Tofacitinib
DRUG STATUS
Approvals
US(FDA), UK(BNF)
Essential Medicine
NO
Teratogenicity
N/A
Pharmaceutical Class
Janus Kinase Inhibitor

Tofacitinib
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Click HereSummary
Tofacitinib is used to treat several types of joint and bowel problems in adults and some children, including severe arthritis (rheumatoid, psoriatic, and ankylosing spondylitis) and severe ulcerative colitis. It's also used for children over two with a specific type of severe arthritis known as juvenile arthritis.
Tofacitinib works by blocking specific enzymes called Janus kinases (JAKs) in the body. These enzymes help control inflammation and the immune response. By inhibiting JAKs, Tofacitinib reduces the production of inflammatory substances that can cause conditions like rheumatoid arthritis and ulcerative colitis, thereby decreasing inflammation and improving symptoms.
The typical adult dose of Tofacitinib is 5 milligrams twice a day. For the immediate-release tablets, you take 5 mg twice daily, while the extended-release version is taken as 11 mg once daily. It's important to swallow the extended-release tablets whole and not to crush, chew, or split them.
Common side effects of Tofacitinib include headaches, nausea, diarrhea, and abdominal pain. More serious side effects can include infections like pneumonia or shingles, especially in the first three months of use. Other side effects like vomiting and acne have also been observed.
Tofacitinib is not suitable for people with severe liver disease or hepatitis B or C. It's also important to tell your doctor about any infections, smoking habits, cancer, heart issues, or blood clots you have before starting Tofacitinib. If you take too much, seek immediate medical help.
Indications and Purpose
What is Tofacitinib used for?
Tofacitinib is a medicine used when other treatments haven't worked. It helps adults with several types of painful joint and bowel problems: severe arthritis (rheumatoid, psoriatic, and ankylosing spondylitis), and severe ulcerative colitis. It's also used for children over two with a specific type of severe arthritis (juvenile arthritis). The medicine is only given if a type of medicine called a TNF blocker didn't work first.
How does Tofacitinib work?
Tofacitinib works by blocking specific enzymes called Janus kinases (JAKs) in the body. These enzymes are involved in sending signals from outside the cell to the inside, which helps control inflammation and the immune response. By inhibiting JAKs, Tofacitinib reduces the production of inflammatory substances that can cause conditions like rheumatoid arthritis and ulcerative colitis. This helps decrease inflammation and improves symptoms, allowing the body to function more normally without excessive immune activity.
Is Tofacitinib effective?
Tofacitinib is a medicine that helps with several types of joint and bowel problems. Studies show it works well for some people with psoriatic arthritis, making them feel better and more active. It's also used for other conditions like ulcerative colitis and rheumatoid arthritis, especially when other medicines haven't worked. While it shows promise for ankylosing spondylitis, it hasn't been proven to stop joint damage in psoriatic arthritis.
How does one know if Tofacitinib is working?
The benefits of Tofacitinib are checked through clinical trials, where researchers study how well it works for conditions like rheumatoid arthritis and ulcerative colitis. In these trials, patients are given either Tofacitinib or a placebo (a dummy treatment) to see how much their symptoms improve. They look at specific scores to measure improvement over time. Real-world studies also help confirm its effectiveness and safety in everyday use, showing how well it helps people manage their conditions.
Directions for Use
What is the usual dose of Tofacitinib?
Tofacitinib's usual adult dose is 5 milligrams twice a day. A higher dose isn't recommended for arthritis. If you have liver or kidney problems, or take certain other medicines, your doctor might need to adjust your dose. This information doesn't cover children.
How do I take Tofacitinib?
Tofacitinib can be taken with or without food, which means you can choose to take it at your convenience. For the immediate-release tablets, the typical dosing is 5 mg twice daily, while the extended-release version is taken as 11 mg once daily. It’s essential to swallow the extended-release tablets whole and not to crush, chew, or split them. There are no specific food restrictions while taking Tofacitinib, but it's always a good idea to follow your healthcare provider's advice for any dietary considerations.
For how long do I take Tofacitinib?
The typical duration of use for Tofacitinib varies based on the condition being treated. For rheumatoid arthritis, patients may be on Tofacitinib for long-term management, with studies showing median treatment durations of around 4.9 years. In clinical trials for ulcerative colitis, treatment can last up to 52 weeks or longer, depending on individual response. For conditions like alopecia areata, treatment duration in studies ranges from 2 to 18 months. Always follow your healthcare provider's recommendations for the appropriate duration based on your specific situation.
How long does it take for Tofacitinib to start working?
It's different for everyone. Some people feel better quickly, while others may take longer to notice a difference. The medicine's effects build up over time, so you might not feel the full benefit right away.
How should I store Tofacitinib?
Keep the medicine in its original bottle and box at room temperature, between 68°F and 77°F (or 20°C and 25°C). Use it within 2 months (60 days) of opening the bottle; throw away any leftover medicine after that. Make sure children can't reach it.
Warnings and Precautions
Who should avoid taking Tofacitinib?
Tofacitinib is a medicine not suitable for people with severe liver disease or hepatitis B or C. Its effects on children aren't fully known except in certain cases of juvenile arthritis. Before starting Xeljanz, tell your doctor about any infections, smoking, cancer, heart issues, or blood clots you have. If you take too much, get immediate medical help.
Can I take Tofacitinib with other prescription drugs?
Tofacitinib is a medicine affected by other medicines you might also be taking. Some medicines, like ketoconazole and fluconazole, make your body keep more tofacitinib, so you might need a lower dose to avoid problems. Other medicines, like rifampin, make your body get rid of tofacitinib faster, meaning it might not work as well, so you shouldn't take them together. Taking tofacitinib with other drugs that weaken your immune system, such as azathioprine, tacrolimus, or cyclosporine, raises your chances of getting sick because your body's defenses are weaker. It's important to talk to your doctor about all the medicines you're taking to make sure it's safe to take tofacitinib.
Can I take Tofacitinib with vitamins or supplements?
Tofacitinib has notable interactions with certain vitamins and supplements. Specifically, while there are no significant interactions reported with Vitamin D3, Vitamin B12, and Vitamin B6, caution is advised when taking high doses of these vitamins alongside Tofacitinib. Additionally, St. John's Wort should be avoided as it can reduce the effectiveness of Tofacitinib by increasing its breakdown in the body.
Can Tofacitinib be taken safely while pregnant?
This medicine may harm a developing baby. Women who are pregnant or might become pregnant should talk to their doctor about the risks before taking this medicine. If you are pregnant or think you might be, tell your doctor right away.
Can Tofacitinib be taken safely while breastfeeding?
If you're taking Tofacitinib, don't breastfeed. The medicine can pass into your breast milk and increase the risk of serious infections for your baby. While there's little evidence of harm in a few cases, we don't know enough about the long-term effects on babies.
Is Tofacitinib safe for the elderly?
Older people are more likely to get infections when taking Tofacitinib. Some studies didn't have enough older patients to be sure if they reacted differently to the medicine than younger people. But, the studies did show that older people (65 and up) taking Tofacitinib got serious infections more often than younger people.
Is it safe to exercise while taking Tofacitinib?
Exercise is generally safe and encouraged. Be cautious if you experience dizziness, fatigue, or joint pain. Stay hydrated and listen to your body during physical activity.
Is it safe to drink alcohol while taking Tofacitinib?
Alcohol may enhance the risk of liver damage, especially if you already have liver concerns. Moderate consumption may be acceptable, but it’s best to consult your doctor.