Xeljanz is a brand-name prescription medication that's used in adults with:

Xeljanz is used to treat these conditions in people who've tried certain other drugs that either weren't effective enough for them or caused bothersome side effects.

Xeljanz contains the drug tofacitinib. It belongs to a class of drugs called Janus kinase inhibitors. These drugs help to decrease inflammation in your body.

Xeljanz comes as a tablet that's taken by mouth. You'll take it either once or twice a day, depending on the condition you're using Xeljanz to treat.

Xeljanz is available in two forms:

  • Xeljanz (immediate release), which comes in 5-mg and 10-mg tablets
  • Xeljanz XR (extended release), which comes in 11-mg tablets

Effectiveness

Xeljanz has been found effective in clinical trials to treat RA, PsA, and UC. The effectiveness of Xeljanz to treat UC is described below. See the section below called "Xeljanz uses" for details on its effectiveness in treating RA and PsA.

Effectiveness for ulcerative colitis

In clinical studies, Xeljanz has been found effective for helping people with UC to achieve remission (have very few or no symptoms) and also to stay in remission.

One study looked at UC treatment over 8 weeks. Remission was reached by 10% to 13% more people taking Xeljanz than by those taking a placebo (treatment with no active drug).

Another clinical study looked at people's results after 1 year of treatment. Remission was reached in 23% to 30% more people taking Xeljanz than in those taking a placebo.

Xeljanz is available only as a brand-name medication. It's not currently available in generic form.

Xeljanz contains the active drug tofacitinib.

Xeljanz can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Xeljanz. These lists do not include all possible side effects.

For more information on the possible side effects of Xeljanz, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Xeljanz can include:

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xeljanz aren't common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Serious infections.* These include reactivation (flare-up) of infections you may already have, such as tuberculosis (TB), hepatitis B or C, or herpes zoster (shingles). The most common infections seen in clinical studies were pneumonia, skin infection, and urinary tract infection (UTI). Your symptoms will depend on the type of infection you have, but they can include:
    • fever
    • fatigue (lack of energy)
    • muscle aches
    • chills
    • rash
    • cough
    • unexplained weight loss
  • Blood clots in your legs or arms. These clots can move to your lungs and block blood flow, which prevents oxygen from traveling through your body.* Symptoms of blood clots can include:
    • shortness of breath
    • chest pain
    • swelling in your arm or leg
    • pain in your arm or leg
    • trouble breathing
  • Gastrointestinal perforations (tears in your digestive tract). Symptoms can include:
    • fever
    • pain in your belly or stomach area
    • changes in your bowel movements, such as having diarrhea or constipation
  • Blood disorders, including low levels of red blood cells and white blood cells (such as neutrophils and lymphocytes). Symptoms can include:
    • frequent infections
    • fever
    • fatigue (lack of energy)
    • weakness
    • shortness of breath
  • Cancer, including skin cancer and lymphoma (a type of blood cancer).* Symptoms can include:
    • changes in moles or beauty marks on your skin
    • fatigue (lack of energy)
    • unexplained weight loss
    • frequent infections

* Xeljanz has boxed warnings from the FDA regarding the risk of serious infections, cancer, and blood clots. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here's some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Xeljanz. It's not known how often allergic reactions to Xeljanz occur. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Xeljanz. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Rash

During studies, rash was one of the more common side effects of Xeljanz. In clinical studies, up to 6% of people who took Xeljanz had a rash. Of people taking a placebo (treatment with no active drug), 4% had a rash.

Rash may also be a sign of a more serious side effect, such as herpes zoster (shingles). This skin condition is caused by the chickenpox virus. If you've had chickenpox in the past, the virus usually lies dormant (inactive) inside your body. But sometimes the virus flares up, resulting in shingles.

Unlike an allergic reaction to a drug, which can cause an itchy rash, shingles typically causes tingling and pain over an area of your skin. This is followed by a blistering rash that often requires medical treatment.

If you have a rash while you're taking Xeljanz, talk with your doctor. They'll check to see what's causing it, and they'll recommend whether any treatment is needed.

Headache

You may have headaches while you're taking Xeljanz. This was one of the more common side effects that occurred in clinical studies. During studies, up to 9% of people taking Xeljanz had headaches. Of people taking a placebo (treatment with no active drug), up to 6% had headaches.

If you have headaches while you're taking Xeljanz, talk with your doctor. They can recommend safe and effective treatment options for your discomfort.

Skin side effects

Skin side effects were seen in people during clinical studies of Xeljanz. These side effects include rash (see "Rash" above), skin redness, itchiness, and acne.

In clinical studies of Xeljanz in people with ulcerative colitis (UC), at least 2% of people who took the drug had acne as a side effect. Acne was seen in at least 1% more people taking Xeljanz than in people taking a placebo (treatment with no active drug).

