Xeljanz (tofacitinib citrate) Cost, Side Effects, Copay Card, Prescribing Information | Cecilia Pham, PharmD | RxEconsult

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Xeljanz (tofacitinib) uses, side effects, drug interactions, and dosing Category: Rheumatoid Arthritis & Inflammatory Conditions by - November 23, 2012 | Views: 14561 | Likes: 1 | Comment: 0  

Brand Name: Xeljanz Xeljanz for RA
Generic Name: tofacitinib

Medication class: Janus kinases (JAKs) inhibitor
Manufactured by: Pfizer US Pharmaceuticals
FDA Approval Date: November 6, 2012

What is Xeljanz and how does it work

Xeljanz is an oral drug that blocks the action of enzymes called Janus Kinases (JAKs) located inside many cells, particularly stem cells in the bones and joints. These enzymes activate the STATs system (Signal Transducers and Activators of Transcription). The STATs system sends chemical signals that trigger blood formation of blood cells (hematopoiesis) and also stimulates immune responses that cause symptoms such as pain, tenderness, and swelling. Because Xeljanz blocks this pathway, it prevents these inflammatory symptoms.

What does Xeljanz treat

Xeljanz is approved to treat adult patients with moderately to severely active rheumatoid arthritis (RA) who have failed treatment with or cannot tolerate methotrexate. It can be used alone or in a combination therapy with methotrexate (MTX) and other non-biologic disease-modifying antirheumatic drugs (DMARDs).

How effective is Xeljanz

6-month trial studies and a 2-year trial study were conducted in patients with active rheumatoid arthritis who had inadequate response to the standard and preferred rheumatoid arthritis treatment drug classes (DMARDs, TNF inhibitors, and MTX).

  • Results of the trials showed higher response rates with either Xeljanz 5 or 10 mg twice daily within 2 weeks compared to placebo.
  • At 3 months of treatment, an average of 55% of patients on Xeljanz 5 mg twice daily had improvement in tender or swollen joints and reduction in other rheumatoid arthritis symptoms compared to only 27% of patients on placebo. All patients previously had inadequate response to methotrexate. Response at 6 and 12 months was similar to the 3 month result.
  • At 3 and 6 months, results also showed that patients stayed in remission and did not experience further active episodes of rheumatoid arthritis.

What are interesting facts about Xeljanz

  • Xeljanz is the first drug in this new class of medications (Janus kinases inhibitor) approved by the FDA for treating RA.
  • Xeljanz is an oral pill. Some other drugs used for rheumatoid arthritis are injections and some need to be infused.
  • Studies showed that Xeljanz was comparable to adalimumab, a TNF inhibitor.
  • Xeljanz increased cholesterol levels.

What are the side effects of Xeljanz

Common: common colds, sinus infections, headache, diarrhea, nasal congestion, sore throat, and runny nose.

Serious: Serious infections have been reported especially when Xeljanz was taken in combination with MTX or medicinal steroids. Infection leading to cancers have also been reported at a higher rate in kidney transplant patients on combination Xeljanz and other drugs that suppress the immune system. If a serious infection occurs, stop taking Xeljanz until the infection is treated or stabilized as directed by a physician. Xeljanz may reduce the number of white blood cells and red blood cells. Perforation of the stomach and intestines may occur. Cholesterol levels may increase and should be treated based on national guidelines.

Xeljanz dosing and administration

Xeljanz is available as a 5 mg tablet to be taken orally twice daily with or without food.

If taking with a CYP3A4 inhibitor or in the case of moderate to severe kidney (no studies on CrCl < 40 mL/min) or liver impairment, Xeljanz 5 mg should be taken once daily.

Xeljanz drug interactions

Certain drugs such as antifungals (for example, ketoconazole and fluconazole) may increase blood levels of Xeljanz. If such drugs are required long term then Xeljanz 5 mg should be taken once daily. Some antibiotics (for example, rifampin and isoniazid) may reduce blood levels of Xeljanz.

The immune system could be suppressed more if Xeljanz is taken with other RA drugs or other immunosuppressive medications (for example, azathioprine, tacrolimus, cyclosporine, or steroids). This may increase the risk for infection.

What is the cost of Xeljanz

The price of Xeljanz 5 mg is about $2,492 or more for 60 tablets.

How to obtain prescription assistance for Xeljanz

For prescription assistance visit the Pfizer Xelsource website for assistance. A copay savings card is also available that can reduce out of pocket cost to zero. 


Xeljanz FDA Prescribing Information and Medication Guide.

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Xeljanz Versus Humira for Rheumatoid Arthritis


This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.


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