Emtricitabine and tenofovir alafenamide

Emtricitabine and tenofovir alafenamide is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. It comes as a single tablet containing 2 drugs, emtricitabine and tenofovir alafenamide.

Emtricitabine belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs) and tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI). These drugs work by preventing the virus from replicating.

This medication comes in tablet form and is taken once daily, with or without food.

A common side effect is nausea. 

Emtricitabine and tenofovir alafenamide is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients 12 years and older. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

In the U.S.

• Descovy

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach discomfort
• bloody urine
• bone pain
• dark urine
• decreased appetite
• decreased frequency or amount of urine
• diarrhea
• fast, shallow breathing
• general feeling of discomfort
• increased thirst
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle pain or cramping
• nausea and vomiting
• shortness of breath
• sleepiness
• swelling of the face, fingers, or lower legs
• troubled breathing
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• weight gain
• yellow eyes and skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat HIV infection.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Bone problems like bone pain, soft bones, and thin bones have happened with emtricitabine and tenofovir alafenamide. This may lead to broken bones. You may need to have a test to check your bones. Talk with your doctor.
• Take calcium and vitamin D as you were told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• This medicine may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use emtricitabine and tenofovir alafenamide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of emtricitabine and tenofovir alafenamide during treatment.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

Mild-to-moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Store below 30°C (86°F). Dispense in original container.

Concerns related to adverse effects:

• Decreased bone mineral density: In clinical trials, tenofovir has been associated with decreases in bone mineral density in HIV-1 infected adults and increases in bone metabolism markers. Consider monitoring of bone density in adult and pediatric patients with a history of pathologic fractures or with other risk factors for bone loss or osteoporosis. Calcium and vitamin D supplementation may be beneficial for all patients. Long-term significance of these changes is unknown. If abnormalities are suspected, expert assessment is recommended.

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, sometimes fatal, have been reported with use of nucleoside analogues, alone or in combination with other antiretrovirals. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (marked transaminase elevation may/may not accompany hepatomegaly and steatosis).

• Osteomalacia and renal dysfunction: In patients taking tenofovir disoproxil fumarate, cases of osteomalacia associated with proximal renal tubulopathy with bone pain or extremity pain (which may contribute to fractures) have been reported; hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy have also occurred in patients at risk for renal dysfunction who present with persistent or worsening bone or muscle symptoms. The risk of osteomalacia in patients taking tenofovir alafenamide is not known. In patients at risk for renal dysfunction, persistent or worsening bone or muscle symptoms should be evaluated for renal dysfunction, hypophosphatemia, and osteomalacia

• Renal toxicity: Cases of acute renal failure and/or Fanconi syndrome have been reported with use of tenofovir prodrugs; patients with preexisting renal impairment and those taking nephrotoxic agents (including NSAIDs) are at increased risk. Assess estimated creatinine clearance, urine protein, and urine glucose prior to initiation of therapy and during therapy. Monitor serum phosphorus in patients with chronic kidney disease (increased risk of developing Fanconi syndrome). Discontinue therapy in patients that develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Disease-related concerns:

• Chronic hepatitis B: [US Boxed Warning]: Safety and efficacy during coinfection of HIV-1 and HBV have not been established; acute, severe exacerbations of HBV have been reported following discontinuation of antiretroviral therapy. Not indicated for treatment of chronic hepatitis B. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue this therapy. If appropriate, antihepatitis B therapy may be warranted, especially in patients with advanced hepatic disease or cirrhosis (post-treatment HBV exacerbations may lead to hepatic decompensation and liver failure). All patients with HIV should be tested for HBV prior to initiation of treatment.

• Renal impairment: Use is not recommended in patients with CrCl <30 mL/minute.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.