More serious skin conditions that may be caused by Xeljanz include skin cancers, such as nonmelanoma skin cancer.* A higher risk of skin cancer was seen in people taking higher dosages (10 mg twice a day) of Xeljanz, compared to those taking lower dosages.

Tell your doctor if you have any skin side effects, including changes in moles or beauty marks, while you're taking Xeljanz. Your doctor will recommend whether you need treatment for these side effects.

* Xeljanz has a boxed warning for cancers, including nonmelanoma skin cancer. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Fatigue

Fatigue (lack of energy) was a side effect seen in clinical studies of Xeljanz. However, it's not known how often this side effect occurs.

Fatigue may also be a symptom of more serious side effects of Xeljanz, including:

  • serious infections
  • blood disorders, such as anemia (low red blood cell level)
  • cancer

If you have fatigue while you're taking Xeljanz, tell your doctor. They may check to see what's causing your fatigue, and they'll recommend ways to improve your energy levels.

Increased cholesterol

Increased cholesterol levels have occurred in people taking Xeljanz. In clinical studies, after 1 month of treatment, people who took Xeljanz had increased levels of both:

  • low-density lipoprotein (LDL), which is also called "bad" cholesterol, and
  • high-density lipoprotein (HDL), which is also called "good" cholesterol

In clinical studies of people with rheumatoid arthritis (RA), 15% to 19% of people who took Xeljanz had increased LDL levels during the first 3 months of treatment. Between 10% and 12% of people taking Xeljanz had increased HDL levels during this same period of time.

In studies of people with psoriatic arthritis (PsA) who took Xeljanz, similar numbers of people had increased cholesterol levels.

In clinical studies of people with ulcerative colitis (UC), 5% to 9% of people who took Xeljanz had increased cholesterol levels during treatment. Of people who took a placebo (treatment with no active drug), 1% had the same result.

During Xeljanz treatment, your doctor will check your cholesterol levels about 1 to 2 months after you've started taking the drug. If your cholesterol levels are too high, your doctor will likely prescribe medication to help lower the level.

Weight gain or weight loss (not a side effect)

Weight gain and weight loss weren't side effects of Xeljanz during clinical studies.

However, Xeljanz can increase your risk for serious infections, such as tuberculosis (TB). With TB, some people can have weight loss.

If you have unexplained weight loss while you're taking Xeljanz, tell your doctor. They may check to see what's causing your weight loss, and they'll recommend whether or not you need medical treatment.

Hair loss (not a side effect)

Hair loss isn't a side effect of Xeljanz. In fact, tofacitinib (the active drug in Xeljanz) has been tested in several small studies, including this one from 2017 and this one from 2018, as a treatment for hair loss. For more details about this use, see the section "Xeljanz for other conditions" below.

The Food and Drug Administration (FDA) approves prescription drugs such as Xeljanz to treat certain conditions. Xeljanz may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Xeljanz for ulcerative colitis

Xeljanz is FDA-approved to treat moderately to severely active ulcerative colitis (UC) in adults. This drug is used for people who didn't receive enough benefit from other medications called tumor necrosis factor (TNF) inhibitors. Xeljanz is also used in people who had bothersome side effects from TNF inhibitors.

With UC, the lining inside of your colon (large intestine) or rectum is inflamed. This long-term condition can cause belly pain, diarrhea, and blood in your stools.

Effectiveness for ulcerative colitis

In clinical studies, Xeljanz has been found effective for helping people with UC to achieve remission (have very few or no symptoms) and also to stay in remission.

One study looked at UC treatment over 8 weeks. Remission was reached by 10% to 13% more people taking Xeljanz than by those taking a placebo (treatment with no active drug).

Another clinical study looked at people's results after 1 year of treatment. Remission was reached in 23% to 30% more people taking Xeljanz than in those taking a placebo.

Xeljanz for rheumatoid arthritis

Xeljanz is FDA-approved to treat moderately or severely active rheumatoid arthritis (RA) in adults. This drug is used in people who didn't receive enough benefit from treatment with methotrexate. It's also used in people who had bothersome side effects from methotrexate.

RA is an autoimmune condition that causes pain and swelling in your joints. Over time, it can cause damage to your joints.

For RA treatment, Xeljanz can be used on its own or in combination with methotrexate or other medications called disease-modifying antirheumatic drugs (DMARDs). Xeljanz is a non-biologic DMARD, which is a DMARD that's not made from living cells. It can only be used in combination with other non-biologic DMARDs.

Effectiveness for rheumatoid arthritis

Xeljanz has been found effective to treat RA in several clinical studies. In these studies, each person's response to treatment was measured using the American College of Rheumatology's (ACR) scoring system. Having a score of ACR20 means that the person had a 20% reduction in their RA symptoms, including fewer painful joints.

One study looked at people who didn't have enough benefit from treatment with other DMARDs before the study. Of these people, 59% who took Xeljanz had an ACR20 score after 3 months. Of people who took a placebo (treatment with no active drug), 26% had the same result.

