Tofacitinib

Xeljanz XR

Xeljanz XR (tofacitinib) is a prescription medication used to treat several inflammatory and autoimmune conditions. As an extended-release tablet, it’s particularly effective for managing diseases like rheumatoid arthritis, psoriatic arthritis, moderate to severe ulcerative colitis, and ankylosing spondylitis in adults. This medication works by blocking enzymes that contribute to inflammation in the body, providing relief from symptoms and helping to maintain disease control. Xeljanz XR is designed for long-term use and must be prescribed and monitored by a healthcare provider due to its potential serious side effects and specific dosage requirements.

Product Overview

Xeljanz XR (tofacitinib) is an oral medication that serves as a Janus kinase (JAK) inhibitor, primarily used to treat inflammatory and autoimmune conditions among adults. This medication is available as extended-release tablets in strengths of 11 mg and 22 mg, allowing for convenient once-daily dosing. The Food and Drug Administration (FDA) has approved Xeljanz XR for the treatment of rheumatoid arthritis, psoriatic arthritis, moderate to severe ulcerative colitis, and ankylosing spondylitis. It is also effective in inducing and maintaining remission in ulcerative colitis.

Xeljanz XR operates by inhibiting the activity of JAK enzymes, which play a significant role in the inflammatory process that contributes to the symptoms of these diseases. By blocking these enzymes, Xeljanz XR helps to reduce inflammation, alleviate symptoms, and prevent further damage to the affected tissues. Treatment with Xeljanz XR requires careful monitoring due to its association with several serious risks, including increased susceptibility to infections, potential for liver and kidney issues, and the possibility of developing certain cancers. Common side effects include respiratory infections, headaches, and high blood pressure.

For optimal safety and effectiveness, it’s crucial for patients to follow their healthcare provider’s instructions regarding dosing and administration. Xeljanz XR should be taken at the same time each day, with or without food, and the tablets should not be crushed or chewed. Regular medical follow-ups and tests are recommended to monitor the drug’s impact and adjust the treatment as necessary.

What Are the Uses of Xeljanz XR?

Xeljanz XR (tofacitinib) is a prescription medication approved by the Food and Drug Administration (FDA) for use in adults to treat several inflammatory conditions. These include:

• Psoriatic Arthritis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Moderate to Severe Ulcerative Colitis

What Are the Forms & Strengths of Xeljanz XR?

Xeljanz XR is available in the form of extended-release tablets. These tablets are designed to release the medication slowly over time as they move through your digestive system, ensuring long-lasting effects. The available strengths are:

• Xeljanz XR 11 mg Tablet
• Xeljanz XR 22 mg Tablet

What Are the Recommended Dosage of Xeljanz XR?

Dosages for Psoriatic Arthritis Using Xeljanz XR

For treating psoriatic arthritis in adults, the recommended dosages are as follows:

• 5 mg of Xeljanz should be taken twice a day.
• 11 mg of Xeljanz XR should be taken once a day.

Dosages for Ulcerative Colitis Using Xeljanz XR

Induction Treatment: For induction therapy, which aims to quickly reduce symptoms and bring ulcerative colitis (UC) under control, the dosages are as follows:

• 10 mg of Xeljanz taken twice daily for 8 to 16 weeks.
• 22 mg of Xeljanz XR taken once daily for 8 to 16 weeks.

Maintenance Treatment: Once the UC is under control, maintenance treatment with a lower dosage is used long-term to keep the condition stable and prevent symptoms from worsening:

• 5 mg of Xeljanz taken twice daily.
• 11 mg of Xeljanz XR taken once daily.

Dosage for Rheumatoid Arthritis Using Xeljanz XR

For treating rheumatoid arthritis in adults, the recommended dosages are:

• 5 mg of Xeljanz should be taken twice daily.
• 11 mg of Xeljanz XR should be taken once daily.

