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FOSAMPRENAVIR CALCIUM tablet, film coated

  1. Drug Interactions:
  2. Contraception:
  3. Severe Skin Reactions:
  4. Sulfa Allergy:
  5. Hepatic Toxicity:
  6. Immune Reconstitution Syndrome:
  7. Increase In Body Fat:
  8. Lipid Elevations:
  9. Pregnancy Registry:
  10. Lactation:
  11. Missed Dose:
  12. Patient Information
  13. What Are Fosamprenavir Calcium Tablets?
  14. Do Not Take Fosamprenavir Calcium Tablets If You:
  15. Fosamprenavir Calcium Tablets May Cause Serious Side Effects Including:
  16. Active Ingredient:
  17. Inactive Ingredients:
  18. Manufactured For:
  19. Manufactured By:

Drug Interactions: 

A statement to patients and healthcare providers is included on the product s bottle label: ALERT: Find out about medicines that should NOT be taken with Fosamprenavir Calcium Tablets.

Fosamprenavir calcium tablets may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, particularly St. John s wort.

Advise patients receiving PDE5 inhibitors that they may be at an increased risk of PDE5 inhibitor-associated adverse events, including hypotension, visual changes, and priapism, and should promptly report any symptoms to their healthcare provider[seeContraindications (4),Warnings and Precautions (5.1),Drug Interactions (7)].


Instruct patients receiving combined hormonal contraception to use an effective alternative contraceptive method or an additional barrier method during therapy with fosamprenavir calcium tablets because hormonal levels may decrease, and if used in combination with fosamprenavir calcium tablets and ritonavir, liver enzyme elevations may occur[seeDrug Interactions (7.2),Use in Specific Populations (8.3)].

Severe Skin Reactions: 

Advise patients that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, have been reported with fosamprenavir calcium tablets. Advise patients to discontinue fosamprenavir calcium tablets immediately for severe or life-threatening skin reactions or for moderate rashes accompanied by systemic symptoms[seeWarnings and Precautions (5.2),Adverse Reactions (6)].

Sulfa Allergy: 

Advise patients to inform their healthcare provider if they have a sulfa allergy. The potential for cross-sensitivity between drugs in the sulfonamide class and fosamprenavir is unknown[seeWarnings and Precautions (5.3)].

Hepatic Toxicity: 

Advise patients that it is recommended to have laboratory testing before and during therapy as patients with underlying hepatitis B or C or marked elevations of transaminases prior to treatment may be at increased risk for developing or worsening transaminase elevations with use of fosamprenavir calcium tablets, particularly at higher than recommended doses which should not be used[seeWarnings and Precautions (5.4)].

Immune Reconstitution Syndrome: 

Advise patients to inform their healthcare provider immediately of any signs or symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when fosamprenavir calcium tablets are started[seeWarnings and Precautions (5.6)].

Increase In Body Fat: 

Inform patients that an increase of body fat may occur in patients receiving protease inhibitors, including fosamprenavir calcium tablets, and that the cause and long-term health effects of these conditions are not known at this time[seeWarnings and Precautions (5.7)].

Lipid Elevations: 

Advise patients that it is recommended to have laboratory testing before and during therapy as increases in the concentration of triglycerides and cholesterol have been reported with use of fosamprenavir calcium tablets[seeWarnings and Precautions (5.8),Adverse Reactions (6)].

Pregnancy Registry: 

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fosamprenavir calcium tablets during pregnancy[seeUse in Specific Populations (8.1)].


Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk[seeUse in Specific Populations (8.2)].

Missed Dose: 

Instruct patients that if they miss a dose of fosamprenavir calcium tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose[seeDosage and Administration (2)].

Patient Information 

Fosamprenavir Calcium Tablets

(fos am pren a vir kal

Fosamprenavir calcium tablets can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with fosamprenavir calcium tablets.

What Are Fosamprenavir Calcium Tablets? 

Fosamprenavir calcium tablets are a prescription medicine that is used together with other antiretroviral medicines to treat human immunodeficiency virus 1 (HIV-1) infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if fosamprenavir is safe and effective in children younger than 4 weeks of age.

Do Not Take Fosamprenavir Calcium Tablets If You: 

are allergicto amprenavir, fosamprenavir calcium, or any of the ingredients in fosamprenavir calcium tablets.

Take fosamprenavir calcium tablets exactly as your healthcare provider tells you to take them.
If you miss a dose of fosamprenavir calcium tablets, take it as soon as you remember. Do not take 2 doses at the same time or take more than your healthcare provider tells you to take.
Stay under the care of a healthcare provider during treatment with fosamprenavir calcium tablets.
If your child is taking fosamprenavir calcium tablets, your child s healthcare provider will decide the right dose based on your child s weight.
Fosamprenavir calcium tablets may be taken with or without food.
Do not run out of fosamprenavir calcium tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
If you take too many fosamprenavir calcium tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Fosamprenavir Calcium Tablets May Cause Serious Side Effects Including: 

Store fosamprenavir calcium tablets at room temperature between 20 to 25 C (68 to 77 F).
Keep the bottle of fosamprenavir calcium tablets tightly closed.
Fosamprenavir calcium tablets come in a child-resistant package.

Keep fosamprenavir calcium tablets and all medicines out of the reach of children.

General information about the safe and effective use of fosamprenavir calcium tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use fosamprenavir calcium tablets for a condition for which they were not prescribed. Do not give fosamprenavir calcium tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your pharmacist or healthcare provider for information about fosamprenavir calcium tablets that is written for health professionals.

Active Ingredient: 

fosamprenavir calcium

Inactive Ingredients: 

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, red iron oxide, silicified microcrystalline cellulose, titanium dioxide and triacetin.

Manufactured For: 

Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Manufactured By: 

Mylan Laboratories Limited,Hyderabad 500 096, India

The brand names listed are trademarks of their respective owners.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad 500 096, India


Revised: 7/2019

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