Another study also looked at people who didn't have enough benefit from treatment with methotrexate before the study. Of these people, 55% who took Xeljanz along with methotrexate had an ACR20 score after 3 months. Of people who took methotrexate with a placebo, 27% had the same result.

A study also looked at people who didn't have enough benefit with a TNF inhibitor before the study. Of these people, 41% who took Xeljanz along with methotrexate had an ACR20 score after 3 months. Of people who took methotrexate with a placebo, 24% had the same result.

Xeljanz for psoriatic arthritis

Xeljanz is FDA-approved to treat active psoriatic arthritis (PsA) in adults. This drug is used in people who didn't have enough benefit from treatment with methotrexate or other drugs called disease-modifying antirheumatic drugs (DMARDs). It's also used in people who had bothersome side effects from methotrexate or other DMARDs.

With PsA, people have symptoms of arthritis (such as sore, swollen joints) and symptoms of psoriasis (such as red, scaly patches on your skin). This is a long-term autoimmune condition.

Effectiveness for psoriatic arthritis

Xeljanz has been found effective to treat PsA. In clinical studies, treatment with Xeljanz in combination with certain DMARDs was compared to treatment with a placebo (treatment with no active drug).

In these studies, each person's response to treatment was measured using the American College of Rheumatology's (ACR) scoring system. Having a score of ACR20 means that the person had a 20% reduction in their PsA symptoms, including fewer painful joints and psoriasis skin patches.

In a 3-month clinical study, an ACR20 score was reached by 17.1% more people who took the Xeljanz combination than by those who took a placebo.

In another 3-month clinical study, an ACR 20 score was reached by 26% more people taking the Xeljanz combination than by those taking a placebo.

Xeljanz for other conditions

In addition to the uses listed above, Xeljanz may be used off-label for other uses. Off-label drug use is when a drug that's approved for one use is used for a different one that's not approved. And you may wonder if Xeljanz is used for certain other conditions.

Xeljanz for alopecia (off-label use)

Xeljanz isn't approved to treat alopecia (hair loss), but sometimes it's used off-label for this condition. A review of several small clinical studies found that tofacitinib (the active drug in Xeljanz) may be effective to treat alopecia. However, more studies are needed to fully understand Xeljanz's role in treating hair loss.

If you'd like to know more about treatment options for hair loss, talk with your doctor.

Xeljanz for psoriasis (off-label use)

Xeljanz isn't approved to treat psoriasis, but sometimes it's used off-label for this condition. However, Xeljanz is approved to treat psoriatic arthritis (PsA), which is closely related to psoriasis.

In a pooled analysis of six clinical studies, tofacitinib (the active drug in Xeljanz) was found to be more effective than a placebo (no active drug) in treating plaque psoriasis.

If you'd like to know more about treatment options for psoriasis, talk with your doctor.

Xeljanz for vitiligo (off-label use)

Xeljanz isn't approved to treat vitiligo, which is condition where your skin loses pigmentation (color) in some areas. But Xeljanz is sometimes used off-label for this condition.

One review looked at several small clinical studies and case reports that included tofacitinib (the active drug in Xeljanz) as a treatment for vitiligo. This drug was found to help produce pigmentation (skin color) in some people. In particular, tofacitinib was found to cause repigmentation (return of skin color) when it was used in combination with light therapy.

If you'd like to know more about treatment options for vitiligo, talk with your doctor.

Xeljanz for lupus (off-label use)

Xeljanz isn't approved to treat lupus, but sometimes it's used off-label for this purpose.

A small clinical study found that tofacitinib (the active drug in Xeljanz) improved skin rash and joint pain in people with systemic lupus erythematosus (SLE).

If you'd like to know more about treatment options for lupus, talk with your doctor.

Xeljanz for eczema (off-label use)

Xeljanz isn't approved for treating eczema, but sometimes it's used off-label for this condition.

One small clinical study looked at using tofacitinib (the active drug in Xeljanz) topically on people's skin, rather than having them take the drug by mouth. In this study, people's eczema symptoms were reduced more with tofacitinib than with a topical placebo (no active drug).

If you'd like to know more about treatment options for eczema, talk with your doctor.

Xeljanz for ankylosing spondylitis (off-label use)

Xeljanz isn't approved to treat ankylosing spondylitis (AS), but sometimes it's used off-label for this condition.

In a 12-week clinical study, tofacitinib (the active drug in Xeljanz) was found to be more effective than a placebo (no active drug) at reducing people's AS symptoms. Another clinical study is currently recruiting people with AS to test the effectiveness of Xeljanz in treating this condition.

If you'd like to know more about treatment options for AS, talk with your doctor.

