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Emtricitabine / Rilpivirine / Tenofovir Dosage

Applies to the following strength(s): 200 mg-25 mg-300 mg ; 200 mg-25 mg-25 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

At least 35 kg: 1 tablet orally once a day with a meal

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine/rilpivirine/tenofovir alafenamide and should be monitored during therapy.
-Replacement of current regimen with emtricitabine/rilpivirine/tenofovir disoproxil fumarate (DF) may be considered for virologically-suppressed patients if: patients have no history of virologic failure; patients have been stably suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months before switching therapy; patients are currently on their first or second antiretroviral regimen before switching therapy; patients have no history of resistance to any of the 3 components.
-After replacing therapy in virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability recommended to assess potential virologic failure or rebound.

Use: As a complete regimen for the treatment of HIV-1 infection:
-Emtricitabine/rilpivirine/tenofovir alafenamide: As initial therapy in patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL, or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components
-Emtricitabine/rilpivirine/tenofovir DF: In patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen

Usual Pediatric Dose for HIV Infection

12 years or older and at least 35 kg: 1 tablet orally once a day with a meal

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine/rilpivirine/tenofovir alafenamide and should be monitored during therapy.
-Replacement of current regimen with emtricitabine/rilpivirine/tenofovir DF may be considered for virologically-suppressed patients if: patients have no history of virologic failure; patients have been stably suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months before switching therapy; patients are currently on their first or second antiretroviral regimen before switching therapy; patients have no history of resistance to any of the 3 components.
-After replacing therapy in virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability recommended to assess potential virologic failure or rebound.

Use: As a complete regimen for the treatment of HIV-1 infection:
-Emtricitabine/rilpivirine/tenofovir alafenamide: As initial therapy in patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL, or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components
-Emtricitabine/rilpivirine/tenofovir DF: In patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen

Renal Dose Adjustments

Emtricitabine/rilpivirine/tenofovir alafenamide:
-Estimated CrCl less than 30 mL/min: Not recommended.

Emtricitabine/rilpivirine/tenofovir DF:
-Estimated CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Dose Adjustments

Emtricitabine/rilpivirine/tenofovir DF:
-If used with rifabutin: An additional 25 mg/day of rilpivirine is recommended.

Precautions

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: This drug is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Emtricitabine/rilpivirine/tenofovir alafenamide: Data not available
Emtricitabine/rilpivirine/tenofovir DF: Not recommended.

Other Comments

Administration advice:
-Take with food; a protein drink is not a replacement for food.
-Administer antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate) at least 2 hours before or at least 4 hours after this drug; administer H2-receptor antagonists at least 12 hours before or at least 4 hours after this drug.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store in original bottle; keep bottle tightly closed.

General:
-The following should be considered when starting emtricitabine/rilpivirine/tenofovir DF in patients with no antiretroviral treatment history:
---More rilpivirine-treated patients starting therapy with HIV-1 RNA greater than 100,000 copies/mL had virologic failure (HIV-1 RNA at least 50 copies/mL) compared to those with HIV-1 RNA up to 100,000 copies/mL.
---Regardless of HIV-1 RNA at start of therapy, more rilpivirine-treated patients with CD4+ cell count less than 200 cells/mm3 had virologic failure compared to those with CD4+ cell count at least 200 cells/mm3.
---The observed virologic failure rate in rilpivirine-treated patients conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to those who failed on efavirenz.
---More rilpivirine-treated patients developed tenofovir- and lamivudine/emtricitabine-associated resistance compared to efavirenz-treated patients.
-Efficacy of emtricitabine/rilpivirine/tenofovir DF was established in virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on stable ritonavir-boosted protease inhibitor-containing regimen.
-Each emtricitabine/rilpivirine/tenofovir alafenamide combination tablet contains emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg.
-Each emtricitabine/rilpivirine/tenofovir DF combination tablet contains emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg.

Monitoring:
-General: HIV-1 RNA; regimen tolerability
-Hepatic: Appropriate laboratory tests (before therapy) and for hepatotoxicity (during therapy) in patients with underlying hepatic disease or marked baseline elevations in liver-associated tests; liver-associated tests in patients without preexisting liver dysfunction or other risk factors; hepatic function of HIV-1/HBV coinfected patients with clinical and laboratory follow-up (for at least several months after stopping this drug)
-Infections/Infestations: For chronic HBV infection in all patients (before therapy)
-Metabolic: Serum phosphorus in patients at risk of renal dysfunction (before starting and periodically during therapy)
-Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: Estimated CrCl in all patients using emtricitabine/rilpivirine/tenofovir DF (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in all patients using emtricitabine/rilpivirine/tenofovir alafenamide or in patients at risk of renal dysfunction using emtricitabine/rilpivirine/tenofovir DF (before starting and periodically during therapy)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Stop this drug if symptoms suggesting lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual/unexpected stomach discomfort, and weakness) develop.
-Stop this drug at once and seek medical attention if rash with fever, blisters, mucosal involvement, eye inflammation (conjunctivitis), severe allergic reaction (swelling of the face, eyes, lips, mouth, tongue, or throat; difficulty swallowing or breathing), and/or any signs/symptoms of liver problems develop.
-If you also have HBV, do not stop this drug without consulting healthcare provider.

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