"May 10, 2012 -- An FDA advisory panel today recommended approval of the drug Truvada to prevent the spread of HIV infection in high-risk, healthy people.
Since 2004, the drug has been been approved to treat people already infected wit"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
EMTRICITABINE/TENOFOVIR - ORAL
COMMON BRAND NAME(S): Truvada
WARNING: Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Immediately tell your doctor if you develop symptoms of liver problems (such as persistent nausea, light-colored stools, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, fast/irregular heartbeat, unusual weakness, feeling cold especially in the arms/legs).
If you have hepatitis B infection as well as HIV, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will perform liver function tests for several months after you stop.
If you are taking this product to prevent HIV infection, you must first get tested to be sure you are HIV-negative. Your doctor will perform laboratory tests before starting this medication and periodically during treatment (every 3 months) to make sure that you do not have HIV infection. Using this product will not always prevent HIV infection. To get the most benefit from it, take this product exactly as directed, and follow all prevention actions. (See also Uses section.) Tell your doctor right away if you have any signs of HIV infection (such as tiredness, fever, persistent sore throat, night sweats, diarrhea, joint/muscle aches, enlarged lymph nodes).
USES: This product 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.
Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and to decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This product may also be used alone or in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus (for example, due to an accidental needle stick injury). Consult your doctor for more details.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
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.
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.
Continue taking this medication (and your other anti-HIV medications) exactly as prescribed by your doctor. This medication works best when the amount of drugs in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each 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.
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