Medication Guide App

fosamprenavir

Generic Name: fosamprenavir (FOS am pren a veer)
Brand Name: Lexiva, Telzir

What is fosamprenavir?

Fosamprenavir is an antiviral medication that 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 purposes not listed in this medication guide.

What is the most important information I should know about fosamprenavir?

Some medicines can cause unwanted or dangerous effects when used with fosamprenavir. Your doctor may need to change your treatment plan if you use any of the following drugs: alfuzosin, cisapride, delavirdine, lovastatin, simvastatin, midazolam, triazolam, pimozide, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or an ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

Slideshow: Flashback: FDA Drug Approvals 2013

Do not take fosamprenavir together with another HIV medicine called ritonavir if you are also using flecainide or propafenone to treat a heart rhythm disorder. Ask your doctor about taking a different heart rhythm medication during treatment with fosamprenavir.

What should I discuss with my healthcare provider before taking fosamprenavir?

You should not take this medication if you have ever had a severe allergic reaction to fosamprenavir.

Some medicines can cause unwanted or dangerous effects when used with fosamprenavir. Your doctor may need to change your treatment plan if you use any of the following drugs: alfuzosin, cisapride, delavirdine, lovastatin, simvastatin, midazolam, triazolam, pimozide, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or an ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

Do not take fosamprenavir together with another HIV medicine called ritonavir if you are also using flecainide or propafenone to treat a heart rhythm disorder. Ask your doctor about taking a different heart rhythm medication during treatment with fosamprenavir.

To make sure fosamprenavir is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • diabetes;

  • a bleeding disorder such as hemophilia;

  • heart disease, history of heart attack;

  • an allergy to sulfa drugs;

  • high cholesterol or triglycerides; or

  • if you have ever used a protease inhibitor in the past.

FDA pregnancy category C. It is not known whether fosamprenavir will harm an unborn baby. However, 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. Tell your doctor if you become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

Taking fosamprenavir together with ritonavir and also using birth control pills can increase your risk of liver problems. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking fosamprenavir and ritonavir.

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.

Fosamprenavir should not be given to an infant younger than 4 weeks (28 days) old.

How should I take fosamprenavir?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Fosamprenavir tablets can be taken with or without food.

Fosamprenavir liquid should be taken with food in children and without food in adults.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Fosamprenavir doses are based on weight in children.

Use fosamprenavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

While using fosamprenavir, you may need frequent blood tests at your doctor's office.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store fosamprenavir tablets at room temperature away from moisture and heat.

You may store fosamprenavir liquid in the refrigerator but do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 fosamprenavir?

Taking this medication will not prevent you from passing HIV to other people. 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.

Fosamprenavir 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.

Stop taking fosamprenavir and call your doctor at once if you have:

  • chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;

  • 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, flu symptoms, easy bruising or bleeding;

  • rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (enlarged thyroid);

  • muscle weakness, tired feeling, joint or muscle pain, feeling short of breath;

  • weakness or prickly feeling in your fingers or toes;

  • problems with walking, breathing, speech, swallowing, or eye movement;

  • loss of bladder or bowel control;

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of fosamprenavir may include:

  • mild nausea, vomiting, 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.

See also: Side effects (in more detail)

Fosamprenavir dosing information

Usual Adult Dose for HIV Infection:

Therapy-naive patients:
Administered without ritonavir: 1400 mg orally twice a day
Administered in combination with ritonavir: Fosamprenavir 1400 mg plus ritonavir 200 mg orally once a day
or
Fosamprenavir 1400 mg plus ritonavir 100 mg orally once a day
or
Fosamprenavir 700 mg plus ritonavir 100 mg orally twice a day

Protease inhibitor (PI)-experienced patients: Fosamprenavir 700 mg plus ritonavir 100 mg orally twice a day

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

Centers for Disease Control and Prevention recommendations: 1400 mg orally twice a day

Duration: 28 days

Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. The alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include fosamprenavir as part of PI-based regimens.

Usual Pediatric Dose for HIV Infection:

Administered without ritonavir:
PI-naive patients who are 2 years of age or older:
Oral suspension: 30 mg/kg (up to 1400 mg/dose) orally twice a day

Tablets:
47 kg or more: 1400 mg orally twice a day

Administered in combination with ritonavir:
PI-naive patients who are at least 4 weeks of age (including infants at a postnatal age of at least 28 days who were born at 38 weeks gestation or greater):
Oral suspension:
Less than 11 kg: Fosamprenavir 45 mg/kg plus ritonavir 7 mg/kg orally twice a day
11 to less than 15 kg: Fosamprenavir 30 mg/kg plus ritonavir 3 mg/kg orally twice a day
15 to less than 20 kg: Fosamprenavir 23 mg/kg plus ritonavir 3 mg/kg orally twice a day
20 kg or more: Fosamprenavir 18 mg/kg (up to 700 mg/dose) plus ritonavir 3 mg/kg (up to 100 mg/dose) orally twice a day

Tablets:
39 kg or more: Fosamprenavir 700 mg plus ritonavir 100 mg orally twice a day

PI-experienced patients who are at least 6 months of age:
Oral suspension:
Less than 11 kg: Fosamprenavir 45 mg/kg plus ritonavir 7 mg/kg orally twice a day
11 to less than 15 kg: Fosamprenavir 30 mg/kg plus ritonavir 3 mg/kg orally twice a day
15 to less than 20 kg: Fosamprenavir 23 mg/kg plus ritonavir 3 mg/kg orally twice a day
20 kg or more: Fosamprenavir 18 mg/kg (up to 700 mg/dose) plus ritonavir 3 mg/kg (up to 100 mg/dose) orally twice a day

Tablets:
39 kg or more: Fosamprenavir 700 mg plus ritonavir 100 mg orally twice a day

Ritonavir capsules may be used for patients weighing at least 33 kg.

What other drugs will affect fosamprenavir?

Many other drugs can cause serious or life-threatening drug interactions if you use them while taking fosamprenavir. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with fosamprenavir, especially:

  • atorvastatin;

  • bosentan;

  • colchicine;

  • rifabutin;

  • antifungal medication--itraconazole, ketoconazole;

  • an antidepressant--amitriptyline, imipramine, paroxetine, trazodone;

  • any other HIV /AIDS medication;

  • a blood thinner such as warfarin (Coumadin);

  • drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection

  • heart rhythm medication--amiodarone, lidocaine, quinidine;

  • heart or blood pressure medicine--amlodipine, diltiazem, nifedipine, verapamil, and others;

  • the hepatitis C medications boceprevir or telaprevir;

  • insulin or oral diabetes medication;

  • medicines to treat erectile dysfunction--avanafil, sildenafil, tadalafil, vardenafil;

  • seizure medications--carbamazepine, phenobarbital, phenytoin (Dilantin); or

  • stomach acid reducers--cimetidine, famotidine, nizatidine, ranitidine (Zantac).

This list is not complete and many other drugs can interact with fosamprenavir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about fosamprenavir.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2013-04-01, 4:08:01 PM.

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