Kaletra

Description

The combination of lopinavir and ritonavir is used 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; however, 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


• Capsule, Liquid Filled


• 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 below 14 days of age. Safety and efficacy have not been established.

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.

Pregnancy

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

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


• Amiodarone


• Astemizole


• Bepridil


• Cisapride


• Conivaptan


• Dihydroergotamine


• Dronedarone


• Encainide


• Eplerenone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Flecainide


• Lovastatin


• Methylergonovine


• Methysergide


• Midazolam


• Pimozide


• Propafenone


• Quinidine


• Ranolazine


• Rifampin


• Sildenafil


• Silodosin


• Simvastatin


• St John`s Wort


• Terfenadine


• Tolvaptan


• Triazolam


• Voriconazole

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.

• Amiodarone


• Aprepitant


• Bepridil


• Bosentan


• Carbamazepine


• Colchicine


• Darunavir


• Dasatinib


• Digoxin


• Etravirine


• Everolimus


• Fentanyl


• Fluticasone


• Fusidic Acid


• Garlic


• Iloperidone


• Irinotecan


• Ixabepilone


• Lapatinib


• Lidocaine


• Methylenedioxymethamphetamine


• Nilotinib


• Pazopanib


• Phenobarbital


• Phenytoin


• Pitavastatin


• Quinidine


• Rifabutin


• Rifampin


• Romidepsin


• Rosuvastatin


• Salmeterol


• Sunitinib


• Tamsulosin


• Temsirolimus


• Tipranavir


• Topotecan


• Venlafaxine


• Vinblastine


• Vincristine


• Voriconazole

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


• Alprazolam


• Amitriptyline


• Amlodipine


• Amprenavir


• Atazanavir


• Atorvastatin


• Bupropion


• Carbamazepine


• Cerivastatin


• Clarithromycin


• Clonazepam


• Clozapine


• Cyclosporine


• Dalfopristin


• Delavirdine


• Desipramine


• Dexamethasone


• Didanosine


• Diltiazem


• Disopyramide


• Docetaxel


• Dutasteride


• Efavirenz


• Ethinyl Estradiol


• Fentanyl


• Fluoxetine


• Fosamprenavir


• Imipramine


• Indinavir


• Itraconazole


• Ketoconazole


• Lamotrigine


• Levonorgestrel


• Levothyroxine


• Maraviroc


• Meperidine


• Mestranol


• Methadone


• Methamphetamine


• Metoprolol


• Mexiletine


• Nefazodone


• Nelfinavir


• Nevirapine


• Norelgestromin


• Norethindrone


• Norgestrel


• Paroxetine


• Phenobarbital


• Phenytoin


• Posaconazole


• Prednisone


• Quinupristin


• Rifapentine


• Risperidone


• Tacrolimus


• Tadalafil


• Tenofovir Disoproxil Fumarate


• Theophylline


• Trazodone


• Valproic Acid


• Verapamil


• 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:

• Diabetes mellitus or


• Hyperglycemia (high blood sugar)a€”May increase blood sugar .

• Heart attack, history of or


• Heart disease (e.g., cardiomyopathy), history of or


• Heart rhythm problems (e.g., prolonged PR or QT interval, congenital long QT syndrome), history of or


• Hypokalemia (low potassium in the blood)a€”Use with caution. May increase risk for more serious side effects.

• Hemophilia (a bleeding problem)a€”May increase the risk of bleeding.

• Hepatitis B or


• Hepatitis C or


• Hyperlipidemia (high cholesterol or fat in the blood) or


• Liver problems or


• Pancreatitis, history ofa€”Use with caution. May make these conditions worse.

Proper Use

Take this medicine exactly as directed by your doctor . Do not change the dose or stop using this medicine without checking with your doctor first. 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 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 will always be given with other medicines for HIV. Take all of the medicines your doctor has prescribed as part of your combination treatment . Do not stop using your medicine unless your doctor tells you to.

