Anifrolumab-fnia Injection

Anifrolumab is used to treat systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs). Anifrolumab injection is in a class of medications called monoclonal antibodies. It works by blocking the activity of a certain protein in people with SLE.

Anifrolumab comes as a solution (liquid) to be injected intravenously (into a vein) or subcutaneously (under the skin). It is given intravenously over a 30-minute period every 4 weeks. It is given subcutaneously in a prefilled syringe or prefilled pen once weekly. Your doctor will decide how often you are to receive anifrolumab based on your body's response to this medication.

Your healthcare provider will show you or your caregiver how to use the prefilled syringe or pen. You will also be given instructions for use that come with step by step directions on how to give your injection. Ask your healthcare provider if you aren't sure on how to use the prefilled pen.

Before injecting anifrolumab, remove the pen or prefilled syringe from the refrigerator and let it warm to room temperature for 60 minutes. Do not try to warm by running under warm water, using a microwave, or any other method. Inspect the pen or syringe carefully to make sure the solution is clear and colorless to slightly yellow. Do not use if there is cloudiness, particulate matter, or discoloration. Anifrolumab injection can be given into the abdomen (avoiding the 2 inch area around the navel) or thigh. The upper arm can be used if a caregiver is giving the injection.

Anifrolumab helps to control lupus but does not cure it. Your doctor will watch you carefully to see how well anifrolumab works for you. It is important to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving anifrolumab,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with anifrolumab. Make sure you have discussed any medications you are currently taking or plan to take before starting anifrolumab with your doctor and pharmacist. Before starting, stopping, or changing any medications while using anifrolumab, please get the advice of your doctor or pharmacist.
• tell your doctor if you have an infection or an infection that keeps coming back, or if you have or have had any type of cancer.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving anifrolumab, call your doctor.
• do not have any vaccinations during your treatment without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive anifrolumab intravenously, call your doctor as soon as possible.

If you forget to use a subcutaneous dose, inject the missed dose as soon as you remember. Then you may start a new weekly schedule from the day the dose was just given or resume your previous schedule before the missed dose. You must allow 3 days between injections.

Anifrolumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• vomiting
• tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, sore throat, chills, cough, or other signs of infection
• stomach pain or diarrhea
• frequent, painful, or difficult urination
• red or painful skin or sores on your body
• swelling of the face, tongue, or mouth
• fainting or lightheadedness
• difficulty breathing

Anifrolumab may increase your risk of certain cancers. Talk to your doctor about the risks of receiving this medication.

Anifrolumab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, do not freeze. It may also be kept at room temperature, 68 to 77° F (20 to 25° C), in the original carton for up to 7 days. After 7 days at room temperature, anifrolumab must be discarded and not returned to the refrigerator.

Keep all medication out of sight and reach of children as many containers are not child resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about anifrolumab.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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