Tofacitinib

tablets
5 mg / 10 mg
Therapeutic equivalent of XELJANZ®

Tofacitinib

extended-release
tablets 11 mg
Therapeutic equivalent of XELJANZ® XR†

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing tofacitinib prescription with a copay savings card.

Restrictions and eligibility requirements apply. See Terms and Conditions below for full details.

Download copay savings card
for tofacitinib tablets
5 mg / 10 mg Download copay savings card
for tofacitinib extended-release tablets 11 mg

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing tofacitinib prescription with a copay savings card.

Download copay
savings card for
tofacitinib tablets
5 mg / 10 mg Download copay
savings card for
tofacitinib extended-release tablets 11 mg

Restrictions and eligibility requirements apply.
See Terms and Conditions below for full details.

Full prescribing information including boxed warning and medication guide set forth below or in links:

Tofacitinib tablets 5 mg, 10 mg

Tofacitinib extended-release tablets 11 mg

Full prescribing information including boxed warning and medication guide set forth below or in links:

Tofacitinib tablets 5 mg, 10 mg

Tofacitinib extended-release tablets 11 mg

Using your tofacitinib copay savings card is simple:

  1. Download or print the copay savings card and present it at the pharmacy. Visit www.tofacitinibcopay.com or call toll free at 833-393-5682 if you need assistance or more information on how to use the card.
  2. Ensure that your prescription is being filled with tofacitinib tablets or tofacitinib extended-release tablets manufactured and distributed by Apotex to access savings under the program.

By participating in the Apotex copay savings program for tofacitinib tablets or tofacitinib extended-release tablets, you agree to abide by the Terms and Conditions below:

  • You may not use the Apotex copay savings program if you have prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program, or other federal or state healthcare programs including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as "La Reforma de Salud").
  • You may not use the Apotex copay savings program if you are uninsured or have no prescription drug coverage for tofacitinib tablets or tofacitinib extended-release tablets.
  • The Apotex copay savings program is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs (i.e. you have no cost-sharing obligation).
  • Offer not available for residents of California or Massachusetts or where prohibited by law.
  • This offer is good only in the U.S. and Puerto Rico.
  • You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • If eligible, commercially insured patients may pay as little as $0* out-of-pocket cost with the tofacitinib copay savings card toward each fill, and the program will pay up to $300 per 30-day supply of the remaining cost after primary insurance coverage, up to $3,600 per calendar year.
  • The Apotex copay savings program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Apotex copay savings program will be accepted only at participating pharmacies.
  • The Apotex copay savings program is not health insurance.
  • Apotex reserves the right, at its sole discretion, to amend, to rescind, revoke, or terminate the offer at any time.
  • There are no membership fees for this savings program.
  • If you receive co-payment assistance under the Apotex copay savings program, your personal information will be used to process payment for your prescription under such program through an Apotex vendor.
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about tofacitinib tablets/tofacitinib extended-release tablets?

Tofacitinib tablets/tofacitinib extended-release tablets may cause serious side effects including:

Serious infections. Tofacitinib can lower the ability of your immune system to fight infections.

What are tofacitinib tablets/ tofacitinib extended-release tablets?

Tofacitinib tablets/tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor used to treat adults with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or cannot be tolerated.
 
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about tofacitinib tablets/tofacitinib extended-release tablets?

Tofacitinib tablets/tofacitinib extended-release tablets may cause serious side effects including:

Serious infections. Tofacitinib can lower the ability of your immune system to fight infections. Some people can have serious infections while taking tofacitinib, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

  • Your healthcare provider should test you for TB before starting tofacitinib and during treatment.
  • Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with tofacitinib. You should not start taking tofacitinib if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

Before starting tofacitinib tablets/tofacitinib extended-release tablets, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweating, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than normal
    • feeling very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB or have been in close contact with someone with TB.
  • live, have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections.
  • have or have had hepatitis B or C.

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking tofacitinib 5 mg or 10 mg twice daily.

Cancer and immune system problems. Tofacitinib may increase your risk of certain cancers by changing the way your immune system works.

