑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 LIVTENCITYc. |
| Anticonvulsants | ||
| Carbamazepine | ↓Maribavir | A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when co-administered with carbamazepine. |
| Phenobarbital | ↓ Maribavir | A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when co-administration with phenobarbital. |
| Phenytoin | ↓Maribavir | A dose adjustment of LIVTENCITY to 1,200 mg twice daily is recommended when co-administration with phenytoin. |
| Antimycobacterials | ||
| Rifabutin | ↓Maribavir | Co-administration of LIVTENCITY and rifabutin is not recommended due to potential for a decrease in efficacy of LIVTENCITY. |
| Rifampinb | ↓ Maribavir | Co-administration of LIVTENCITY and rifampin is not recommended due to potential for a decrease in efficacy of LIVTENCITY. |
| Herbal Products | ||
| St. John’s wort | ↓Maribavir | Co-administration of LIVTENCITY and St. John’s wort is not recommended due to potential for a decrease in efficacy of LIVTENCITY. |
| HMG-CoA Reductase Inhibitors | ||
| Rosuvastatinc | ↑Rosuvastatin | The patient should be closely monitored for rosuvastatin-related events, especially the occurrence of myopathy and rhabdomyolysisc |
| Immunosuppressants | ||
| Cyclosporine | ↑ Cyclosporine | Frequently monitor cyclosporine levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as neededc. |
| Everolimus | ↑Everolimus | Frequently monitor everolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as neededc. |
| Sirolimus | ↑Sirolimus | Frequently monitor sirolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as neededc. |
| Tacrolimusb | ↑Tacrolimus | Frequently monitor tacrolimus levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust dose, as neededc. |
| ↓=decrease, ↑ = increase a This table is not all inclusive. b The interaction between LIVTENCITY and the concomitant drug was evaluated in a clinical study [see CLINICAL PHARMACOLOGY]. c Refer to the respective prescribing information. |
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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, S-warfarin, voriconazole, dextromethorphan, or midazolam [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Livtencity (Maribavir Tablets)
SLIDESHOW
Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow© Livtencity Patient Information is supplied by Cerner Multum, Inc. and Livtencity Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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