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fosamprenavir (Oral route)

fos-am-PREN-a-vir

Commonly used brand name(s)

In the U.S.

  • Lexiva

Available Dosage Forms:

  • Tablet
  • Suspension

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For fosamprenavir

Fosamprenavir is used in combination with other medicines to treat patients who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Slideshow: Flashback: FDA Drug Approvals 2013

Fosamprenavir may slow down the destruction of the immune system caused by HIV. This may help delay problems that are usually related to AIDS or HIV disease from occurring. However, fosamprenavir will not cure or prevent HIV infection, and it will not keep you from spreading the virus to other people. Patients who receive fosamprenavir may continue to have other problems usually related to AIDS or HIV disease.

fosamprenavir is available only with your doctor's prescription.

Before Using fosamprenavir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fosamprenavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fosamprenavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fosamprenavir in infants and children 4 weeks of age and older who have not taken HIV medicines in the past called protease inhibitors. Use is not recommended in children younger than 6 months of age who have taken HIV medicines called protease inhibitors in the past. Safety and efficacy have not been established in infants younger than 4 weeks of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of fosamprenavir have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of fosamprenavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fosamprenavir.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fosamprenavir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fosamprenavir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Cisapride
  • Delavirdine
  • Dihydroergotamine
  • Eletriptan
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Everolimus
  • Lomitapide
  • Lovastatin
  • Methylergonovine
  • Midazolam
  • Pimozide
  • Ranolazine
  • Rifampin
  • Sildenafil
  • Simvastatin
  • St John's Wort
  • Triazolam

Using fosamprenavir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Artemether
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Bepridil
  • Boceprevir
  • Bosentan
  • Bosutinib
  • Carbamazepine
  • Ceritinib
  • Clozapine
  • Colchicine
  • Crizotinib
  • Cyclophosphamide
  • Dabrafenib
  • Dexamethasone
  • Dolutegravir
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etravirine
  • Fentanyl
  • Garlic
  • Hydrocodone
  • Ibrutinib
  • Ixabepilone
  • Lidocaine
  • Lumefantrine
  • Lurasidone
  • Mitotane
  • Nevirapine
  • Piperaquine
  • Posaconazole
  • Quinidine
  • Raltegravir
  • Rifabutin
  • Rifapentine
  • Rosuvastatin
  • Salmeterol
  • Saquinavir
  • Siltuximab
  • Simeprevir
  • Tadalafil
  • Telaprevir
  • Tipranavir
  • Tolvaptan
  • Vilazodone

Using fosamprenavir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Buprenorphine
  • Cobicistat
  • Cyclosporine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Ketoconazole
  • Levonorgestrel
  • Lopinavir
  • Maraviroc
  • Medroxyprogesterone Acetate
  • Mestranol
  • Methadone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Paroxetine
  • Phenytoin
  • Ranitidine
  • Ritonavir
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fosamprenavir. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia, hemolytic or
  • Cholesterol problem (high fat in the blood) or
  • Diabetes or
  • Hemophilia (a bleeding problem) or
  • Hyperglycemia (high blood sugar) or
  • Kidney problems (e.g., kidney stones)—Use with caution. May make these conditions worse.
  • Hepatitis B or
  • Hepatitis C or
  • Liver disease or
  • Sulfa allergy, history of—Use with caution. May cause side effects to become worse.

Proper Use of fosamprenavir

Take fosamprenavir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking fosamprenavir without first checking with your doctor. When your supply of fosamprenavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of fosamprenavir.

fosamprenavir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Fosamprenavir suspension should be taken by adults without food. Children should take the oral suspension with food.

Shake the oral suspension well before each use. Use a marked measuring spoon, oral syringe, or medicine cup to measure the dose. The average household teaspoon may not hold the right amount of liquid.

Fosamprenavir tablets may be taken with or without food. However, it should not be taken with a high-fat meal. Taking fosamprenavir with a high-fat meal may decrease the amount of fosamprenavir that is absorbed by the body and prevent the medicine from working properly.

It is important to take fosamprenavir as part of a combination treatment. Your dose of medicine will be based on what other medicines you are taking, as well as your weight. Be sure to take all the medicines your doctor has prescribed for you, including fosamprenavir.

