Xeljanz dosage, forms, and strengths

Xeljanz is a brand-name prescription drug that treats rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ulcerative colitis. These are all autoimmune conditions in which the immune system attacks healthy cells. The resulting inflammation causes pain and progressive tissue damage. Tofacitinib, the active ingredient in Xeljanz, dials down the immune system by blocking key chemicals the body uses to signal an immune system response. Xeljanz tablets or oral solution are taken by mouth twice per day with a meal or on an empty stomach. Extended-release Xeljanz XR tablets are available for once-a-day dosing. 

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Xeljanz forms and strengths

Xeljanz is normally taken as a tablet in one of two strengths, but people who have difficulty swallowing tablets can use an oral solution.

• Tablets: 5 milligrams (mg), 10 mg

• Oral solution: 1 mg per mL

Xeljanz is also available as an extended-release tablet, but daily doses will be slightly higher. Switching to extended-release Xeljanz XR will require a new prescription.

 Xeljanz dosage for adults

Xeljanz is FDA approved to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in adults. The usual dose is 5 mg twice per day, though the starting dosage may vary.

Source: Epocrates, Prescriber’s Digital Reference

Xeljanz dosage for rheumatoid arthritis (RA)

Xeljanz is prescribed to improve the symptoms of moderate to severe rheumatoid arthritis after methotrexate treatment has been tried. Rheumatoid arthritis is an autoimmune disease that causes swelling and pain in the joints. Over time this leads to a loss of joint function and progressive tissue damage. 

Because Xeljanz changes the immune response that causes rheumatoid arthritis it is called a disease-modifying antirheumatic drug (DMARD). 

Xeljanz can be used alone as treatment, but it is often used together with other drugs that treat rheumatoid arthritis.

• Standard dosage active rheumatoid arthritis: 5 mg twice per day

• Maximum dosage for active rheumatoid arthritis: 10 mg per day

Xeljanz dosage for psoriatic arthritis (PsA)

Xeljanz is also FDA approved as a second-line treatment for active psoriatic arthritis (PsA) after methotrexate or other DMARDs have been tried. Psoriatic arthritis is an autoimmune arthritis that is associated with psoriasis (PsO), an autoimmune skin condition. Approximately 20% to 30% of people with psoriasis also have psoriatic arthritis. As with rheumatoid arthritis, the immune system overreacts and attacks healthy tissues in the joints. Xeljanz is never used alone in psoriatic arthritis treatment but is always combined with another medication. 

• Standard dosage for active psoriatic arthritis: 5 mg twice per day

• Maximum dosage for active psoriatic arthritis: 10 mg per day

Xeljanz dosage for ulcerative colitis

Ulcerative colitis is a  condition in which the immune system attacks healthy tissues that line the colon and rectum, causing inflammation and sores. People with ulcerative colitis—about a million people in the United States alone—go through periods of active, painful flare-ups followed by remission periods. 

Xeljanz is FDA approved as a second-line treatment for moderately to severely active ulcerative colitis in patients who cannot take or are not successfully treated by TNF (tumor necrosis factor) blockers. TNF is another substance in the body that signals the immune system to start the inflammatory process. Xeljanz treatment will continue as maintenance treatment after symptoms have subsided to allow colon tissues to heal.

• Standard dosage for moderately to severely active ulcerative colitis: 10 mg twice per day for at least eight weeks followed by 5 mg twice per day as maintenance treatment

• Maximum dosage for moderately to severely active ulcerative colitis: 20 mg per day

Xeljanz dosage for children

Xeljanz is approved to treat children as young as 2 years of age for active polyarticular juvenile idiopathic arthritis (JIA), a rheumatic disorder that affects children and adolescents. Xeljanz dosages will be based on body weight for children weighing less than 40 kilograms (88 pounds). For children weighing more than 40 kg, dosages are the same as the recommended dose for adults. 

Source: Epocrates

Xeljanz dosage restrictions

Xeljanz doses will be lowered in people with kidney or liver problems since both the kidneys and liver eliminate tofacitinib from the body. Kidney or liver problems will result in higher concentrations of tofacitinib in the blood, increasing the risk and severity of adverse reactions, particularly serious infections. Some drugs interfere with the liver enzymes that break down tofacitinib, so people taking those drugs will also need a lower dose. 

Tofacitinib also suppresses the bone marrow’s production of white blood cells. White blood cells are the body’s first line of defense against infection and some forms of cancer. Bone marrow suppression can also cause a drop in red blood cells that carry oxygen to the body. People taking Xeljanz will have regular blood tests. If blood counts drop too far, doses will either be halved or Xeljanz stopped altogether. 

Some people with pre-existing conditions can take Xeljanz at normal doses but will need to be carefully watched for adverse effects. Because Xeljanz suppresses the immune system, anyone with a latent infection or at risk for infection or cancer will need very close monitoring. Caution is also required in anyone with risk factors for gastrointestinal disease (such as diverticulitis), heart disease or stroke, or blood clots (thrombosis). 