Dosages for Juvenile Idiopathic Arthritis

For children aged 2 years and older diagnosed with polyarticular course juvenile idiopathic arthritis, the dosage of Xeljanz is determined based on the child’s body weight in kilograms (kg):

• For children who weigh 40 kg or more, the dosage is consistent whether they use the tablets or the oral solution.

Dosage for Ankylosing Spondylitis Using Xeljanz XR

For adults with ankylosing spondylitis, the recommended dosages are:

• 5 mg of Xeljanz to be taken twice daily.
• 11 mg of Xeljanz XR to be taken once daily.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Use Xeljanz XR?

• Long-term Use: Xeljanz XR is intended for long-term use. If your doctor confirms that it’s suitable for you, expect to use it over an extended period.
• Dosage Adjustments:
  • Your doctor may change your dose based on new medications you start or stop or changes in your liver or kidney function.
  • If tests show changes in your blood cells or hemoglobin levels, your doctor might temporarily halt your treatment.
• Daily Administration: Take Xeljanz XR once daily at the same time each day to maintain a consistent level in your body. Setting a reminder on your phone or using a medication timer can help you not to forget a dose.
• Food Instructions: You can take Xeljanz XR with or without food.
• Tablet Instructions:
  • Do not crush, split, or chew Xeljanz XR tablets; swallow them whole.
  • If you find it difficult to swallow the extended-release tablets, discuss it with your doctor. They might suggest alternative methods to make swallowing easier or prescribe a different form of Xeljanz.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Xeljanz XR Work?

Xeljanz XR helps reduce the activity of your immune system. It targets specific proteins within your cells called JAK enzymes (specifically JAK1, JAK2, JAK3, and TYK2). These enzymes are key players in the process that sends inflammation signals throughout your body, which are involved in the release of substances called cytokines. By inhibiting these enzymes, Xeljanz XR effectively reduces the inflammation and immune responses that contribute to conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. This action helps manage the symptoms associated with these diseases.

Important Safety Information for Using Xeljanz XR

What Are the Side Effects of Xeljanz XR?

Common Xeljanz Side Effects: Here are some of the more common side effects experienced by people taking Xeljanz XR (which contains the active drug tofacitinib) during clinical studies. These side effects can differ depending on the condition being treated. For those taking Xeljanz XR for rheumatoid arthritis, psoriatic arthritis, and polyarticular course juvenile idiopathic arthritis, common side effects may include:

• Headache
• Rash
• Upper respiratory tract infection
• Diarrhea
• Headache
• Elevated blood cholesterol levels

Mild Xeljanz Side Effects: Mild side effects can happen with Xeljanz XR. This list doesn’t cover all possible mild side effects of the medication. These side effects might be temporary, lasting just a few days or weeks. However, if they persist, worsen, or cause concern, make sure to consult your doctor or pharmacist. Mild side effects of Xeljanz XR may include:

• Headache
• Nausea
• Rash
• Elevated blood cholesterol levels
• Upper respiratory tract infection, such as sinusitis (pain and swelling in your sinuses) or the common cold
• Diarrhea
• High blood pressure

Serious Xeljanz Side Effects: Xeljanz XR can cause serious side effects. The list below doesn’t cover all the possible serious side effects of this medication. If you experience any serious side effects while taking Xeljanz XR, contact your doctor immediately. If the side effects feel life-threatening or you think you’re having a medical emergency, call 911 or your local emergency number right away. Serious side effects of Xeljanz XR may include:

• Risk of blood clots
• Risk of death in certain people
• Tears in your digestive tract
• Cardiovascular problems, such as heart attack or stroke
• Blood disorders
• Allergic reaction
• Risk of serious infections
• Risk of cancer and immune system disorders

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Are There Any Warnings for Xeljanz XR? 

