Tofacitinib Oral tablet

TOFACITINIB (TOE fa SYE it nib) treats autoimmune conditions, such as arthritis and ulcerative colitis. It is prescribed when other medications have not worked or cannot be tolerated. It works by slowing down an overactive immune system. This decreases inflammation.

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot in your leg—pain, swelling, or warmth in the leg
• Blood clot in your lungs—shortness of breath or chest pain
• Change in your skin, such as a new growth, a sore that doesn't heal, or a change in a mole
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Stomach pain that is severe, does not go away, or gets worse
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Fever
• Headache
• Increase in blood pressure
• Nausea
• Runny or stuffy nose
• Sore throat

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

They need to know if you have any of these conditions:

• Blood clots
• Cancer
• Diabetes
• Heart disease
• High blood pressure
• High cholesterol
• HIV or AIDS
• Immune system problems
• Infection, such as tuberculosis (TB), or other bacterial, fungal, or viral infections
• Kidney disease
• Liver disease
• Low blood counts (white cells, red cells, and platelets)
• Lung or breathing disease, such as asthma or COPD
• Organ transplant
• Stomach or intestine problems
• Tobacco use
• An unusual or allergic reaction to tofacitinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Baricitinib
• Upadacitinib

This medication may also interact with the following:

• Azathioprine
• Biologic medications, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, ofatumumab, rituximab, sarilumab, secukinumab, tocilizumab, ustekinumab, vedolizumab
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cyclosporine
• Live virus vaccines
• Medications that lower your chance of fighting infection
• Rifampin
• Supplements, such as St. John's wort
• Tacrolimus

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

Do not breastfeed while taking this medication and for 18 hours after the last dose.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.