The full range of Xeljanz dosage restrictions are summarized below:

• Renally impaired patients (kidney disease): 

  • Moderate to severe renal impairment: 5 mg once daily or 5 mg twice daily (half of usual dose)

  • Dialysis: 5 mg once daily or 5 mg twice daily (half of usual dose) administered after dialysis

• Hepatically impaired patients (liver disease): 

  • Moderate to severe hepatic impairment: 5 mg once daily or 5 mg twice daily (half of usual dose)

  • Severe hepatic impairment: Not recommended

• Low neutrophil count (neutropenia) ANC (absolute neutrophil count)= 500 to 1000 cells per mL: Stop medication until ANC is above 1000, then begin 5 mg once daily or 5 mg twice daily (half of usual dose)

• Low neutrophil count (neutropenia) ANC less than 500 cells per mL: Discontinue Xeljanz

• Low lymphocyte count (lymphopenia) less than 500 cells per mL: Discontinue Xeljanz

• Low hemoglobin: Discontinue Xeljanz until hemoglobin has recovered

• Concomitant use of drugs that strongly or moderately block the metabolism of tofacitinib (strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors): 5 mg once daily or 5 mg twice daily (half of usual dose)

How to take Xeljanz

Xeljanz is normally taken twice per day as a tablet or oral solution. Both the tablets and oral solution can be taken with or without food.

• Take this medicine as directed. 

• Xeljanz comes packaged with a medication guide. Please read this guide when starting each prescription.

Xeljanz tablets

• Swallow the tablet with water.

• Store Xeljanz tablets at room temperature (68°F to 77°F).

Xeljanz oral solution

• Xeljanz oral solution must be used within 60 days of opening the bottle. Throw out any remaining oral solution after 60 days.

• The oral solution dose should be measured out with an oral dosing syringe. Do not measure doses using kitchen utensils.

• Store Xeljanz oral solution at room temperature (68°F to 77°F) in the original carton protected from heat and light.

 Xeljanz dosage FAQs

Xeljanz vs. Xeljanz XR: What’s the difference in doses?

Xeljanz is normally taken as two 5 mg or 10 mg doses per day. The daily dosing schedule can be simplified by taking Xeljanz 11 mg tablets either once a day or twice a day. Because the doses are different, switching to Xeljanz XR will require a new prescription.

How long does Xeljanz stay in your system?

Tofacitinib has an elimination half-life of three hours, so it will take less than a day for the body to completely clear the last dose of Xeljanz. However, after several weeks of treatment, it can take the immune system up to six weeks to return to normal after the last dose of Xeljanz.

What happens if I miss a dose of Xeljanz?

Take a missed dose as soon as it’s remembered unless it’s almost time for the next dose. In that case, skip the forgotten dose and take the next scheduled dose on time. Do not take an extra dose to make up for a missed dose.

How do I stop taking Xeljanz?

Xeljanz can be stopped without causing withdrawal symptoms.

A healthcare professional may stop Xeljanz immediately for a variety of reasons: severe allergic reactions, low white blood cell counts, anemia, or other problems due to immunosuppression such as severe infections, opportunistic infections, non-melanoma skin cancer, lymphoma, or reactivation of viral infections such as hepatitis B or varicella (shingles). Serious side effects such as gastrointestinal perforation, cardiovascular problems, or blood clots may also require immediate discontinuation of Xeljanz.

Some people may wish to stop taking Xeljanz because of less serious but bothersome side effects such as periodic upper respiratory tract infections, herpes zoster infections, and urinary tract infections. There are also potentially worrisome Xeljanz side effects such as elevated cholesterol or high blood pressure. Before stopping Xeljanz for any reason, get medical advice from a healthcare professional. 

If Xeljanz needs to be stopped, a healthcare provider can prescribe other medicines to treat the condition. People who stop taking Xeljanz can take a variety of drugs that dial back the immune system including corticosteroids, conventional immune-suppressing drugs such as methotrexate, non-biologic DMARDs, and biologic DMARDs (immune-suppressing monoclonal antibodies).

What interacts with Xeljanz?

All immunosuppressive drugs like Xeljanz have a number of potentially hazardous drug interactions that patients should be aware of. The most problematic are live vaccines or other drugs that also suppress the immune system.

• Live vaccines can cause serious infections in any person with a compromised immune system, so they are never given to anyone taking Xeljanz. Not every vaccine is a live vaccine. Talk to a healthcare professional before receiving vaccines.

• Healthcare providers are cautioned not to combine Xeljanz with monoclonal antibodies that suppress the immune system, called biologic DMARDs. These include well-known anti-rheumatic or anti-psoriasis drugs such as Humira (adalimumab) and Enbrel (etanercept). 

• Other non-biologic immunosuppressants also significantly raise the risk of infection and cancer when combined with Xeljanz. Some of these, such as azathioprine and cyclosporine, are used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, but healthcare professionals will avoid combining them with Xeljanz. 

• Several drugs block the ability of the liver to break down tofacitinib, increasing the risk of infection and other side effects. Xeljanz doses will be reduced in half if any of these drugs are being taken. Some are well-known, like the antifungal drugs ketoconazole and fluconazole, but doctors, pharmacists, and other healthcare professionals know what these drugs are and what to do when they’re combined with other medications.

Is it safe to take Xeljanz during pregnancy?

Pregnant women are given Xeljanz, but healthcare professionals have no information about whether Xeljanz is safe to take during pregnancy. Animal studies have shown that tofacitinib can cause birth defects and fetal death when given at high doses to pregnant animals. Unfortunately, active rheumatoid arthritis or ulcerative colitis can also cause problems during pregnancy, so women should weigh the pros and cons of Xeljanz treatment with their doctor.

Women who are breastfeeding will be advised to either not take Xeljanz or stop breastfeeding. Both Pfizer, the manufacturer, and the FDA recommend that a woman not breastfeed an infant until at least 18 hours have passed since the last dose of Xeljanz or 36 hours after the last dose of Xeljanz XR has been taken.

Related resources for Xeljanz dosages:

• Tofacitinib drug summary, Prescriber’s Digital Reference

• Ulcerative colitis, StatPearls

• Xeljanz, Epocrates

• Xeljanz prescribing information, U.S. National Library of Medicine