Xeljanz can be used alone or with other medications. These other medications can include:

  • methotrexate (Otrexup, Rasuvo, Trexall)
  • hydroxychloroquine (Plaquenil)
  • leflunomide (Arava)
  • sulfasalazine (Azulfidine)
  • corticosteroids, such as prednisone

The Xeljanz dosage your doctor prescribes will depend on several factors. These include:

  • the condition you're using Xeljanz to treat
  • how your body responds to Xeljanz
  • the form of Xeljanz you're taking
  • other medical conditions that you may have
  • other medications that you may be taking with Xeljanz

Typically, your doctor will start you on a low dosage. Then they'll adjust it over time to reach the amount that's right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Xeljanz comes in two forms, which are each taken by mouth. The two forms are:

  • Xeljanz (immediate release), which is available in 5-mg and 10-mg tablets
  • Xeljanz XR (extended release), which is available in 11-mg tablets

Dosage for rheumatoid arthritis

The usual dosage for rheumatoid arthritis (RA) in each form of Xeljanz is as follows:

  • Xeljanz 5 mg taken by mouth twice each day
  • Xeljanz XR 11 mg taken by mouth once a day

Dosage for psoriatic arthritis

The usual dosage of Xeljanz for psoriatic arthritis (PsA) in each form of Xeljanz is as follows:

  • Xeljanz 5 mg taken by mouth twice each day
  • Xeljanz XR 11 mg taken by mouth once a day

Dosage for ulcerative colitis

The usual dosage of Xeljanz for ulcerative colitis (UC) depends on the purpose for using the drug. Xeljanz (immediate release) can be used to induce (cause) remission or to maintain (keep) remission of UC. Remission is generally described as having very few or no UC symptoms.

Dosage to induce remission of ulcerative colitis

When Xeljanz is used to induce UC remission, the typical dosage is 10 mg taken by mouth twice a day for 8 weeks.

If your UC is in remission after 8 weeks, your doctor will prescribe the maintenance dose of Xeljanz for you to take going forward. But if your UC isn't in remission after 8 weeks, your doctor may have you take the induction dosage for up to 16 weeks.

Dosage to maintain remission of ulcerative colitis

When Xeljanz is used to maintain UC remission, the usual dosage is 5 mg taken by mouth twice a day.

What if I miss a dose?

If you miss a dose of Xeljanz, let your healthcare provider know. They'll recommend whether you should take the missed dose or wait until your next regular dose. Don't take more than one dose of Xeljanz at a time. This can lead to serious side effects.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Xeljanz is meant to be used as a long-term treatment. If you and your doctor determine that Xeljanz is safe and effective for you, you'll likely take it long term.

There aren't any known interactions between Xeljanz and alcohol. Talk with your doctor to see if it's safe for you to drink alcohol during Xeljanz treatment.

Xeljanz can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Xeljanz and other medications

Below are lists of medications that can interact with Xeljanz. These lists do not contain all the drugs that may interact with Xeljanz.

Before taking Xeljanz, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Xeljanz and certain antibiotics and antifungals

Taking Xeljanz with certain antibiotics and antifungals can increase your risk of serious side effects. Certain antibiotics and antifungals can prevent your body from breaking down Xeljanz. This leads to high levels of the Xeljanz in your body, which can increase side effects from the drug.

Examples of antibiotics that can increase your risk of serious side effects if taken with Xeljanz include:

  • clarithromycin (Biaxin XL)
  • erythromycin (Ery-Tab, Eryped, many others)

Examples of antifungals that can increase your risk of serious side effects if taken with Xeljanz include:

  • ketoconazole (Extina, Nizoral, Xolegel)
  • fluconazole (Diflucan)
  • itraconazole (Omnel, Sporanox, Tolsura)
  • voriconazole (Vfend)

If you need to take one of these antibiotics or antifungals while you're taking Xeljanz, your doctor will monitor you closely for side effects of Xeljanz. Your doctor will also likely recommend that you take a lower dosage of Xeljanz until you're no longer taking the antibiotic or antifungal.

Xeljanz and certain seizure drugs

Taking Xeljanz with certain seizure medications can increase how quickly your body clears (gets rid of) Xeljanz. This lowers your levels of Xeljanz, which could decrease its effectiveness to treat your condition.

Examples of seizure drugs that can decrease the effectiveness of Xeljanz include:

  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • phenytoin (Dilantin, Phenytek)
  • phenobarbital

If you need to take a seizure medication with Xeljanz, your doctor may change your seizure medication, or they may prescribe a drug other than Xeljanz for you.

Xeljanz and certain drugs that suppress your immune system

Taking Xeljanz with certain drugs that suppress (decrease the ability of) your immune system can increase your risk of serious infections.

Examples of drugs that can increase your risk of serious infections if taken with Xeljanz include:

  • azathioprine (Azasan, Imuran)
  • cyclosporine (Neoral)
  • adalimumab (Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz)
  • etanercept (Enbrel, Erelzi, Eticovo)
  • golimumab (Simponi)
  • infliximab (Inflectra, Ixifi, Remicade, Renflexis)

Taking Xeljanz with these drugs isn't recommended. Be sure to tell your doctor about all medications you're taking before you start Xeljanz.

