Janssen Announces Two-drug Combination of Dolutegravir and Rilpivirine Demonstrates Efficacy in Maintaining Viral Suppre

- 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 full Product Information [http://www.edurant.com/shared/product/Edurant/EDURANT-PI.pdf ] for more details.

TIVICAY(R) (dolutegravir) tablets  

Professional Indication(s) and Important Safety Information  

Indications and Usage  

TIVICAY(R) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

Limitations of Use:  

- Use of TIVICAY(R) in INSTI-experienced patients should be guided by the number and
type of baseline INSTI substitutions. The efficacy of TIVICAY(R) 50 mg twice daily is
reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more
additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C,
Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information  

Contraindications:  

TIVICAY(R) is contraindicated in patients:

- with previous hypersensitivity reaction to dolutegravir
- receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions:  

- Hypersensitivity reactions have been reported and were characterized by rash,
constitutional findings, and sometimes organ dysfunction, including liver injury. The
events were reported in <1% of subjects receiving TIVICAY(R) in Phase 3 clinical
trials.
- Discontinue TIVICAY(R) and other suspect agents immediately if signs or symptoms of
hypersensitivity reactions develop, as a delay in stopping treatment may result in a
life-threatening reaction. Monitor clinical status, including liver aminotransferases,
and initiate appropriate therapy if hypersensitivity reaction is suspected.

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:  

- Patients with underlying hepatitis B or C may be at increased risk for worsening
or development of transaminase elevations with use of TIVICAY(R). In some cases the
elevations in transaminases were consistent with immune reconstitution syndrome or
hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was
withdrawn.
- Appropriate laboratory testing prior to initiating therapy and monitoring for
hepatotoxicity during therapy with TIVICAY(R) are recommended in patients with
underlying hepatic disease such as hepatitis B or C. 

Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (greater than or equal to2%) adverse reactions of moderate to severe intensity in treatment-naive adult subjects in any one trial receiving TIVICAY(R) in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%). 

Drug Interactions:   

- Coadministration of TIVICAY(R) with certain inducers of UGT1A and/or CYP3A may
reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
(R).
- Administer TIVICAY(R) 2 hours before or 6 hours after taking polyvalent
cation-containing antacids or laxatives, sucralfate, oral supplements containing iron
or calcium, or buffered medications. Alternatively, TIVICAY(R) and supplements
containing calcium or iron can be taken with food
- Consult the full Prescribing Information for TIVICAY(R) for more information on
potentially significant drug interactions, including clinical comments

Pregnancy: TIVICAY(R) should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

Cautions Concerning Forward-Looking Statements  

(CONTINUA)