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emtricitabine, nelfinavir, and tenofovir

Pronunciation: em trye SYE ta been, nel FIN a veer, ten OF oh vir

Brand: AccessPak for HIV PEP Expanded with Viracept

What is the most important information I should know about this medicine?

You should not take this medicine if you have severe liver or kidney disease. Do not take with other medicines that contain emtricitabine, tenofovir, or lamivudine.

This medicine is sometimes used to reduce the risk of becoming infected with HIV. You must be HIV-negative to use emtricitabine, nelfinavir, and tenofovir for this purpose.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is emtricitabine, nelfinavir, and tenofovir?

Emtricitabine, nelfinavir, and tenofovir are antiviral drugs that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Emtricitabine, nelfinavir, and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

This medicine may also be used together with safer-sex practices to reduce the risk of becoming infected with HIV. You must be HIV-negative and an adult to use the medicine for this purpose. Emtricitabine, nelfinavir, and tenofovir may not provide protection from disease in every person.

Emtricitabine, nelfinavir, and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

You should not take this medicine if you are allergic to emtricitabine, nelfinavir, or tenofovir, or if you have severe liver or kidney disease.

Do not take if you also use other medicines that contain emtricitabine, tenofovir, or lamivudine (Atripla, Complera, Emtriva, Odefsey, Stribild, Triumeq, Viread, and others).

Do not take this medicine to reduce infection risk if you are HIV-positive, if you have been exposed to HIV within the past month, or if you had any symptoms (such as fever, sore throat, night sweats, swollen glands, diarrhea, body aches).

If you take emtricitabine, nelfinavir, and tenofovir to reduce your risk of HIV infection: You must have a negative HIV test immediately before you start taking the medicine. An HIV test is also required every 3 months during treatment.

Many drugs can interact with this medicine and cause dangerous effects. Your doctor may change your treatment plan if you also use:

  • alfuzosin;
  • pimozide;
  • rifampin;
  • sildenafil (Revatio for pulmonary arterial hypertension);
  • St. John's wort;
  • lovastatin or simvastatin;
  • dihydroergotamine, ergotamine, ergonovine, or methylergonovine;
  • amiodarone or quinidine; or
  • oral midazolam, or triazolam.

Tell your doctor if you have ever had:

  • a bleeding or blood-clotting disorder such as hemophilia;
  • liver or kidney disease; or
  • hepatitis B infection.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

This medicine is not approved for use by anyone younger than 2 years old.

How should I take this medicine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

You may need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine. Your doctor may want to check your liver function for several months after you stop using this medicine.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking this medicine?

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of this medicine?

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

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • kidney problems --little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems --nausea, swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This medicine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection --fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • stomach pain;
  • headache, dizziness, feeling depressed or tired;
  • sleep problems (insomnia), strange dreams;
  • rash;
  • weight loss; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

If you also take didanosine, take it 1 hour before or 2 hours after you take emtricitabine, nelfinavir, and tenofovir.

Tell your doctor about all your current medicines, especially:

  • antiviral medicine to treat hepatitis C --ledipasvir, sofosbuvir, velpatasvir;
  • other HIV medications --atazanavir, darunavir, didanosine, lopinavir, ritonavir; or
  • some pain or arthritis medicines --aspirin, Tylenol, Advil, and Aleve.

This list is not complete and many other drugs may affect emtricitabine, nelfinavir, and tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about emtricitabine, nelfinavir, and tenofovir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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