Tofacitinib (Xeljanz) for ulcerative colitis

What is tofacitinib (Xeljanz)?

Xeljanz is the brand name for tofacitinib. It’s a type of biologic drug called a JAK (Janus-associated tyrosine kinase) inhibitor used in the treatment of adults with moderately or severely active ulcerative colitis.

How does tofacitinib work?

JAKs are proteins that are involved in activating your immune response, which can cause inflammation in the gut in ulcerative colitis patients. Tofacitinib works to block the effects of JAKs and reduce inflammation. It can help to reduce the symptoms of ulcerative colitis and reduce your need for steroids. It aims to reduce inflammation in the gut, prevent flares and improve symptoms including diarrhoea, bleeding and pain.

Who can take tofacitinib?

Tofacitinib is recommended as a treatment option for adults with moderately or severely active ulcerative colitis when other inflammatory bowel disease (IBD) treatments have been tried but prove unsuccessful. This means in general if your ulcerative colitis did not respond adequately to standard* treatments or biologic treatments, you have not got better or have stopped getting better while on them, or you can’t tolerate standard treatments or biologic treatments.

*including steroids, immunosuppressants (such as azathioprine, mercaptopurine, methotrexate) or biological drugs (infliximab, adalimumab, golimumab, vedolizumab).

Before starting tofacitinib you should tell your doctor if you believe you may currently have any infections. Tofacitinib can reduce your body’s ability to fight infections. It may make an existing infection worse or increase the chance of you getting a new infection. Use of tofacitinib in patients older than 65 years is not recommended, unless no suitable alternative is available, as tofacitinib has been found to increase the risk of serious infections¹.

Signs of infection may include; fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired. 

Other considerations are;

• If you have ever had tuberculosis (TB), or have come into contact with somebody with TB. You may need tests to check for tuberculosis before and during treatment with tofacitinib

• If you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) in the past. Tofacitinib may increase the risk of blood clots²

• If you have ever had hepatitis. You may need regular checks for this as tofacitinib may increase the risk of you getting hepatitis again

• If you have cancer or if you have previously had cancer. You may have a slightly increased risk of developing some types of cancer including lymphoma and some types of  skin cancer. Your doctor will have to make a decision to prescribe tofacitinib or not

• If you have heart problems such as congestive heart failure or ischemic heart disease, tofacitinib may make your symptoms worse

• If you have any condition that increases your chance of infection (e.g diabetes, HIV/AIDS, or a weak immune system)

• If you have a history of fainting, tofacitinib may make this worse

• If you are pregnant. Tofacitinib can’t be taken in pregnancy because of the risk of damage to the developing baby

• If you recently had a vaccine, or are due to have one. You should wait a certain amount of time before starting tofacitinib, which your doctor can advise you about 

You should also tell your doctor if you take any other medications, over-the-counter medicines or vitamins or supplements.

How do you take tofacitinib?

Tofacitinib is in tablet form, usually taken orally twice a day, once in the morning and once in the evening, with or without food.

How long does tofacitinib take to work?

Some people may find they begin to feel better as little as three days after starting treatment, but you should hopefully feel an improvement in your symptoms within eight weeks if tofacitinib is working for you.  

However, if taking tofacitinib hasn’t improved your symptoms after taking it for 16 weeks, you will need to stop taking it as it’s not the right treatment for you. 

What are the side effects and risks of tofacitinib?

The most common reported side effects of tofacitinib are³:

• Lung infection (bronchitis and pneumonia)
• Shingles 
• Stuffy or runny nose
• Sore throat 
• Bladder and urine infections 
• Stomach pain
• Vomiting
• Diarrhoea
• Nausea
• Indigestion 
• Fever
• Fatigue
• Swelling of the feet and hands
• Headache
• High blood pressure (hypertension)
• Cough
• Rash

Uncommon side effects are:

• Tuberculosis
• Kidney infection
• Skin infection
• Cold sores
• Low white blood cell count
• Increased cholesterol (blood fat)
• Weight gain
• Dehydration
• Muscle and joint pain
• Poor sleep
• Shortness of breath or difficulty breathing
• Skin redness and itching
• Some types of skin cancers (non-melanoma types)

Possible serious side effects:

• Lung cancer
• White blood cell cancer
• Heart attack

Can I take tofacitinib with other medication?

Tofacitinib may interact with some other medications so it’s important you tell your doctor about any medications you are taking before starting, including over-the-counter medicines and supplements, especially St John’s Wort which may reduce the effectiveness of tofacitinib.

Other medicines that may also affect how tofacitinib works are antibiotics used to treat bacterial infections such as rifampicin and clarithromycin. Antifungals for treating fungal infections such as voriconazole, fluconazole, ketoconazole, clotrimazole and itraconazole.

It’s really important you tell your doctor as there may be other drug interactions not mentioned here. 

Will I be monitored?

Prior to starting tofacitinib you should expect to be screened for various things. Blood tests to check your kidney function and blood count, and screening for tuberculosis may be carried out. 

You should also be offered blood tests after taking tofacitinib for eight weeks and then every three months during treatment. This is to monitor your red and white blood cells as tofacitinib can cause a reduction in these. Tofacitinib can increase cholesterol levels for some people, so your cholesterol levels and liver function should be monitored too.

More information:

Xeljanz is licensed by Pfizer and is available on the NHS in the UK. It is approved by the Food and Drug Administration (FDA) in the US.