Tofacitinib (oral route)

What is Tofacitinib?

Tofacitinib is a Janus kinase (JAK) inhibitor used to treat autoimmune and inflammatory diseases, including:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ulcerative colitis
• Ankylosing spondylitis
• Polyarticular course juvenile idiopathic arthritis (pcJIA)

It may be used alone or together with other DMARDs when previous treatments, such as methotrexate, were not effective.

How It Works?

Tofacitinib works by suppressing certain immune system pathways involved in inflammation, helping reduce pain, swelling, and disease activity.

Important Precautions

• Take exactly as prescribed by your doctor.
• Do not crush, break, or chew extended-release tablets.
• Regular medical monitoring and blood tests are required during treatment.
• This medicine may weaken the immune system and increase infection risk.

Serious Safety Warnings

Risk of Serious Infections

Tofacitinib can increase the risk of serious infections, including:

• Tuberculosis (TB)
• Shingles (Herpes Zoster)
• Bacterial, viral, and fungal infections

Seek medical help immediately if you develop:

• Fever or chills
• Persistent cough
• Flu-like symptoms
• Unusual tiredness
• Painful urination

Risk of Blood Clots & Cardiovascular Events

This medicine may increase the risk of:

• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Heart attack
• Stroke

Risk may be higher in:

• Patients over 50 years old
• Smokers or former smokers
• Patients with cardiovascular disease

Seek emergency help for:

• Chest pain
• Sudden shortness of breath
• Leg swelling or redness
• Sudden weakness or slurred speech

Cancer Risk Warning

Tofacitinib may increase the risk of certain cancers, including:

• Lymphoma
• Lung cancer
• Skin cancer

Tell your doctor if you notice:

• Swollen glands
• Unexplained weight loss
• Persistent skin lesions
• Non-healing sores

Drug & Vaccine Interactions

Important Drug Interactions

Use caution with:

• Azathioprine
• Cyclosporine
• Tacrolimus
• Rifampin
• Carbamazepine
• Phenytoin
• Fluconazole
• St. John’s Wort

►Vaccines

Avoid live vaccines during treatment, including:

• MMR vaccine
• Varicella vaccine
• Yellow fever vaccine
• Nasal flu vaccine
• Rotavirus vaccine

Always inform your healthcare provider about all medicines, supplements, and vaccines.

Patients Requiring Extra Caution

Use cautiously in patients with:

• Diabetes
• Lung disease
• Liver or kidney disease
• Hepatitis B or C history
• Tuberculosis history
• High cholesterol
• Weak immune system

►Smoking Warning

Current or former smokers may have a greater risk of serious side effects.

Pregnancy & Fertility

• Tofacitinib may harm an unborn baby.
• Effective contraception is recommended during treatment.
• Some women may experience reduced fertility while using this medicine.

Common Side Effects

Common side effects may include:

• Diarrhea
• Headache
• Upper respiratory infections
• Joint or muscle pain
• Indigestion
• Trouble sleeping
• Skin rash or acne

Serious Side Effects – Seek Immediate Medical Attention

Contact your doctor immediately if you experience:

• Signs of infection
• Chest pain or trouble breathing
• Severe allergic reactions or swelling
• Yellowing of skin or eyes
• Unusual bleeding or bruising
• Blood clot symptoms
• Severe dizziness or weakness

Monitoring

Your doctor may regularly monitor:

• Complete blood count (CBC)
• Liver function tests
• Kidney function
• Cholesterol levels
• Tuberculosis screening
• Signs of infection or blood clots

Patient Disclaimer

This information is for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Tofacitinib should only be used under the supervision of a qualified healthcare provider. Do not start, stop, or change your medication without consulting your doctor or pharmacist. Seek immediate medical attention if you develop signs of infection, severe allergic reactions, chest pain, shortness of breath, or symptoms of blood clots.