Description and Brand Names

US Brand Name

1. Kaletra

Descriptions

Lopinavir and ritonavir combination is used with other medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.

Lopinavir and ritonavir combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lopinavir and ritonavir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Tablet
• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lopinavir and ritonavir combination in infants younger than 14 days of age. Safety and efficacy have not been established. Kaletra® should not be used once a day in children. Kaletra® oral liquid should not be given to premature infants.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lopinavir and ritonavir combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving lopinavir and ritonavir combination.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Alprazolam
• Amiodarone
• Apalutamide
• Astemizole
• Atorvastatin
• Bepridil
• Carbamazepine
• Cisapride
• Colchicine
• Conivaptan
• Crizotinib
• Dihydroergotamine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Efavirenz
• Elbasvir
• Eletriptan
• Eliglustat
• Encainide
• Enzalutamide
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Estetrol
• Ethinyl Estradiol
• Etonogestrel
• Everolimus
• Finerenone
• Flecainide
• Flibanserin
• Fluconazole
• Fosphenytoin
• Gepirone
• Grazoprevir
• Isavuconazonium Sulfate
• Ivabradine
• Ivacaftor
• Ketoconazole
• Levoketoconazole
• Lisuride
• Lomitapide
• Lonafarnib
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Metergoline
• Methylergonovine
• Methysergide
• Midazolam
• Mitotane
• Naloxegol
• Nelfinavir
• Nicergoline
• Nimodipine
• Pacritinib
• Phenobarbital
• Phenytoin
• Pimozide
• Piperaquine
• Posaconazole
• Primidone
• Propafenone
• Quinidine
• Ranolazine
• Rifampin
• Rifapentine
• Riociguat
• Romidepsin
• Sildenafil
• Silodosin
• Simvastatin
• Sirolimus
• Sparfloxacin
• St John’s Wort
• Tacrolimus
• Terfenadine
• Thioridazine
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin
• Voriconazole
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Alfentanil
• Alpelisib
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Amlodipine
• Amoxapine
• Amphetamine
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asciminib
• Asenapine
• Atazanavir
• Atidarsagene Autotemcel
• Atogepant
• Atorvastatin
• Atovaquone
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Bedaquiline
• Benzhydrocodone
• Benzphetamine
• Bepridil
• Betamethasone
• Betrixaban
• Bictegravir
• Boceprevir
• Bosentan
• Bosutinib
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Cabazitaxel
• Cabotegravir
• Cabozantinib
• Calcifediol
• Capivasertib
• Carbamazepine
• Cariprazine
• Celecoxib
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciclesonide
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Cyclophosphamide
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darunavir
• Dasatinib
• Deferasirox
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dienogest
• Digoxin
• Dihydrocodeine
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Drospirenone
• Duvelisib
• Elacestrant
• Elagolix
• Elexacaftor
• Eluxadoline
• Encorafenib
• Entrectinib
• Enzalutamide
• Erdafitinib
• Erlotinib
• Erythromycin
• Escitalopram
• Estradiol
• Eszopiclone
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etrasimod
• Etravirine
• Fedratinib
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Fluoxetine
• Fluticasone
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Fusidic Acid
• Futibatinib
• Garlic
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Gilteritinib
• Givinostat
• Glasdegib
• Glecaprevir
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Hemin
• Histrelin
• Hydrocodone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Isavuconazonium Sulfate
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lacosamide
• Lamotrigine
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levonorgestrel
• Lidocaine
• Lisdexamfetamine
• Lofexidine
• Lonafarnib
• Lorlatinib
• Lovotibeglogene Autotemcel
• Lumacaftor
• Lumateperone
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Mavacamten
• Mavorixafor
• Medroxyprogesterone
• Mefloquine
• Meperidine
• Mestranol
• Methadone
• Methamphetamine
• Methotrexate
• Methylenedioxymethamphetamine
• Methylprednisolone
• Metronidazole
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mobocertinib
• Mometasone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Neratinib
• Nifedipine
• Nilotinib
• Nirogacestat
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Oliceridine
• Omaveloxolone
• Omeprazole
• Ondansetron
• Orlistat
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pibrentasvir
• Pimavanserin
• Piperaquine
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Ponatinib
• Ponesimod
• Posaconazole
• Pralsetinib
• Pravastatin
• Prednisone
• Primidone
• Procainamide
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Reboxetine
• Regorafenib
• Relugolix
• Repotrectinib
• Retapamulin
• Ribociclib
• Rifabutin
• Rifapentine
• Rilpivirine
• Rimegepant
• Ritlecitinib
• Rivaroxaban
• Roflumilast
• Rosuvastatin
• Ruxolitinib
• Salmeterol
• Saquinavir
• Segesterone
• Selpercatinib
• Selumetinib
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Talazoparib
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telavancin
• Telithromycin
• Temsirolimus
• Tenofovir Alafenamide
• Tetrabenazine
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tipranavir
• Topotecan
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Triamcinolone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Upadacitinib
• Valbenazine
• Valproic Acid
• Vamorolone
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Vortioxetine
• Voxilaprevir
• Zanubrutinib
• Zolpidem
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Amitriptyline
• Amprenavir
• Aripiprazole Lauroxil
• Cerivastatin
• Clonazepam
• Dalfopristin
• Delavirdine
• Desipramine
• Didanosine
• Dutasteride
• Efavirenz
• Eltrombopag
• Fosamprenavir
• Gemfibrozil
• Imipramine
• Indinavir
• Lamotrigine
• Levothyroxine
• Mexiletine
• Nefazodone
• Nelfinavir
• Nevirapine
• Prasugrel
• Quinupristin
• Risperidone
• Tenofovir Disoproxil Fumarate
• Theophylline
• Valproic Acid
• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cirrhosis (liver disease) or
• Diabetes mellitus or
• Hemophilia (a bleeding problem) or
• Hyperglycemia (high blood sugar) or
• Hyperlipidemia (high cholesterol or fat in the blood) or
• Liver disease (eg, hepatitis B or C) or
• Pancreatitis, history of—Use with caution. May make these conditions worse.

