May 25, 2017
Recommended Topic Related To:

Truvada

"The National Institutes of Health has launched a clinical trial to assess the effects of aspirin and cholesterol-lowering drugs, or statins, on preventing cardiovascular disease in people with long-term HIV infections. This group, which includ"...

A A A

Truvada

TRUVADA®
(emtricitabine/tenofovir disoproxil fumarate) Tablets




WARNING

POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see WARNINGS AND PRECAUTIONS].

TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

TRUVADA tablets are fixed-dose combination tablets containing emtricitabine and tenofovir DF. Emtricitabine is a synthetic nucleoside analog of cytidine. Tenofovir DF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both emtricitabine and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase.

Emtricitabine

The chemical name of emtricitabine is 5-fluoro-1-(2R,5S)-[2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.

It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula:

Emtricitabine - Strucutural Formula Illustration

Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 °C. The partition coefficient (log p) for emtricitabine is −0.43 and the pKa is 2.65.

Tenofovir DF

Tenofovir DF is a fumaric acid salt of the bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P • C4H4O4 and a molecular weight of 635.52. It has the following structural formula:

Tenofovir DF -  Strucutural Formula Illustration

Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of tenofovir DF except where otherwise noted.

TRUVADA tablets are for oral administration, and are available in the following strengths:

  • Film-coated tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients
  • Film-coated tablet containing 167 mg of emtricitabine and 250 mg of tenofovir DF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients
  • Film-coated tablet containing 133 mg of emtricitabine and 200 mg of tenofovir DF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients
  • Film-coated tablet containing 100 mg of emtricitabine and 150 mg of tenofovir DF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients

All strengths of TRUVADA tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The 200 mg/300 mg strength tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg strength tablets are coated with Opadry II Blue, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin.

What are the possible side effects of emtricitabine and tenofovir (AccessPak for HIV PEP Basic, Truvada)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, vomiting, fast or...

Read All Potential Side Effects and See Pictures of Truvada »

What are the precautions when taking emtricitabine and tenofovir disoproxil fumarate (Truvada)?

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having...

Read All Potential Precautions of Truvada »

Last reviewed on RxList: 5/8/2017
This monograph has been modified to include the generic and brand name in many instances.

Truvada - User Reviews

Truvada User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Truvada sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


WebMD Daily

Get breaking medical news.