Before starting Xeljanz XR, it’s important to discuss your health history with your doctor. Xeljanz XR may not be suitable for you if you have certain medical conditions or other health factors. These include:

• Blood Disorders: Xeljanz XR can lower the levels of certain blood cells, including red blood cells and specific white blood cells (neutrophils and lymphocytes). This reduction can increase your risk of serious infections or anemia. If you already have low levels of these blood cells, you shouldn’t start Xeljanz XR. 
• Digestive Tract Issues: Xeljanz XR can raise the risk of holes forming in the stomach or intestines (called perforations). If you’ve had certain gastrointestinal problems, like diverticulitis, or if you regularly use nonsteroidal anti-inflammatory drugs (NSAIDs), Xeljanz XR may not be safe for you. It could also worsen existing digestive issues, such as intestinal narrowing or blockages. 
• Severe Allergic Reactions: Xeljanz XR has been known to cause severe allergic reactions in some individuals. If you’ve had a serious allergic reaction to this medication in the past, it might not be safe for you to take it again. If you’re unsure whether you’ve experienced such a reaction, be sure to discuss it with your doctor.
• Kidney Problems: If you have moderate or severe kidney damage, the levels of Xeljanz XR in your bloodstream may increase. This could lead to more side effects. If you have any kidney issues, it’s important to talk to your doctor before starting Xeljanz XR. Your doctor may need to adjust your dosage to ensure the medication is safe and effective for you.
• Liver Problems: Xeljanz XR may not be suitable for people with severe liver disease or liver damage, such as those with hepatitis B or C. If you have any liver issues, consult your doctor to determine if Xeljanz XR is a safe option for you.

What Are the FDA Boxed Warnings for Xeljanz XR?

Xeljanz XR comes with several serious warnings from the FDA, known as boxed warnings, which highlight potential risks:

• Risk of Serious Infections: Xeljanz XR can weaken your immune system, making it harder for your body to fight infections. This may increase your risk of serious infections like tuberculosis (TB) or shingles. Before starting Xeljanz XR, your doctor will check if you have TB or another infection. If you do, your doctor may suggest treating the infection first.
• Risk of Blood Clots and Death: People aged 50 and older with rheumatoid arthritis (RA) and at least one cardiovascular risk factor have a higher risk of blood clots and death when taking Xeljanz XR. This risk is especially high for those taking 10 mg of Xeljanz twice daily. If you have these risk factors, your doctor may advise against using Xeljanz XR. If you develop symptoms of a blood clot while on this medication, your doctor will likely recommend stopping it.
• Risk of Cancer and Immune System Disorders: Xeljanz XR has been linked to an increased risk of certain cancers, including lymphoma, especially in people who have had a kidney transplant and are also taking other immune-suppressing drugs. Your doctor will assess whether this medication is suitable for you.
• Risk of Death: Xeljanz XR may raise the risk of death in certain individuals, particularly those aged 50 and older with RA and cardiovascular risk factors. Your doctor will evaluate your specific risks and determine the safest dosage and treatment duration for you.

What Are the Xeljanz XR Precautions?

• Regular Monitoring: While taking Xeljanz XR, you will need regular medical tests, including checks on liver and kidney function, blood counts, cholesterol levels, and skin exams. Make sure to attend all your medical and lab appointments.
• Do Not Share: Never share this medication with others.
• Infection Signs: Let your doctor know if you have been sick with symptoms like fever, chills, muscle aches, cough, breathing difficulties, skin sores, diarrhea, or painful urination.
• Inform Your Doctor: Tell your doctor if you have had:
  • Kidney disease or if you are on dialysis
  • Any type of cancer
  • Heart problems, including a history of stroke, heart attack, or blood clots
  • A weakened immune system or chronic infections (like hepatitis, shingles, tuberculosis, HIV)
  • High cholesterol
  • Digestive issues like stomach ulcers or diverticulitis
  • A history of smoking
• Pre-Existing Conditions: Make sure your doctor knows if you have had:
  • Diabetes
  • Liver disease, especially hepatitis B or C
  • A scheduled vaccination
  • Chronic lung disease
• Travel History: Inform your doctor if you have had or been exposed to tuberculosis or if you’ve traveled recently, as some infections are more common in certain areas.
• Fertility: Xeljanz may affect fertility and your ability to have children during and after treatment.
• Cancer Risk: Xeljanz may increase the risk of certain cancers, like lymphoma or lung cancer. Discuss this risk with your doctor.
• Children: Do not give Xeljanz XR to children without medical advice. The extended-release tablets are not approved for use in individuals under 18 years old.
• Pregnancy: If you are pregnant or planning to become pregnant, let your doctor know. Xeljanz may pose risks during pregnancy, but treating conditions like rheumatoid arthritis or ulcerative colitis might outweigh these risks. If you become pregnant while on Xeljanz, your information may be recorded to track the drug’s effects on your baby.
• Breastfeeding: Do not breastfeed while taking Xeljanz, and wait at least 18 hours after your last dose (36 hours for extended-release tablets) before breastfeeding. Discard any breast milk pumped during this time.

