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Drugs reference index «Lexiva»

Lexiva


Lexiva

Generic Name: 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 Lexiva

Fosamprenavir is a protease inhibitor. It 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).

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

This medicine is available only with your doctor's prescription.

Before Using Lexiva

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 have not been performed on the relationship of age to the effects of fosamprenavir in children less than 2 years of age. Safety and efficacy have not been established.

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 CategoryExplanation
All TrimestersCAnimal 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

Using this medicine 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.

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

Using this medicine 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
  • Atazanavir
  • Bepridil
  • Colchicine
  • Dexamethasone
  • Efavirenz
  • Etravirine
  • Everolimus
  • Fentanyl
  • Garlic
  • Ixabepilone
  • Lidocaine
  • Nevirapine
  • Quinidine
  • Rifabutin
  • Rifapentine
  • Rosuvastatin
  • Saquinavir
  • Tipranavir
  • Tolvaptan

Using this medicine 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.

  • Atorvastatin
  • Cyclosporine
  • Desogestrel
  • Drospirenone
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Ketoconazole
  • Levonorgestrel
  • Lopinavir
  • 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia, hemolytic or
  • Bleeding problems (e.g., hemophilia) or
  • Cholesterol problem (high fat in the blood) or
  • Diabetes or
  • Hyperglycemia (high blood sugar)—May make these conditions worse.
  • Hepatitis B or
  • Hepatitis C or
  • Liver disease—Use with caution. May cause side effects to become worse.
  • Sulfa or sulfonamide allergy, history of—Use with caution. This medicine has a sulfonamide-type structure.

Proper Use of Lexiva

Take this medicine 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 this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

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

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

Shake the 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.

This medicine 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 this medicine 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 this medicine. 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 form (suspension and 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 one time per day or 1400 mg (2 tablets) fosamprenavir with 100 mg ritonavir one time per 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 one time 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 above 6 years of age 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 milligrams (mg) per kilogram (kg) of body weight two times a day.
      • Children above 6 years of age who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is fosamprenavir 18 mg per kg of body weight with ritonavir 3 mg per kg of body weight two times a day.
      • Children above 6 years of age who have taken HIV medicines called protease inhibitors in the past (fosamprenavir alone) and weigh 47 kg or more—1400 mg (2 tablets) two times a day.
      • Children above 6 years of age who have taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is fosamprenavir 18 milligrams (mg) per kilogram (kg) of body weight with ritonavir 3 mg per kg of body weight two times a day.
      • Children 2 to 5 years of age 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 a day.
      • Children below 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

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

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.

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

Precautions While Using Lexiva

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using flecainide (Tambocor®), propafenone (Rythmol®), rifampin (Rifadin®, Rimactane®), lovastatin (Mevacor®), simvastatin (Zocor®), cisapride (Propulsid®), delavirdine (Rescriptor®), pimozide (Orap®), midazolam (Versed®), triazolam (Halcion®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, 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.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

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 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.

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; itching; white spots in the mouth or on the lips; or redness of the skin.

Check with your doctor right away if you have any of the following symptoms while taking this medicine: itching; skin rash; or swelling of the face, lips, and tongue. You may be having a serious skin reaction or a condition called angioedema.

This medicine may cause you to have excess body fat. Tell your doctor if you 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.

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

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 are taking this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Lexiva 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 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
  • fat redistribution
  • 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.

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  • Lexiva Prescribing Information (FDA)
  • Lexiva Detailed Consumer Information (PDR)
  • Lexiva MedFacts Consumer Leaflet (Wolters Kluwer)
  • Lexiva Consumer Overview

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