KALETRA- lopinavir and ritonavir tablet, film coated 
KALETRA- lopinavir and ritonavir solution 
AbbVie Inc.

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MEDICATION GUIDE


KALETRA® (kuh-LEE-tra)

(lopinavir/ritonavir)

Tablets

KALETRA® (kuh-LEE-tra)

(lopinavir/ritonavir)

Oral Solution

Read this Medication Guide before you start taking KALETRA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. You and your doctor should talk about your treatment with KALETRA before you start taking it and at regular check-ups. You should stay under your doctor’s care when taking KALETRA.

What is the most important information I should know about KALETRA?

KALETRA may cause serious side effects, including:

Tell your doctor right away if you have any of these symptoms while taking KALETRA:

See “What are the possible side effects of KALETRA?” for more information about serious side effects.

What is KALETRA?

KALETRA is a prescription HIV-1 medicine that is used with other HIV medicines to treat HIV-1 (Human Immunodeficiency Virus) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). KALETRA is a type of HIV medicine called a protease inhibitor. KALETRA contains two medicines: lopinavir and ritonavir.

When used with other HIV medicines, KALETRA may help to reduce the amount of HIV in your blood (called “viral load”). KALETRA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

It is not known if KALETRA is safe and effective in children under 14 days old.

KALETRA does not cure HIV infection or AIDS. People taking KALETRA may develop infections or other conditions associated with HIV infection, including opportunistic infections (for example, pneumonia and herpes virus infections).

Avoid doing things that can spread HIV-1 infection to others:

Ask your doctor if you have any questions on how to prevent passing HIV to other people.

Who should not take KALETRA?

Do not take KALETRA if you take any of the following medicines:

Serious problems can happen if you or your child take any of the medicines listed above with KALETRA.

What should I tell my doctor before taking KALETRA?

KALETRA may not be right for you. Tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA.

Especially tell your doctor if you take:

KALETRA should not be administered once daily in combination with carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), phenobarbital, or phenytoin (Dilantin®, Phenytek®)

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know all the medicines that you take. Keep a list of them with you to show doctors and pharmacists when you get a new medicine.

If you are not sure if you are taking a medicine above, ask your doctor.

How should I take KALETRA?

What are the possible side effects of KALETRA?

KALETRA can cause serious side effects, including:

Common side effects of KALETRA include:

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of KALETRA. For more information, ask your doctor or pharmacist.

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

How should I store KALETRA?

KALETRA tablets:

KALETRA oral solution:

Throw away any medicine that is out of date or that you no longer need.

Keep KALETRA and all medicines out of the reach of children.

General information about KALETRA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KALETRA for a condition for which it was not prescribed. Do not give KALETRA to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about KALETRA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about KALETRA that is written for health professionals. For more information about KALETRA call 1-800-633-9110 or go to www.KALETRA.com.


What are the ingredients in KALETRA?

Active ingredients: lopinavir and ritonavir

Inactive ingredients:

KALETRA 200 mg lopinavir and 50 mg ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, colloidal silicon dioxide, polyethylene glycol 3350, yellow ferric oxide 172, and polysorbate 80.

KALETRA 100 mg lopinavir and 25 mg ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: polyvinyl alcohol, titanium dioxide, talc, polytheylene glycol 3350, and yellow ferric oxide E172.

KALETRA oral solution: acesulfame potassium, alcohol, artificial cotton candy flavor, citric acid, glycerin, high fructose corn syrup, Magnasweet-110 flavor, menthol, natural and artificial vanilla flavor, peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, saccharin sodium, sodium chloride, sodium citrate, and water.

KALETRA oral solution contains 42.4% alcohol (v/v). “See How should I take KALETRA?”.






This Medication Guide has been approved by the U.S. Food and Drug Administration.


2013, ALL RIGHTS RESERVED


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


KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir

Manufactured by AbbVie LTD, Barceloneta, PR 00617

for AbbVie Inc., North Chicago, IL 60064 USA


KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir and KALETRA Oral Solution

AbbVie Inc., North Chicago, IL 60064 USA


03-A841 November 2013

Revised: 11/2013
 
AbbVie Inc.