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Indication and Important Safety Information About KALETRA

Indication1

KALETRA® (lopinavir/ritonavir) is a type of medicine called an HIV-1 (human immunodeficiency virus-1) protease (PRO-tee-ase) inhibitor. KALETRA is always used in combination with other anti-HIV medicines to treat HIV-1 infection. KALETRA is a combination of two medicines. They are lopinavir and ritonavir. KALETRA is for adults and for children aged 6 months and older.

Important Safety Information

KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others.

Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir.

You must tell your doctor about all medicines you are taking or planning to take, including those without a prescription, and herbal products.

Do not take KALETRA with the following medicines, as they can cause serious problems or death: dihydroergotamine, ergonovine, ergotamine, and methylergonovines, such as Cafergot®, Migranal®, D.H.E. 45®, Ergotrate Maleate, and Methergine, as well as Halcion® (triazolam), Orap® (pimozide), Propulsid® (cisapride), or Versed® (midazolam).

Do not take KALETRA with rifampin, also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®, or products containing St. John's wort (Hypericum perforatum). These medicines may lower the amount of KALETRA in your blood.

Do not take KALETRA with the cholesterol-lowering medicines Mevacor® (lovastatin), or Zocor® (simvastatin) because of possible serious reactions. There is also an increased risk of drug interactions between KALETRA and Lipitor® (atorvastatin) or Crestor® (rosuvastatin); talk to your doctor before you take any of these cholesterol-reducing medicines with KALETRA.

Talk to your doctor before you take Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil), since the interaction with KALETRA and these medicines may result in an increase in their side effects.

If you are taking oral contraceptives (“the pill”) or using the contraceptive patch to prevent pregnancy, you should use an additional or different type of contraception since KALETRA may reduce how well the oral or patch contraceptives work.

You should not take KALETRA once a day with the following medicines: Sustiva® (efavirenz), Viramune® (nevirapine), Agenerase® (amprenavir), fosamprenavir, Viracept® (nelfinavir), phenobarbital, phenytoin (Dilantin® and others) and carbamazepine (Tegretol® and others). Your doctor may change your dose of KALETRA if you are taking these medicines.

If you are taking Mycobutin® (rifabutin), your doctor will lower the dose of Mycobutin®.

If you are using or before you begin using inhaled Flonase® (fluticasone propionate), talk to your doctor about problems these two medicines may cause when taken together. Your doctor may choose not to keep you on inhaled Flonase®.

KALETRA oral solution contains alcohol. Talk with your doctor if you are taking or planning to take metronidazole or disulfiram. Severe nausea and vomiting can occur.

When preparing a dose of KALETRA oral solution for your child, you should carefully measure the dose of KALETRA as instructed by your healthcare provider. This will reduce the possibility of giving too much or too little medicine, which could cause serious harm to your child or cause the medicine not to work well. KALETRA should not be given once-daily to children.

All strengths of KALETRA tablets should be swallowed whole and not chewed, broken, or crushed.

The most commonly reported side effects of moderate severity that are thought to be drug-related are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea. Children taking KALETRA may sometimes get a skin rash. This is not a complete list of reported side effects.

Pancreas and liver problems, which can cause death, have been reported in patients receiving KALETRA. Tell your doctor if you have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if you have or have had liver disease, such as hepatitis B or C.

Some patients receiving KALETRA have had large increases in triglycerides and cholesterol. The long-term chances of getting complications such as heart attacks or strokes due to these increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.

Diabetes and high blood sugar have occurred in patients taking protease inhibitors.

Changes in body fat have been seen in some patients receiving antiretroviral (anti-HIV) therapy. The cause and long-term health effects of these conditions are not known at this time.

Some patients with hemophilia have increased bleeding when taking protease inhibitors.

The effects of KALETRA on pregnant women or their unborn babies are not known. Mothers should not breast-feed if they are taking KALETRA.

KALETRA tablets should be stored at room temperature. Exposure of this product to high humidity outside the pharmacy container for longer than 2 weeks is not recommended.

Refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 77°F (25°C), KALETRA oral solution should be used within 2 months.

Avoid exposure to excessive heat.

1KALETRA Prescribing Information

This website and the information contained herein are intended for use by US residents only, are provided for informational purposes only and are not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

 

 
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