Tenofovir disoproxil fumarate + Emtricitabine

By

Generic Name: Tenofovir disoproxil fumarate + Emtricitabine Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Tenofovir disoproxil fumarate + Emtricitabine used for?

Tenofovir disoproxil fumarate + Emtricitabine is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs.

This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used.

This product is also approved in the US to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol.

How should I take Tenofovir disoproxil fumarate + Emtricitabine?

Take this medication by mouth as directed by your doctor, usually once daily with or without food. The dosage is based on your kidney function, medical condition, and response to treatment. For children, the dosage is also based on weight.

When used to treat HIV infection, this product is taken with other medicines that treat HIV. If you are also taking didanosine enteric-coated tablets, take both products either on an empty stomach or with a light meal. If you are taking the didanosine buffered tablets, take both drug products on an empty stomach.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

How do I store Tenofovir disoproxil fumarate + Emtricitabine?

Tenofovir disoproxil fumarate + Emtricitabine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Tenofovir disoproxil fumarate + Emtricitabine in the bathroom or the freezer. There may be different brands of Tenofovir disoproxil fumarate + Emtricitabine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Tenofovir disoproxil fumarate + Emtricitabine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Tenofovir disoproxil fumarate + Emtricitabine?

Before taking emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to either of the medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), kidney disease.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and emtricitabine/tenofovir may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Also, if you have HIV infection, do not breast-feed because breast milk can transmit HIV.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Tenofovir disoproxil fumarate + Emtricitabine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Tenofovir disoproxil fumarate + Emtricitabine. Tenofovir disoproxil fumarate + Emtricitabine is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Tenofovir disoproxil fumarate + Emtricitabine?

Diarrhea, headache, dizziness, trouble sleeping, back pain, or change in the color of skin on your palms or soles of your feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), signs of kidney problems (such as change in the amount of urine, pink/bloody urine).

Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness).

Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Tenofovir disoproxil fumarate + Emtricitabine?

Some products that may interact with this drug include: adefovir, orlistat, other drugs that may harm the kidneys (including aminoglycosides such as amikacin/gentamicin).

Tenofovir can decrease the effectiveness of another medication, atazanavir (by decreasing blood levels). If you are taking atazanavir with this product, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details.

Check the labels on all your medicines for HIV infection because they may contain the same or similar ingredients as those in this product (such as tenofovir, emtricitabine, lamivudine). Do not take medications that contain the same or similar ingredients as this product.

Tenofovir disoproxil fumarate + Emtricitabine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Tenofovir disoproxil fumarate + Emtricitabine?

Tenofovir disoproxil fumarate + Emtricitabine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Tenofovir disoproxil fumarate + Emtricitabine?

Tenofovir disoproxil fumarate + Emtricitabine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Tenofovir disoproxil fumarate + Emtricitabine.

What is the dose of Tenofovir disoproxil fumarate + Emtricitabine for an adult?

Usual Adult Dose for HIV Infection

Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day

Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

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-tenofovir alafenamide and should be monitored during therapy.

-Emtricitabine-tenofovir alafenamide is recommended for patients at least 35 kg.

-Emtricitabine-tenofovir DF is not recommended as a component of a triple nucleoside regimen; it should not be used with other emtricitabine-containing, tenofovir-containing, or lamivudine-containing products.

-Use of emtricitabine-tenofovir DF in therapy-experienced patients should be guided by laboratory testing and treatment history.

Use: In combination with other antiretroviral agents, for treatment of HIV-1 infection

Usual Adult Dose for Pre-Exposure Prophylaxis

Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:

-This drug should be used only as part of a comprehensive prevention plan that includes other prevention measures (e.g., safer sex practices); this drug is not always effective in preventing acquisition of HIV-1.

-Uninfected individuals should be advised to strictly adhere to the dosing regimen; efficacy of this drug in reducing risk of acquiring HIV-1 strongly correlated with adherence.

-The manufacturer product information (and current guidelines) should be consulted for further guidance.

Use: In combination with safer sex practices, for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 in uninfected individuals at high risk

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Duration of therapy: 28 days, if tolerated

Comments:

-This drug plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug is also recommended as a component in various alternative regimens.

-Prophylaxis should be started as soon as possible, preferably within hours after exposure.

-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.

-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Duration of therapy: 28 days

Comments:

-This drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adults (including pregnant women) with CrCl at least 60 mL/min; this drug plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this drug is recommended as a component in various regimens.

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-Current guidelines should be consulted for additional information.

Liver Dose Adjustments

Emtricitabine-tenofovir alafenamide:

-Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.

Dialysis

Emtricitabine-tenofovir DF: Not recommended.

What is the dose of Tenofovir disoproxil fumarate + Emtricitabine for a child?

Usual Pediatric Dose for HIV Infection

Emtricitabine-tenofovir alafenamide:

12 years or older and at least 35 kg: Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day

Emtricitabine-tenofovir DF:

17 to less than 22 kg: Emtricitabine 100 mg-tenofovir DF 150 mg (1 tablet) orally once a day

22 to less than 28 kg: Emtricitabine 133 mg-tenofovir DF 200 mg (1 tablet) orally once a day

28 to less than 35 kg: Emtricitabine 167 mg-tenofovir DF 250 mg (1 tablet) orally once a day

At least 35 kg: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

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-tenofovir alafenamide and should be monitored during therapy.

-Emtricitabine-tenofovir DF is recommended for pediatric patients who can swallow a whole tablet.

-Emtricitabine-tenofovir DF is not recommended as a component of a triple nucleoside regimen; it should not be used with other emtricitabine-containing, tenofovir-containing, or lamivudine-containing products.

-Use of emtricitabine-tenofovir DF in therapy-experienced patients should be guided by laboratory testing and treatment history.

Use: In combination with other antiretroviral agents, for treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure

US CDC recommendations for adolescents 13 years or older: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Duration of therapy: 28 days

Comments:

-This drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents with CrCl at least 60 mL/min; this drug plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this drug is recommended as a component in various regimens.

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Emtricitabine-tenofovir alafenamide:

-Severe renal dysfunction (estimated CrCl less than 30 mL/min): Not recommended.

Emtricitabine-tenofovir DF:

Treatment of HIV-1 Infection:

Adults:

-Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended.

-Moderate renal dysfunction (CrCl 30 to 49 mL/min): Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally every 48 hours

-Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Preexposure Prophylaxis:

-Estimated CrCl less than 60 mL/min: Not recommended.

Comments (emtricitabine-tenofovir DF):

-Routine monitoring of estimated CrCl, serum phosphorus, urine glucose, and urine protein recommended for all patients (with or without HIV-1 infection) with mild renal dysfunction.

-Safety and efficacy of the dosing interval adjustment have not been clinically evaluated in patients with moderate renal dysfunction; clinical response to therapy and renal function should be closely monitored in these patients.

-If estimated CrCl decreases during preexposure prophylaxis, potential causes should be evaluated and potential risks and benefits of continued use should be reassessed.

How is Tenofovir disoproxil fumarate + Emtricitabine available?

Tenofovir disoproxil fumarate + Emtricitabine is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral kit.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Tenofovir disoproxil fumarate + Emtricitabine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 9, 2018 | Last Modified: August 9, 2018

You might also like