Uses

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

Fosamprenavir belongs to a class of drugs known as protease inhibitors. It may be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of fosamprenavir. This helps fosamprenavir work better.

Fosamprenavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking fosamprenavir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once or twice daily.

Fosamprenavir tablets may be taken with or without food.

If you are taking fosamprenavir suspension, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Adults should take the suspension without food. Children should take the suspension with food. If vomiting occurs less than 30 minutes after taking a dose, repeat the dose.

The dosage is based on your medical condition, response to treatment, other medications you may be taking, and if you have taken protease inhibitors to treat HIV before. For children, the dosage is also based on age and weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you are directed to take ritonavir with this medication, take them both at the same time(s).

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side Effects

Diarrhea, nausea, vomiting, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
• signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Tell your doctor right away if you have any serious side effects, including:

• increased thirst/urination
• signs of a kidney stone (such as pain in side/back/abdomen, painful urination, blood in the urine)

Changes in body fat may occur while you are taking this medication (such as 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 treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Get medical help right away if you have any very serious side effects, including:

• signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

Fosamprenavir 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. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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 or at www.fda.gov/medwatch.

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 (such as propylene glycol in the suspension), 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:

• liver problems (including hepatitis B or C infections)
• kidney problems (including kidney stones)
• heart problems (such as coronary artery disease, heart attack)
• diabetes
• a certain bleeding problem (hemophilia)

Fosamprenavir may increase the level of cholesterol and fats (triglycerides) in your blood. HIV infection can also cause this effect. This could increase your risk for heart problems such as a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease such as high blood pressure, diabetes, or high cholesterol/triglyceride levels.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially vomiting and signs of infection (such as sore throat that doesn't go away, fever).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and fosamprenavir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• certain HIV protease inhibitors (such as lopinavir, tipranavir)
• orlistat

Other medications can affect the removal of fosamprenavir from your body, which may affect how fosamprenavir works. Examples include apalutamide, etravirine, rifampin, St. John's wort, among others.

Fosamprenavir can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alpha blockers (such as alfuzosin), certain benzodiazepines (midazolam, triazolam), ergot alkaloids (such as dihydroergotamine, ergotamine), fluticasone, pimozide, ranolazine, rivaroxaban, drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), certain drugs to treat irregular heartbeat (such as flecainide, propafenone), certain "statin" cholesterol drugs (lovastatin, simvastatin), salmeterol, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts, liver function, cholesterol/triglyceride levels, blood sugar levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important not to miss doses of this drug. If you miss a dose by less than 4 hours, take it as soon as you remember. However, if you miss a dose by more than 4 hours, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the tablets at room temperature away from light and moisture. Store the suspension at room temperature or in the refrigerator. Refrigeration may improve the taste of the suspension. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.