ViiV Healthcare Begins Phase III Programme with dolutegravir/rilpivirine Combination for HIV Maintenance Therapy (2)

Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.

Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/585....

How TIVICAY Works TIVICAY belongs to a class of HIV medicines called integrase inhibitors. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit http://www.viivhealthcare.com.

Important Information about EDURANT(R)(rilpivirine)

EDURANT(R) (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults:

- Who have never taken HIV medicines before and
- Who have an amount of HIV in their blood (called "viral load") that is no more
than 100,000 copies/mL. Your healthcare professional will measure your viral load

EDURANT(R) should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines

It is important that you remain under the care of your healthcare professional during treatment with EDURANT(R)

EDURANT(R) is not recommended for patients less than 18 years of age

EDURANT(R) does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.

Important Safety Information for EDURANT(R) (rilpivirine)

Can EDURANT(R) betaken withother medicines?

EDURANT(R) may affect the way other medicines work and other medicines may affect how EDURANT(R) works and may cause serious side effects. If you take certain medicines with EDURANT(R), the amount of EDURANT(R) in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT(R) or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT(R) with a meal. A protein drink alone does not replace a meal.

Do not take EDURANT(R) if:

- 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 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)

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:

- 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 negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call1-800-FDA-1088.

Please see full Product Information for more details: http://www.edurant.com/sites/default/files/EDURANT-PI.pdf

About Edurant(R) (rilpivirine)

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