Keep taking fosamprenavir for the full time of treatment, even if you begin to feel better.

fosamprenavir works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses a day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed especially for you. Do not share your medicine with others.

Dosing

The dose of fosamprenavir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fosamprenavir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (suspension or tablets):
    • For treatment of HIV infection:
      • Adults who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir alone)—1400 milligrams (mg) (2 tablets) two times a day.
      • Adults who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—1400 mg (2 tablets) fosamprenavir with 200 mg ritonavir once a day or 1400 mg (2 tablets) fosamprenavir with 100 mg ritonavir once a day or 700 mg fosamprenavir with 100 mg ritonavir two times a day.
      • Adults who have taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—700 mg fosamprenavir with 100 mg ritonavir two times a day. Adults who have taken HIV medicines called protease inhibitors in the past should not take the combination of fosamprenavir with ritonavir only once a day. Check with your doctor if you are unsure of what amounts and how many times a day you should be taking your medicines. If you are taking fosamprenavir with ritonavir and efavirenz, check with your doctor for the correct doses.
      • Children 4 weeks of age and older (fosamprenavir together with ritonavir)—Dose based on body weight and must be determined by your doctor. The usual fosamprenavir suspension dose for patients weighing more than 20 kilogram (kg) is 18 milligrams (mg) per kilogram (kg) of body weight two times a day with ritonavir 3 mg per kg two times per day. Fosamprenavir doses up to 45 mg per kg two times per day with ritonavir 7 mg/kg two times per day are used for patients weighing less than 11 kg. However, the dose is usually not more than fosamprenavir 700 mg with ritonavir 100 mg two times per day.
      • Children 2 years of age and older who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir alone)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is 30 mg per kg of body weight two times per day. Doses up to 1400 mg (2 tablets) two times per day may be used for children weighing 47 kg or more.
      • Children 4 weeks of age and older—Using fosamprenavir once a day is not recommended for children. Fosamprenavir should always be given twice daily unless otherwise determined by your doctor.
      • Children younger than 4 weeks of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of fosamprenavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you or your child vomits 30 minutes after the first dose, a second dose should be taken right away.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The oral suspension may also be refrigerated. Do not freeze.

Precautions While Using fosamprenavir

It is very important that your doctor check the progress of you or your child at regular visits to make sure fosamprenavir is working properly. Blood tests may be needed to check for unwanted effects.

Do not use fosamprenavir if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), delavirdine (Rescriptor®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.

Tell your doctor if you are also taking sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). Taking these medicines together with fosamprenavir may increase your risk of having side effects such as low blood pressure, changes in vision, or prolonged erection of the penis.

Birth control pills may not work as well while you are using fosamprenavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

fosamprenavir may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Serious skin reactions can occur with fosamprenavir. Stop using fosamprenavir and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; itching; white spots in the mouth or on the lips; or redness of the skin.

fosamprenavir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

fosamprenavir may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

fosamprenavir may increase your risk of having kidney stones. Check with your doctor right away and stop using fosamprenavir if you or your child have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

Fosamprenavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

Tell the doctor in charge that you or your child are taking fosamprenavir before you have any medical tests. The results of some tests may be affected by fosamprenavir.

fosamprenavir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Large amount of fat in the blood
  • severe skin rash
Less common
  • Abdominal or stomach pain
  • blurred vision
  • depression
  • dry mouth
  • fatigue
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • mood or mental changes
  • nausea
  • sweating
  • troubled breathing
  • unexplained weight loss
  • vomiting
Rare
  • Back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • chills
  • cough
  • dark urine
  • diarrhea
  • difficulty with breathing
  • fever
  • general body swelling
  • itching
  • joint or muscle pain
  • loss of appetite
  • nosebleeds
  • pale skin
  • red skin lesions often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unusual tiredness or weakness
  • yellowing of the eyes or skin
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Itching skin
  • mild or moderate rash
Less common
  • Burning or prickling sensation around the mouth
  • headache
Incidence not known
  • Breast enlargement
  • buffalo hump
  • increased fat deposits on the face, neck, and trunk
  • obesity

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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