• Heart attack, history of or
• Heart disease (eg, cardiomyopathy, ischemic heart disease), history of or
• Heart rhythm problems (eg, prolonged PR or QT interval, congenital long QT syndrome), history of or
• Hypokalemia (low potassium in the blood)—Use with caution. May increase risk for more serious side effects.

Proper Use

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a Medication Guide. Read and follow the instructions carefully before starting treatment and each time you refill your prescription. Ask your doctor or pharmacist if you have any questions.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

Lopinavir and ritonavir combination must be taken with other medicines that are used to treat HIV. Take all of the medicines your doctor has prescribed at the right time of day and in correct order. Do not stop using your medicine unless your doctor tells you to.

It is important that lopinavir and ritonavir oral liquid be taken with food. Use a calibrated dosing syringe or medicine cup to measure the dose for the oral liquid. It may also be given through some types of feeding tubes (eg, silicone and polyvinyl chloride [PVC]). Do not use a polyurethane feeding tube to give this medicine.

Lopinavir and ritonavir tablets may be taken with or without food. Swallow the tablets whole. Do not crush, break, or chew them.

If you are also using didanosine (Videx®), take it 1 hour before or 2 hours after taking Kaletra® oral liquid. Didanosine can be taken (without food) at the same time as Kaletra® tablets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of HIV infection:
  • For oral dosage form (solution):
    • Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) two times a day with food or 800 mg of lopinavir and 200 mg of ritonavir (10 mL) once a day with food. Your doctor may adjust your dose as needed.
    • Children 6 months and older—Dose is based on body weight or body size and must be determined by your child’s doctor. The recommended dose is 10 to 12 milligrams per kilogram (mg/kg) of body weight or 230 milligrams per square meter (mg/m[2]) of body size for lopinavir and 2.5 to 3 mg/kg or 57.5 (mg/m[2]) for ritonavir two times a day with food. Your doctor may adjust your dose as needed.
    • Children 14 days to 6 months of age—Dose is based on body weight or body size and must be determined by your child’s doctor. The recommended dose is 16 milligrams per kilogram (mg/kg) of body weight or 300 milligrams per square meter (mg/m[2]) of body size for lopinavir and 4 mg/kg or 75 (mg/m[2]) for ritonavir two times a day with food.
    • Children younger than 14 days of age—Use is not recommended, unless your doctor determines it is safe to be given.
  • For oral dosage form (tablets):
    • Adults—400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) two times a day or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) once a day. Your doctor may adjust your dose as needed.
    • Children 6 months and older—The child must be able to swallow a tablet whole. Dose is based on body weight and must be determined by your child’s doctor. The recommended dose is 200 to 400 milligrams (mg) of lopinavir and 50 to 100 mg of ritonavir (2 to 4 tablets) two times a day. Your doctor may adjust your dose as needed.
    • Children 14 days to 6 months of age—This dosage form is usually not used for infants. Please refer to the oral solution dosage form.
    • Infants younger than 14 days of age—Use is not recommended, unless your doctor determines it is safe to be given.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is best to store the Kaletra® oral liquid in a closed container in the refrigerator. Do not freeze. If you must store the liquid at room temperature, use the medicine within 2 months and keep it away from excessive heat.

The Kaletra® tablets should be stored in a closed container at room temperature, away from heat, moisture, and direct light. Do not store this medicine out of the original container and in places with high humidity for more than 2 weeks.

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