What Kaletra is used for and how to use it
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Kaletra - Consumer Medicine Information

Manufacture: AbbVie
Country: Canada
Condition: HIV Infection, Nonoccupational Exposure
Class: Protease inhibitors
Form: Tablets
Ingredients: lopinavir, ritonavir, colloidal silicon dioxide, copovidone, polyethylene glycol 3350, polyvinyl alcohol, sodium stearyl fumarate, sorbitan monolaurate, talc, titanium dioxide, yellow ferric oxide E172

KALETRA Tablets

lopinavir/ritonavir

About this Medication

What the medication is used for

  • KALETRA is for adults and children 6 months of age or older who are infected with the human immunodeficiency virus (HIV), the virus which causes AIDS.
  • KALETRA is prescribed for use in combination with other antiretroviral medicines.

What it does

KALETRA is an inhibitor of the HIV protease enzyme. It helps control HIV infection by inhibiting or interfering with the protease enzyme that HIV needs to multiply.

KALETRA is not a cure for HIV infection or AIDS. People taking KALETRA may still develop infections or other serious illnesses associated with HIV disease and AIDS.

KALETRA does not reduce the risk of passing HIV to others with sexual contact or blood contamination. You should use appropriate precautions, such as practicing safe sex, and not reusing or sharing needles.

When it should not be used

Do not take KALETRA if you/your child:

  • are allergic to lopinavir, ritonavir or to any of the non-medicinal ingredients in KALETRA. Refer to the subheading What the important non-medicinal ingredients are for a complete listing.
  • are currently taking any of the following medicines, because they can cause serious problems or death if taken with KALETRA:
    • alfuzosin (e.g., Xatral) - used to treat high blood pressure
    • astemizole*, terfenadine* - used to relieve allergy symptoms
    • cisapride* - used to relieve certain stomach problems
    • ergotamine, dihydroergotamine (used to treat headaches), ergonovine, methylergonovine* (used after labour and delivery), such as Cafergot, Migranal, D.H.E. 45, Methergine*, and others
    • fusidic acid (e.g., Fucidin) – antibiotic
    • pimozide (e.g., Orap) - used to treat schizophrenia
    • sildenafil (e.g., Revatio) – used to treat pulmonary arterial hypertension
    • triazolam, midazolam - used to relieve anxiety and/or trouble sleeping
  • are currently taking rifampin, also known as Rimactane, Rifadin, Rifater, or Rifamate. Rifampin may lower the amount of KALETRA in your/your child’s blood and make it less effective
  • are currently taking St. John's Wort (Hypericum perforatum), a herbal product sold as a dietary supplement, or products containing St. John's Wort. Talk with your/your child’s doctor if you/your child are taking or planning to take St. John's Wort. Taking St. John's Wort may decrease KALETRA levels and lead to increased viral load and possible resistance to KALETRA or cross-resistance to other anti-HIV medicines
  • are currently taking the cholesterol-lowering medicines lovastatin (e.g., Mevacor) or simvastatin (e.g., Zocor) because of possible serious reactions. Talk to your/your child’s doctor before you/your child take any cholesterol-lowering medicines with KALETRA
  • are currently taking the PDE5 inhibitors vardenafil (e.g., Levitra), used to treat erectile dysfunction, or sildenafil (e.g., Revatio), used for the treatment of pulmonary arterial hypertension (PAH). These drugs may increase the risk of hypotension (low blood pressure), syncope (fainting), visual changes and prolonged erection
  • are currently taking salmeterol, also known as Advair and Serevent. Salmeterol may increase the risk of cardiovascular (heart) adverse events
  • are currently taking any of these medications; your/your child’s doctor may switch your/your child’s medication

* Products not marketed in Canada.

What the medicinal ingredient is

lopinavir and ritonavir

What the important non-medicinal ingredients are

KALETRA 100/25 mg tablets also contain colloidal silicon dioxide, copovidone, polyethylene glycol 3350, polyvinyl alcohol, sodium stearyl fumarate, sorbitan monolaurate, talc, titanium dioxide, and yellow ferric oxide E172.

KALETRA 200/50 mg tablets also contain colloidal silicon dioxide, copovidone, hypromellose, hydroxypropyl cellulose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, sodium stearyl fumarate, sorbitan monolaurate, talc, titanium dioxide, and yellow ferric oxide E172.

What dosage form it comes in

KALETRA is available as film-coated tablets containing the following combinations of lopinavir and ritonavir: 100 mg/25 mg; 200 mg/50 mg.

KALETRA is also available as an oral solution. Each mL of KALETRA contains 80 mg of lopinavir and 20 mg of ritonavir.

