Indications
Xeljanz (active ingredient: tofacitinib) is a prescription medication indicated for the following:
- Rheumatoid Arthritis: Xeljanz is used to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
- Psoriatic Arthritis: Xeljanz is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
- Ulcerative Colitis: Xeljanz is used to treat adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers.
- Ankylosing Spondylitis: Xeljanz is indicated for the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
Xeljanz belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which work by interfering with the signaling pathways inside cells that are involved in the immune response, thereby reducing inflammation and immune system activity.
Uses and Dosage
You should take tofacitinib as directed by your doctor. It comes in the form of a 5 mg tablet that you take by mouth once or twice daily, with or without food. Swallow the tablets whole and do not split, chew, or crush them. Take tofacitinib at around the same time(s) every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.
The dosages of Tofacitinib may vary depending on the medical condition being treated. Here are some of the recommended dosages:
- For Rheumatoid Arthritis and Psoriatic Arthritis: the recommended dose is 5 mg twice a day for immediate-release tablets.
- For Ulcerative Colitis: the recommended dose is 5 mg four times a day for at least 8 weeks, followed by 5 mg or 10 mg twice a day.
- For Polyarticular Course Juvenile Idiopathic Arthritis: the recommended dose is 5 mg twice a day.
Side Effect
Common Side Effects of Xeljanz (Tofacitinib):
- Diarrhea
- Elevated blood cholesterol levels
- Headache
- Nausea
- Rash
- Stuffy nose
- Throat irritation
- Upper respiratory tract infection, such as sinusitis (pain and swelling in your sinuses) or the common cold
- Upper respiratory tract infection, such as sinusitis or the common cold
Serious Side Effects of Xeljanz (Tofacitinib):
- Allergic reaction
- Blood disorders
- Cardiovascular problems, such as heart attack or stroke
- Fast heartbeat
- Night sweats
- Painful urination
- Persistent cough
- Risk of blood clots
- Risk of cancer and immune system disorders
- Risk of death in certain people
- Risk of serious infections
- Severe abdominal pain
- Shortness of breath
- Signs of infection (fever, chills, persistent sore throat)
- Signs of liver problems (persistent vomiting, dark urine, yellowish eyes, and skin)
- Tears in your digestive tract
- Unusual tiredness or fatigue
- Warm and painful skin
Form and Strength
Xeljanz (Tofacitinib) is available in the following forms and strength:
Xeljanz: ER Tablet
- 5 mg
- 10 mg
Tofacitinib: ER Tablet
- 5 mg
Caution
- Tofacitinib should not be used during pregnancy, as it may harm the developing fetus. It is also not known if tofacitinib is excreted in human breast milk, so it is not recommended for use while breastfeeding.
- Xeljanz should be used with caution in patients with risk factors for serious infections.
- Tofacitinib has a boxed warning for major adverse cardiovascular events, malignancy, and serious infections and it should be used with caution in patients with at least one heart disease risk factor.
- Xeljanz should be used with caution in patients with a history of cancer and immune system problems. JAK inhibitors, including Xeljanz, should be used with caution in patients with certain risk factors.
- Xeljanz may have possible side effects, and patients should be aware of the potential risks and benefits of treatment. Tofacitinib should be prescribed at the lowest effective dose necessary to achieve the desired therapeutic outcome.
- Xeljanz may increase the risk of infections or worsen current infections. Avoid contact with individuals who have infections that may be contagious, such as chickenpox, measles, or flu. Seek medical advice if you have been exposed to an infection or for further information.
- Tell your doctor and pharmacist if you are allergic to tofacitinib, any other medications, or any of the ingredients in tofacitinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
Frequently Asked Questions (FAQ)
Does tofacitinib lower the immune system?
Yes, tofacitinib can lower the immune system's ability to fight infections.
Was tofacitinib approved for psoriatic arthritis?
Tofacitinib was approved by the FDA for psoriatic arthritis treatment in 2022.
Was tofacitinib approved for ulcerative colitis?
Yes, tofacitinib was approved by the FDA for ulcerative colitis treatment in 2018.
Can tofacitinib be used in combination with other medications?
Tofacitinib can be used in combination with other medications used to treat autoimmune diseases but talk to your doctor about the potential risks and benefits of combining medications.
How often is tofacitinib taken?
Tofacitinib is usually taken twice a day.
Resources
- https://www.webmd.com/drugs/2/drug-162865/xeljanz-oral/details
- https://www.xeljanz.com/safety-side-effects
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68e3d6b2-7838-4d2d-a417-09d919b43e13
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf
- https://medlineplus.gov/druginfo/meds/a613025.html
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