What is KALETRA?

KALETRA is made up of two medicines. They are lopinavir and ritonavir. The ritonavir increases blood levels of lopinavir. KALETRA is one of a class of drugs called protease inhibitors (PIs). It is used to treat HIV infection in adults and children over 6 months old. KALETRA is always used in combination with other anti-HIV medicines.

How does KALETRA work?

HIV infection destroys CD4 T-cells, which are important to the immune system. After a large number of T-cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

KALETRA blocks HIV protease, a chemical which is needed for HIV to multiply. KALETRA helps reduce the amount of HIV in your blood and increases the number of T-cells. Reducing the amount of HIV in the blood and helping to raise the number of T-cells reduces the chance of death or infections that happen when your immune system is weak (opportunistic infections).

Is KALETRA a cure for HIV or AIDS?

No HIV medication, including KALETRA, can cure HIV or AIDS. The long-term effects of KALETRA are not known at this time. People taking KALETRA may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex infections. Because of this, you should always remain under the care of a doctor.

Does taking KALETRA reduce the risk of passing HIV to others?

No, KALETRA does not reduce the risk of passing HIV to others through sexual contact or blood contamination (for example, sharing needles). You should take steps to minimize the risks associated with these behaviors. Continue to practice safe sex and do not use or share dirty needles.

What should I do if I miss a dose of KALETRA?

It is important that you do not miss any doses. If you miss a dose of KALETRA, take it as soon as possible and then take your next scheduled dose as its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose.

What happens if I take too much KALETRA?

If you suspect that you took more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately.

As with all prescription medicines, KALETRA should be kept out of the reach of young children. KALETRA liquid contains a large amount of alcohol. If a toddler or young child accidentally drinks more than the recommended dose of KALETRA, it could make him/her sick from too much alcohol. Contact your local poison control center or emergency room immediately if this happens.

Who should not take KALETRA?

Together with your doctor, you need to decide whether KALETRA is right for you.

• Do not take KALETRA if you are taking certain medicines. These could cause serious side effects that could cause death. Before you take KALETRA, you must tell your doctor about all the medicines you are taking or are planning to take. These include other prescription and non-prescription (over-the-counter) medicines and herbal products.
• Do not take KALETRA if you have an allergy to KALETRA or any of its ingredients, including ritonavir or lopinavir.

For more information about medicines you should not take with KALETRA, please read the section titled "What are the medicines I should not take with KALETRA?"

What are the medicines I should not take with KALETRA?

KALETRA may interact with other medicines, including those you take without a prescription (over-the-counter and herbal products). You must tell your doctor about all the medicines you are taking or planning to take before you take KALETRA.

Medicines you should not take with KALETRA:

Do not take the following medicines with KALETRA because they can cause serious problems or death if taken with KALETRA.

• Dihydroergotamine, ergonovine, ergotamine and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, Ergotrate Maleate, Methergine, and others
• Halcion® (triazolam)
• Hismanal® (astemizole)
• Orap® (pimozide)
• Propulsid® (cisapride)
• Seldane® (terfenadine)
• Versed® (midazolam)
• Do not take KALETRA with rifampin, also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®. Rifampin may lower the amount of KALETRA in your blood and make it less effective.
• Do not take KALETRA with St. John's wort (hypericum perforatum), an herbal product sold as a dietary supplement or products containing St. John's wort. Talk with your doctor if you are taking or planning to take St. John's wort. Taking St. John's wort may decrease KALETRA levels and lead to increased viral load and possible resistance to KALETRA or cross-resistance to other HIV medicines.
• 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); talk to your doctor before you take any of these cholesterol-reducing medicines with KALETRA.

Can I take KALETRA with other medicines?

KALETRA may interact with other medicines, including those youtake without a prescription. Remember to tell your doctor all medicines you are taking or plan to take.

Medicines that require dosage adjustments:
It is possible that your doctor may need to increase or decrease the dose of other medicines you are taking. Remember to tell your doctor about all medicines you are taking or plan to take.

