Lexiva

DRUG DESCRIPTION

LEXIVA (fosamprenavir calcium) is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium is (3S)-tetrahydrofuran-3-yl (1S,2R)-3?[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula:

LEXIVA (fosamprenavir calcium) Structural Formula Illustration

Fosamprenavir calcium is a white to cream-colored solid with a solubility of approximately 0.31 mg/mL in water at 25 C.

LEXIVA Tablets are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). Each 700-mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K30. The tablet film-coating contains the inactive ingredients hypromellose, iron oxide red, titanium dioxide, and triacetin.

LEXIVA Oral Suspension is available in a strength of 50 mg/mL of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir. LEXIVA Oral Suspension is a white to off-white suspension with a grape-bubblegum-peppermint flavor. Each one milliliter (1 mL) contains the inactive ingredients artificial grape-bubblegum flavor, calcium chloride dihydrate, hypromellose, methylparaben, natural peppermint flavor, polysorbate 80, propylene glycol, propylparaben, purified water, and sucralose.

What are the possible side effects of fosamprenavir (Lexiva)?

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.

Stop taking fosamprenavir and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • sudden and...

Read All Potential Side Effects and See Pictures of Lexiva

What are the precautions when taking fosamprenavir calcium (Lexiva)?

Before taking fosamprenavir, tell your doctor or pharmacist if you are allergic to it or to amprenavir; 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: heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats), blood disorders (hemophilia), diabetes, kidney problems (such as kidney stones), liver disease.

Children may be more sensitive to the side effects of this drug, especially vomiting.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and...

Read All Potential Precautions of Lexiva


Lexiva Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, vomiting, headache, fatigue, and stomach/abdominal pain may occur. If any of these effects persist or worsen, notify 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual increase in thirst or urination, mental/mood changes, numbness or tingling of hands or feet, symptoms of kidney stones (such as pain in your side, blood in your urine, pain when urinating).

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

If you are taking HIV medications for the first time, you may experience symptoms of an old infection. This may happen as your immune system begins to work better. Contact your doctor immediately if you notice any of the following symptoms: new cough, trouble breathing, fever, new vision problems, new headaches, new skin problems.

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

This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fosamprenavir, tell your doctor or pharmacist if you are allergic to it or to amprenavir; 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: heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats), blood disorders (hemophilia), diabetes, kidney problems (such as kidney stones), liver disease.

Children may be more sensitive to the side effects of this drug, especially vomiting.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Lexiva Patient Information Including Side Effects

Brand Names: Lexiva

Generic Name: fosamprenavir (Pronunciation: FOS am pren a veer)

  • What is fosamprenavir (Lexiva)?
  • What are the possible side effects of fosamprenavir (Lexiva)?
  • What is the most important information I should know about fosamprenavir (Lexiva)?
  • What should I discuss with my healthcare provider before taking fosamprenavir (Lexiva)?
  • How should I take fosamprenavir (Lexiva)?
  • What happens if I miss a dose (Lexiva)?
  • What happens if I overdose (Lexiva)?
  • What should I avoid while taking fosamprenavir (Lexiva)?
  • What other drugs will affect fosamprenavir (Lexiva)?
  • Where can I get more information?

What is fosamprenavir (Lexiva)?

Fosamprenavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Fosamprenavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Fosamprenavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Fosamprenavir is not a cure for HIV or AIDS.

Fosamprenavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fosamprenavir (Lexiva)?

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.

Stop taking fosamprenavir and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • easy bruising or bleeding; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

Less serious side effects of fosamprenavir may include:

  • mild nausea, vomiting, diarrhea, stomach pain;
  • numbness or tingling, especially around your mouth;
  • headache, mood changes; 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 is the most important information I should know about fosamprenavir (Lexiva)?

Do not take fosamprenavir with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine, and others.

Fosamprenavir should not be taken together with ritonavir (Norvir) if you are also using a heart rhythm medication called flecainide (Tambocor) or propafenone (Rythmol). Ask your doctor about taking a different medication for your heart rhythm disorder.

These drugs can cause life-threatening side effects if you use them while you are taking fosamprenavir.

There are many other medicines that can cause serious interactions if you use them while taking fosamprenavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.

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