Xeljanz and herbs and supplements

There aren't any herbs or supplements that have been specifically reported to interact with Xeljanz. However, you should still check with your doctor or pharmacist before using any of these products while taking Xeljanz.

Xeljanz and foods

Eating grapefruit or drinking grapefruit juice while you're taking Xeljanz could increase your risk of serious side effects. This is because grapefruit prevents your body from breaking down and clearing Xeljanz. This leads to higher levels of the drug in your body.

Talk with your doctor about how much grapefruit is safe for you to consume while you're taking Xeljanz.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you're interested in finding an alternative to Xeljanz, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Alternatives for rheumatoid arthritis

Examples of other drugs that may be used to treat rheumatoid arthritis (RA) include:

  • methotrexate (Otrexup, Rasuvo, Trexall)
  • hydroxychloroquine (Plaquenil)
  • leflunomide (Arava)
  • sulfasalazine (Azulfidine)
  • adalimumab (Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz)
  • certolizumab pegol (Cimzia)
  • etanercept (Enbrel, Erelzi, Eticovo)
  • golimumab (Simponi)
  • infliximab (Inflectra, Ixifi, Remicade, Renflexis)
  • abatacept (Orencia)
  • rituximab (Rituxan, Ruxience, Truxima)
  • tocilizumab (Actemra)
  • baricitinib (Olumiant)

Alternatives for psoriatic arthritis

Examples of other drugs that may be used to treat psoriatic arthritis (PsA) include:

  • methotrexate (Otrexup, Rasuvo, Trexall)
  • sulfasalazine (Azulfidine)
  • cyclosporine (Neoral)
  • leflunomide (Arava)
  • apremilast (Otezla)
  • etanercept (Enbrel, Erelzi, Eticovo)
  • infliximab (Inflectra, Ixifi, Remicade, Renflexis)
  • adalimumab (Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz)
  • golimumab (Simponi)
  • certolizumab pegol (Cimzia)
  • ustekinumab (Stelara)
  • secukinumab (Cosentyx)
  • ixekizumab (Taltz)
  • brodalumab (Siliq)
  • abatacept (Orencia)

Alternatives for ulcerative colitis

Examples of other drugs that may be used to treat ulcerative colitis (UC) include:

  • mesalamine (Apriso, Asacol HD, Canasa, Lialda)
  • olsalazine (Dipentum)
  • sulfasalazine (Azulfidine)
  • budesonide (Uceris)
  • azathioprine (Azasan, Imuran)
  • mercaptopurine (Purinethol, Purixan)
  • adalimumab (Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz)
  • golimumab (Simponi)
  • infliximab (Inflectra, Ixifi, Remicade, Renflexis)
  • vedolizumab (Entyvio)

You may wonder how Xeljanz compares to other medications that are prescribed for similar uses. Here we look at how Xeljanz and Humira are alike and different.

Uses

Xeljanz and Humira are both approved for use in adults with:

Humira is also approved to treat:

Drug forms and administration

Xeljanz contains the drug tofacitinib. It comes as a tablet that's taken by mouth, once or twice a day.

Humira contains the drug adalimumab. It's given as a subcutaneous (under the skin) injection, typically once every other week. Your healthcare provider may give you the injection, or they may show you how to self-inject Humira at home.

Side effects and risks

Xeljanz and Humira contain different drugs. Therefore, they can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Xeljanz, with Humira, or with both drugs (when taken individually).

  • Can occur with Xeljanz:
  • Can occur with Humira:
    • injection site reactions
    • belly pain
  • Can occur with both Xeljanz and Humira:
    • headache
    • upper respiratory infections, such as the common cold
    • rash

Serious side effects

These lists contain examples of serious side effects that can occur with Xeljanz, with Humira, or with both drugs (when taken individually).

* Xeljanz and Humira both have boxed warnings from the FDA regarding the risk of serious infections and cancer. Xeljanz also has a boxed warning regarding the risk of blood clots. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Xeljanz and Humira have different FDA-approved uses, but they're both used to treat the following conditions:

  • rheumatoid arthritis (RA)
  • psoriatic arthritis (PsA)
  • ulcerative colitis (UC)

These drugs haven't been directly compared in clinical studies for psoriatic arthritis and ulcerative colitis. But separate studies have found both Xeljanz and Humira to be effective for treating these conditions.

Xeljanz and Humira were compared in a clinical study that looked at people with RA. The study found that treating RA with Xeljanz and methotrexate wasn't less effective than treating RA with Humira and methotrexate. After 6 months, 46% of people who took Xeljanz and methotrexate had a 50% reduction in their RA symptoms. Of people who took Humira and methotrexate, 44% had the same result.

Costs

Xeljanz and Humira are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Xeljanz may cost less than Humira. The actual price you'll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Like Humira (described above), the drug Enbrel has uses similar to those of Xeljanz. Here's a comparison of how Xeljanz and Enbrel are alike and different.

