AccessPak for HIV PEP Expanded with Viracept

Name: AccessPak for HIV PEP Expanded with Viracept

What is the most important information I should know about AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

You should not take this medication if you have severe liver or kidney disease, or if you are allergic to emtricitabine (Emtriva, Atripla), nelfinavir (Viracept), or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other drugs that can cause serious or life threatening medical problems if you take them together with this medication. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Some people develop lactic acidosis while taking emtricitabine or tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

You should not take this medication if you have severe liver or kidney disease, or if you are allergic to emtricitabine (Emtriva, Atripla), nelfinavir (Viracept), or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other drugs that can cause serious or life threatening medical problems if you take them together with emtricitabine, nelfinavir, and tenofovir. The following drugs should not be used while you are taking this medication:

  • amiodarone (Cordarone, Pacerone);

  • quinidine (Quin-G);

  • pimozide (Orap);

  • midazolam (Versed) or triazolam (Halcion); or

  • an ergot medicine such as D.H.E. 45, Ergomar, Cafergot, Ergotrate, Methergine, Migergot, or Migranal.

To make sure you can safely take emtricitabine, nelfinavir, and tenofovir, tell your doctor if you have any of these other conditions:

  • diabetes;

  • a bleeding or blood-clotting disorder such as hemophilia;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • liver or kidney disease;

  • osteopenia (low bone mineral density); or

  • if you also have hepatitis B infection.

Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine or tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

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

Do not give this medicine to a child younger than 2 years old without medical advice.

What happens if I overdose?

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

AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir) side effects

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, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have a serious side effect such as:

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • increased thirst, urinating less than usual or not at all;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • swelling, rapid weight gain, feeling short of breath; or

  • signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

  • vomiting, diarrhea, bloating;

  • headache, tired feeling, dizziness, depressed mood;

  • sleep problems (insomnia), strange dreams;

  • runny or stuffy nose, cough; 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 AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

Emtricitabine, nelfinavir, and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

  • lithium (Lithobid);

  • methotrexate (Rheumatrex, Trexall);

  • pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others;

  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  • IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  • antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine, nelfinavir, and tenofovir.

Many other drugs can interact with emtricitabine, nelfinavir, and tenofovir. Below is just a partial list:

  • antiviral medications for herpes or HIV;

  • antifungal medicine;

  • cholesterol-lowering medicines;

  • heart or blood pressure medications;

  • insulin or oral diabetes medication;

  • seizure medications; or

  • medicines to treat erectile dysfunction.

This list is not complete and other drugs may interact with emtricitabine, nelfinavir, and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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