Xeljanz

What is Xeljanz?

Xeljanz (tofacitinib) can be taken orally as a Janus kinase (JAK) inhibitor that can be taken by itself or in conjunction with other medicines to decrease inflammation that is associated with chronic autoimmune and inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Xeljanz is a drug that reduces the function of the body's immune system. It accomplishes this by blocking the function that occurs in JAK enzymes (JAK1, JAK2, JAK3, JAK2, TYK2) within cells. These enzymes transmit inflammation signals to the body, which are linked with the release of cytokines. By preventing these enzymes, Xeljanz assists in reducing the immune reaction that triggers the autoimmune diseases psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Xeljanz can be used to treat the following disorders in adults who are not able to or did not react to one or more TNF-inhibiting medications:

• Moderate to severe Rheumatoid Arthritis, moderate to severe
• Active psoriatic arthritis
• Mild to very severe ulcerative colitis
• Ankylosing spondylitis.

Xeljanz has also been approved for treating polyarticular juvenile idiopathic arthritis patients aged 2 or older who have an insufficient response or intolerance towards one or several TNF blockers.

Xeljanz was approved by the Food and Drug Administration on November 6, 2012.

Warnings

The use of Xeljanz can increase your risk of acquiring life-threatening medical issues, such as serious infections, a tear or hole in the digestive tract, stroke or heart attack, blood clots, or cancer.

Inform your doctor if you are suffering from weak immunity, chronic lung disease, diabetes, or an infection like hepatitis, tuberculosis, or shingles. Be sure to inform your doctor if you've suffered from diverticulitis, an occlusion in your stomach or intestines, kidney transplants, cancer, a heart condition, a smoking history, a heart attack, stroke, or blood clots.

Contact your physician immediately. If you experience night sweats, fever, constant fatigue, weight loss, stomach pains, diarrhea, or changes in bowel habits, problems breathing, wheezing or an intense cough, or lumps that appear in your neck, armpits, or groin.

You should seek medical assistance immediately when you notice an abrupt shortness of breath and chest pain that extends to your arms or neck; nausea; severe dizziness; a chill sweat weakening on the other part of the body; slurred speech or pain; or redness or swelling of your leg or arm.

The use of Xeljanz in conjunction with biologic DMARDs or powerful immunosuppressants such as cyclosporine and azathioprine is not recommended.

Xeljanz XR (extended-release tablets) are not interchangeable or compatible in conjunction with Xeljanz Oral Solution.

Xeljanz shouldn't be used for patients with a lymphocyte count lower than 500 cells/mm3, an Absolute count of neutrophils (ANC) of less than 1000 cells/mm3, or hemoglobin levels less than 9 mg/dL.

Do not take this medication if you are suffering from severe liver impairment. Do not use it during an active, serious infection, which includes localized infections.

Regular monitoring of the laboratory is recommended due to the possibility of changes in neutrophils, lymphocytes, hemoglobin, liver enzymes, and lipids.

Before you take this drug

Tell your doctor if you've had:

• A weak immune system or chronic infections (such as shingles, tuberculosis, HIV, or hepatitis);
• Any cancer of any kind;
• Kidney disease, kidney transplant, or you are taking dialysis
• Diverticulitis, a rash of ulcers in the stomach or intestines of your body;
• Heart-related problems;
• A stroke, heart attack, or blood clot
• Excessive cholesterol
• If you've ever had the pleasure of smoking

Consult your physician. If you've experienced symptoms of infection like chills, fever, muscle aches, coughs, breathing problems, skin sores, diarrhea, or painful urine,

Consult your physician to determine whether you've been exposed to tuberculosis in the case that you've recently gone on a trip. Certain infections are more prevalent in specific regions around the globe, and you might have come across the disease during your travels.

Also, to ensure Xeljanz is suitable for you, ask your doctor if you've ever experienced:

• The liver (especially hepatitis B or C);
• Chronic lung disease;
• Diabetes
• If you are due to get any vaccinations.

The use of Xeljanz can increase the chance of developing certain types of cancer, like lymphoma and lung cancer. Talk to your doctor about the possibility.

Inform your physician if you are expecting or planning to be pregnant. If you suffer from rheumatoid arthritis or ulcerative colitis while pregnant, it can increase the chance of a premature birth or a low-weight baby. The benefits of treating these ailments with Xeljanz might outweigh any risk for the baby. If you fall pregnant while using Xeljanz and you are pregnant, your name could be listed on the registry for pregnancy to monitor any effects caused by Xeljanz on the infant.

If you're a female, Xeljanz may affect your fertility and the potential to have children during treatment as well as in the future.

Do not breastfeed when you are taking this medication or for at least 18 hours after the most recent dosage (36 hours if taking extended-release pills). If you have an infant pump during this period, don't give this milk directly to your child.

