Xeljanz oral: Side Effects, Uses, Warnings

Side Effects

Headache or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, fast heartbeat, signs of liver disease (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

How to use Xeljanz

Read the Medication Guide provided by your pharmacist before you start taking tofacitinib and each time you get a refill. If you are using the liquid form of this medication, also read the Instructions for Use. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children’s dosage is also based on weight. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Take this medication regularly to get the most benefit from it. Remember to take it at the same time(s) each day.

Tell your doctor if your condition does not get better or if it gets worse.

How long does it take for this medicine to take effect?

The onset of action for Xeljanz can vary among individuals. Clinical improvement in symptoms of rheumatoid arthritis or psoriatic arthritis may be observed as early as 2 weeks after starting treatment, but it may take several months for the full therapeutic effects to become apparent. For ulcerative colitis, some patients may see improvement within a few weeks, with optimal therapeutic effects potentially taking longer.

How long do the effects of this medicine last?

The effects of Xeljanz are sustained with continuous daily administration. The medication has a half-life of approximately 3 hours in healthy individuals, necessitating twice-daily dosing to maintain therapeutic levels in the body.

Is it safe to consume alcohol while taking this medicine?

There is limited data on the direct interaction between alcohol consumption and the efficacy or safety profile of Xeljanz. However, given that alcohol can exacerbate certain conditions being treated with Xeljanz and potentially interact with its mechanism of action, patients are generally advised to limit or avoid alcohol consumption while taking this medication.

Is this a habit forming medicine?

Xeljanz is not considered habit-forming and does not have the potential for abuse or psychological dependence. It is prescribed for its immunomodulatory effects rather than any psychoactive effects.

Can this medicine be taken during pregnancy?

Xeljanz is classified as FDA Pregnancy Category C, indicating that animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The use of Xeljanz during pregnancy should be carefully considered, only if the potential benefits justify the potential risks to the fetus.

Can this medicine be taken while breast-feeding?

It is not known whether tofacitinib is excreted in human breast milk. Due to the potential for serious adverse reactions in nursing infants from Xeljanz, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother’s health.

Precautions

Before taking tofacitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as in the lungs, legs), blood/bone marrow disorders (such as anemia, low lymphocyte/neutrophil count), cancer, heart problems (such as previous heart attack), kidney disease, liver disease (such as hepatitis B or C), lung disease, past/recent/current infections (such as tuberculosis, herpes zoster, HIV infection), current or past smoking, other stomach/intestinal disorders (such as ulcers, diverticulitis), stroke.

Tofacitinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using tofacitinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Liquid products may contain sugar and/or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for infections while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Tell your doctor if you are planning pregnancy or become pregnant.

It is unknown if this medication passes into breast milk. However, because of the possible risk to the infant, breast-feeding while using this drug and for at least 18 hours after the last dose is not recommended. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as liver/kidney function, complete blood count, cholesterol levels, skin exams) should be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Store the liquid form in the original bottle with the cap tightly closed. After each use, place the bottle back into the carton to protect from light. After opening, discard any remaining liquid medication after 60 days.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Other medications can affect the removal of tofacitinib from your body, which may affect how tofacitinib works. Examples include rifampin, among others.

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