KALETRA®
(lopinavir/ritonavir) tablets and oral solution

ALERT: Find out about medicines that should NOT be taken with KALETRA. Please also read the section “MEDICINES YOU SHOULD NOT TAKE WITH KALETRA.”

KALETRA®
(kuh-LEE-tra)

Generic Name: lopinavir/ritonavir (lop-IN-uh-veer/rit-ON-uh-veer)

Read this leaflet carefully before you start taking KALETRA. Also, read it each time you get your KALETRA prescription refilled, in case something has changed. This information does not take the place of talking with your doctor when you start this medicine and at check ups. Ask your doctor if you have any questions about KALETRA.

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description provided below. Contact your pharmacist immediately if you believe a dispensing error has occurred.

What is KALETRA and how does it work?

KALETRA is a combination of two medicines. They are lopinavir and ritonavir. KALETRA is a type of medicine called an HIV-1 (human immunodeficiency virus) protease (PRO-tee-ase) inhibitor. KALETRA is always used in combination with other anti-HIV-1 medicines to treat people with human immunodeficiency virus (HIV-1) infection. KALETRA is for adults and for children age 14 days and older.

HIV-1 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-1 protease, a chemical which is needed for HIV-1 to multiply. KALETRA reduces the amount of HIV-1 in your blood and increases the number of T cells. Reducing the amount of HIV-1 in the blood reduces the chance of death or infections that happen when your immune system is weak (opportunistic infections).

Does KALETRA cure HIV-1 or AIDS?

KALETRA does not cure HIV-1 infection 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-1 infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.

Does KALETRA reduce the risk of passing HIV-1 to others?

KALETRA does not reduce the risk of passing HIV-1 to others through sexual contact or blood contamination. Continue to practice safe sex and do not use or share dirty needles.

How should I take KALETRA?

• You should stay under a doctor's care when taking KALETRA. Do not change your treatment or stop treatment without first talking with your doctor.
• You must take KALETRA every day exactly as your doctor prescribed it. The dose of KALETRA may be different for you than for other patients. Follow the directions from your doctor, exactly as written on the label.
• Dosing in adults: The usual KALETRA dose for adults is 400/100 mg (given as two yellow KALETRA tablets (200 mg lopinavir/ 50 mg ritonavir) or 5 mL of KALETRA oral solution) twice a day (morning and night), in combination with other anti-HIV-1 medicines. The doctor may prescribe a KALETRA dose of 800/200 mg (given as four yellow KALETRA tablets (200 mg lopinavir/ 50 mg ritonavir) or 10 mL of KALETRA oral solution) once-daily in combination with other anti-HIV-1 medicines for some patients who have not taken anti-HIV-1 medications in the past.
• Dosing in children greater than 14 days of age: Children greater than 14 days of age can also take KALETRA. The child's doctor will decide the right dose based on the child's weight. KALETRA should not be administered once-daily in children.
• KALETRA tablets (all strengths) should be swallowed whole and not chewed, broken, or crushed.
• KALETRA tablets can be taken with or without food.
• When preparing a dose of KALETRA oral solution for your child, you should carefully measure the dose of KALETRA as instructed by your health care provider. This will reduce the possibility of giving too little or too much medicine which could reduce the effectiveness of therapy or cause serious harm to your child.
• Take KALETRA oral solution with food to help it work better.
• Do not change your dose or stop taking KALETRA without first talking with your doctor.
• When your KALETRA 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 KALETRA and become harder to treat.
• Be sure to set up a schedule and follow it carefully.
• Only take medicine that has been prescribed specifically for you. Do not give KALETRA to others or take medicine prescribed for someone else.

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 at 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 nonprescription medicines and herbal supplements.

For more information about medicines you should not take with KALETRA, please read the section titled “MEDICINES YOU SHOULD NOT TAKE WITH KALETRA.”

• Do not take KALETRA if you have an allergy to KALETRA or any of its ingredients, including ritonavir or lopinavir.

Can I take KALETRA with other medications?*

KALETRA may interact with other medicines, including those you take without a prescription. You must tell your doctor about all the medicines you are taking or planning to take before you take KALETRA.

KALETRA can be taken with acid reducing agents (such as omeprazole and ranitidine) with no dose adjustment.

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)
• Orap®(pimozide)
• Propulsid®(cisapride)
• 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 crossresistance to other anti-HIV-1 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) or Crestor® (rosuvastatin); talk to your doctor before you take any of these cholesterol-reducing medicines with KALETRA.

Medicines that require dosage adjustments:

It is possible that your doctor may need to increase or decrease the dose of other medicines when you are also taking KALETRA. Remember to tell your doctor 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®), amprenavir (Agenerase®) and nelfinavir (Viracept®) 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 FlonaseR.
• 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.

What are the possible side effects of KALETRA?

• This list of side effects is not complete. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your doctor right away. Your doctor may be able to help you manage these side effects.
• The most commonly reported side effects of moderate severity that are thought to be drug related are: abdominal pain, abnormal stools (bowel movements), diarrhea, feeling weak/tired, headache, and nausea. Children taking KALETRA may sometimes get a skin rash.
• Blood tests in patients taking KALETRA may show possible liver problems. People with liver disease such as Hepatitis B and 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 have diabetes before starting protease inhibitors, others do 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 should I tell my doctor before 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-1. 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-1, there is a chance that HIV-1 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.

How do I store KALETRA?

• Keep KALETRA and all other medicines out of the reach of children.
• KALETRA tablets should be stored at room temperature. Exposure of KALETRA tablets 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 25°C (77F), KALETRA oral solution should be used within 2 months.
• Avoid exposure to excessive heat.
• Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.

General advice about prescription medicines:

Talk to your doctor or other health care provider if you have any questions about this medicine or your condition. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you have any concerns about this medicine, ask your doctor. Your doctor or pharmacist can give you information about this medicine that was written for health care professionals. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people.

* The brands listed are trademarks of their respective owners and are not trademarks of Abbott Laboratories. The makers of these brands are not affiliated with and do not endorse Abbott Laboratories or its products.

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