Lopinavir/
Ritonavir

Pronunciation: loe-PIN-a-vir/rit-OH-na-vir
Generic Name: Lopinavir/Ritonavir
Brand Name: Kaletra

Lopinavir/Ritonavir is used for:

Treating HIV infection. It is used along with other medicines for HIV.

Lopinavir/Ritonavir is a combination of 2 HIV protease inhibitors. It works by stopping the HIV virus from multiplying.

Do NOT use Lopinavir/Ritonavir if:

• you are allergic to any ingredient in Lopinavir/Ritonavir
• you have a certain type of irregular heartbeat (congenital long QT syndrome) or low blood potassium levels
• you cannot swallow the tablet whole
• you are taking alfuzosin, astemizole, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, conivaptan, eletriptan, an ergot derivative (eg, ergotamine, methylergonovine), meperidine, oral midazolam, pimozide, rifampin, salmeterol, St. John's wort, terfenadine, tipranavir, or triazolam
• you are taking sildenafil to treat pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lopinavir/Ritonavir:

Some medical conditions may interact with Lopinavir/Ritonavir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have hepatitis, other liver problems, or abnormal liver function tests
• if you have high cholesterol or triglyceride levels, or hemophilia or another bleeding disorder
• if you have a history of kidney problems, pancreas problems (eg, pancreatitis), diabetes or high blood sugar (hyperglycemia), or low potassium or magnesium blood levels
• if you have a history of heart problems (eg, heart failure, conduction abnormalities), heart blood vessel problems, irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of irregular heartbeat
• if you take another HIV protease inhibitor (eg, atazanavir, tipranavir)

Some MEDICINES MAY INTERACT with Lopinavir/Ritonavir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Astemizole, cisapride, meperidine, pimozide, salmeterol, or terfenadine because serious side effects, such as seizures, blood problems, or heart problems (eg, irregular heartbeat), may occur
• Sildenafil (when used to treat PAH) because serious side effects, such as low blood pressure, prolonged erection, or vision changes, may occur
• Midazolam or triazolam because serious side effects, such as prolonged sedation or breathing problems, may occur
• Ergot derivatives (eg, ergotamine, methylergonovine) because serious blood flow problems may occur
• Rifampin, St. John's wort, or tipranavir because they may decrease Lopinavir/Ritonavir's effectiveness
• Alfuzosin, conivaptan, eletriptan, or certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin) because the risk of their side effects may be increased by Lopinavir/Ritonavir
• Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, allergies, asthma or other breathing problems, pain, birth control, blood thinning, cancer, enlarged prostate, gout, irregular heartbeat or other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, PAH, seizures, sleep disorders, smoking cessation, depression or other mood or mental problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Lopinavir/Ritonavir, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lopinavir/Ritonavir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lopinavir/Ritonavir:

Use Lopinavir/Ritonavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lopinavir/Ritonavir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lopinavir/Ritonavir refilled.
• Take Lopinavir/Ritonavir by mouth with or without food.
• Swallow Lopinavir/Ritonavir whole. Do not break, crush, or chew before swallowing.
• Lopinavir/Ritonavir must be taken with other HIV medicines to be effective.
• If you are also taking didanosine, you may take it at the same time as Lopinavir/Ritonavir without food.
• Taking Lopinavir/Ritonavir at the same time each day will help you remember to take it.
• Continue to take Lopinavir/Ritonavir even if you feel well. Do not miss any doses. Do not stop taking Lopinavir/Ritonavir without checking with your doctor.
• If you miss a dose of Lopinavir/Ritonavir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lopinavir/Ritonavir.

Important safety information:

• Lopinavir/Ritonavir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Lopinavir/Ritonavir.
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Lopinavir/Ritonavir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• If the patient is a child, tell the child's doctor if his or her weight changes. The dose of Lopinavir/Ritonavir may need to be changed.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Lopinavir/Ritonavir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Lopinavir/Ritonavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Lopinavir/Ritonavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Hormonal birth control (eg, birth control pills) may not work as well while you are taking Lopinavir/Ritonavir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Hemophilia patients - Report all bleeding episodes to your doctor.
• Lopinavir/Ritonavir may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including cholesterol and triglyceride levels, viral load, and liver function, may be performed while you use Lopinavir/Ritonavir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Lopinavir/Ritonavir in CHILDREN; they may be more sensitive to its effects, especially skin rash.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Lopinavir/Ritonavir while you are pregnant. It is not known if Lopinavir/Ritonavir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Lopinavir/Ritonavir to the baby.

Possible side effects of Lopinavir/Ritonavir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain or upset; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of consciousness; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, unusual fatigue); unusual bleeding or bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lopinavir/Ritonavir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Lopinavir/Ritonavir:

Store Lopinavir/Ritonavir between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not expose Lopinavir/Ritonavir to high humidity outside of the original container for longer than 2 weeks. Keep Lopinavir/Ritonavir out of the reach of children and away from pets.

General information:

• If you have any questions about Lopinavir/Ritonavir, please talk with your doctor, pharmacist, or other health care provider.
• Lopinavir/Ritonavir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lopinavir/Ritonavir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.