Warnings and Precautions

Serious Warnings and Precautions

Tell your/your child’s doctor if you or your child develop symptoms such as:

  • nausea
  • vomiting
  • abdominal pain

These may be signs of problems with your/your child’s pancreas (pancreatitis). Your/your child’s doctor must decide if these are related to pancreatitis and what to do about them.

Do not take KALETRA once daily if you/your child:

  • are currently taking the anticonvulsants carbamazepine (e.g., Tegretol), phenytoin (e.g., Dilantin) and phenobarbital
  • are currently taking HIV medications efavirenz (e.g., Sustiva), nevirapine (e.g., Viramune), and nelfinavir (e.g., Viracept).

BEFORE you or your child use KALETRA talk to your doctor or pharmacist if:

  • have liver problems or are infected with hepatitis B or hepatitis C
  • have diabetes, or symptoms such as frequent urination and/or increase in thirst
  • have hemophilia. Patients taking KALETRA may have increased bleeding
  • are taking or planning to take other medicines, including prescription, herbal and other medicines you/your child can buy without a prescription
  • have heart disease or a heart condition, including conditions of Congenital Long QT Syndrome
  • have low potassium levels in your/your child’s blood
  • are pregnant or planning to become pregnant; pregnant women should not take KALETRA oral solution unless specifically directed by the doctor. Be sure to tell your/your child’s doctor immediately if you/your child are or may be pregnant. If you/your child take KALETRA while you/your child are pregnant, talk to your/your child’s doctor about how you can be included in the Antiretroviral Pregnancy Registry
  • are breastfeeding or planning to breastfeed. It is recommended that HIV-infected women should not breast-feed their infants because of the possibility the baby could be infected with HIV through the breast milk

Severe liver problems, including deaths, have been reported in those using KALETRA. This has often occurred in those with advanced HIV disease, other liver disease or those taking many medications. There is no proven link to KALETRA use.

Changes in body fat have been seen in some patients taking antiretroviral therapy. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Interactions with this Medication

KALETRA may interact with certain other medications with possible clinical effects. The following medicines should only be used together with KALETRA if advised by your/your child’s physician:

  • medicines used to treat erectile dysfunction such as sildenafil (e.g., Viagra) or tadalafil (e.g., Cialis); vardenafil (e.g., Levitra) should not be taken with KALETRA
  • medicines used to treat pulmonary arterial hypertension such as bosentan (e.g., Tracleer) or tadalafil (e.g., Adcirca)
  • medicines used to lower blood cholesterol such as rosuvastatin (e.g., Crestor), atorvastatin (e.g., Lipitor), lovastatin (e.g., Mevacor) or simvastatin (e.g., Zocor) should not be taken with KALETRA
  • some medicines affecting the immune system such as cyclosporin, sirolimus (e.g., Rapamune) and tacrolimus
  • some medicines used to treat seasonal allergies and ear and eye infections such as dexamethasone and fluticasone propionate (e.g., Flonase)
  • medicines used to treat asthma such as budesonide (e.g., Pulmicort)
  • contraceptives used to prevent pregnancy (e.g., ethinyl estradiol)
  • medicines used to treat AIDS and related infections such as amprenavir*, fosamprenavir (e.g., Telzir), indinavir (e.g., Crixivan), nelfinavir (e.g., Viracept), saquinavir (e.g., Invirase), didanosine (e.g., Videx), tenofovir (e.g., Viread), efavirenz (e.g., Sustiva), maraviroc (e.g., Celsentri), nevirapine (e.g., Viramune), rifabutin (e.g., Mycobutin), etravirine (e.g., Intelence), rilpivirine (e.g., Edurant, Complera), tipranavir (e.g., Aptivus) when used with low-dose ritonavir
  • medicines used to treat hepatitis C virus (HCV) and related infections such as telaprevir (e.g., Incivek), boceprevir (e.g., Victrelis), simeprevir (e.g., Galexos)
  • medicines used to treat depression such as trazodone and bupropion (e.g., Wellbutrin SR)
  • certain heart medicines such as calcium channel antagonists including felodipine (e.g., Plendil), nifedipine (e.g., Adalat) and nicardipine*
  • medicines used to correct heart rhythm such as amiodarone (e.g., Cordarone), flecainide (e.g., Tambocor), bepridil*, systemic lidocaine, propafenone hydrochloride (e.g., Rythmol), quinidine and digoxin
  • antifungals such as ketoconazole (e.g., Nizoral), itraconazole (e.g., Sporanox) and voriconazole (e.g., Vfend)
  • morphine-like medicines (e.g., methadone)
  • anticonvulsants such as carbamazepine (e.g.,Tegretol), lamotrigine (e.g., Lamictal), phenytoin (e.g., Dilantin), phenobarbital, and valproate (e.g. Depakene)
  • anticoagulants such as warfarin or rivaroxaban (e.g., Xarelto)
  • certain antibiotics such as clarithromycin (e.g., Biaxin)
  • medicines used to treat cancer such as dasatinib (e.g., Sprycel), nilotinib (e.g., Tasigna), vincristine and vinblastine as KALETRA® may increase the concentrations of these drugs and increase adverse effects
  • fentanyl (e.g., Duragesic) in all forms as this interaction may reduce breathing
  • colchicine used for the treatment of gout
  • quetiapine used to treat schizophrenia, bipolar disorder and major depressive disorder.

