- 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.
About cabotegravir
Cabotegravir is an investigational integrase strand inhibitor (INSTI) and analogue of dolutegravir (TIVICAY(R)). Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a LA nanosuspension formulation for intramuscular (IM) injection.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
References
1) World Health Organization. Global summary of the AIDS epidemic. Available
at: http://www.who.int/gho/hiv/en. Last accessed October 2015.
2) Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism. Prog Lipid
Res 2003; 42(2):81-92.
3) World Health Organization. Global summary of the AIDS epidemic. Available
at: http://www.who.int/hiv/data/2012_epi_cor.... Last accessed October 2015.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland UC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Photo:
http://photos.prnewswire.com/prnh/201403...
CONTACT: Press Contacts: Daniel De Schryver, +49-173-76-89-149,ddschryv@its.jnj.com; Ronan Collins (EU), +47-488-425-00,rcollin5@its.jnj.com; Investor Contacts: Louise Mehrotra, +1(732)524-6491,Lesley Fishman, +1(732)524-3922
