Ritlecitinib: Patient drug information

Warning

Severe infections like tuberculosis, shingles, fungal infections and other bacterial or viral infections have happened in patients who take this drug. Sometimes, these have been deadly. The risk is greater if you also take drugs that suppress the immune system like methotrexate or corticosteroids. If you get a bad infection, your doctor may stop this drug until the infection is under control. Call your doctor right away if you have fever, chills, or sweating; cough; muscle aches; shortness of breath; more sputum or change in color of sputum; red, warm, swollen, painful, or blistered skin; weight loss; stomach pain; diarrhea; pain with passing urine or passing urine more often; or feeling tired or weak.
TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.
Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.
Blood clots have happened with this drug. This includes blood clots in the lungs or eyes. If you have questions, talk with the doctor.
A drug (tofacitinib) like this one has been shown to raise the risk of heart attack, stroke, blood clots, and death. These effects were seen in a study of people taking tofacitinib to treat rheumatoid arthritis. These people were at least 50 years of age and also had at least 1 heart disease risk factor. It is not known if the raised risk happens with this drug. Call your doctor right away if you have signs of a heart attack, stroke, or blood clot like chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; abnormal arm, back, neck, jaw, or stomach pain; coughing up blood; shortness of breath; cold sweats; severe upset stomach or throwing up; swelling, warmth, numbness, coldness, color change, or pain in a leg or arm; trouble speaking, swallowing, or thinking; weakness on 1 side of the body; change in balance; drooping on one side of the face; feeling lightheaded; or change in eyesight.
Tell your doctor if you smoke, have smoked in the past, or have ever had a heart attack, other heart problems, stroke, or blood clot.

What is this drug used for?

It is used to treat a type of hair loss called alopecia areata.

What do I need to tell my doctor BEFORE I take this drug?

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have a low white blood cell count or a low platelet count.
If you have liver disease or if you have had hepatitis B or hepatitis C infections.
If you have an infection.
If you have recently had a live vaccine.
If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
If you are taking any drugs used to suppress your immune system like azathioprine or cyclosporine. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
If you are breast-feeding. Do not breast-feed while you take this drug and for 14 hours after your last dose.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
Hepatitis testing needs to be done before taking this drug.
Some viral infections like herpes zoster (shingles) have become active again with this drug. Tell your doctor if you have ever had a viral infection like herpes zoster. Talk with your doctor.
Have your blood work and other lab tests checked as you have been told by your doctor.
Make sure you are up to date with all your vaccines before treatment with this drug.
Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.
The chance of skin cancer may be raised. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
If you are 65 or older, use this drug with care. You could have more side effects.
Tell your doctor if you are pregnant or get pregnant while taking this drug. You will need to talk about the benefits and risks of using this drug while you are pregnant.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Warm, red, or painful skin or sores on the body.
Shingles.
A skin lump or growth.
Dizziness or passing out.
Feeling very tired or weak.
Mouth irritation or mouth sores.
Call your doctor right away if you have a swollen gland, night sweats, shortness of breath, or weight loss without trying.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
Headache.
Diarrhea.
Pimples (acne).
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Take with or without food.
Swallow whole. Do not chew, break, open, or crush.
Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it.
If it is less than 8 hours until your next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

Store at room temperature in a dry place. Do not store in a bathroom.
Store in original container.
The bottle has a desiccant in it to keep the drug dry. Keep the desiccant in the bottle. Do not eat or swallow the desiccant.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else's drugs.
Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination and assessment of a patient's specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

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Ritlecitinib: Patient drug information