Starting with Saphnelo

Your healthcare provider should show you or your caregiver how to use SAPHNELO PEN the right way. SAPHNELO PEN is for use under the skin (subcutaneous) only.

Read this Instructions for Use before you start using SAPHNELO PEN and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

If you or your caregiver have any questions, talk to your healthcare provider.

Your SAPHNELO pen

Do not remove the cap until right before injecting SAPHNELO. Do not touch the green needle guard.

How it works

The injection starts automatically when the green needle guard is pushed against the skin.

You must keep the pen pressed down firmly for 15 seconds to deliver the full dose.

After the injection starts, it cannot be stopped.

Lifting the pen too early could allow the needle guard to slide down and lock into place over the needle. If this happens the injection cannot be restarted, and you may not receive your full dose.

The needle guard is only intended to slide down over the needle after the injection is finished, to protect against touching the needle.

The injection is finished when the green plunger fills the viewing window.

Each SAPHNELO PEN contains 1 dose of SAPHNELO that is for one time use only.

Storage

Store SAPHNELO PEN in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton until ready to use.

Keep SAPHNELO PEN in original carton to protect from light.

Keep SAPHNELO and all medicines out of the sight and reach of children.

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.

Additional important information

Do not use SAPHNELO PEN if:

it has been frozen or exposed to heat
it has been dropped or damaged
it appears to be tampered with
the expiration date (EXP) has passed

Do not:

shake SAPHNELO PEN
share SAPHNELO PEN with other people

If any of the above happens, throw away SAPHNELO PEN in an FDA-cleared sharps disposal container and use a new SAPHNELO PEN.

Part 1

Prepare

By completing this registration, I confirm that I am at least 18 years old, agree to receive information about SAPHNELO, and may receive information about other immunology medicines and services related to my condition which includes, but is not limited to, educational and promotional materials, special offers and services and for market research purposes, which includes contacting me to participate in focus groups, surveys or interviews. This may include AstraZeneca or a third party working on AstraZeneca's behalf contacting me by telephone, e-mail and text message regarding AstraZeneca Support Programs that may be of interest to me. Information provided by AstraZeneca does not take the place of talking to your healthcare provider about your treatment or condition. If you no longer want to receive health-related materials, call 1-800-236-9933. Please visit www.azprivacynotice.com to review our Privacy Notice.

By providing your phone number, you are opting in to receive updates and support messages from SAPHNELO. Text STOP to opt out. Text HELP for help. Message frequency will vary. Message and data rates may apply. For more information, visit Privacy Notice or Terms & Conditions.

IMPORTANT SAFETY INFORMATION

Do not use SAPHNELO if you are allergic to anifrolumab-fnia or to any of the ingredients
Before you receive SAPHNELO, tell your healthcare provider about all of your medical conditions, including if you:
- Think you have an infection or have an infection that keeps coming back
- Are scheduled to receive a vaccination or if you think you may need a vaccination. You should not receive live vaccines during treatment with SAPHNELO
- Have or have had cancer
- Are receiving other biologic medicines or monoclonal antibodies
- Are pregnant or plan to become pregnant. It is not known if SAPHNELO will harm your unborn baby. Tell your healthcare provider if you are, might be, or plan to become pregnant during treatment with SAPHNELO
  - Pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO. You can find out more information about the registry by calling AstraZeneca at 1-877-693-9268
- Are breastfeeding or plan to breastfeed. It is not known if SAPHNELO passes into your breast milk

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.

SAPHNELO may cause serious side effects, including:

Serious infections: SAPHNELO can lower the ability of your immune system to fight infections. You may be at a higher risk of developing respiratory infections and shingles (herpes zoster) during treatment with SAPHNELO. Infections could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- burning when urinating
- urinating more often
- diarrhea or stomach pain
- warm, red, or painful skin or sores on your body
Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen during or after SAPHNELO administration. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of a serious allergic reaction:
- swelling of your face, mouth, and tongue
- breathing problems
- fainting or dizziness
- feeling lightheaded (low blood pressure)
Cancer: SAPHNELO may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers

The most common side effects of SAPHNELO include:

Upper respiratory infections
Bronchitis
Infusion reactions (when given intravenously)
Shingles (herpes zoster)
Cough

These are not all the possible side effects of SAPHNELO. Call your healthcare provider for medical advice about side effects.

What is SAPHNELO?

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.

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

Please see full Prescribing Information, including Patient Information.

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