* Products not marketed in Canada.

If you/your child are taking KALETRA you/your child should not take products containing St. John’s Wort (Hypericum perforatum), as this may stop KALETRA from working properly.

KALETRA can be taken with acid-reducing agents (such as omeprazole and ranitidine) with no dose adjustment.

Proper Use of this Medication

It is important that you/your child take KALETRA every day exactly as your/your child’s doctor prescribed it. Even if you/your child feel better, do not stop taking KALETRA without talking to your/your child’s doctor. Using KALETRA as recommended should give you/your child the best chance to delay the development of resistance to the product.

It is therefore important that you/your child remain under the supervision of your/your child’s doctor while taking KALETRA.

Usual Dose

The usual dose for adults is two 200/50 mg tablets (400/100 mg) twice a day (morning and night), in combination with other anti-HIV medicines. The doctor may prescribe KALETRA as four 200/50 mg tablets (800/200 mg) once daily in combination with other anti-HIV medicines for some patients.

The dose for children from 6 months to 18 years of age will be determined by your/your child’s doctor based on the child’s height and weight. KALETRA should not be administered once daily in pediatric patients less than 18 years of age.

KALETRA tablets (all strengths) can be taken with or without food. KALETRA tablets should be swallowed whole and not chewed, broken, or crushed.

Overdose

If you/your child realize you have taken more KALETRA than you/your child were supposed to, contact your/your child’s doctor or local poison control centre right away, even if you/your child have no symptoms. If you cannot reach your/your child’s doctor, go to the hospital.

Missed dose

If you/your child miss a dose of KALETRA, it should be taken as soon as possible, and the next scheduled dose taken at its regular time. If it is almost time for your/your child’s next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose.

Side Effects and what to do about them

The most commonly reported side effects of KALETRA are abdominal pain, diarrhea (abnormal stool and/or bowel movement), feeling weak or tired, headache, nausea, vomiting and rash.

  • If you/your child have liver disease such as Hepatitis B and Hepatitis C, taking KALETRA may worsen your/your child’s liver disease.
  • Some patients have large increases in triglycerides and cholesterol (forms of fat that are found in your/your child’s blood).
  • Diabetes and high blood sugar (hyperglycemia) may occur in patients taking protease inhibitors such as KALETRA. Symptoms of diabetes or high blood sugar may include frequent urination or increased thirst. Let your/your child’s doctor know if you/your child have or develop these symptoms while taking KALETRA.
  • Some patients with hemophilia have increased bleeding with protease inhibitors.
  • Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
  • Changes in your/your child’s immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you/your child start taking HIV medicines. Your/your child’s immune system may get stronger and begin to fight infections that have been hidden in your/your child’s body for a long time, or you/your child could develop an autoimmune disease in which your /your child’s immune system reacts against your own body (e.g. Grave's disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you/your child develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your/your child’s doctor straight away.

Serious Side Effects, how often they Happen and what to do about them

Symptom / Effect Talk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Common Diarrhea
Rash
Headache
Nausea
Vomiting
Tingling feeling in
hands, feet and
around lips
Uncommon Chest pain
Pancreatitis
- Abdominal pain
- Nausea
- Vomiting

This is not a complete list of side effects. For any unexpected effects while taking KALETRA, contact your doctor or pharmacist.</strong>

How to Store it

Keep KALETRA and all other medicines out of the reach and sight of children.

KALETRA film-coated tablets should be stored between 15 and 30°C. It is recommended that the product be stored and dispensed in the original container.

It is important to keep KALETRA in the original package. Do not transfer to any other container.

Do not use after the expiry date stated on the package.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, ON K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

The most recent version of this document plus the full Product Monograph, prepared for healthcare professionals can be found at:

www.abbvie.ca

or by contacting the sponsor, AbbVie Corporation, St-Laurent, QC, H4S 1Z1 at 1-888-704-8271.