- Do not take PREZISTA(R) if you are taking the following medicines:
alfuzosin (Uroxatral(R)), dihydroergotamine (D.H.E.45(R), Embolex(R), Migranal(R)),
ergonovine, ergotamine (Cafergot(R), Ergomar(R)), methylergonovine, cisapride
(Propulsid(R)), pimozide (Orap(R)), oral midazolam, triazolam (Halcion(R)), the herbal
supplement St. John's wort (Hypericum perforatum), lovastatin (Mevacor(R),
Altoprev(R), Advicor(R)), simvastatin (Zocor(R), Simcor(R), Vytorin(R)), rifampin
(Rifadin(R), Rifater(R), Rifamate(R), Rimactane(R)), sildenafil (Revatio(R)) when used
to treat pulmonary arterial hypertension, indinavir (Crixivan(R)), lopinavir/ritonavir
(Kaletra(R)), saquinavir (Invirase(R)), boceprevir (Victrelis(TM)), or telaprevir
(Incivek(TM))
- Before taking PREZISTA(R), tell your healthcare professional if you are taking
sildenafil (Viagra(R), Revatio(R)), vardenafil (Levitra(R), Staxyn(R)), tadalafil
(Cialis(R), Adcirca(R)), atorvastatin (Lipitor(R)), rosuvastatin (Crestor(R)),
pravastatin (Pravachol(R)), or colchicine (Colcrys(R), Col-Probenecid(R)). Tell your
healthcare professional if you are taking estrogen-based contraceptives (birth
control). PREZISTA(R) might reduce the effectiveness of estrogen-based contraceptives.
You must take additional precautions for birth control, such as condoms
This is not a complete list of medicines. 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.
What should I tell my doctor before I take PREZISTA(R)?
- Before taking PREZISTA(R), tell your healthcare professional if you have
any medical conditions, including liver problems (including hepatitis B or C), allergy
to sulfa medicines, diabetes, or hemophilia
- Tell your healthcare professional if you are pregnant or planning to become
pregnant, or are breastfeeding
- The effects of PREZISTA(R) on pregnant women or their unborn babies are not
known. You and your healthcare professional will need to decide if taking PREZISTA(R)
is right for you
- Do not breastfeed. It is not known if PREZISTA(R) can be passed to your baby
in your breast milk and whether it could harm your baby. Also, mothers with HIV should
not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA(R)?
- High blood sugar, diabetes or worsening of diabetes, and increased
bleeding in people with hemophilia have been reported in patients taking protease
inhibitor medicines, including PREZISTA(R)
- Changes in body fat have been seen in some patients taking HIV medicines,
including PREZISTA(R). The cause and long-term health effects of these conditions are
not known at this time
- Changes in your immune system can happen when you start taking HIV medicines.
Your immune system may get stronger and begin to fight infections that have been
hidden
- The most common side effects related to taking PREZISTA(R) include diarrhea,
nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all
possible side effects. If you experience these or other side effects, talk to your
healthcare professional. Do not stop taking PREZISTA(R) or any other medicines without
first talking to your healthcare professional
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir(R)) Product Information (PI and PPI) for additional information on precautionary measures.
Please see full Product Information for more details:
http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf#zoom=100 [http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf ]
About Janssen Pharmaceutical Companies of Johnson & Johnson
The Janssen Pharmaceutical Companies of Johnson & Johnson 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.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 including 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 R&D Ireland and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; changes to regulations and domestic and foreign health care reforms; and general industry conditions, including 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 29, 2013, 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 undertake to update any forward-looking statement as a result of new information or future events or developments.
###
1) Sax P, Brar I, Elion R, et al. 48 Week study of tenofovir alafenamide
(TAF) versus tenofovir disoproxil fumarate (TDF), each in a single tablet regimen with
elvitegravir, cobicistat, and emtricitabine for initial HIV treatment. 53rd ICAAC.
September 10-13, 2013. Denver. Abstract H1464d.
2) World Health Organization. Global summary of the AIDS epidemic. Available at:
http://www.who.int/gho/hiv/en/. [http://www.who.int/gho/hiv/en/.%20 ] Last accessed
July 2014.
3) Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism. Prog
Lipid Res 2003; 42(2):81-92.
4) World Health Organization. Global summary of the AIDS epidemic. Available at:
http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed July 2014.
MEDIA CONTACT:
Daniel De Schryver
+49-173-768-9149
ddschryv@its.jnj.com
Ronan Collins
+47-488-425-00
rcollin5@its.jnj.com
INVESTOR RELATIONS:
Stan Panasewicz
+1-732-524-2524
Louise Mehrotra
+1-732-524-6491
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