Uses

Xeljanz and Enbrel are both approved for use in adults with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

Xeljanz is also approved to treat ulcerative colitis (UC) in adults.

Enbrel is also approved to treat:

Drug forms and administration

Xeljanz contains the drug tofacitinib. It comes as a tablet that's taken by mouth, once or twice a day.

Enbrel contains the drug etanercept. It's given as a subcutaneous (under the skin) injection, typically once every week. You may receive the injection from your healthcare provider, or they may show you how to self-inject the drug at home.

Side effects and risks

Xeljanz and Enbrel contain different drugs. Therefore, they can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Xeljanz, with Enbrel, or with both drugs (when taken individually).

  • Can occur with Xeljanz:
  • Can occur with Enbrel:
    • injection site reactions
  • Can occur with both Xeljanz and Enbrel:
    • diarrhea
    • rash
    • upper respiratory infections, such as the common cold

Serious side effects

These lists contain examples of serious side effects that can occur with Xeljanz, with Enbrel, or with both drugs (when taken individually).

* Xeljanz and Enbrel both have boxed warnings from the FDA regarding the risk of serious infections and cancer. Xeljanz also has a boxed warning regarding the risk of blood clots. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Xeljanz and Enbrel have different FDA-approved uses, but they're both used to treat adults with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

These drugs haven't been directly compared in clinical studies, but separate studies have found both Xeljanz and Enbrel to be effective for treating these conditions.

Costs

Xeljanz and Enbrel are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Xeljanz may cost less than Enbrel. The actual price you'll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Here are answers to some frequently asked questions about Xeljanz.

Can I take Xeljanz with a biologic?

No, you shouldn't take Xeljanz with a biologic drug. Biologic drugs are made in a lab from living cells. Many biologics are designed to suppress (decrease) the ability of your immune system to fight infections. This is because biologics are generally used to treat autoimmune disorders, which are caused by your immune system mistakenly attacking your own body.

Taking Xeljanz with biologics can suppress your immune system too much. This can increase your risk of very serious infections that your body won't be able to fight off.

Talk with your doctor to learn more about which medications are safe to use with Xeljanz.

Will I have withdrawal symptoms if I stop using Xeljanz?

Possibly. If you stop taking Xeljanz, the symptoms that you were using Xeljanz to treat may come back or become worse.

A small clinical study that included people with rheumatoid arthritis (RA) found that 37% of people who stopped taking Xeljanz were able to stay off the drug for 1 year without their disease getting worse. In this study, people who had less severe RA symptoms were more likely to be able to stop taking Xeljanz without their symptoms worsening.

If you're interested in stopping Xeljanz, talk with your doctor before doing so. They can discuss with you the risks of stopping treatment.

Does Xeljanz cause mouth sores?

It's possible that Xeljanz may cause mouth sores.

Xeljanz decreases the ability of your immune system to fight infections. This means that while you're taking the drug, you have an increased risk for viruses that are already in your body to become reactivated (flare-up). For example, herpes simplex virus (a common virus that causes cold sores) can become active and cause symptoms.

If you have bothersome cold sores while you're taking Xeljanz, talk with your doctor. They can recommend ways to reduce how often your cold sores occur and how long they last.

How can I prevent infections while I'm taking Xeljanz?

It's important to try to prevent infections while you're taking Xeljanz. This is because Xeljanz is an immunosuppressant (a drug that lowers your immune system's ability to fight infections).

The Centers for Disease Control and Prevention (CDC) recommends several easy ways to reduce your risk of getting an infection:

  • Wash your hands with soap and water:
    • before preparing or eating food
    • after changing diapers or using the restroom
    • after touching any items that have been in contact with people who are sick
    • Properly wash and cook your food.
    • Make sure your water is safe to drink.
    • Avoid touching farm animals and the stool of any pets.
    • Avoid swallowing water from any natural bodies of water, such as lakes or rivers.
    • Practice safe sex by using condoms or other barrier methods.

Talk with your doctor about specific ways that you can prevent infections in your daily life.

Should I avoid certain vaccines during Xeljanz treatment?

Yes, you should avoid getting live vaccines during Xeljanz treatment. Live vaccines contain weakened particles of live viruses or bacteria. These particles cause your immune system to react against that particular virus or bacteria. This is how your body develops immunity to protect you from the condition you were vaccinated for.

When you're taking Xeljanz, your immune system isn't as effective at fighting infections. If you get a live vaccine during Xeljanz treatment, you may end up getting infected by the virus or bacteria that the vaccine is meant to protect you from.

Examples of live vaccines include:

Before starting Xeljanz, talk with your doctor about your vaccination history. They'll make sure that you're up to date on your vaccines before you start Xeljanz.

Xeljanz use before and during pregnancy hasn't been studied in humans. Some results from animal studies are described below.

