FAQs

Talk to your healthcare provider about your treatment plan.

SAPHNELO is a prescription medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

SAPHNELO contains anifrolumab-fnia, which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body’s system that fights infection). When given together with other medicines for lupus, SAPHNELO may help to reduce lupus disease activity more than other lupus medicines alone.

It is not known if SAPHNELO is effective in people with severe active lupus nephritis or central nervous system lupus. It is not known if SAPHNELO is safe and effective in children under 18 years of age.

SAPHNELO is a prescription medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. When given together with other medicines for lupus, SAPHNELO may help to reduce your lupus disease activity more than other lupus medicines alone.

SAPHNELO is the only FDA-approved biologic for adults with moderate to severe lupus that’s shown to significantly lower steroid use.*^,†,‡

Individual results may vary.

Talk to your healthcare provider before stopping or changing any medication, including steroids.

Before your infusion, it is important that you speak with your healthcare provider to know what to expect.

Download the discussion guide to help write down and prepare your questions for your healthcare team.

It takes about 30 minutes to give you the full dose of SAPHNELO.

Ask your healthcare provider or infusion center team about the amount of time you can expect to be at your appointment.

• There may be preparation time before and additional time needed after your infusion. Talk to your healthcare team
• Your healthcare team may also ask you to stay for a short while after you are done to monitor you

Talk to your healthcare provider about what you should expect during an infusion.

You will likely be seated in a treatment chair as you receive your infusion. Your healthcare provider will give you SAPHNELO through a needle placed in a vein.

You may be able to do light activities during this time, such as reading, listening to music, or even using your electronic device. Check with your healthcare provider or infusion center team about their specific dos and don’ts and to learn more about services available to you.

No. Your SAPHNELO infusion treatment is not chemotherapy. SAPHNELO contains anifrolumab-fnia, which is in a group of medicines called monoclonal antibodies. SAPHNELO is a biologic therapy that targets type 1 interferon (IFN-1) activity, which plays a key role in how lupus attacks your body.

If you are having any problems with your SAPHNELO Pen, you can call SAPHNELO Supports at 1-866-SAPHNELO (1-866-727-4635) for assistance. Also, let your doctor know.

To inject SAPHNELO, gather the following supplies:

• 1 SAPHNELO Pen or pre-filled syringe
• 1 alcohol wipe
• 1 cotton ball or gauze
• 1 small bandage
• 1 FDA-cleared sharps disposal container

The SAPHNELO Pen is administered once every week. Each SAPHNELO Pen contains 1 dose for one-time use only.

Your SAPHNELO Pen carton may contain 1 pen or 4 pens. Store your pens in their original carton to protect them from light in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C) until ready to use. If needed, an unopened carton can be stored at room temperature between 68 °F to 77 °F (20 °C to 25 °C) for up to 7 days.

You or your caregiver can inject SAPHNELO in the following areas:

• The front of your thigh
• The lower part of your stomach (abdomen), avoiding the 2-inch (5 cm) area around your belly button

A caregiver may also inject into the upper arm.

Do not inject:

• Into skin that is red, warm, tender, bruised, scaly, or hard
• Into scarred, damaged, discolored, or tattooed skin
• Through clothing

Always choose an injection site that is at least 1 inch (3 cm) away from where you last injected.

Click here to read the full Instructions for Use about how to self-administer your SAPHNELO Pen. Or, you can also watch a step-by-step instructional video here. Both will show you how to self-administer your SAPHNELO Pen.

To deliver a full dose, press and hold the SAPHNELO Pen down firmly for 15 seconds until the green plunger fills the viewing window.

Do not lift the pen up early. Wait to lift the pen until the green plunger has completely filled the viewing window.

Your doctor is the best source of information for your health and how to self-administer using your SAPHNELO Pen. If you would like additional information on how to inject your SAPHNELO Pen, you can call SAPHNELO Supports at 1-866-SAPHNELO (1-866-727-4635) for assistance.

Your SAPHNELO Pen or pre-filled syringe can be stored at room temperature (68 °F to 77 °F; 20 °C to 25 °C) for up to 7 days.

However, do not return the device to the refrigerator once it has reached room temperature.

If it has been longer than 7 days, dispose of the device in an FDA-cleared sharps disposal container and use a new one.

Yes, you can travel with your SAPHNELO Pen or pre-filled syringe, but follow these guidelines:

• Keep the device refrigerated between 36 °F to 46 °F (2 °C to 8 °C) while traveling
• If refrigeration is not possible, the device can be stored at room temperature (68 °F to 77 °F; 20 °C to 25 °C) for up to 7 days
• Do not expose the device to heat or freeze it. Always keep it in its original carton to protect it from light

Plan ahead to ensure proper storage during your trip. If you have any concerns, talk to your healthcare provider or pharmacist.

Once you have completed the injection process, immediately dispose of the pen in an FDA-cleared sharps disposal container.

Do not throw away the pen in your household trash. Throw away the cap and other used supplies in your trash.

If you do not have an FDA-cleared sharps disposal container, you can:

• Request one from your Specialty Pharmacy that fulfills your SAPHNELO Pen prescription
• Use a heavy-duty plastic household container, such as a laundry detergent bottle, that:

– Has a tight-fitting, puncture-resistant lid

– Is upright and stable during use

– Is leak-resistant

– Is properly labeled to warn of hazardous waste inside

When the container is almost full, follow your community guidelines for proper disposal. For more information, visit www.fda.gov/safesharpsdisposal.

If you are currently receiving SAPHNELO as an IV (intravenous) infusion and are interested in switching to self-injections with the SAPHNELO Pen, talk to your healthcare provider.

Your healthcare provider will assess whether the SAPHNELO Pen is right for you and determine if switching to self-injections is appropriate for your treatment plan.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SAPHNELO may affect the way other medicines work, and other medicines may affect how SAPHNELO works.