Invirase

Invirase is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. Invirase belongs to a group of drugs called protease inhibitors. This medication works by preventing HIV cells from multiplying.

This medication comes in capsule form and tablet forms. It is usually taken twice daily.

Some of the common side effects of Invirase include nausea, vomiting, diarrhea, stomach pain, and tiredness. 

Invirase is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection in people 16 years and older. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

• See "Drug Precautions".

Diabetes and high blood sugar. Some people who take protease inhibitors get new or more serious diabetes, or high blood sugar. Tell your healthcare provider if you notice an increase in thirst or urinate more often than normal while taking Invirase.

• Liver problems. People with liver problems such as Hepatitis B or C, cirrhosis or have a history of alcoholism may have worsening liver problems. 
  Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
  • loss of appetite
  • yellowing of your skin or whites of your eyes (jaundice)
  • dark-colored urine
  • pale colored stools
  • itchy skin
  • stomach area (abdominal) pain
• Increased bleeding in people with hemophilia. Some people with hemophilia have increased bleeding with protease inhibitors including Invirase.
• Increase in certain fat (cholesterol and triglycerides) levels in your blood. Your healthcare provider will check your blood for high levels of cholesterol and triglycerides before you start Invirase and during treatment with Invirase.
• Changes in body fat. Changes in body fat have been seen in some people who take anti-HIV medications. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breasts, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
• Immune System Changes (Immune Reconstitution Syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking Invirase.

The most common side effects of Invirase include:

• nausea
• vomiting
• diarrhea
• stomach area (abdominal) pain
• tiredness
• pneumonia

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Invirase. For more information, ask your healthcare provider or pharmacist.

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

You may also report side effects to Genentech at 1-800-835-2555.

Tell your healthcare provider about all the medicines you take, including prescriptions and non-prescriptions medicines, vitamins and herbal supplements. Invirase and other medicines may affect each other causing side effects. Do not start taking a new medicine without talking with your healthcare provider or pharmacist. Your healthcare provider can tell you if it is safe to take Invirase with other medicines.

Taking Invirase with certain other medicines can cause serious problems or life threatening reactions.

Medicines you should not take with Invirase and Norvir include:

• alfuzosin (Uroxatral)
• anti-infectives: clarithromycin (Biaxin), erythromycin, halofantrine, pentamidine (Pentam)
• atazanavir (Reyataz)
• tacrolimus (Prograf)
• chlorpromazine
• clozapine (Clozaril)
• haloperidol (Haldol)
• mesoridazine
• phenothiazines
• thioridazine
• ziprasidone (Geodon)
• CYP3A4 substrates: dapsone, disopyramide (Norpace), quinine
• cobicistat (Tybost)
• amiodarone (Cordarone, Pacerone)
• dofetilide (Tikosyn)
• flecainide (Tambocor)
• lidocaine
• propafenone (Rhythmol)
• quinidine
• trazodone (Oleptro)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• Ergot containing medicines, including:
  • dihydroergotamine mesylate (DHE 45, Embolex, Migranal)
  • ergonovine, ergonovine and methylergonovine (Ergotrate, Methergine), ergotamine and methylergonovine
  • ergotamine tartrate (Cafergot, Migergot, Ergomar, Ergostate, Medihaler Ergotamine, Wigraine, Wigrettes)
• lovastatin (Mevacor)
• simvastatin (Zocor)
• pimozide (Orap)
• sildenafil (Revatio)
• triazolam (Halcion)
• midazolam hydrochloride oral syrup

The following medicines may increase blood levels and side effects of Invirase when taken with Invirase and Norvir:

• delavirdine (Rescriptor)
• omeprazole (Prilosec)
• indinavir (Crixivan)

Invirase and Norvir may not work as well when taken together with the following medicines, herbal products, or dietary supplements:

• efavirenz (Sustiva)
• nevirapine (Viramune)
• tipranavir (Aptivus)
• ritonavir (Norvir)
• Anticonvulsants such as carbamazepine (Carbatrol, Tegretol), phenobarbital, and phenytoin (Dilantin)
• dexamethasone
• garlic capsules, an herbal product sold as a dietary supplement
• the herbal supplement St. John's wort (Hypericum perforatum) or products containing St. John's wort

Your healthcare provider may need to monitor your therapy more closely if you take Invirase and Norvir with the following medicines:

