Sarilumab: Patient drug information

Warning

This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
Do not take this drug if you have an infection.
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.
If you have a long term infection or an infection that keeps coming back, talk with your doctor.
Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.

What is this drug used for?

It is used to treat rheumatoid arthritis.
It is used to treat polymyalgia rheumatica (PMR).
It may be given to you for other reasons. Talk with the doctor.

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 liver disease or raised liver enzymes.
If you have a low platelet count or a low white blood cell count.
If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab, or vedolizumab.
If you are taking tofacitinib.
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.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
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.
Talk with your doctor before getting any vaccines while you take this drug and after you stop taking it. Vaccine use with this drug may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
Holes in the GI (gastrointestinal) tract may rarely happen.
This drug may add to the chance of getting some types of cancer. Talk with the doctor.
If you are 65 or older, use this drug with care. You could have more side effects.
Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
If you used this drug when you were pregnant, tell your baby's doctor.

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 a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
Stomach pain; black, tarry, or bloody stools; throwing up blood; or throw up that looks like coffee grounds.
Shortness of breath.
Chest pain.
Dizziness or passing out.
Warm, red, or painful skin or sores on the body.
Sweating a lot.
Weight loss.
Diarrhea.
Feeling very tired or weak.
Low platelet counts have rarely happened with this drug. This may lead to a higher chance of bleeding. Call your doctor right away if you have any unexplained bruising or bleeding.

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:
Irritation where the shot is given.
Signs of a common cold.
Nose or throat irritation.
Runny or stuffy nose.
Constipation.
Muscle pain.
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.
All products:
It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
Do not remove the cap or cover until ready to use.
Wash your hands before and after use.
Do not shake.
Do not use if the solution is cloudy, leaking, or has particles.
This drug is colorless to a faint yellow. Do not use if the solution changes color.
Move the site where you give the shot with each shot.
Do not give into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not give into skin within 2 inches (5 cm) of the belly button.
Do not rub the site where you give the shot.
Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
Prefilled syringes:
If stored in a refrigerator, let this drug come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat this drug.
Prefilled pen:
If stored in a refrigerator, let this drug come to room temperature before using it. Leave it at room temperature for at least 60 minutes. Do not heat this drug.

What do I do if I miss a dose?

Be sure you know what to do if you forget to take a dose.
If you are not sure what to do if you miss a dose, call your doctor.

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

Store in a refrigerator. Do not freeze.
Store in the original container to protect from light.
If needed, you may store at room temperature for up to 14 days. Write down the date you take this drug out of the refrigerator. If stored at room temperature and not used within 14 days, throw this drug away.
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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Sarilumab: Patient drug information