Generic Name: lopinavir and ritonavir (loe-PIN-a-vir & ri-TOE-na-vir)
Brand Name: Kaletra
Kaletra is used for:
Treating HIV infection. It is used along with other medicines for HIV.
Kaletra is a combination of 2 HIV protease inhibitors. It works by stopping the HIV virus from multiplying.
Do NOT use Kaletra if:
- you are allergic to any ingredient in Kaletra
- 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, avanafil, boceprevir, cisapride, dihydroergotamine, ergotamine, lovastatin, methylergonovine, oral midazolam, pimozide, rifampin, rivaroxaban, salmeterol, simvastatin, St. John's wort, telaprevir, or triazolam
- you are taking sildenafil to treat pulmonary arterial hypertension (PAH)
- you are taking colchicine and you also have kidney or liver problems
- you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Contact your doctor or health care provider right away if any of these apply to you.
Before using Kaletra:
Some medical conditions may interact with Kaletra. 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 high cholesterol or triglyceride levels, or hemophilia or another bleeding disorder
- if you have a history of kidney problems, liver problems (eg, hepatitis B or C) or abnormal liver function tests, 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, or 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 Kaletra. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for abortion, aches or pain, allergies, asthma or other lung or breathing problems, birth control, blood thinning, blood vessel problems, bone marrow problems, cancer, Cushing syndrome, cystic fibrosis, depression or other mental or mood problems, diabetes, enlarged prostate, erectile dysfunction, gout, hepatitis C, high blood pressure, high cholesterol, HIV infection, immune suppression, infection, inflammation, irregular heartbeat or other heart problems, low blood sodium levels, migraines, PAH, seizures, sleep disorders, smoking cessation), multivitamin products, and herbal or dietary supplements (eg, garlic) because they may interact with Kaletra. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Kaletra.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Kaletra 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 Kaletra:
Use Kaletra as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Kaletra comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Kaletra refilled.
- Take Kaletra by mouth with or without food.
- Swallow Kaletra whole. Do not break, crush, or chew before swallowing.
- Kaletra 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 Kaletra without food.
- Taking Kaletra at the same time each day will help you remember to take it.
- Continue to take Kaletra even if you feel well. Do not miss any doses. Do not stop taking Kaletra without checking with your doctor.
- If you miss a dose of Kaletra, 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 Kaletra.
Important safety information:
- Tell your doctor or dentist that you take Kaletra before you receive any medical or dental care, emergency care, or surgery.
- Kaletra interacts with many other medicines. The risk of Kaletra's side effects may be increased or Kaletra's effectiveness may be decreased. The risk of the other medicines' side effects may also be increased. This may include severe, life-threatening, or fatal side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take Kaletra with all of your other medicines (prescription or OTC, natural products, vitamins).
- Kaletra 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 Kaletra.
- 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 Kaletra. 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 Kaletra 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 Kaletra, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Do NOT change your dose or stop taking Kaletra without checking with your doctor.
- Kaletra is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
- Kaletra does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
- Hormonal birth control (eg, birth control pills) may not work as well while you are taking Kaletra. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as Kaletra. Report all bleeding episodes to your doctor.
- Very bad and sometimes deadly skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have happened with Kaletra. They can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have symptoms like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Serious and sometimes fatal liver problems have happened with Kaletra. Discuss any questions or concerns with your doctor.
- Kaletra 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 may be performed while you use Kaletra. 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 Kaletra 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 Kaletra while you are pregnant. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Kaletra to the baby.
Possible side effects of Kaletra:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; headache; muscle or joint pain; nausea; stomach pain; tiredness; vomiting; weakness.
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 or irregular heartbeat; fever, chills, or sore throat; loss of consciousness; severe or persistent nausea or vomiting; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, stomach pain, unusual fatigue); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); 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.
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 Kaletra:
Store Kaletra at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not expose Kaletra to high humidity outside of the original container for longer than 2 weeks. Keep Kaletra out of the reach of children and away from pets.
- If you have any questions about Kaletra, please talk with your doctor, pharmacist, or other health care provider.
- Kaletra 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 should not be used to decide whether or not to take Kaletra or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kaletra. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Kaletra. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Kaletra.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.