Xeljanz use in pregnancy

There isn't enough information available to know if Xeljanz is safe to take during pregnancy. In animal studies, harm was seen in fetuses when pregnant females were given Xeljanz. But animal studies don't always predict what will happen in humans.

Keep in mind that there are known risks to fetuses of pregnant women who have active rheumatoid arthritis (RA) or ulcerative colitis (UC).

If you're pregnant or considering becoming pregnant, talk with your doctor about whether Xeljanz is right for you. Your doctor will discuss the benefits and risks of using Xeljanz during pregnancy. They'll also discuss the benefits and risks of not treating your condition during pregnancy.

If you're taking or have taken Xeljanz during pregnancy, you're encouraged to enroll in the Xeljanz pregnancy registry. A pregnancy registry allows healthcare providers to collect information about the safety of using certain drugs during pregnancy. To enroll in this pregnancy registry, call 877-311-8972 or visit the registry website.

The effect of Xeljanz on fertility

Animal studies have found that Xeljanz affects the ability of certain animals to become pregnant. It's not known if this effect is also seen in humans. If you're trying to become pregnant, talk with your doctor before starting Xeljanz.

It's not known if Xeljanz is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you're using Xeljanz.

You shouldn't breastfeed while you're taking Xeljanz. In animal studies, Xeljanz did pass into the breast milk of lactating females. It's not known for sure if this will also happen in humans.

However, it's recommended that you don't breastfeed while taking Xeljanz or for at least 18 hours after your last dose of Xeljanz. (If you're taking Xeljanz XR, you shouldn't breastfeed for at least 36 hours after your last dose of the drug.) This is because Xeljanz could possibly cause serious side effects if it's passed to your child.

If you're breastfeeding and considering taking Xeljanz, talk with your doctor about other healthy ways to feed your child.

As with all medications, the cost of Xeljanz can vary. To find current prices for Xeljanz in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance company may require you to get prior authorization before they approve coverage for Xeljanz. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Xeljanz.

If you're not sure whether you'll need to get prior authorization for Xeljanz, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Xeljanz, or if you need help understanding your insurance coverage, help is available.

Pfizer Inc., the manufacturer of Xeljanz, offers a program called XelSource. For more information and to find out if you're eligible for support, call 844-935-5269 and say "representative." To find out more information online, visit the websites below, which are specific for your condition:

You should take Xeljanz according to your doctor or healthcare provider's instructions.

When to take Xeljanz

Xeljanz (immediate release) is taken either once a day or twice a day, depending on what condition you're using it to treat. It can be taken as follows:

  • if you're taking Xeljanz once a day, it can be taken at any time of the day. But you should take it at the same time each day.
  • if you're taking Xeljanz twice a day, your two doses should be taken about 12 hours apart. For example, you could take one dose in the morning and one dose in the evening.

Xeljanz XR (extended release) is only taken once a day. It can be taken at any time of the day. But you should take it at the same time each day.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Xeljanz with food

Xeljanz and Xeljanz XR can each be taken with or without food.

Can Xeljanz be crushed, split, or chewed?

You may be able to crush, split, or chew Xeljanz (immediate-release) tablets. If you have trouble swallowing the tablets, talk with your doctor or pharmacist. They can recommend ways to make swallowing the medication easier for you.

However, you shouldn't crush, split, or chew Xeljanz XR (extended-release) tablets. These should be swallowed whole. If you have trouble swallowing Xeljanz XR tablets, talk with your healthcare provider. They can recommend ways to help you swallow the tablets, or they may prescribe a different form of Xeljanz for you.

Xeljanz is used to decrease pain and inflammation in people with certain autoimmune disorders.

What autoimmune disorders are

With autoimmune disorders, your immune system mistakenly attacks your own body. Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC) are autoimmune disorders that Xeljanz is used to treat.

With these conditions, your immune system mistakenly attacks:

  • your joints, if you have RA
  • your joints and your skin, if you have PsA
  • the lining of your intestines or rectum, if you have UC

In each of these conditions, your immune system is overactive. This results in inflammation (swelling) in your joints, skin, or intestines and causes pain and other symptoms.

What Xeljanz does

Xeljanz contains the active drug tofacitinib. It belongs to a class of drugs called Janus kinase (JAK) inhibitors.

Xeljanz inhibits (blocks the activity) of an enzyme called JAK. This enzyme is a special protein that works inside your cells to cause inflammation and swelling. By blocking the activity of JAK, Xeljanz decreases the amount of inflammation in your body. This helps reduce pain and other symptoms of certain autoimmune disorders.

How long does it take to work?