It is important that lopinavir and ritonavir oral solution be taken with food. Use a calibrated dosing syringe or medicine cup to measure the dose for the oral solution.

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

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

If you are also using didanosine (VidexA®), take it one hour before or two hours after taking KaletraA® oral solution. Didanosine can be taken (without food) at the same time as KaletraA® 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):
    
    
    
    • Adultsa€”400 milligrams (mg) of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) twice 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 if needed.
    
    
    • Children and infants 6 months to 18 years of agea€”Dose is based on body weight and must be determined by your child`s doctor . The recommended dose is 10 to 12 milligrams per kilogram (mg/kg) of lopinavir and 2.5 to 3 mg/kg of ritonavir twice a day with food. Your doctor may adjust your dose if needed.
    
    
    • Infants 14 days to 6 months of agea€”Dose is based on body weight and must be determined by your child`s doctor . The recommended dose is 16 milligrams per kilogram (mg/kg) of lopinavir and 4 mg/kg of ritonavir twice a day with food.
    
    
    • Infants below 14 days of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For oral dosage form (tablets):
    
    
    
    • Adultsa€”400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) twice a day or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) once a day. Your doctor may adjust your dose if needed.
    
    
    • Children and infants 6 months to 18 years of agea€”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) twice a day. Your doctor may adjust your dose if needed.
    
    
    • Infants 14 days to 6 months of agea€”This dosage form is usually not used for infants. Please refer to the oral solution dosage form .
    
    
    • Infants below 14 days of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

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.

The oral solution should be stored in a closed container in the refrigerator. Do not freeze and keep away from heat.

The tablets should be stored in a closed container at room temperature, away from heat, moisture, and direct light.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take efavirenz, nevirapine, fosamprenavir, or nelfinavir together with lopinavir and ritonavir combination without first talking with your doctor . Your doctor may need to adjust the dose of lopinavir and ritonavir combination that you are taking.

Do not use this medicine if you are also using cisapride (PropulsidA®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, CafergotA®, ErgomarA®, MethergineA®, MigranalA®), lovastatin (MevacorA®), midazolam (VersedA®), pimozide (OrapA®), rifampin (RifadinA®), simvastatin (ZocorA®), or triazolam (HalcionA®).

Do not take other medicines unless they have been discussed with your doctor . This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John`s wort) or vitamin supplements.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method . This medicine will also not keep you from giving HIV to other people if they are exposed to your blood . Do not re-use or share needles with anyone.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

If you are taking the oral solution form of this medicine, you should limit the amount of alcohol you drink. The oral solution contains 42% alcohol . Talk to your doctor if you are taking, or plan to take, metronidazole (FlagylA®) or disulfiram (AntabuseA®).

Birth control pills that contain estrogen may not work as well while you are using this medicine. To keep from getting pregnant, use a second type of birth control with the pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor .

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bloating


• Blurred vision


• Chills


• Constipation


• Darkened urine


• Dry mouth


• Fast heartbeat


• Fever


• Flushed, dry skin


• Fruit-like breath odor


• Increased hunger


• Increased thirst


• Increased urination


• Indigestion


• Loss of appetite


• Loss of consciousness


• Nausea


• Pains in the stomach, side, or abdomen, possibly moving to the back


• Sweating


• Troubled breathing


• Unexplained weight loss


• Vomiting


• Yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• Chest pain or discomfort


• Cough


• Diarrhea


• Itching


• Joint or muscle pain


• Lightheadedness, dizziness, or fainting


• Red irritated eyes


• Red skin lesions, often with a purple center


• Shortness of breath


• Slow or irregular heartbeat


• Sore throat


• Sores, ulcers, or white spots in the mouth or on the lips


• Unusual tiredness

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abnormal stools


• Acid or sour stomach


• Belching


• Headache


• Heartburn


• Lack or loss of strength


• Pain


• Skin rash


• Stomach discomfort, upset, or pain


• Trouble with sleeping

Incidence not known

• Redistribution of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.