emtricitabine, rilpivirine and tenofovir disoproxil fumarate 200 mg/1
emtricitabine, rilpivirine and tenofovir disoproxil fumarate · TABLET, FILM COATED · Laurus Labs Limited
emtricitabine, rilpivirine and tenofovir disoproxil fumarate is a tablet, film coated containing emtricitabine, rilpivirine and tenofovir disoproxil fumarate at 200 mg/1, taken oral. Manufactured by Laurus Labs Limited.
Key Facts
- Brand Name
- emtricitabine, rilpivirine and tenofovir disoproxil fumarate
- Generic Name
- emtricitabine, rilpivirine and tenofovir disoproxil fumarate
- NDC Code (Product)
42385-801- Manufacturer
- Laurus Labs Limited
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220232
- Drug Class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Marketing Start
- 03/05/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: • as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or • to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets [see Microbiology (12.4) and Clinical Studies (14) ]. Limitations of Use: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14) ]. Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, a combination of two nucleoside…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Testing: Prior to or when initiating emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, test for hepatitis B virus infection. Prior to initiation and during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. ( 2.1 ) • Recommended dosage in adults and pediatric patients weighing at least 35 kg: One tablet taken orally once daily with food. ( 2.2 ) • For pregnant patients who are already on emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy; therefore, viral load should be monitored closely. ( 2.3 ) • Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. ( 2.4 ) • Recommended dosage with rifabutin coadministration: an add…
Contraindications
4 CONTRAINDICATIONS Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are contraindicated when coadministered with the following drugs; coadministration may result in loss of virologic response and possible resistance to emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets or to the class of NNRTIs [see Warnings and Precautions (5.7) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ]: • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin • Antimycobacterials: rifampin, rifapentine • Glucocorticoid (systemic): dexamethasone (more than a single-dose) • Herbal Products: St John’s wort (Hypericum perforatum) • Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are contraindicated when coadministered with drugs which may result in loss of virologic response and possible resistance to emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. ( 7.1 ) • Consult the Full Prescribing Information prior to and during treatment for important drug interactions. ( 4 , 5.7 , 7 ) 7.1 Not Recommended with Other Antiretroviral Medications Because emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Comprehensive information regarding potential drug-drug interactions with other antiretroviral medications is not provided. This section describes clinically relevant drug interactions with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Drug interaction studies were conducted with the components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets (FTC, RPV, and TDF as single agents) or with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets as a combination produ…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ]. • Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ]. • Hepatotoxicity [see Warnings and Precautions (5.3) ]. • Depressive Disorders [see Warnings and Precautions (5.4) ]. • New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.5) ]. • Bone Loss and Mineralization Defects [see Warnings and Precautions (5.6) ]. • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.8) ]. • Immune Reconstitution Syndrome [see Warnings and Precautions (5.9) ]. • Most common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2 to 4) are depressive disorders, insomnia, and headache. ( 6.1 ) • Most common adverse reactions to emtricitabine and tenofovir disoproxil fumarate (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Laurus Generics …
Frequently Asked Questions
What is emtricitabine, rilpivirine and tenofovir disoproxil fumarate used for?
emtricitabine, rilpivirine and tenofovir disoproxil fumarate contains emtricitabine, rilpivirine and tenofovir disoproxil fumarate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is emtricitabine, rilpivirine and tenofovir disoproxil fumarate a controlled substance?
emtricitabine, rilpivirine and tenofovir disoproxil fumarate is not classified as a controlled substance by the DEA.
What is the generic name for emtricitabine, rilpivirine and tenofovir disoproxil fumarate?
The generic name for emtricitabine, rilpivirine and tenofovir disoproxil fumarate is emtricitabine, rilpivirine and tenofovir disoproxil fumarate. There are no other listed brand versions of emtricitabine, rilpivirine and tenofovir disoproxil fumarate.
What is the NDC code for emtricitabine, rilpivirine and tenofovir disoproxil fumarate 200 mg/1?
The NDC (National Drug Code) for emtricitabine, rilpivirine and tenofovir disoproxil fumarate 200 mg/1 is 42385-801, listed by Laurus Labs Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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