Question 1

What is Xeljanz?

Accepted Answer

Xeljanz contains the active ingredient tofacitinib and belongs to a class of medications known as Janus kinase (JAK) inhibitors . It works by interfering with specific signaling pathways that contribute to inflammation and immune system overactivity.

By blocking these enzymes, the medication helps to reduce the underlying inflammatory processes in the body. It is considered a targeted synthetic disease-modifying drug that helps regulate the immune response.

Question 2

What is Xeljanz used for?

Accepted Answer

Xeljanz is used to treat the following conditions:

Rheumatoid arthritis

Psoriatic arthritis

Ulcerative colitis

Others

Question 3

How does Xeljanz work?

Accepted Answer

Mechanism of Action

Xeljanz belongs to a class of medications known as Janus kinase (JAK) inhibitors. It works by targeting specific pathways inside the body's immune cells to help control inflammation.

Blocking JAK Enzymes

In many autoimmune conditions, the immune system is overactive and produces too many inflammatory signals. These signals rely on enzymes called Janus kinases (specifically JAK1, JAK2, and JAK3) to communicate. These enzymes act like internal switches that, when turned on, tell the cell to produce proteins that cause inflammation.

Xeljanz works by:

Entering the cell and binding to these JAK enzymes.

Interfering with the signaling process that triggers an immune response.

Reducing the production of cytokines, which are the proteins responsible for causing swelling, pain, and tissue damage.

Difference from Biologics

While Xeljanz affects the immune system in a way similar to biologic medications, it works differently. Biologics are large proteins that usually target inflammatory signals outside of the cells. Xeljanz is a small-molecule drug that works from the inside of the cell. Because of its smaller size, it can be taken orally as a tablet rather than through an injection or infusion.

Question 4

What are the active ingredients in Xeljanz?

Accepted Answer

The active ingredient in Xeljanz is tofacitinib .

Question 5

What are the side effects of Xeljanz?

Accepted Answer

Common side effects of Xeljanz may include:

upper respiratory infection

headache

diarrhea

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Xeljanz?

Accepted Answer

Xeljanz belongs to the JAK inhibitor drug class.

Question 7

What is the dosage of Xeljanz and how do I take it?

Accepted Answer

How to Take Xeljanz

Xeljanz is taken by mouth and is available as immediate-release tablets, extended-release tablets, or an oral solution. It can be taken with or without food.

Administration Guidelines

Swallowing Tablets: Extended-release tablets must be swallowed whole. Do not crush, split, or chew them.

Oral Solution: When using the liquid form, use a proper dose-measuring device to ensure the dose is accurate.

Dosing Frequency

The timing of doses depends on the formulation prescribed. Immediate-release versions are generally taken twice a day, while extended-release versions are typically taken once a day.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. Do not take extra medicine to make up for a missed dose.

Question 8

Is Xeljanz safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is limited information regarding the safety of Xeljanz during pregnancy. It is not yet known if the medication can cause harm to an unborn baby. Healthcare providers typically recommend using this medication during pregnancy only if the potential benefit justifies the potential risk to the fetus.

If you are pregnant or planning to become pregnant, you should inform your doctor before starting or continuing treatment. There may be pregnancy registries available to monitor the health of individuals and their babies after exposure to the medication during pregnancy.

Breastfeeding

It is not known whether Xeljanz passes into human breast milk. However, because of the potential for serious adverse reactions in a nursing infant, breastfeeding is generally not recommended while taking this medication.

Specific guidelines for when it may be safe to breastfeed after stopping the medication include:

Immediate-release tablets or oral solution: Wait at least 18 hours after the last dose.

Extended-release tablets: Wait at least 36 hours after the last dose.

Question 9

What forms and strengths does Xeljanz come in?

Accepted Answer

Xeljanz is administered orally and is available in the following forms:

Tablets: Immediate-release tablets for standard oral administration.

Extended-release tablets: These tablets, often labeled as Xeljanz XR, are designed to release the medication slowly into the body.

Oral solution: A liquid form of the medication for oral use.

Question 10

What is the FDA approval status of Xeljanz?

Accepted Answer

FDA Approval and Indications

Xeljanz (tofacitinib) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several inflammatory conditions, including:

Rheumatoid arthritis

Psoriatic arthritis

Ulcerative colitis

Ankylosing spondylitis

Polyarticular juvenile idiopathic arthritis

Boxed Warning

The FDA requires a Boxed Warning for Xeljanz, which is the agency's most serious type of warning. This warning was implemented and later updated following clinical trial results that identified significant safety concerns. The Boxed Warning includes information regarding:

Serious heart-related events: An increased risk of heart attack, stroke, and cardiovascular death, particularly in patients who are current or past smokers.

Cancer: An increased risk of certain cancers, including lymphomas and lung cancer.

Blood clots: A higher risk of blood clots in the lungs (pulmonary embolism) and deep veins.

Death: An increased risk of death from all causes compared to patients taking TNF blockers.

Infections: A risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death.

Regulatory History and Safety Communications

In 2021, the FDA required updates to the Xeljanz prescribing information based on the final results of a large safety clinical trial. This trial compared Xeljanz to another class of drugs called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis who were at least 50 years old and had at least one cardiovascular risk factor. The study found that Xeljanz carried a higher risk of serious heart-related events and cancer than TNF blockers.

The FDA has also issued specific warnings regarding dosage. The 10 mg twice-daily dose is only approved for the initial treatment of ulcerative colitis and for limited maintenance use in certain patients, as higher doses have been linked to an increased risk of blood clots and death.

Question 11

What should I know about Xeljanz and cost?

Accepted Answer

Insurance Coverage

Xeljanz is a brand-name prescription medication. Most health insurance plans, including Medicare, provide coverage for it, but the specific out-of-pocket cost depends on the plan's formulary and benefit structure. Many insurance companies require prior authorization before approving coverage for this medication.

Factors Affecting Price

Several factors can influence the final cost of Xeljanz:

Formulation: The price may differ between the immediate-release tablets, the extended-release (XR) tablets, and the oral solution.

Pharmacy Choice: As a specialty medication, Xeljanz is often dispensed through specialty pharmacies, which may have different pricing or delivery arrangements compared to retail pharmacies.

Dosage: The strength and frequency of the dose prescribed for conditions like rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis can impact the total cost.

Generic Availability

Xeljanz is currently available as a brand-name drug. Because there is limited generic competition for this specific Janus kinase (JAK) inhibitor, the cost typically remains higher than that of older, non-biologic disease-modifying antirheumatic drugs (DMARDs).

Xeljanz

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

Found an Error?