Before you take Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil) with KALETRA, talk to your doctor about problems these two medicines can cause when taken together. You may get increased side effects of VIAGRA, CIALIS, or LEVITRA such as low blood pressure, vision changes, and penis erection lasting more than 4 hours. If an erection lasts longer than 4 hours, get medical help right away to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.

• If you are taking oral contraceptives ("the pill") or the contraceptive patch to prevent pregnancy you should use an additional or different type of contraception since KALETRA may reduce the effectiveness of oral or patch contraceptives.
• Efavirenz (Sustiva™), nevirapine (Viramune®), Agenerase (amprenavir), and Viracept (nelfinavir) may lower the amount of KALETRA in your blood. Your doctor may increase your dose of KALETRA if you are also taking efavirenz, nevirapine, amprenavir or nelfinavir. KALETRA should not be taken once-daily with these medicines.
• If you are taking Mycobutin® (rifabutin), your doctor will lower the dose of Mycobutin.
• A change in therapy should be considered if you are taking KALETRA with:
  • Phenobarbital
  • Phenytoin (Dilantin® and others)
  • Carbamazepine (Tegretol® and others)
  
  These medicines may lower the amount of KALETRA in your blood and make it less effective. KALETRA should not be taken once-daily with these medicines.
• If you are taking 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®.
• Other Special Considerations:
  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.
• If you are taking both didanosine (Videx®) and KALETRA: Didanosine (Videx®) can be taken at the same time as KALETRA tablets without food. Didanosine (Videx®) should be taken one hour before or two hours after KALETRA oral solution.

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What are the possible side effects of KALETRA?

In KALETRA clinical studies, the most commonly reported side effects of moderate severity were abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea. Children taking KALETRA may sometimes get a skin rash.

This list of side effects is not complete. Your doctor, nurse, or pharmacist can answer your questions about side effects with KALETRA. In KALETRA clinical studies, 4-13% of patients stopped taking KALETRA because of side effects. The studies included patients who had never taken HIV medicines, patients who had taken only one other HIV medicine similar to KALETRA, and patients who had taken several different HIV medicines similar to KALETRA. Talk to your doctor right away about any new or continuing symptoms. Your doctor may be able to help you manage these side effects.

Are there any other side effects I could have while taking KALETRA?

• Blood tests in patients taking KALETRA may show possible liver problems. People with liver disease such as hepatitis B or hepatitis C who take KALETRA may have worsening liver disease. Liver problems including death have occurred in patients taking KALETRA. In studies, it is unclear if KALETRA caused these liver problems because some patients had other illnesses or were taking other medicines.
• Some patients taking KALETRA can develop serious problems with their pancreas (pancreatitis), which may cause death. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if you have nausea, vomiting, or abdominal pain. These may be signs of pancreatitis.
• Some patients have large increases in triglycerides and cholesterol. The long-term chance of getting complications such as heart attacks or stroke due to increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.
• Diabetes and high blood sugar (hyperglycemia) occur in patients taking protease inhibitors such as KALETRA. Some patients had diabetes before starting protease inhibitors, others did not. Some patients need changes in their diabetes medicine. Others need new diabetes medicine.
• Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, 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.
• Some patients with hemophilia have increased bleeding with protease inhibitors.
• There have been other side effects in patients taking KALETRA. However, these side effects may have been due to other medicines that patients were taking or to the illness itself. Some of these side effects can be serious.

What does my doctor need to know before I start taking KALETRA?

• If you are pregnant or planning to become pregnant: The effects of KALETRA on pregnant women or their unborn babies are not known.
• If you are breast feeding: Do not breast-feed if you are taking KALETRA. You should not breast-feed if you have HIV. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby. You should be aware that if your baby does not already have HIV, there is a chance HIV can be transmitted through breast-feeding.
• If you have liver problems: If you have liver problems or are infected with Hepatitis B or Hepatitis C, you should tell your doctor before taking KALETRA.
• If you have diabetes: Some people taking protease inhibitors develop new or more serious diabetes or high blood sugar. Tell your doctor if you have diabetes or an increase in thirst or frequent urination.
• If you have hemophilia: Patients taking KALETRA may have increased bleeding.