Patient information: uses, side effects, how to take - Saphnelo

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

Do not use SAPHNELO if you:

are allergic to anifrolumab-fnia or any of the ingredients in SAPHNELO. See the end of this Patient Information leaflet for a complete list of ingredients in SAPHNELO.

Before you receive SAPHNELO, tell your healthcare provider about all of your medical conditions, including if you:

think you have an infection or have infections that keep coming back. You should not receive SAPHNELO if you have an infection unless your healthcare provider tells you to. See “What are the possible side effects of SAPHNELO?”
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 any type of 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 pregnant, think you might be pregnant, or plan to become pregnant during your treatment with SAPHNELO.
Pregnancy Exposure Registry. If you become pregnant while receiving SAPHNELO, talk to your healthcare provider. A 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. Talk to your healthcare provider about the best way to feed your baby while receiving SAPHNELO.

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.

How will I receive SAPHNELO?

SAPHNELO is intended for use under your healthcare provider’s care and may be administered as an intravenous infusion or as a subcutaneous injection.

When given into a vein (intravenously)

Your healthcare provider will give you SAPHNELO through a needle placed in a vein (IV or intravenous infusion). It takes about 30 minutes to give you the full dose of SAPHNELO.
SAPHNELO is usually given 1 time every 4 weeks.
If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.

When given under the skin (subcutaneously)

SAPHNELO may be prescribed as a single-dose prefilled syringe or as a single-dose autoinjector (SAPHNELO PEN).
Use SAPHNELO exactly as your healthcare provider tells you to use it.
SAPHNELO is injected under your skin (subcutaneously) in your stomach (abdomen), thigh or upper arm (for caregiver administration only) 1 time every week.
Before you use SAPHNELO, your healthcare provider will train you or your caregiver how to give the injections.
Read the Instructions for Use that comes with SAPHNELO for information on how to prepare and inject SAPHNELO.
If you miss your dose of SAPHNELO inject a dose as soon as you remember. Then, continue to inject 1 time each week based on the new day SAPHNELO was injected or at your regularly scheduled time as long as there are at least 3‑days between the doses. In case you are not sure when to inject SAPHNELO, call your healthcare provider.

What are the possible side effects of SAPHNELO?

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 (including COVID-19) 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 you get your SAPHNELO infusion or take your SAPHNELO injection. 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
infusion reactions (when given intravenously)
cough

bronchitis
shingles (herpes zoster)

These are not all of the possible side effects of SAPHNELO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.

How should I store SAPHNELO?

Store SAPHNELO prefilled syringe and autoinjector in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
If needed, the SAPHNELO prefilled syringe or autoinjector (SAPHNELO PEN) can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days protected from light. After the SAPHNELO prefilled syringe or autoinjector has reached room temperature, do not return to the refrigerator. Throw away SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage.
Do not shake SAPHNELO.
Do not freeze SAPHNELO.
Do not expose SAPHNELO to heat.
Do not use SAPHNELO past the expiration date.
Keep SAPHNELO and all medicines out of the reach of children.

General information about the safe and effective use of SAPHNELO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SAPHNELO for a condition for which it was not prescribed. Do not give SAPHNELO to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about SAPHNELO, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SAPHNELO that is written for health professionals.

What are the ingredients in SAPHNELO?

Active ingredient: anifrolumab-fnia

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, lysine hydrochloride, trehalose, polysorbate 80 and Water for Injection.

The SAPHNELO prefilled syringe and autoinjector are not made with natural rubber latex.

Manufactured by: AstraZeneca AB Södertälje, Sweden SE-15185

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

SAPHNELO is a registered trademark of AstraZeneca.

For more information, go to https://www.SAPHNELO.com or call 1-800-236-9933.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: September 2026

INSTRUCTIONS FOR USE SAPHNELO® (saf-NEL-low) (anifrolumab-fnia) injection, for subcutaneous use Single-dose prefilled syringe 120 mg/0.8 mL
This Instructions for Use contains information on how to inject using SAPHNELO prefilled syringe. Read this Instructions for Use before you start using SAPHNELO prefilled syringe 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. Your healthcare provider should show you or your caregiver how to use SAPHNELO prefilled syringe the right way. If you or your caregiver have any questions, talk to your healthcare provider. SAPHNELO prefilled syringe is for use under the skin (subcutaneous) only.
Important storage information and warnings
Store SAPHNELO prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If needed, SAPHNELO prefilled syringe can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light. After SAPHNELO prefilled syringe has reached room temperature, do not return to the refrigerator. Throw away SAPHNELO prefilled syringe if not used within 7 days at room temperature. Each SAPHNELO prefilled syringe contains 1 dose for one time use only. Do not share SAPHNELO prefilled syringe with other people.
Do not use SAPHNELO prefilled syringe if it has: been frozen or exposed to heat. been dropped, damaged, or appears to be tampered with. Do not shake SAPHNELO prefilled syringe.
If any of the above happens, throw away the prefilled syringe in an FDA-cleared sharps disposal container and use a new prefilled syringe. Keep SAPHNELO prefilled syringe and all medicines out of the sight and reach of children.
SAPHNELO prefilled syringe parts
Do not remove the needle cover until right before injecting SAPHNELO. Do not touch the needle guard activation clips. This will keep you from activating the needle guard too soon.