• medicines for erectile problems, such as tadalafil (Cialis), vardenafil (Levitra), or sildenafil citrate (Viagra)
• a blood thinner medicine such as warfarin (Coumadin, Jantoven)
• Antidepressants such as trazodone (Desyrel), amitriptyline (Elavil), or imipramine (Tofranil)
• Benzodiazepines used as sedatives or sleeping pills such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), and flurazepam (Dalmane)
• atorvastatin (Lipitor) used for lowering cholesterol
• Calcium channel blockers used for treatment of high blood pressure or heart disease, such as diltiazem (Cardizem, Cartia XT, Dilacor XR, Diltzac, Taztia XT, Tiazac), felodipine (Plendil), nifedipine (Procardia), nicardipine (Cardene), nimodipine (Nimotop), verapamil-containing medications (such as Calan, Verelan), amlodipine-containing medications (such as Caduet, Norvasc), nisoldipine (Sular), and isradipine (Dynacirc)
• ketoconazole (Nizoral) and itraconazole (Sporanox) used to treat fungal infections
• Medicines to prevent organ transplant rejection: cyclosporine (Sandimmune), cyclosporine (Neoral), sirolimus (Rapamune)
• fluticasone propionate (Flonase, Flovent, Advair), given by nose or inhaled to treat allergic symptoms or asthma
• digoxin (Lanoxin) used to treat heart rhythm problems or other heart conditions
• bosentan (Tracleer) and tadalafil (Adcirca) used to treat pulmonary arterial hypertension
• medicines for gout, such as colchicine (Colcrys)
• Oral contraceptives containing ethinyl estradiol used for preventing pregnancy
• Methadone
• rifabutin (Mycobutin)

If you are not sure if you take a medicine above, ask your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Invirase may cause serious side effects including:

• Interactions with other medicines. It is important to know the medicines that should not be taken with Invirase. See "Invirase Interactions".
• Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
  • already have a history of abnormal heart rhythm, including Congenital Long QT Syndrome, or other types of heart disease.
  • take other medicines that can affect your heart rhythm while you take Invirase.

Tell your healthcare provider right away if you have any of these symptoms while taking Invirase:

• dizziness
• lightheadedness
• fainting
• sensation of abnormal heartbeats

Do not take Invirase if:

• you are taking certain medicines. See "Invirase Interactions".
• your healthcare provider has told you that you have a condition called Congenital Long QT Syndrome.
• your healthcare provider has told you that you have complete AV (atrioventricular) block and you do not have a pacemaker or you are at risk for complete AV block.
• your healthcare provider has told you that you have low potassium or low magnesium in your blood.
• you have severe liver problems.
• you have had a severe allergic reaction to Invirase or any of the ingredients in Invirase.

Grapefruit and grapefruit juice may interact with Invirase and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take Invirase, tell your healthcare provider if you:

• have any heart problems, including a condition called Congenital Long QT Syndrome.
• have diabetes.
• have liver problems, including Hepatitis B or Hepatitis C.
• have hemophilia. People who take Invirase may have increased bleeding.
• are pregnant or plan to become pregnant. It is not known if Invirase will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if Invirase can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines you take, including prescriptions and non-prescriptions medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. Experience in pregnant women is limited. Invirase should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

If you take Invirase during pregnancy, talk with your healthcare provider about how you can take part in an antiretroviral pregnancy registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if Invirase can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

• Take Invirase exactly as your healthcare provider tells you.
• Invirase comes as a 500 mg tablet or a 200 mg capsule.
• Do not change your dose of Invirase or stop treatment without first talking with your healthcare provider.
• Invirase must be used along with ritonavir (Norvir).
• Take Invirase with meals or up to 2 hours after a meal.
• When your Invirase supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ritonavir and become harder to treat.
• Do not miss a dose of Invirase. It is very important to take your medicine every day. If you skip doses or take less than the prescribed dose the medicine will not work as well, and the virus may become harder to treat.
• If you miss a dose of Invirase, you should take the next dose as soon as possible. Do not double your dose.

• Take Invirase exactly as your healthcare provider tells you.
• Invirase must be taken in combination with Norvir (ritonavir).
• Adults (over the age of 16 years ): Invirase 1000 mg twice daily (5 × 200 mg capsules or 2 × 500 mg tablets) in combination with ritonavir 100 mg twice daily.
• For patients already taking ritonavir 100 mg twice daily as part of their treatment, no additional ritonavir is needed.
• Invirase and ritonavir should be taken within 2 hours after a meal.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Invirase at room temperature.
• Keep Invirase in a tightly closed container.
• Keep Invirase and all medicine out of the reach of children.

Avoid doing things that can spread infection to others:

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection.
• Do not breastfeed.