Anifrolumab

This information from UpToDate^® Lexidrug^™ explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Saphnelo; Saphnelo Pen

Brand Names: Canada

Saphnelo

What is this drug used for?

• It is used to treat lupus.

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 kidney or nervous system problems caused by lupus.
• If you have an infection.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

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 of a chance of getting an infection. Some infections have been severe or deadly. Wash hands often. Stay away from people with infections, colds, or flu.
• 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.
• Drugs that may suppress the immune system like this drug may raise the risk of cancer. If you have questions, talk with the doctor.
• 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.

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 shingles like pain, itching, or tingling; fever; muscle aches; or rash (with or without blisters).
• Warm, red, or painful skin or sores on the body.
• Stomach pain or diarrhea.
• Passing urine more often.
• Muscle pain.
• Sweating a lot.
• Shingles.
• Dizziness or passing out.
• Headache.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Some people have had side effects during the infusion. Tell your doctor if you have any side effects during the infusion like headache, dizziness, tiredness, upset stomach, or throwing up.

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:

• Signs of a common cold.

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.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Prefilled syringes and auto-injectors:

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Other drugs may be given before this drug to help avoid side effects.
• Wash your hands before and after use.
• Do not shake.
• 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.
• This drug is colorless to slightly yellow. This drug may also be clear to slightly pearly. Do not use if the solution changes color or is cloudy, leaking, or has particles.
• If you see small air bubbles in the device, do not try to get rid of them.
• Move the site where you give the shot with each shot. Inject at least 1 inch (2.5 cm) away from where the last dose was given.
• Do not give into skin within 2 inches (5 cm) of the belly button.
• Do not inject through clothes. Do not give into skin that is bruised, red, scaly, hard, scarred, damaged, warm, tender, discolored, or tattooed.
• Do not use this drug if it has been dropped or if it is broken.
• Each autoinjector or prefilled syringe is for one use only. Throw away any part left over after the dose is given.
• 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.

Vials:

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given before this drug to help avoid side effects.

What do I do if I miss a dose?

Prefilled syringes and auto-injectors:

• Take a missed dose as soon as you think about it.
• You may start a new schedule based on when the dose is taken or go back to your usual day as long as there are 3 days between the doses.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

Vials:

• Call your doctor to find out what to do.

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

Prefilled syringes and auto-injectors:

• Store in a refrigerator. Do not freeze.
• Do not use if it has been frozen.
• Store in the original container to protect from light.
• Protect from heat.
• If needed, you may store at room temperature for up to 7 days. Write down the date you take this drug out of the refrigerator. If stored at room temperature and not used within 7 days, throw this drug away.
• Do not put this drug back in the refrigerator after it has been stored at room temperature.

Vials:

• If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.

All products:

• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. 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.

Last Reviewed Date

2026-05-08

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