Directions
How to take JULUCA?
•Take JULUCA 1 time a day exactly as your healthcare provider tells you
•Always take JULUCA with a meal. A protein drink alone does not replace a meal
What is JULUCA?
JULUCA is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if JULUCA is safe and effective in children.
Cautions
Do not take JULUCA if you:
•have ever had an allergic reaction to a medicine that contains dolutegravir or rilpivirine
• are taking any of the following medicines: odofetilide
ocarbamazepine
ooxcarbazepine
ophenobarbital
ophenytoin
orifampin
orifapentine
oproton pump inhibitors (including esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole)
oSt. John’s wort (Hypericum perforatum)
omore than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
Side Effects
What are the possible side effects of JULUCA?
JULUCA can cause serious side effects, including:
•Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with JULUCA. Stop taking JULUCA and get medical help right away if you develop a rash with any of the following signs or symptoms: ofever
ogenerally ill feeling
otiredness
omuscle or joint aches
oblisters or sores in mouth
oblisters or peeling of the skin
oredness or swelling of the eyes
oswelling of the mouth, face, lips, or tongue
oproblems breathing
•Liver problems. People with a history of hepatitis B or C virus who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment with JULUCA. Liver problems, including liver failure, have also happened in people without history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems: oyour skin or the white part of your eyes turns yellow (jaundice)
odark or “tea-colored” urine
olight-colored stools (bowel movements)
onausea or vomiting
oloss of appetite
opain, aching, or tenderness on the right side of your stomach area
• Depression or mood changes. Tell your healthcare provider right away or get medical help if you have any of the following symptoms: ofeeling sad or hopeless
ofeeling anxious or restless
ohave thoughts of hurting yourself (suicide) or have tried to hurt yourself
• The most common side effects of JULUCA include: odiarrhea
oheadache
These are not all the possible side effects of JULUCA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider right away if you have any new symptoms while taking JULUCA.
Before you take JULUCA, tell your healthcare provider if you:
•have ever had a severe skin rash or an allergic reaction to medicines that contain dolutegravir or rilpivirine
•have or have had liver problems, including hepatitis B or C infection
•have ever had a mental health problem
•are pregnant or plan to become pregnant. One of the medicines in JULUCA, called dolutegravir, may harm your unborn baby
oYou should not take JULUCA at the time of becoming pregnant or during the first 12 weeks of pregnancy. Your healthcare provider may change your medicine during this time in your pregnancy
oIf you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with JULUCA, and you should consistently use effective birth control (contraception) during treatment with JULUCA
oTell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with JULUCA
•are breastfeeding or plan to breastfeed. Do not breastfeed if you take JULUCA. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. It is not known if JULUCA can pass to your baby in your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with JULUCA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
•You can ask your healthcare provider or pharmacist for a list of medicines that interact with JULUCA
•Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take JULUCA with other medicines
Product Code : 13226