Everything You Should Know About Tofacitinib(Xeljanz)

Everything You Should Know About Tofacitinib(Xeljanz)

What is Xeljanz?

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor that may be used alone or with other medications to treat inflammatory and autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.

Xeljanz XR is an extended-release tablet form of Xeljanz that is taken once a day.

Xeljanz works by decreasing the activity of the immune system. It does this by blocking the activity of JAK enzymes (JAK1, JAK2, JAK3, TYK2) inside the cell – these enzymes are responsible for sending inflammatory signals in the body which are associated with cytokine release. Xeljanz's mechanism of action of blocking these enzymes helps to decrease the immune reaction which causes rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Xeljanz was FDA-approved on November 6, 2012, and was the first JAK inhibitor to be approved for rheumatoid arthritis.

Xeljanz uses

Xeljanz or Xeljanz XR may be used to treat the following conditions in adults who are unable to take or did not respond to one or more tumor necrosis factor (TNF) inhibitor medication(s):

moderate to severe rheumatoid arthritis

active psoriatic arthritis

moderate to severe ulcerative colitis

ankylosing spondylitis.

Xeljanz and Xeljanz oral solution are also approved to treat polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

Using Xeljanz along with other medications that suppress the immune system can increase the risk of serious side effects. Tell your healthcare provider about all the medications you take.

Xeljanz side effects

The most common side effects of Xeljanz are:

skin rash, acne, shingles

upper respiratory tract infection or cold symptoms such as stuffy nose, sneezing, sore throat

increased blood pressure

diarrhea

abnormal blood tests

elevated cholesterol levels

fever

headache

nausea, or vomiting.

Serious side effects and warnings

Xeljanz and Xeljanz XR carry a Boxed Warning for serious infections, death, cancer, cardiovascular events, and blood clots.

Serious infections. Xeljanz is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Some people can have serious infections while taking Xeljanz, 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 Xeljanz and during treatment.

•Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with Xeljanz.

•You should not start taking Xeljanz 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 (herpes zoster).

•People with ulcerative colitis taking the higher dose of Xeljanz (10 mg twice daily) or Xeljanz XR (22 mg one time each day) have a higher risk of serious infections and shingles.

After starting Xeljanz, call your healthcare provider right away if you have any symptoms of an infection. Xeljanzcan makes you more likely to get infections or make existing infections worse.

Taking Xeljanz is associated with an increased risk of death and major cardiovascular events (such as heart attack or stroke) in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor especially if they are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Xeljanz, 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.

Cancer and immune system problems. Xeljanz may increase your risk of certain cancers by changing the way your immune system works. People taking Xeljanz have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. People with ulcerative colitis taking higher dosages of Xeljanz have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken Xeljanz with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots. Stop taking Xeljanzand tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

Tears (perforation) in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have a fever, stomach-area pain that does not go away, and a change in your bowel habits.

Allergic reactions. Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in people taking Xeljanz. Some of these reactions were serious. If any of these symptoms occur while you are taking Xeljanz, stop taking it and call your healthcare provider right away.

Hepatitis B or C activation in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use Xeljanz. Your healthcare provider may do blood tests before you start treatment with Xeljanz and while you are taking Xeljanz. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:

•feel very tired

•skin or eyes look yellow

•little or no appetite

•vomiting

•clay-colored bowel movements

•fevers

•chills

•stomach discomfort

•muscle aches

•dark urine

•skin rash.

Before taking

Do not take Xeljanz if:

•you have reacted to tofacitinib, Xeljanz, or any of the inactive ingredients contained in Xelanjz or Xeljanz XR tablets, or Xeljanz oral solution

•your lymphocytes, neutrophils, or hemoglobin levels are below the recommended level. Talk with your healthcare provider about this

•you have an active serious or localized infection or severe liver disease.

Before taking Xeljanz, tell your healthcare provider about all of your medical conditions, including if you:

•have an infection, including chronic infections such as tuberculosis, shingles, HIV, or hepatitis. Symptoms of an infection include fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired, or warm, red, or painful skin or sores on your body.

•have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance of infections

•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 (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you take Xeljanz. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common

•have had any type of cancer

•have had a heart attack, other heart problems, or stroke

•have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past

•have liver or kidney problems

•have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines

•high cholesterol •have recently received or are scheduled to receive a vaccine. People who take Xeljanz should not receive live vaccines. People taking Xeljanz can receive non-live vaccines

•are a current or past smoker

•plan to become pregnant or are pregnant

•plan to breastfeed or are breastfeeding.

Using Xeljanz may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.

Do not give this medicine to a child without medical advice. Xeljanz XR (extended-release) tablets are not approved for use by anyone younger than 18 years.

Who makes Xeljanz, Xeljanz XR, and Xeljanz oral solution?

Pfizer Inc. manufactures Xeljanz, Xeljanz XR, and Xeljanz oral solution.