Prezcobix (Darunavir/Cobicistat)

Always use PREZCOBIX exactly as your doctor has told you. You must check with your doctor if you are not sure.

You should always take PREZCOBIX with food. The type of food is not important.

Continue taking PREZCOBIX unless your doctor tells you to stop. Take the exact amount of PREZCOBIX that your doctor tells you to take, right from the very start. To help make sure you will benefit from PREZCOBIX, you must not skip doses or interrupt therapy. If you don’t take PREZCOBIX as prescribed, the beneficial effects of PREZCOBIX may be reduced or even lost.

If you have also been prescribed enteric-coated didanosine as well as PREZCOBIX, take didanosine 2 hours before or after PREZCOBIX.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of PREZCOBIX by more than 12 hours, wait and then take the next dose of PREZCOBIX at the regularly scheduled time. If you miss a dose of by less than 12 hours, take your missed dose of PREZCOBIX immediately. Then take your next dose of PREZCOBIX at the regularly scheduled time.

If a dose of PREZCOBIX is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZCOBIX at any one time.

Do not stop using PREZCOBIX without talking to your doctor first.

Like all prescription drugs, PREZCOBIX can cause side effects. The following is not a complete list of side effects reported with PREZCOBIX when taken either alone or with other anti-HIV medicines. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZCOBIX. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.

Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Rash has been reported in 15.7% of patients receiving PREZCOBIX. In patients taking PREZCOBIX and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either drug separately. Contact your doctor immediately if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether PREZCOBIX should be stopped.

In some patients, severe or life-threatening rash has been reported. If you develop a severe rash (e.g., blisters, peeling skin) which may be accompanied with symptoms such as fever, fatigue, swelling of the face or lymph glands, muscle aches and pain, and liver problems, immediately discontinue PREZCOBIX and contact your doctor.

Other relevant severe side effects reported at an uncommon or rare frequency were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat.

The most common side effects include diarrhea, nausea, headache, abdominal pain and vomiting.

Some side effects are typical for anti-HIV medicines in the same family as PREZCOBIX. These are:

• high blood sugar (hyperglycemia) and diabetes. This can happen in patients taking PREZCOBIX or other protease inhibitor medicines. Some patients have diabetes before starting treatment with PREZCOBIX, which gets worse. Some patients get diabetes during treatment with PREZCOBIX. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine.
• increased bleeding in patients with hemophilia. This may happen in patients taking PREZCOBIX as it has been reported with other protease inhibitor medicines.
• changes in body fat. These changes can happen in patients taking anti-HIV medicines. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• increases in triglycerides and cholesterol (forms of fat that are found in your blood). Your doctor may order blood testing for you.
• development of pancreatitis (inflammation of the pancreas) with symptoms such as abdominal pain, nausea and vomiting. If you suffer these symptoms while taking PREZCOBIX, contact your doctor.
• Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your 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 develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

BEFORE you use PREZCOBIX talk to your doctor or pharmacist if you:

• have diabetes. In general, anti-HIV medicines, such as PREZCOBIX, might increase sugar levels in the blood.
• have liver problems, including hepatitis B and/or C.
• have hemophilia. Anti-HIV medicines, such as PREZCOBIX, might increase the risk of bleeding.
• are pregnant or planning to become pregnant. It is not known if PREZCOBIX can harm your unborn baby. You and your doctor will need to decide if takingPREZCOBIX is right for you. If you take PREZCOBIX while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
• are breast-feeding. Do not breast-feed if you are taking PREZCOBIX. You should not breast-feed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.
• are allergic to sulpha medications.
• are less than 18 years of age.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John’s wort (Hypericum perforatum). PREZCOBIX and many other medicines can interact. Sometimes serious side effects will happen if PREZCOBIX is taken with certain other medicines.

PREZCOBIX should not be combined with vardenafil, because you may be at increased risk of side effects of vardenafil such as low blood pressure, visual changes and penile erection lasting more than 4 hours.

Tell your doctor if you are taking estrogen-based contraceptives. PREZCOBIX might reduce the effectiveness of estrogen-based contraceptives (birth control). Therefore, alternative methods of non-hormonal contraception, such as a condom, are recommended.

Tell your doctor if you take other anti-HIV medicines (e.g. rilpivirine, tenofovir disoproxil fumarate). PREZCOBIX can be combined with some other anti-HIV medicines while other combinations are not recommended.

If you are taking PREZCOBIX you should not take:

• medications that may affect your kidneys and have not been discussed with your doctor
• other medicines that contain protease inhibitors: e.g., atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), lopinavir (Kaletra), or darunavir (Prezista)
• other medicines that contain cobicistat (Stribild)
• Tell your doctor if you are taking any medicines that you obtained without a prescription.
• This is not complete list of medicines that you should tell your doctor that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your doctors and pharmacists any time you get a new medicine. Both your doctor and your pharmacist can tell you if you can take these other medicines with PREZCOBIX. Do not start any new medicines while you are taking PREZCOBIX without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with PREZCOBIX.
• ritonavir (Kaletra, Norvir).