Don't give this medicine to an infant without medical guidance. Extended-release tablets aren't permitted for use by anyone who is younger than

What is the best way to do it, Xeljanz?

You should take Xeljanz exactly as directed by your physician. Follow all instructions on your prescription label, and go through all medication guides and instructions. The doctor might modify your dosage.

You can take Xeljanz with or without food.

Suck the tablet up in its entirety and don't crush, chew, or break it.

Take measurements of liquid medicine using the device that comes with it (not the kitchen spoon).

Doses are determined by the weight of children and teens. The dosage for your child may be altered if your child loses or gains weight.

Details on dosage

Adults suffering from rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis

• Tablets for immediate release (5 mg), taken every day, twice
• Extended-release tablets: 11 mg taken orally daily.

Reduce dosage to 5mg twice every day in patients with mild to moderate renal impairment.

Psoriatic arthritis treatment: in conjunction with non-biologic DMARDs

Adults suffering from ulcerative colitis

Immediate-Release Tablets:

• Initial: 10 mg, orally every day, twice per day, for at least 8 weeks.
• 5 mg taken orally every day, twice.

Extended-Release Tablets:

• Initial: 22 mg taken orally every day for at least 8 weeks
• Maintenance: 11 mg taken orally every day, once.

If necessary, the doses for induction can be maintained until 16 weeks. In the event that a sufficient therapeutic effect is not seen within 16 weeks of the induction, then the induction dose should be stopped.

In patients who have lost response to treatment for maintenance, you can consider 10 mg taken orally twice daily (immediate-release tablets) or 22 mg daily (extended-release tablets) for a brief period. Utilize the lowest dose necessary to maintain an effective response.

Juvenile Idiopathic Arthritis in Children 2 Years and Older

Oral solution:

• Weight between 10 and 20kg: 3.2 mg, orally two times per day.
• Between 20 and 40 kg: 4 mg per day, every day, twice
• At least 40 kg of weight requires 5 mg taken orally every day, twice.

Immediate-release tablets:

• Aim for a weight of at least 40 kg and 5 mg every day, twice.

What happens if I miss a dose?

You should take the medication as quickly as you are able, but do not take any missed doses if it's close to the time of the next dose. Don't take two doses at once.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line at 1-800-222-1222.

What should be avoided Xeljanz?

Do not receive the "live" vaccine. Live vaccines comprise measles, mumps, and rubella (MMR), as well as typhoid, rotavirus, and yellow fever, as well as varicella (chickenpox) and zoster (shingles).

Side effects of Xeljanz

See a doctor immediately. Get medical attention immediately if you notice symptoms of an allergy reaction, like asthmatic hives, difficulty breathing, or swelling of your lips, face, and tongue.

Certain people who take Xeljanz have suffered strokes, heart attacks, or even blood clots with serious consequences. Stop taking this medication and seek immediate medical attention if you suffer from:

• Rapid breathlessness;
• Chest pressure or pain that can extend into your shoulder, jaw, arm, or back;
• Nausea, vomiting, and cold sweat;
• A lightheaded sensation, similar to feeling like you're about to pass out.
• An area of weakness in one part of your body.
• The speech is slurred, drooping on the opposite or other side,
• Pain or swelling in the arm or leg.

Xeljanz may cause serious side effects. Consult your physician immediately. If you suffer from:

• Fever, chills, night sweats, and constant tiredness;
• Coughing, difficulty breathing, excessive or worsening cough;
• More frequent urination, pain, or burning after you urinate
• Unexplained weight loss
• Lumps in your armpits, neck, or groin
• Symptoms of shingles: signs of flu, tingling sensations, or painful blisters that itch on the body's side;
• An opening (perforation) within the digestive tract, such as fever, severe digestive pain, diarrhea, or changes in your bowel habits or
• Indicators of hepatitis losing appetite stomach pain, vomiting (upper right) dark urine, stool with a clay color, jaundice (yellowing of the eyes or skin)

Common Xeljanz adverse effects could include:

• Skin eruptions and skin rashes,
• Upper respiratory tract illness or cold-like symptoms like congestion, sneezing, and sore throat
• An increase in blood pressure
• Diarrhea
• Abnormal blood tests
• Increased cholesterol levels
• Febrile
• Headache
• Nausea, or vomiting.

Patients taking Xeljanz XR may notice an inert tablet shell that has passed through the stool or through the colostomy. The active drug has been absorbed by the time the tablet shell of the inert tablet is noticed.

This isn't a complete list of possible side effects, and other side effects could occur. Contact your doctor to seek medical advice on the effects. You can report symptoms to the FDA at 1-800-FDA-1088.