Xeljanz starts working shortly after you start taking it. In clinical studies, some people had fewer symptoms within the first month after starting the drug. However, each person's response to Xeljanz will be unique.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

  • Serious infections. Xeljanz decreases your immune system's ability to fight off infections. This may increase your risk of serious infections, such as tuberculosis (TB) or herpes zoster (shingles). Your doctor will check to make sure that you don't have TB before you start taking Xeljanz. If you have TB or another infection before starting Xeljanz, your doctor may recommend that you wait to start Xeljanz until your infection has been treated.
  • Increased risk of blood clots and death. People ages 50 years and older with both rheumatoid arthritis (RA) and at least one risk factor for heart disease have an increased risk of blood clots and death while taking Xeljanz. This risk is increased in people with these conditions who are taking 10 mg of Xeljanz twice a day, compared to people taking lower doses of Xeljanz or using certain other drugs. People with these risk factors shouldn't take Xeljanz. If you have symptoms of a blood clot while you're taking Xeljanz, your doctor will advise that you stop taking the drug.
  • Cancer and immune system disorders. Cancer and lymphoma (a type of blood cancer) have occurred in people taking Xeljanz. The risk of immune system disorders is also increased in people who have had a kidney transplant and also are taking Xeljanz with other drugs that decrease their immune system's ability.

Other precautions

Before taking Xeljanz, talk with your doctor about your health history. Xeljanz may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Digestive tract problems. Xeljanz may increase your risk of digestive tract perforations (holes in the lining of your stomach or intestines). If you have a history of certain gastrointestinal problems, such as diverticulitis (swollen pouches that form in your digestive tract), or you're using nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular basis, Xeljanz may not be safe for you. Xeljanz XR may also worsen certain digestive tract problems, such as narrowing or blockages in your intestines. Talk with your doctor to find out if Xeljanz is right for you.
  • Blood disorders. Xeljanz decreases levels of certain blood cells in your body, including red blood cells and two types of white blood cells (called neutrophils and lymphocytes). This can increase your risk of serious infections or anemia. You shouldn't start taking Xeljanz if you have low levels of these blood cells. Your doctor will check your blood counts before you start Xeljanz. This allows them to determine if the drug is safe for you.
  • Severe allergic reaction. Xeljanz has caused severe allergic reactions in some people. Xeljanz may not be safe for you if you've had a severe allergic reaction to the drug in the past. If you're unsure of whether you've had a severe allergic reaction to Xeljanz in the past, talk with your doctor.
  • Liver problems. Xeljanz may not be safe for people with severe liver disease or liver damage, including hepatitis B and hepatitis C. If you have liver problems, talk with your doctor about whether Xeljanz is right for you.
  • Kidney problems. The level of Xeljanz in your bloodstream may be increased in people with moderate or severe kidney damage. If you have any problems with your kidneys, talk with your doctor before starting Xeljanz. They may adjust your dosage of this drug if you have kidney damage.
  • Pregnancy. It's not known how safe Xeljanz is to take during pregnancy. For more information, please see the "Xeljanz and pregnancy" section above.
  • Breastfeeding. You shouldn't breastfeed your baby while you take Xeljanz. For more information, please see the "Xeljanz and breastfeeding" section above.

Note: For more information about the potential negative effects of Xeljanz, see the "Xeljanz side effects" section above.

Using more than the recommended dosage of Xeljanz can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • diarrhea
  • headache
  • rash

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Xeljanz from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Xeljanz tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Xeljanz and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Xeljanz is approved by the Food and Drug Administration (FDA) for use in adults with any of the following:

  • moderately to severely active rheumatoid arthritis (RA), if methotrexate (MTX) was ineffective or intolerable for them*
  • active psoriatic arthritis (PsA), if MTX or other disease-modifying antirheumatic drugs (DMARDs) were ineffective or intolerable for them
  • moderately to severely active ulcerative colitis (UC), if tumor necrosis factor (TNF) blockers were ineffective or intolerable for them

* Xeljanz is approved for use as monotherapy or in combination with MTX or other non-biologic DMARDs for this condition.

Mechanism of action

Xeljanz contains the drug tofacitinib, which is a Janus kinase (JAK) inhibitor. JAK is an intracellular enzyme that activates Signal Transducers and Activators of Transcription (STATs), which are modulators of gene expression that stimulate hematopoiesis and immune cell function. Xeljanz inhibits the JAK enzyme, thereby repressing STAT activity and immune cell activation.

Pharmacokinetics and metabolism

Following oral administration, the bioavailability of Xeljanz is 74%. Peak plasma concentrations are reached within 0.5 to 1 hour for Xeljanz and within 4 hours for Xeljanz XR. Steady-state concentrations are achieved after approximately 24 to 48 hours for Xeljanz and 48 hours for Xeljanz XR.

Protein binding is about 40%, primarily to albumin. The majority of Xeljanz metabolism occurs via CYP3A4, with minority occurring via CYP2C19. Elimination half-life is about 3 hours for Xeljanz and about 6 hours for Xeljanz XR.

Contraindications

There are no contraindications to Xeljanz use.

Storage

Xeljanz tablets should be stored in the original container at room temperature (68°F to 77°F/20°C to 25°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.