Kaletra

Kaletra is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. 

Kaletra is a prescription medication that contains two medicines: lopinavir and ritonavir.

Lopinavir and ritonavir belong to a group of drugs called protease inhibitors. These work by stopping the virus from replicating. Ritonavir helps to increase the amount of lopinavir in the body so that the medication will have a greater effect.

This medication comes in capsule, tablet, and oral liquid forms. It is usually taken once or twice daily.

Swallow Kaletra tablets whole.

Common side effects of Kaletra include diarrhea, nausea, and stomach pain.

Kaletra is a prescription medication that contains two medicines, lopinavir and ritonavir. It is used in combination with other HIV medicines to treat human immunodeficiency virus (HIV) infection.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• AbbVie Inc.

Kaletra may cause serious side effects, including: 

• Interactions with other medicines. It is important to know the medicines that should not be taken with Kaletra.
• Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
  • already have a history of abnormal heart rhythm or other types of heart disease.
  • take other medicines that can affect your heart rhythm while you take Kaletra.

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

• dizziness
• lightheadedness
• fainting
• sensation of abnormal heartbeats

Liver problems, including death, can happen in people who take Kaletra. Signs and symptoms of liver problems include:

• loss of appetite
• yellow skin and whites of eyes (jaundice)
• dark colored urine
• pale colored stools,
• itchy skin
• abdominal pain (stomach pain)

Kaletra may cause pancreatitis (inflammation of the pancreas). Tell your doctor if you have nausea, vomiting, or abdominal pain (stomach pain) while taking Kaletra.

Large increases of triglycerides and cholesterol can be seen in blood tests of some people who take Kaletra.

Some people taking Kaletra get new or more serious diabetes or high blood sugar.

Changes in body fat have occurred in people taking Kaletra.

Some people with hemophilia have increased bleeding while taking Kaletra.

Allergic reactions, including sometimes severe skin rashes, have occurred in people taking Kaletra.

Common side effects of Kaletra include:

• diarrhea
• nausea
• stomach area (abdominal) pain
• feeling weak
• vomiting
• headache
• upset stomach

Serious problems or death can happen if you take these medicines with Kaletra:

• ergotamine tartrate (Cafergot, Migergot, Ergomar, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
• dihydroergotamine mesylate (D.H.E. 45, Embolex, Migranal)
• ergonovine, ergonovine and methylergonovine (Ergotrate, Methergine), ergotamine and methylergonovine
• Ergotrate Maleate, methylergonovine maleate (Methergine)
• triazolam (Halcion), midazolam hydrochloride oral syrup
• pimozide (Orap)
• the cholesterol lowering medicines lovastatin (Mevacor) or simvastatin (Zocor)
• sildenafil (Revatio) only when used for the treatment of pulmonary arterial hypertension.
• alfuzosin (Uroxatral) 

Medicines that you should not take with Kaletra since they may make Kaletra not work as well:

• the herbal supplement St. John's Wort (hypericum perforatum)
• rifampin (Rimactane, Rifadin, Rifater, or Rifamate)

Medicines that may need changes:

• birth control pills that contain estrogen ("the pill") or the birth control (contraceptive) patches
• certain anticancer medicines, such as nilotinib (Tasigna) and dasatinib (Sprycel)
• certain cholesterol lowering medicines, such as atorvastatin (Lipitor) or rosuvastatin (Crestor)
• certain other antiretroviral medicines, such as efavirenz (Atripla and Sustiva), nevirapine (Viramune), amprenavir (Agenerase) and nelfinavir (Viracept)
• anti-seizure medicines, such as phenytoin (Dilantin) carbamazepine, (Tegretol), phenobarbital
• medicines for erectile problems, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• medicines for tuberculosis (TB), such as rifabutin (Mycobutin)
• inhaled steroid medicines, such as fluticasone propionate (Flonase)
• inhaled medicines such as salmeterol (Serevent) or salmeterol in combination with fluticasone propionate (Advair). Your doctor may need to change to a different medicine
• medicines for gout, such as colchicine (Colcrys)
• medicines to treat pulmonary arterial hypertension (PAH), such as bosentan (Tracleer) or tadalafil (Adcirca)
• pain medicines, such as fentanyl (Duragesic, Ionsys, Fentora) and methadone
• metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with Kaletra.

Kaletra may cause serious side effects, including: 

• Interactions with other medicines. See "Drug Interactions" section.
• Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
  • already have a history of abnormal heart rhythm or other types of heart disease.
  • take other medicines that can affect your heart rhythm while you take Kaletra.

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

• dizziness
• lightheadedness
• fainting
• sensation of abnormal heartbeats

Do not take Kaletra if you are taking certain medicines. For more information about medicines you should not take with Kaletra, and consult with your doctor about all other medicines you take.

Do not take Kaletra if you have an allergy to Kaletra or any of its ingredients.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kaletra there are no specific foods that you must exclude from your diet when receiving Kaletra.