What If You Missed a Dose of Xeljanz XR?

• If you forget to take a dose of Xeljanz XR, take it as soon as you remember. However, if it’s almost time for your next dose, skip the missed one and just take the next scheduled dose. Do not take two doses at once to make up for the missed dose.
• If you’re unsure about whether to take or skip a missed dose, consult your doctor or pharmacist. To help avoid missing doses in the future, consider setting a reminder on your phone, using a timer, or downloading a reminder app.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

What Happens If You Take Too Much of Xeljanz XR?

It’s crucial to follow your doctor’s instructions and not take more Xeljanz XR than prescribed. Taking too much of this medication can lead to side effects or an overdose.

If you think you’ve taken too much Xeljanz XR, contact your doctor immediately. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool for guidance. If you experience severe symptoms, call 911 or your local emergency number right away or go to the nearest emergency room.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

How to Store a Xeljanz XR?

• Store Xeljanz XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep it in the original bottle and carton to protect it from light.
• Keep out of reach of children.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

What Medications Interact with Xeljanz XR?

Xeljanz XR can interact with various medications, supplements, and even certain foods. These interactions can have different effects. For example, some interactions might reduce the effectiveness of the medication, while others can increase the risk or severity of side effects.

Xeljanz XR and Other Medications

Below are examples of medications that can interact with Xeljanz XR:

• Xeljanz XR and Certain Seizure Medications: Taking Xeljanz XR with certain seizure medications can cause your body to clear the drug too quickly, reducing its effectiveness.
  • Seizure Drugs:
    • Carbatrol (carbamazepine)
    • Epitol (carbamazepine)
    • Equetro (carbamazepine) 
    • Tegretol (carbamazepine)
    • Dilantin (phenytoin)
    • Phenytek (phenytoin)
    • Phenobarbital
• Xeljanz XR and Certain Antibiotics and Antifungals: Taking Xeljanz XR with certain antibiotics or antifungals can increase your risk of serious side effects. These medications can prevent your body from properly breaking down Xeljanz XR, leading to higher levels of the drug in your body.
  • Antibiotics:
    • Biaxin XL (clarithromycin)
    • Ery-Tab (erythromycin)
    • Eryped (erythromycin)
  • Antifungals:
    • Extina (ketoconazole) 
    • Nizoral (ketoconazole) 
    • Xolegel (ketoconazole)
    • Diflucan (fluconazole)
    • Omnel (itraconazole)
    • Sporanox (itraconazole)
    • Tolsura (itraconazole)
    • Vfend (voriconazole)
• Xeljanz XR and Immune-Suppressing Drugs: Taking Xeljanz XR with drugs that suppress your immune system can increase your risk of serious infections.
  • Immune-Suppressing Drugs:
    • Simponi (golimumab)
    • Neoral (cyclosporine)
    • Amjevita (adalimumab)
    • Cyltezo (adalimumab)
    • Hadlima (adalimumab)
    • Humira (adalimumab)
    • Hyrimoz (adalimumab)
    • Azasan, Imuran (azathioprine)
    • Inflectra (infliximab)
    • Remicade (infliximab)
    • Ixifi (infliximab)
    • Renflexis (infliximab)
    • Enbrel (etanercept)
    • Erelzi (etanercept)
    • Eticovo (etanercept)

What Are the Other Xeljanz XR Interactions?

