Kaletra is a brand name for a combination of two active ingredients: lopinavir and ritonavir. Lopinavir, an HIV-1 protease inhibitor, and ritonavir, which inhibits the metabolism of lopinavir to increase its plasma levels, form the drug class. The medication is available as oral tablets in dosages of 200 mg/50 mg and 100 mg/25 mg and contains inactive ingredients such as colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The tablets are intended to increase lopinavir plasma levels by including ritonavir.

How should I use this medication?

Take this medication by mouth with water. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew the medication. Swallow the tablets whole. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substances. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Fatigue
• Headache
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Heart disease
• Hemophilia
• History of pancreatitis
• Liver disease
• An unusual or allergic reaction to lopinavir, ritonavir, castor oil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Adagrasib
• Alfuzosin
• Certain medications for anxiety or sleep, such as midazolam, triazolam
• Certain medications for cancer, such as apalutamide, enzalutamide
• Certain medications for cholesterol, such as lomitapide, lovastatin, simvastatin
• Certain medications for fungal infections, such as fluconazole, posaconazole
• Certain medications for hepatitis C, such as elbasvir, grazoprevir, boceprevir, dasabuvir, ombitasvir, paritaprevir, ritonavir
• Cisapride
• Dronedarone
• Eletriptan
• Ergot alkaloids, such as dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Lurasidone
• Meperidine
• Naloxegol
• Pimozide
• Ranolazine
• Red yeast rice
• Ribociclib
• Rifampin
• Silodosin
• St. John's wort
• Thioridazine
• Ubrogepant

This medication may also interact with the following:

• Atovaquone
• Bedaquiline
• Bosentan
• Bupropion
• Certain medications for blood pressure, such as felodipine, nicardipine, nifedipine
• Certain medications for cancer, such as abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine
• Certain medications for cholesterol, such as atorvastatin
• Certain medications for erectile dysfunction, such as sildenafil, tadalafil, vardenafil
• Certain medications for fungal infections, such as isavuconazonium, itraconazole, ketoconazole, voriconazole
• Certain medications for irregular heartbeat, such as amiodarone, bepridil, lidocaine, quinidine
• Certain medications for seizures, such as carbamazepine, lamotrigine, phenobarbital, phenytoin, valproate
• Certain medications that treat or prevent blood clots, such as rivaroxaban, warfarin
• Clarithromycin
• Colchicine
• Cyclosporine
• Elagolix
• Estrogen and progestin hormones
• Fentanyl
• Fostamatinib
• Methadone
• Other medications for HIV or AIDS
• Other medications that cause heart rhythm changes, such as dofetilide, ziprasidone
• Quetiapine
• Rifabutin
• Rifapentine
• Salmeterol
• Sirolimus
• Steroid medications, such as budesonide, dexamethasone, fluticasone, prednisone, triamcinolone
• Tacrolimus
• Trazodone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

Estrogen and progestin hormones may not work as well while you are taking this medication. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.