Olumiant medicine for rheumatoid arthritis

Introducing a new treatment

for adults with moderately to severely active rheumatoid arthritis (RA)

Olumiant 2mg pill Not actual size.Olumiant, pronounced: [O-loo’-mē-ant]

Olumiant^® (baricitinib) is an oral prescription medicine called a Janus kinase (JAK) inhibitor used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist. It is not known if Olumiant is safe and effective in children.

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INDICATION AND IMPORTANT SAFETY INFORMATION Warning: Serious Infections, Cancers and Blood Clots

Warning: Serious Infections, Cancers and Blood Clots

INDICATION

Olumiant is an oral prescription medicine called a Janus kinase (JAK) inhibitor used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist. It is not known if Olumiant is safe and effective in children.

IMPORTANT SAFETY INFORMATION

THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT OLUMIANT:

Serious infections. Olumiant is a medicine that affects your immune system. Olumiant can lower your immune system’s ability to fight infections, which can make you more likely to get infections or make infections worse. Some people have had serious infections while using Olumiant, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting Olumiant and watch closely for signs and symptoms of TB during treatment. You should not start Olumiant if you have any kind of infection unless your HCP tells you it is okay. You may be at higher risk of developing shingles. While taking Olumiant, tell your HCP right away if you have symptoms of an infection, including:
- fever
- sweating
- chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling very tired
Cancer and immune system problems. Olumiant may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers including skin cancers, can happen in people taking Olumiant.
Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking Olumiant. This may be life-threatening and cause death. While taking Olumiant, tell your HCP right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.
Tears in the stomach or intestines can happen to some people taking Olumiant. This happens most often in people who also take nonsteroidal anti-inflammatory drugs, corticosteroids, or methotrexate. While taking Olumiant, tell your HCP right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
Changes in laboratory test results. Your HCP should routinely check certain liver tests and should do blood tests before you start and while you take Olumiant to check your lymphocyte (white blood cells), neutrophil (white blood cells), and red blood cell counts. You should not take Olumiant if your blood cell counts are too low or your liver blood tests are too high. Your HCP may stop Olumiant for a period of time if these test results change. Your HCP should check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed after that, as blood cholesterol levels may change.

BEFORE STARTING OLUMIANT

BEFORE STARTING OLUMIANT, TELL YOUR HCP ABOUT ALL YOUR MEDICAL CONDITIONS, INCLUDING IF YOU:

are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
have TB or have been in close contact with someone with TB
have had hepatitis B or C
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River Valleys and the Southwest) with an increased chance for getting certain fungal infections. These infections may happen or become more severe if you use Olumiant.
have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections while taking Olumiant.
have ever had any type of cancer
have had blood clots in the veins of your legs or lungs in the past
have any stomach-area pain or have been diagnosed with diverticulitis (inflammation in the large intestine) or ulcers in your stomach or intestines
have kidney problems, liver problems, or low red or white blood cell counts
have recently received or are scheduled to receive a vaccine. People who take Olumiant should not receive live vaccines.
are pregnant or plan to become pregnant. It is not known if Olumiant will harm an unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Olumiant passes into your breast milk. You and your healthcare provider should decide if you will take Olumiant or breastfeed. You should not do both.

TALK TO YOUR DOCTOR

Also tell your HCP about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your HCP if you take a medicine called probenecid or any medicine to treat rheumatoid arthritis, such as tocilizumab (Actemra^®), etanercept (Enbrel^®), adalimumab (Humira^®), infliximab (Remicade^®), rituximab (Rituxan^®), abatacept (Orencia^®), anakinra (Kineret^®), certolizumab pegol (Cimzia^®), golimumab (Simponi^®), tofacitinib (Xeljanz^®; Xeljanz XR^®), sarilumab (Kevzara^®), azathioprine, or cyclosporine. Taking Olumiant with these medicines may increase your risk of infection.

COMMON SIDE EFFECTS

The most common side effects of Olumiant include upper respiratory tract infections (common cold, sinus infections), nausea, cold sores, and shingles. Tell your HCP about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Olumiant. Ask your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

ADDITIONAL INFORMATION

Olumiant is available by prescription only.

Please see full Prescribing Information, including Boxed Warning on Serious Infections, Cancers, and Blood Clots, and Medication Guide.

BA CON ISI 01JUN2018

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