• Xeljanz XR and Alcohol: There are no known interactions between Xeljanz XR and alcohol. However, it’s best to ask your doctor if it’s safe for you to drink alcohol while taking this medication.
• Xeljanz XR and Herbs/Supplements: No specific herbs or supplements have been reported to interact with Xeljanz XR. Still, you should consult your doctor or pharmacist before using any of these products while on Xeljanz XR.
• Xeljanz XR and Foods: Consuming grapefruit or grapefruit juice while taking Xeljanz XR may increase the risk of serious side effects. Grapefruit can interfere with how your body processes the medication, leading to higher levels of the drug.

[Note: This isn’t a complete list, and there could be other drugs that interact with Xeljanz XR. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

What Are the Xeljanz XR Alternatives?

There are other medications available that can treat your condition. Some options might be a better fit for you than Xeljanz XR. If you’re considering an alternative, talk to your doctor. They can help you explore other medications that may be more suitable for your needs.

Alternatives for Rheumatoid Arthritis

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

Alternatives for Ulcerative Colitis

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

Alternatives for Psoriatic Arthritis

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

Alternatives for Juvenile Idiopathic Arthritis

• Otrexup (methotrexate)
• Rasuvo (methotrexate)
• Trexall (methotrexate)
• Humira (adalimumab)
• Enbrel (etanercept)
• Simponi (golimumab)
• Remicade (infliximab)

Alternatives for Ankylosing Spondylitis

• Humira (adalimumab)
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• Simponi (golimumab)
• Remicade (infliximab)
• Rinvoq (upadacitinib)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

Xeljanz XR Cost & Coupons

Xeljanz XR is often prescribed to manage conditions like rheumatoid arthritis and ulcerative colitis. To help make this medication more affordable, especially for US residents, you might consider buying Xeljanz XR online from Canada. Canadian pharmacies such as Polar Bear Meds offer competitive prices. When purchasing from Polar Bear Meds, you can use the “WELCOMEPB10” Xeljanz coupon code at checkout to receive a 10% discount on your first order. Additionally, joining their referral program could provide further savings, including free coupons for future purchases. 

Frequently Asked Questions

Should I Avoid Certain Vaccines During Xeljanz XR Treatment?

Yes, you should avoid live vaccines while taking Xeljanz XR. Live vaccines contain weakened versions of viruses or bacteria that trigger your immune system to build protection. Since Xeljanz XR weakens your immune system, getting a live vaccine could lead to an infection from the virus or bacteria in the vaccine. Examples of live vaccines include MMR (measles, mumps, rubella), smallpox, and chickenpox (varicella).

Will I Have Withdrawal Symptoms if I Stop Using Xeljanz XR?

It’s possible that your symptoms could return or worsen if you stop taking Xeljanz XR. A small study found that about 37% of people with rheumatoid arthritis (RA) who stopped taking Xeljanz were able to remain off the medication for a year without their disease getting worse. People with less severe RA symptoms were more likely to stop the medication without their symptoms worsening. 

Can I Take Xeljanz XR with a Biologic?

No, you should not take Xeljanz XR with a biologic drug. Biologics are medications made from living cells and are often used to suppress the immune system in autoimmune disorders. Combining Xeljanz XR with a biologic can overly suppress your immune system, raising the risk of serious infections. 

Does Xeljanz XR Cause Mouth Sores?

Mouth sores are a possible side effect of Xeljanz XR. This medication can weaken your immune system, which may increase the risk of viruses in your body, like the herpes simplex virus that causes cold sores, becoming active again. 

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