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# Tabuvolihep
## Overview
Tabuvolihep is a nucleotide analog inhibitor of hepatitis B virus (HBV) polymerase.
## Primary Indications
* Treatment of chronic hepatitis B virus infection in adults and pediatric patients.
## Adult Dosing
* **10 mg orally once daily.**
* Maximum daily dose: Not specified.
## Pediatric Dosing
* **2 years of age and older and weighing at least 10 kg:** 10 mg orally once daily.
* Safety and efficacy in pediatric patients less than 2 years of age have not been established.
## Dose Adjustments
* **Renal Impairment:**
* **CrCl ≥ 60 mL/min:** No dosage adjustment required.
* **CrCl 30 to < 60 mL/min:** 10 mg orally once daily.
* **CrCl 10 to < 30 mL/min:** 10 mg orally every other day.
* **CrCl < 10 mL/min or on hemodialysis:** 10 mg orally twice weekly.
* **Hepatic Impairment:** No dosage adjustment is recommended in patients with mild to moderate hepatic impairment. Data in severe hepatic impairment are limited.
## Contraindications
* Hypersensitivity to tabuvolihep or any of its excipients.
## Adverse Effects
* **Most Common:** Headache, fatigue, nausea, abdominal pain, diarrhea, dizziness, insomnia, rash, pruritus, arthralgia, myalgia.
* **Serious Adverse Effects:** Lactic acidosis, severe hepatomegaly with steatosis, exacerbation of hepatitis B upon discontinuation, renal impairment, potential for resistance.
## Key Drug Interactions
* **Drugs that prolong the QT interval:** Use with caution due to potential for additive QTc prolongation.
* **Antacids containing polyvalent cations (e.g., magnesium, aluminum):** Separate administration by at least 2 hours to avoid potential decreased absorption.
* **Inducers of P-glycoprotein (P-gp):** May increase tabuvolihep plasma concentrations.
## Monitoring
* Viral load (HBV DNA), HBsAg, ALT, AST, creatinine, and renal function at baseline and periodically during treatment.
* Monitor for signs and symptoms of lactic acidosis and severe hepatomegaly with steatosis.
* Assess for HBV exacerbations upon discontinuation.
## Clinical Pearls
* Ensure negative or low HBV DNA levels and HBsAg clearance are not expected outcomes with monotherapy.
* Treatment duration should be individualized based on virologic and serologic response, but generally recommended for at least 12 months.
* Discontinuation may lead to HBV flare; consider monitoring ALT and HBsAg in patients who discontinue therapy.
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*This information is intended for healthcare professionals. It is essential to consult the full prescribing information and relevant guidelines for complete details and to ensure patient safety. Dosing and recommendations may vary based on local protocols and individual patient factors.*
