- Your HIV infection has been previously treated with HIV medicines
- You are taking any of the following medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol(R), Equetro(R), Tegretol(R),
Tegretol-XR(R), Teril(R), Epitol(R)), oxcarbazepine (Trileptal(R)), phenobarbital
(Luminal(R)), phenytoin (Dilantin(R), Dilantin-125(R), Phenytek(R))
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater(R), Rifamate(R),
Rimactane(R), Rifadin(R)), rifapentine (Priftin(R))Proton pump inhibitor (PPI)
medicine for certain stomach or intestinal problems: esomeprazole (Nexium(R),
Vimovo(R)), lansoprazole (Prevacid(R)), omeprazole (Prilosec(R), Zegerid(R)),
pantoprazole sodium (Protonix(R)), rabeprazole (Aciphex(R))
- More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium
phosphate
- St. John's wort (Hypericum perforatum)
Especially tell your doctor if you take:
- Rifabutin (Mycobutin(R)), a medicine to treat some bacterial infections). Talk to
your doctor or pharmacist about the right amount of EDURANT(R) you should take if you
also take rifabutin
- Medicines used to treat HIV
- An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate.
Take antacids at least 2 hours before or at least 4 hours after you take EDURANT(R)
- Medicines to block acid in your stomach, including cimetidine (Tagamet(R)), famotidine
(Pepcid(R)), nizatidine (Axid(R)), or ranitidine hydrochloride (Zantac(R)). Take these
medicines at least 12 hours before or at least 4 hours after you take EDURANT(R)
- Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin(R)),
erythromycin (E-Mycin(R), Eryc(R), Ery-Tab(R), PCE(R), Pediazole(R), Ilosone(R)),
fluconazole (Diflucan(R)), itraconazole (Sporanox(R)), ketoconazole (Nizoral(R)),
methadone (Dolophine(R)), posaconazole (Noxafil(R)), telithromycin (Ketek(R)),
voriconazole (Vfend(R))
This is not a complete list of medicines. Before starting EDURANT(R), be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Before taking EDURANT(R), also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT(R) will harm your unborn baby.
You and your healthcare professional will need to decide if taking EDURANT(R) is right for you.
Do not breastfeed if you are taking EDURANT(R). You should not breastfeed if you have HIV because of the chance of passing HIV to your baby
What are the possible side effects of EDURANT(R)? EDURANT(R) can cause serious side effects including:
- Severe skin rash and allergic reactions. Call your doctor right away if you get a
rash. Stop taking EDURANT(R) and seek medical help right away if you get a rash with
any of the following symptoms: severe allergic reaction causing swelling of the face,
eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or
breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis);
fever; dark urine; or pain on the right side of the stomach area (abdominal pain)
- Depression or mood changes. Tell your doctor right away if you have any of the
following symptoms: feeling sad or hopeless, feeling anxious or restless, have
thoughts of hurting yourself (suicide), or have tried to hurt yourself
- Liver problems. People with a history of hepatitis B or C virus infection or who have
certain liver function test changes may have an increased risk of developing new or
worsening liver problems during treatment. Liver problems were also reported during
treatment in some people without a history of liver disease. Your healthcare
professional may need to do tests to check liver function before and during treatment
- Changes in body shape or body fat have been seen in some patients taking HIV
medicines. The exact cause and long-term health effects of these conditions are not
known
- Changes in your immune system (immune reconstitution syndrome).
- Your immune system may get stronger and begin to fight infections. Tell your
healthcare professional right away if you start having any new symptoms of infection
- Other common side effects of EDURANT(R) include depression, headache, trouble sleeping
(insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT(R) or any other medications without first talking to your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, [http://www.fda.gov/medwatch ] or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please see accompanying full Product Information [http://www.edurant.com/shared/product/Edurant/EDURANT-PI.pdf ] for more details.
[1] http://apps.who.int/iris/bitstream/10665...
[2] http://www.who.int/mediacentre/factsheet...
Photo:
http://photos.prnewswire.com/prnh/201602...
CONTACT: Contact: Sébastien Desprez (UK), +44 7920 567 707, GlobalCommunications, ViiV Healthcare; Marc Meachem, (US), +1 919 483 8756, USCommunications, ViiV Healthcare, GSK enquiries: UK Media enquiries: SimonSteel, +44 (0) 20 8047 5502, (London), David Daley, +44 (0) 20 8047 5502,(London), US Media enquiries: Kathleen Cuca, +1 215 859 1922,(Philadelphia), Mary Anne Rhyne, +1 919 483 0492, (North Carolina), SarahSpencer, +1 215 751 3335, (Philadelphia), Analyst/Investor enquiries: ZibaShamsi, +44 (0) 20 8047 5543, (London), Tom Curry, + 1 215 751 5419,(Philadelphia), Gary Davies, +44 (0) 20 8047 5503, (London), James Dodwell,+44 (0) 20 8047 2406, (London), Jeff McLaughlin, +1 215 751 7002,(Philadelphia)