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

• have any heart problems, including if you have a condition called Congenital Long QT Syndrome.
• have liver problems, including Hepatitis B or Hepatitis C.
• have diabetes.
• have hemophilia. People who take Kaletra may have increased bleeding.
• have low potassium in your blood.
• are pregnant or plan to become pregnant. 
• take Kaletra during pregnancy, talk with your doctor about how you can take part in an antiretroviral pregnancy registry. The purpose of the pregnancy registry is to follow the health of you and your baby.
• are breastfeeding. Do not breastfeed if you are taking Kaletra. You should not breastfeed if you have HIV-1. If you are a woman who has or will have a baby while taking Kaletra, talk with your doctor about the best way to feed your baby. If your baby does not already have HIV-1, there is a chance that HIV-1 can be passed to your baby through your breast milk.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Kaletra falls into category C. It is not known if Kaletra will harm your unborn baby.

To monitor maternal-fetal outcomes of pregnant women exposed to Kaletra, an Antiretroviral Pregnancy Registry has been established. Patients can register by calling 1-800-258-4263.

Birth control pills or patches may not work as well while you take Kaletra. To prevent pregnancy while taking Kaletra, women who take birth control pills or use estrogen patch for birth control should either use a different type of birth control or an extra form of birth control. Talk to your doctor about how to prevent pregnancy while taking Kaletra.

Tell your doctor if you are breastfeeding or planning to breastfeed. You should not breastfeed if you are infected with HIV or if you are taking Kaletra.

• Take Kaletra every day exactly as prescribed by your doctor.
• It is very important to set up a dosing schedule and follow it every day. Do not miss a dose of Kaletra. This could make the virus harder to treat. If you forget to take Kaletra, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of Kaletra at one time.
• Do not change your treatment or stop treatment without first talking with your doctor.
• Swallow Kaletra tablets whole. Do not chew, break, or crush Kaletra tablets.
• Kaletra tablets can be taken with or without food.
• Take Kaletra oral solution and Kaletra capsules with food to help it work better.
• If Kaletra is being used for your child, tell your doctor if your child’s weight changes.
• Kaletra should not be given one time each day in children. When giving Kaletrar to your child, give Kaletra exactly as prescribed.
• Kaletra oral solution contains propylene glycol and a large amount of alcohol. Kaletra oral solution should not be given to babies younger than 14 days of age unless your doctor thinks it is right for your baby.
• If a young child drinks more than the recommended dose, it could make them sick. Contact your local poison control center or emergency room right away.
• Talk with your doctor if you take or plan to take metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with Kaletra.
• When your Kaletra supply starts to run low, get more from your doctor or pharmacy. It is important not to run out of Kaletra. The amount of HIV-1 virus in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to Kaletra and become harder to treat.
• Kaletra can be taken with acid reducing agents used for heartburn or reflux such as omeprazole (Prilosec) and ranitidine (Zantac ) with no dose adjustment.
• Kaletra should not be administered once daily in combination with carbamazepine (Tegretol and Epitol), phenobarbital (Luminal), or phenytoin (Dilantin).

If you are taking both Videx (didanosine) and Kaletra:

• Didanosine can be taken at the same time as Kaletra tablets, without food.
• Take didanosine either one hour before or two hours after taking Kaletra oral solution.

Avoid doing things that can spread HIV infection. Kaletra does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Take Kaletra exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dosage for you. Tablets may be taken with or without food, swallowed whole and not chewed, broken, or crushed. Oral solution and capsules must be taken with food. 

Recommended dosage for:

Adult Patients

• 400/100 mg (two 200/50 mg tablets, 3 capsules, or 5 mL oral solution) twice daily

• Kaletra 400/100 mg (3 capsules or 5.0 mL) twice-daily taken with food.
• Kaletra 800/200 mg (6 capsules or 10 mL) once-daily taken with food.
• Kaletra 800/200 mg (10 mL) once-daily taken with food.
• Kaletra 800/200 mg (four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions.

Once-daily administration of Kaletra is not recommended in therapy-experienced patients.

Pediatric patients (ages 14 days and older) 

• Twice daily dose is based on body weight or body surface area.

Concomitant Therapy in Adults and Pediatric Patients 

• Dose adjustments of Kaletra may be needed when co-administering with efavirenz, nevirapine, amprenavir, or nelfinavir.

Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been attained 

If you have taken too much Kaletra call your local Poison Control Center or seek emergency medical treatment right away.

Kaletra tablets:

• Store Kaletra tablets at room temperature, between 59°F to 86°F (15°C to 30°C).
• Do not keep Kaletra tablets out of the container it comes in for longer than 2 weeks, especially in areas where there is a lot of humidity. Keep the container closed tightly.

Kaletra capsules:

• Store Kaletra capsules at room temperature, between 36°F - 46°F (2°C - 8°C) until dispensed.
• Avoid exposure to excessive heat.
• For patient use, refrigerated Kaletra capsules remain stable until the expiration date printed on the label. If stored at room temperature up to 77°F (25°C), capsules should be used within 2 months.

Kaletra oral solution:

• Store Kaletra oral solution in a refrigerator, between 36°F to 46°F (2°C to 8°C). Kaletra oral solution that is kept refrigerated may be used until the expiration date printed on the label.
• Kaletra oral solution that is stored at room temperature (less than 77°F or 25°C) should be used within 2 months.
• Keep Kaletra away from high heat.
• 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.