Complete SPL Sections#
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
BOXED WARNING SECTION
Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue ODEFSEY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL or to replace a stable antiretroviral regimen in those 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 of ODEFSEY [see Microbiology (12.4) and Clinical Studies (14) ].
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Each ODEFSEY tablet contains 200 mg of emtricitabine (FTC), 25 mg of rilpivirine (RPV) (equivalent to 27.5 mg of rilpivirine hydrochloride), and 25 mg of tenofovir alafenamide (TAF) (equivalent to 28 mg of tenofovir alafenamide fumarate). The tablets are gray, capsule-shaped, film-coated and debossed with "GSI" on one side and "255" on the other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
ODEFSEY is contraindicated when coadministered with the following drugs; coadministration may result in loss of virologic response and possible resistance to ODEFSEY or to the class of NNRTIs [see Warnings and Precautions (5.6) , 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
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B [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) ] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.7) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.8) ]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Limited data are available on overdose of the components of ODEFSEY in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with ODEFSEY consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
11 DESCRIPTION
DESCRIPTION SECTION
ODEFSEY (emtricitabine, rilpivirine, and tenofovir alafenamide) is a fixed-dose combination tablet containing emtricitabine (FTC), rilpivirine (RPV), and tenofovir alafenamide (TAF) for oral administration. FTC, a synthetic nucleoside analog of cytidine, is an HIV-1 nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI). RPV is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). TAF, an HIV-1 NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Each tablet contains 200 mg of FTC, 25 mg of RPV (equivalent to 27.5 of rilpivirine hydrochloride) and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, and povidone. The tablets are film-coated with a coating material containing iron oxide black, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
ODEFSEY tablets are gray, capsule-shaped, and film coated with "GSI" debossed on one side and "255" on the other side. Each bottle contains 30 tablets (NDC 61958-2101-1), a silica gel desiccant, and a polyester coil, and is closed with a child-resistant closure.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
ODEFSEY is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
SPL PATIENT PACKAGE INSERT SECTION
SPL PATIENT PACKAGE INSERT SECTION
Patient Information ODEFSEY ® (oh-DEF-see) (emtricitabine, rilpivirine and tenofovir alafenamide) tablets This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 02/2025 Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with ODEFSEY. For more information, see " What should I tell my healthcare provider before taking ODEFSEY? " What is the most important information I should know about ODEFSEY? ODEFSEY can cause serious side effects, including: Worsening of hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV before or when you start treatment with ODEFSEY. If you have HBV and take ODEFSEY, your HBV may get worse (flare-up) if you stop taking ODEFSEY. A "flare-up" is when your HBV suddenly returns in a worse way than before. Do not run out of ODEFSEY. Refill your prescription or talk to your healthcare provider before your ODEFSEY is all gone. Do not stop taking ODEFSEY without first talking to your healthcare provider. If you stop taking ODEFSEY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking ODEFSEY. For more information about side effects, see " What are the possible side effects of ODEFSEY? " What is ODEFSEY? ODEFSEY is a prescription medicine that is used to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children who weigh at least 55 pounds (25 kg): who have not received HIV-1 medicines in the past and who have an amount of HIV-1 in their blood (this is called "viral load") that is no more than 100,000 copies/mL, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). ODEFSEY contains the prescription medicines emtricitabine, rilpivirine and tenofovir alafenamide. It is not known if ODEFSEY is safe and effective in children who weigh less than 55 pounds (25 kg). Who should not take ODEFSEY? Do not take ODEFSEY if you also take a medicine that contains: carbamazepine dexamethasone dexlansoprazole esomeprazole lansoprazole omeprazole oxcarbazepine pantoprazole sodium phenobarbital phenytoin rabeprazole rifampin rifapentine St. John's wort ( Hypericum perforatum ) or a product that contains St. John's wort What should I tell my healthcare provider before taking ODEFSEY? Before taking ODEFSEY, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, including HBV or hepatitis C virus have kidney problems have a history of depression or suicidal thoughts are pregnant or plan to become pregnant. It is not known if ODEFSEY can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with ODEFSEY. Pregnancy Registry: There is a pregnancy registry for those who take ODEFSEY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. Two of the medicines in ODEFSEY can pass to your baby in your breast milk. It is not known if the other medicine in ODEFSEY can pass into your breast milk. Talk to your healthcare provider about the following risks of breastfeeding during treatment with ODEFSEY: The HIV-1 virus may pass to your baby if your baby does not have HIV-1. The HIV-1 virus may become harder to treat if your baby has HIV-1. Your baby may get side effects from ODEFSEY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with ODEFSEY. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with ODEFSEY. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ODEFSEY with other medicines. How should I take ODEFSEY? Take ODEFSEY exactly as your healthcare provider tells you to take it. ODEFSEY is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection. Take ODEFSEY 1 time each day with a meal. If you are on dialysis, take your daily dose of ODEFSEY following dialysis. Do not change your dose or stop taking ODEFSEY without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with ODEFSEY. Do not miss a dose of ODEFSEY. When your ODEFSEY supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ODEFSEY and become harder to treat. If you take too much ODEFSEY, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of ODEFSEY? ODEFSEY may cause serious side effects, including: See " What is the most important information I should know about ODEFSEY? " Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital. If you get a rash with any of the following symptoms, stop taking ODEFSEY and call your healthcare provider or get medical help right away: fever skin blisters mouth sores redness or swelling of the eyes (conjunctivitis) swelling of the face, lips, mouth, or throat trouble breathing or swallowing pain on the right side of the stomach (abdominal) area dark "tea colored" urine Change in liver enzymes. People with a history of hepatitis B or C virus or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with ODEFSEY. Liver problems can also happen during treatment with ODEFSEY in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with ODEFSEY. Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feel sad or hopeless feel anxious or restless have thoughts of hurting yourself (suicide) or have tried to hurt yourself New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with ODEFSEY. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems. Too much lactic acid in your blood (lactic acidosis) . Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems . In rare cases, severe liver problems can happen that can lead to death . Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight ...
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 61958- 2101 -1 30 tablets Odefsey ® (emtricitabine, rilpivirine, and tenofovir alafenamide) Tablets 200 mg/25 mg/25 mg Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Odefsey ®
