Kaletra

Generic name: Lopinavir and ritonavir

What is Kaletra?

Kaletra is a combination of two medicines, lopinavir and ritonavir, used to treat HIV-infected people. Kaletra is always used with other anti-HIV medicines. Kaletra is a protease inhibitor, which blocks a chemical that HIV needs to multiply itself. HIV infection destroys CDr, or T cells, which are important to the immune system. Kaletra may increase the number of T cells and reduce the amount of HIV in the blood, which reduces the chance of death or infections that happen when your immune system is weak.

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

Kaletra does not cure human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), nor does it reduce the risk of passing HIV to others through sexual contact or blood contamination.

Combining Kaletra with certain other medications can cause serious, even life-threatening, reactions. See "What are possible food and drug interactions associated with this medication?" below before taking Kaletra with any other medication.

There have been reports of inflammation of the pancreas (sometimes fatal) in people taking Kaletra. Tell your doctor if you experience abdominal pain, nausea, or vomiting while taking Kaletra.

Who should not take Kaletra?

Do not take Kaletra if you are allergic to the medication or any of its ingredients, including ritonavir or lopinavir. Do not take Kaletra if you are taking certain medicines (see "What are possible food and drug interactions associated with this medication?")

What should I tell my doctor before I take the first dose of Kaletra?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Kaletra. Also, talk to your doctor about your complete medical history, especially if you have diabetes; hemophilia; or liver problems, including infection with hepatitis B or hepatitis C.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Tablets

Adults and children 12 years and older: Each Kaletra tablet contains 200 milligrams (mg) of lopinavir and 50 mg of ritonavir. For patients who have not taken any anti-HIV medications in the past, your doctor may prescribe 2 tablets (400/100 mg) taken 2 times each day or 4 tablets (800/200 mg) taken once daily. For patients with experience with anti-HIV medications, the usual dose is 2 tablets (400/100mg) taken 2 times each day.

Oral Suspension

Adults and children≥12 years and older: For patients who have not taken any anti-HIV medications in the past, your doctor may prescribe either 5 milliliters (mL) taken 2 times each day or 10mL to be taken 1 time each day. For patients with experience with anti-HIV medications, the usual dose is 5 mL taken 2 times each day.

Capsules

Adults and children 12 years and older: For patients who have not taken any anti-HIV medications in the past, your doctor may prescribe either 3 capsules taken 2 times each day or 6 capsules taken once daily. For patients with experience with anti-HIV medications, the usual dose is 3 capsules taken 2 times each day.

Dosage adjustments may be made depending on the other medicines you are taking.

Children 6 months to 12 years: The usual dose is calculated based on weight.

How should I take Kaletra?

Take Kaletra oral solution with food to help it work most effectively.

Kaletra tablets can be taken with or without food. Kaletra tablets and capsules should be swallowed whole and not chewed, broken, or crushed. Let your doctor know when your Kaletra supply starts to run low.

What should I avoid while taking Kaletra?

Avoid doing things that can spread HIV infection, since Kaletra doesn't stop you from passing HIV to others. Practice safe sex and do not share needles or personal items that can have blood or bodily fluids on them.

Avoid taking any new medications without first talking to your doctor (see "What are possible food and drug interactions associated with this medication?" below).

Do not stop taking Kaletra unless your doctor tells you to do so. If the medicine is stopped for even a short time, the amount of HIV in your blood may increase, or the virus may develop resistance to Kaletra and become harder to treat.

What are possible food and drug interactions associated with Kaletra?

If Kaletra is taken with certain other drugs, the effects of either could be increased, decreased, or altered. If you use birth control pills or a contraceptive patch, you should use an additional or different kind of contraception, because Kaletra can affect the effectiveness of contraceptives.

Combining Kaletra with certain medications can cause serious, even life-threatening, reactions. It is important to check with your doctor before combining Kaletra with the following: astemizole, cholesterol-lowering medicines (such as lovastatin, simvastatin, and atorvastatin), cisapride, ergot-based medications that are often used for migraines (such as dihydroergotamine, ergonovine, ergotamine, and methylergonovine), midazolam, pimozide, rifampin, St. John's wort, terfenadine, triazolam.

It is also very important to check with your doctor before combining Kaletra with the following medications: amprenavir, carbamazepine, didanosine, disulfiram, efavirenz, fluticasone propionate, metronidazole, nelfinavir, nevirapine, phenobarbital, phenytoin, rifabutin, sildenafil, tadalafil, vardenafil.

What are the possible side effects of Kaletra?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, nausea, skin rash (in children)

Can I receive Kaletra if I am pregnant or breastfeeding?

The effects of Kaletra during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed if you have HIV, as there is a chance that the virus can be transmitted via breastfeeding.

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. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not take 2 doses at once.

How should I store Kaletra?

Store Kaletra tablets at room temperature; avoid excessive heat and do not expose Kaletra tablets to high humidity outside the pharmacy container for longer than 2 weeks.

Kaletra oral solution and capsules can be used within 2 months if stored at room temperature. If you refrigerate your Kaletra oral solution and capsules, you will be able to use it until the printed expiration date. Avoid exposing Kaletra oral solution and capsules to excessive heat.