Kaletra (Lopinavir/Ritonavir)

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. Once daily dosing is not recommended for pregnant women.

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.

Your doctor may monitor blood levels of fats (lipids), cholesterol and glucose before and during KALETRA treatment.

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.

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 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. Graves' disease (which affects the thyroid gland), Guillain-Barré 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 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 use KALETRA talk to your/your child’s doctor or pharmacist if you or your child:

• 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 blood
• are pregnant or planning to become pregnant; pregnant women should not take KALETRA 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 breast-feed. 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.

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 KALETRAmay 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 to treat gout
• quetiapine used to treat schizophrenia, bipolar disorder and major depressive disorder
• medicines to treat anxiety such as midazolam (injected)

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.