Baricitinib

Baricitinib is used to treat moderately to severely active rheumatoid arthritis and COVID-19 in adults and alopecia areata in patients 12 years and older. It is an oral tablet taken once a day. The duration of treatment depends on the condition. It is an oral tablet taken once a day. The duration of treatment depends on the condition.

Baricitinib works by blocking Janus kinase (JAK) enzymes. These are enzymes inside cells that relay signals from cytokines, the chemical messengers that drive inflammation and immune activity. By blocking JAK enzymes, baricitinib prevents them from switching on proteins called STATs that would otherwise turn on inflammation-related genes. This interrupts the overactive immune response behind rheumatoid arthritis, alopecia areata, and severe COVID-19. Baricitinib belongs to the drug class called JAK inhibitors.

Baricitinib first received FDA approval on May 31, 2018, under the brand name Olumiant. A generic is available.

Baricitinib is FDA-approved to:

• adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well enough or could not be tolerated
• adults hospitalized with coronavirus disease 2019 (COVID-19) who need oxygen or help with breathing
• adults and children 12 years of age and older with severe alopecia areata.

Take baricitinib exactly as your healthcare provider tells you to take it.

• For people with rheumatoid arthritis or alopecia areata, take baricitinib 1 time a day by mouth with or without food.
• For people with COVID-19, baricitinib will be given to you 1 time a day by mouth with or without food, for up to 14 days or until you are discharged from the hospital (whichever comes first), as instructed by your healthcare provider.

Talk to your healthcare provider if you cannot swallow tablets whole.

If you take too much baricitinib, call your healthcare provider or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Baricitinib carries a Boxed Warning for serious infections, an increased risk of death, cancer, major cardiovascular side effects, and blood clots:

• Serious infections. Baricitinib is a medicine that affects your immune system. Baricitinib can lower the ability of your immune system to fight infections. Some people have had serious infections while taking baricitinib, 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 should test you for TB before starting treatment with baricitinib for rheumatoid arthritis or alopecia areata. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with baricitinib. You should not start taking baricitinib if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles. Before starting baricitinib, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance of infections have TB or have been in close contact with someone with TB have had shingles (herpes zoster) 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) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use baricitinib. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches cough shortness of breath blood in your phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than normal feeling tired After starting baricitinib, call your healthcare provider right away if you have any symptoms of an infection. Baricitinib can make you more likely to get infections or make any infection that you have worse. If you get a serious infection, your healthcare provider may stop your treatment with baricitinib until your infection is controlled.
• Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. Baricitinib is a JAK inhibitor medicine.
• Cancer and immune system problems. Baricitinib 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 baricitinib. People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer. Follow your healthcare provider's advice about having your skin checked for skin cancer during treatment with baricitinib.
• Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking baricitinib, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech
• Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) and arteries (arterial thrombosis) can happen in some people taking baricitinib. This may be life-threatening and cause death. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and have at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Stop taking baricitinib and tell your healthcare provider or get emergency help right away if you have any signs and symptoms of blood clots during treatment with baricitinib, including: swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.
• Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, which may mean you are having an allergic reaction, have been seen in people taking baricitinib. Some of these reactions were serious. If any of these symptoms occur during treatment with baricitinib, stop taking baricitinib and get emergency help right away.
• Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking baricitinib can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider and get medical help right away if you get stomach-area pain that does not go away, fever, chills, nausea, or vomiting.
• Low blood sugar (hypoglycemia) in people with diabetes. If you have diabetes, your healthcare provider may tell you to check your blood sugar (glucose) more often during treatment with baricitinib. Call your healthcare provider if you have any problems with low blood sugar.
• Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking baricitinib and while you take baricitinib to check for the following: low neutrophil and lymphocyte counts. Neutrophils and lymphocytes are types of white blood cells that help the body fight off infections. low red blood cell counts. This may mean that you have anemia, which may make you feel weak and tired. increased cholesterol levels. If you are being treated for rheumatoid arthritis or alopecia areata, your healthcare provider should do blood tests to check your cholesterol levels approximately 12 weeks after you start taking baricitinib, and as needed. elevated liver enzymes. Liver enzymes help to tell if your liver is functioning normally. Elevated liver enzymes may indicate that your healthcare provider needs to do additional tests on your liver. You should not take baricitinib if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your baricitinib treatment for a period of time if needed because of changes in these blood test results.

Before taking baricitinib, tell your healthcare provider about all your medical conditions (see also important information above), including if you:

• have an infection
• are a current or past smoker
• have had a heart attack, other heart problems, or a stroke
• have kidney problems
• have liver problems
• have diabetes
• have low red or white blood cell counts
• have recently received or are scheduled to receive a vaccine. People who take baricitinib should not receive live vaccines.
• have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
• are pregnant or plan to become pregnant. It is not known if baricitinib will harm an unborn baby. There is a pregnancy exposure registry that monitors women exposed to baricitinib during pregnancy. If you become pregnant during treatment with baricitinib call 1-800-284-1695 or visit https://pregnancyregistry.lilly.com to report the pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if baricitinib passes into your breast milk. You should not breastfeed during treatment with baricitinib and for 4 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with baricitinib.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Baricitinib may cause serious side effects, including:

• See "What is the most important information I should know about baricitinib?"

The most common side effects of baricitinib in people treated for rheumatoid arthritis include:

• upper respiratory tract infections (common cold, sinus infections)
• nausea
• herpes simplex virus infections, including cold sores
• shingles (herpes zoster)

The most common side effects of baricitinib in people treated for COVID-19 include:

• increased liver enzyme levels
• increased platelets in your blood (thrombocytosis)
• increased blood creatine phosphokinase
• low white blood cell count (neutropenia)
• blood clots in the veins of your legs (DVT)
• blood clot in your lungs (pulmonary embolism)
• urinary tract infection

The most common side effects of baricitinib in people treated for alopecia areata include:

• upper respiratory tract infections (common cold, sinus infections)
• headache
• acne
• increased blood cholesterol
• increased blood creatine phosphokinase
• urinary tract infection
• increased liver enzyme levels
• inflammation of hair follicles (folliculitis)
• tiredness
• lower respiratory tract infections
• nausea
• genital yeast infection
• low red blood cell count (anemia)
• low number of certain types of white blood cells (neutropenia)
• stomach-area (abdominal) pain
• shingles (herpes zoster)
• increased weight

These are not all of the possible side effects of baricitinib. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Baricitinib and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take:

• a medicine called probenecid
• medicines that affect your immune system, such as biologic medications, other JAK inhibitors, and strong immunosuppressants (such as azathioprine and cyclosporine) as these medicines may increase your risk of infection. Ask your healthcare provider or pharmacist if you are not sure if you are taking one of these medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Eli Lilly and Company make baricitinib under the brand name Olumiant. Olumiant is a registered trademark of Eli Lilly and Company and is marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA. For more information, call 1-800-545-5979 or go to the following website: www.olumiant.com.

Aurobindo Pharma Ltd makes generic baricitinib.

Store baricitinib at room temperature between 68°F and 77°F (20°C and 25°C).

Keep baricitinib and all medicines out of the reach of children.

Active ingredient: baricitinib

Inactive ingredients (Olumiant): croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.