  • Lymphoma and other cancers, including skin cancers, can happen. People taking tofacitinib tablets 5 mg or 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with ulcerative colitis taking the higher dose of tofacitinib tablets (10 mg twice daily) or tofacitinib extended-release tablets (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking tofacitinib 5 mg or 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking tofacitinib, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or one side of your body
  • slurred speech

Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking tofacitinib 5 mg or 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking tofacitinib and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking tofacitinib can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Allergic reactions. Stop using tofacitinib and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives (raised, red patches of skin that are often very itchy) because that may mean you are having an allergic reaction.

Changes in certain lab test results. Your healthcare provider should do blood tests to check your white and red blood cells before starting and while you are taking tofacitinib. Your healthcare provider should also check certain liver tests. You should not take tofacitinib if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your tofacitinib treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving tofacitinib.

Before you use tofacitinib tablets/tofacitinib extended-release tablets, tell your healthcare provider if you:

  • are a current or past smoker.
  • have had any type of cancer.
  • have had a heart attack, other heart problems or stroke.
  • have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
  • have liver problems.
  • have kidney problems.
  • have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
  • have had a reaction to tofacitinib or any of the ingredients in tofacitinib tablets or tofacitinib extended-release tablets.
  • have recently received or are scheduled to receive a vaccine. People who take tofacitinib should not receive live vaccines. People taking tofacitinib can receive non-live vaccines.
  • plan to become pregnant or are pregnant. Tofacitinib may affect the ability of females to get pregnant. It is not known if this will change after stopping tofacitinib. It is not known if tofacitinib will harm an unborn baby.
  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take tofacitinib or breastfeed. You should not do both. After you stop your treatment with tofacitinib, do not start breastfeeding again until:
    • 18 hours after your last dose of tofacitinib tablets
    • 36 hours after your last dose of tofacitinib extended-release tablets
  • Have had a reaction to tofacitinib or any of the ingredients in tofacitinib tablets or tofacitinib extended-release tablets.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tofacitinib tablets and other medicines may affect each other causing side effects.
  • Especially tell your healthcare provider if you take:
    • any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, or polyarticular course juvenile arthritis. You should not take tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), ixekizumab (Taltz), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking tofacitinib. Taking tofacitinib with these medicines may increase your risk of infection.
    • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

What are other possible side effects of tofacitinib tablets/tofacitinib extended-release tablets?

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 tofacitinib. Your healthcare provider may do blood tests before starting and while using treatment with tofacitinib. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), high blood pressure (hypertension), and acne.

Common side effects in people with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, acne, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular course juvenile arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, vomiting, and acne.

Tofacitinib & Pregnancy

Tofacitinib may affect the ability of females to get pregnant. It is not known if this will change after stopping tofacitinib. It is not known if tofacitinib will harm an unborn baby.

You and your healthcare provider should decide if you will take tofacitinib or breastfeed. You should not do both. After you stop your treatment with tofacitinib do not start breastfeeding again until 18 hours after your last dose of tofacitinib tablets or 36 hours after your last dose of tofacitinib extended-release tablets.

The safety information above applies to all formulations of tofacitinib marketed by Apotex. Specific risks associated with certain dosing forms are noted.

These are not all the possible side effects of tofacitinib tablets/tofacitinib extended-release tablets. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for tofacitinib tablets or full Prescribing Information for tofacitinib extended-release tablets, including boxed warning and Medication Guide.

What are tofacitinib tablets/ tofacitinib extended-release tablets?

Tofacitinib tablets/tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor used to treat adults with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or cannot be tolerated.
  • Active psoriatic arthritis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.
  • Active ankylosing spondylitis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.
  • Moderately to severely active ulcerative colitis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.

It is not known if tofacitinib tablets/tofacitinib extended-release tablets are safe and effective in people with Hepatitis B or C. Tofacitinib tablets/tofacitinib extended-release tablets are not recommended for people with severe liver problems.

Tofacitinib tablets are used to treat children 2 years of age and older with:

  • active polyarticular course juvenile arthritis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.

It is not known if tofacitinib tablets are safe and effective in children for treatment other than active polyarticular course juvenile arthritis and psoriatic arthritis.

It is not known if tofacitinib extended-release tablets are safe and effective in children.