【Drug Name】

Name:Tofacitinib Tablets

Product Name: TOFADX

【Specification】5mg

【Indications】

 TOFADX is a prescription medicine called a Janus kinase (JAK) inhibitor.

TOFADX is used to treat adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well.

TOFADX is used to treat adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well.

TOFADX is used to treat adults with moderately to severely active ulcerative colitis.

It is not known if TOFADX is safe and effective in people with Hepatitis B or C.

TOFADX is not recommended for people with severe liver problems.

It is not known if TOFADX is safe and effective in children.

【Recommended Dosage】

·Take TOFADX 2 times a day with or without food.

·Take TOFADX 1 time a day with or without food for rheumatoid or psoriatic arthritis. Do not take TOFADX for ulcerative colitis.  

·Swallow TOFADX tablets whole and intact. Do not crush, split, or chew.

·When you take TOFADX, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

·If you take too much TOFADX, call your healthcare provider or go to the nearest hospital emergency room right away.

·For the treatment of psoriatic arthritis, take TOFADX in combination with

methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

【Side Effects】

Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use TOFADX. Your healthcare provider may do blood tests before you start treatment with TOFADX and while you are using TOFADX. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:

o feel very tired

o skin or eyes look yellow

o little or no appetite

o vomiting

o clay-colored bowel movements

o fevers

o chills

o stomach discomfort

o muscle aches

o dark urine

o skin rash

Common side effects of TOFADX in rheumatoid arthritis patients and psoriatic arthritis patients include:

· upper respiratory tract infections (common cold, sinus infections)

· headache

· diarrhea

· nasal congestion, sore throat, and runny nose (nasopharyngitis)

· high blood pressure (hypertension)

Common side effects of TOFADX in ulcerative colitis patients include:

· nasal congestion, sore throat, and runny nose (nasopharyngitis)

· increased cholesterol levels

· headache

· upper respiratory tract infections (common cold, sinus infections)

· increased muscle enzyme levels

· rash

· diarrhea

· shingles (herpes zoster)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

【Storage】

· Store TOFADX at room temperature between 68°F to 86°F (20°C to 30°C).

· Safely throw away medicine that is out of date or no longer needed.

Keep TOFADX and all medicines out of the reach of children.