Benlysta's active ingredient is belimumab, a human IgG1λ monoclonal antibody used as a specific inhibitor of the B lymphocyte stimulator protein (BLyS). It is available as a clear to pale yellow injection for subcutaneous use, in 1-mL single-dose autoinjectors or prefilled syringes, each containing 200 mg of belimumab. Key inactive ingredients include L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, and sodium chloride. The solution is designed for administration via a fixed 27-gauge, half-inch needle.

How should I use this medication?

This medication is injected into a vein or under the skin. Injections into a vein are given by your care team in a hospital or clinic setting. Injections under the skin may be given at home. If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. A special MedGuide will be given to you by the pharmacist with each prescription and refill. If you are getting this medication in a hospital or clinic, a special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it be prescribed for children as young as 5 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment. If you give yourself this medication at home: If you miss a dose, take it as soon as you can. Then, resume dosing on the usual day you get your medication or start a new weekly dosing schedule from the day that the missed dose was given. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Keep out of the reach of children and pets. Store in the refrigerator. Do not freeze. Keep this medication in the original container until you are ready to take it. Protect from light. Avoid exposure to extreme heat. Get rid of any unused medication after the expiration date. Do not use this medication or put it back in the refrigerator if it is left out at room temperature for more than 12 hours. If it is stored at room temperature, throw away any unused medication after 12 hours or after it expires, whichever is first. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Dizziness, loss of balance or coordination, confusion or trouble speaking -Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell -Thoughts of suicide or self-harm, worsening mood, or feelings of depression Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Headache -Nausea -Pain, redness, or irritation at injection site -Runny or stuffy nose -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cancer -Depression -Immune system problems -Infection -Recent or upcoming vaccine -Suicidal thoughts, plans, or attempt -An unusual or allergic reaction to belimumab, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Live virus vaccines This medication may also interact with the following: -Biologic medications, such as adalimumab, certolizumab, etanercept, golimumab, infliximab -Cyclophosphamide -Monoclonal antibodies, such as ocrelizumab, ofatumumab, rituximab

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek another source of medical care. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.