Xeljanz Dosage, forms & strengths
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Xeljanz (tofacitinib) is a Janus kinase inhibitor (JAK inhibitor) that is manufactured by Pfizer Inc. It is U.S. Food and Drug Administration (FDA) approved in adults who did not respond to 1 or more biological drugs such as tumor necrosis factor (TNF) blockers with inflammatory conditions such as:
- Moderate to severe active rheumatoid arthritis (RA).
- Active psoriatic arthritis. Xeljanz should be taken along with a nonbiologic disease-modifying antirheumatic drug (DMARD) such as sulfasalazine or methotrexate.
- Ankylosing spondylitis.
- Ulcerative colitis.
Xeljanz is also indicated in polyarticular course juvenile idiopathic arthritis in pediatric patients aged 2 years and older. They must weigh between 10kg (22lbs) and 40kg (88lbs) and have failed or couldn’t tolerate at least 1 TNF blocker. Xeljanz Oral Solution and Xeljanz tablets are used to treat this condition in pediatric patients. They should not be taken in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.
How does Xeljanz work?
Xeljanz is a Janus kinase (JAK) inhibitor that changes the activity of your immune system to reduce inflammation. It works by blocking the actions of Janus kinase enzymes. JAK enzymes play an important role in the inflammation that causes symptoms and complications of several inflammatory conditions.
Xeljanz dosage forms and strengths
- 5mg tablet
- 10mg tablet
- 11 mg extended-release tablet
- 22mg extended-release tablet
- 1 mg/ml oral solution
Rheumatoid Arthritis, psoriatic arthritis, and ankylosing spondylitis:
- Xeljanz 5mg twice daily or Xeljanz XR 11mg once daily.
- Initial Xeljanz treatment is 10mg twice daily or Xeljanz XR 22mg once daily for 8 weeks. Your doctor will reevaluate your condition and can continue for a maximum of 16 weeks if needed. Once you have an adequate response, your maintenance dose will be Xeljanz 5mg twice daily or Xeljanz XR 11mg once daily.
Polyarticular Course Juvenile Idiopathic Arthritis (dose is based on weight):
- Body weight of 10kg to less than 20kg: 3.2 mg (3.2ml of oral solution) twice daily
- Body weight of 20kg to less than 40kg: 4mg (4ml of oral solution) twice daily
- Body weight ≥40 kg: 5mg (one 5 mg tablet or 5ml of oral solution) twice daily
Xeljanz dosage restrictions
No dosage adjustment is needed for patients with mild renal impairment. A dosage adjustment is recommended in patients with moderate to severe renal impairment.
No dosage adjustment is needed for patients with mild hepatic impairment. A dosage adjustment is recommended in patients with moderate hepatic impairment. The use of Xeljanz in patients with severe hepatic impairment is not recommended.
How to take Xeljanz
- Read the Full Prescribing Information including the Black Boxed Warning, Instructions for Use, and Medication Guide that comes with Xeljanz.
- Take Xeljanz exactly as your prescriber tells you to. Do not change your dose or stop taking Xeljanz without talking to them first.
- Xeljanz tablets and Xeljanz Oral Solution are taken 2 times a day with or without food. Xeljanz XR tablets are taken once daily with or without food.
- Swallow Xeljanz XR tablets whole. Don’t crush, split, or chew Xeljanz XR tablets. The empty shell of a Xeljanz XR tablet may show up in your stool. This is normal and there is no medicine left in the tablet.
- If you think you have taken too much Xeljanz, call your doctor or go to the nearest emergency room right away.
- Store Xeljanz tablets and Xeljanz XR tablets at room temperature between 68°F to 77°F (20°C to 25°C). Store Xeljanz Oral Solution in the original bottle at room temperature between 15°C and 30°C (between 59°F and 86°F). Discard any unused oral solution 60 days after opening.
Xeljanz dosage FAQs
What are the most common side effects of Xeljanz?
The most common adverse reactions of Xeljanz in clinical trials include:
- Upper respiratory tract infection
- Nasopharyngitis (cold symptoms)
- Hypertension (high blood pressure)
- Increased triglyceride and cholesterol levels
- Shingles (herpes zoster)
- Abdominal pain
- Neutropenia (low neutrophil count)
- Lymphopenia (low lymphocyte count)
Xeljanz can sometimes cause more serious adverse reactions, including:
- Severe allergic reactions
- Serious infections such as tuberculosis
- Increased risk of cardiovascular events
- Increased risk of thrombosis (blood clots)
- Liver impairment or increased liver enzymes
- GI problems including diverticulitis
Contact your healthcare professional for medical advice about any adverse effects you experience while taking Xeljanz. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What drug interactions occur with Xeljanz?
When Wixela is taken with other medications, it may change the way they work or increase the frequency and severity of side effects. Discuss with your doctor whether any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, including:
- Moderate to strong CYP3A4 inhibitors such as ketoconazole or fluconazole
- Strong CYP3A4 Inducers such as rifampin
- Immunosuppressive medications such as azathioprine, tacrolimus, or cyclosporine
Are there any contraindications or precautions with Xeljanz?
Xeljanz should not be taken if you have any of the following conditions:
- Severe allergy to any ingredients in this formulation.
Caution should also be taken in the following situations:
- Avoid using Xeljanz if you have a serious infection.
- Increased risk of infections, including tuberculosis and other serious infections, with the use of Xeljanz. You should be tested for latent tuberculosis before starting this medication and monitored for active tuberculosis during treatment.
- Increased risk of cardiovascular death, heart attacks, and stroke, especially in patients 50 years of age and older with at least one cardiovascular risk factor.
- History of malignancies, including lymphomas, lung cancer, and skin cancer.
- Xeljanz may activate the hepatitis B or C virus if you are a carrier of the virus.
- Increased risk of GI perforations (holes). NSAIDs such as ibuprofen and corticosteroids such as prednisone might increase your risk of GI complications.
- Your doctor may recommend lab monitoring to check for changes in your white blood cells, red blood cells, liver enzymes, and cholesterol.
- You should not receive a live vaccine while taking Xeljanz. You can however receive a non-live vaccine
Can you take Xeljanz while you are pregnant or breastfeeding?
There is limited data on Xeljanz use during pregnancy. Miscarriages and birth defects were reported in clinical development programs associated with Xeljanz. There is a pregnancy exposure registry that monitors outcomes for Xeljanz use in women during pregnancy. Please call the toll-free number 1-877-311-8972 for more information.
You should not breastfeed while taking Xeljanz and for at least 18 hours after your last dose of Xeljanz. You should wait at least 36 hours after your last dose of Xeljanz XR.
You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
What do I do if I miss a dose of Xeljanz?
If you miss a dose of Xeljanz, take it as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take it at its regularly scheduled time. Do not take extra doses of this medication to make up for a missed dose.
What is the maximum dose of Xeljanz?
The maximum daily dose of Xeljanz is 10mg twice a day. For Xeljanz XR, the maximum daily dose is 22mg once daily.
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