Preparing to inject using SAPHNELO prefilled syringe
Step 1 – Gather supplies for your injection

See Step 9 for instructions on how to throw away (dispose of) the used SAPHNELO prefilled syringe.
Step 2 – Inspect the carton and wait 60 minutes
Select a clean, well-lit, flat work surface, such as a table. Check the expiration date (EXP) on the carton. Do not use if the expiration date has passed. Check the carton for damage. Do not use if the carton looks damaged.
Let SAPHNELO prefilled syringe come to room temperature for 60 minutes before injecting. Keep SAPHNELO prefilled syringe in the original carton to protect from light. Do not warm SAPHNELO prefilled syringe in any other way. For example, do not warm it in a microwave, hot water, direct sunlight or near other heat sources.
Step 3 – Remove the prefilled syringe from the carton and inspect
Open the carton and remove SAPHNELO prefilled syringe by holding the middle of the syringe body. Do not hold or remove by the plunger.
Check the expiration date on the prefilled syringe. Do not use if the expiration date has passed.
Check the prefilled syringe for damage. Do not use if damaged.
Check the liquid through the viewing window. The liquid should be clear and colorless to slightly yellow. Do not use if the liquid is cloudy, discolored, or contains visible particles. It is normal to see small air bubbles in the liquid. Do not try to remove the air bubbles.
Injecting using your SAPHNELO prefilled syringe
Step 4 – Choose an injection site
You or your caregiver can inject in the front of your thigh or the lower part of your stomach (abdomen). A caregiver may also inject your upper arm. Do not try to inject yourself in the upper arm. Choose an injection site that is at least 1-inch (3 cm) away from where you last injected. Do not inject: into the 2-inch (5 cm) area around your belly button. where the skin is red, warm, tender, bruised, scaly or hard. into scarred, damaged, discolored or tattooed skin. through clothing.
Step 5 – Wash your hands and clean the injection site
Wash your hands well with soap and water. Clean the injection site with an alcohol wipe or with soap and water. Let the site air dry.
Do not touch the cleaned injection site again or blow on it before injecting.
Step 6 – Pull off the needle cover
Hold the SAPHNELO prefilled syringe body with 1 hand and carefully pull the needle cover straight off with your other hand. Do not twist or wiggle the needle cover to remove it. Do not touch or pull the plunger or plunger head while removing the needle cover. You may see a drop of liquid at the end of the needle. This is normal. Do not recap the needle. Put the needle cover to the side to throw it in the trash later. Do not touch the needle or let it touch any surface. Do not use if the needle is damaged or dirty. Go to Step 7 right away after removing the needle cover.
Step 7 – Injecting SAPHNELO
Hold SAPHNELO prefilled syringe in 1 hand as shown. Use your other hand to gently pinch and hold the cleaned injection site. Do not press down on the plunger head until the needle is inserted into the skin. Do not pull back on the plunger head at any time. Inject using the SAPHNELO prefilled syringe by following the steps in figures a, b, and c.

Using a 45 degree angle, fully insert the needle into the pinched skin. Do not reposition the SAPHNELO prefilled syringe after you insert the needle into the skin.	Use your thumb to push down the plunger head. To make sure you inject all the medicine and activate the needle guard, keep pushing firmly on the plunger head until it is fully down as far as it will go.	Slowly let go of the plunger head until the needle guard covers the needle. If the needle is not covered, carefully throw away (dispose of) the SAPHNELO prefilled syringe right away (see Step 9).
Step 8 – Check the injection site
There may be a small amount of blood or liquid at the injection site. This is normal. If needed, press a cotton ball or gauze on the area and apply a small bandage. Do not rub the injection site.
Step 9 – Throw away (dispose of) the used SAPHNELO prefilled syringe
Each prefilled syringe contains 1 single-dose of SAPHNELO and cannot be used again. Do not recap the needle. Put your used SAPHNELO prefilled syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) SAPHNELO prefilled syringe in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting puncture resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labelled to warn of hazardous waste inside the container. When your sharp disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185 US License No. 2059 Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 ©AstraZeneca 2026 SAPHNELO is a registered trademark of AstraZeneca. For more information, go to https://www.SAPHNELO.com or call 1-800-236-9933.
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: September 2026

INSTRUCTIONS FOR USE SAPHNELO® PEN (saf-NEL-low) (anifrolumab-fnia) injection, for subcutaneous use Single-dose Autoinjector 120 mg/0.8 mL
This Instructions for Use contains information on how to inject using SAPHNELO PEN. 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. Your healthcare provider should show you or your caregiver how to use SAPHNELO PEN the right way. If you or your caregiver have any questions, talk to your healthcare provider. SAPHNELO PEN is for use under the skin (subcutaneous) only.
Important storage information and warnings
Store SAPHNELO PEN in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If needed, SAPHNELO PEN can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days protected from light. After SAPHNELO PEN has reached room temperature, do not return to the refrigerator. Throw away SAPHNELO PEN if not used within 7 days at room temperature. Each SAPHNELO PEN contains 1 dose for one time use only. Do not share SAPHNELO PEN with other people.
Do not use SAPHNELO PEN if it has: been frozen or exposed to heat. been dropped, damaged, or appears to be tampered with. Do not shake SAPHNELO PEN. If any of the above happens, throw away SAPHNELO PEN in an FDA-cleared sharps disposal container and use a new SAPHNELO PEN.
Keep SAPHNELO PEN and all medicines out of the sight and reach of children.
SAPHNELO PEN parts
Do not remove the cap until right before injecting SAPHNELO. Do not touch the green needle guard.

Preparing to inject using SAPHNELO PEN
Step 1 – Gather supplies for your injection

See Step 10 for instructions on how to throw away (dispose of) the used SAPHNELO PEN.
Step 2 – Remove SAPHNELO PEN from the carton and wait 60 minutes
Select a clean, well-lit, flat work surface, such as a table. Check the expiration date (EXP) on the carton. Do not use if the expiration date has passed. Check the carton for damage. Do not use if the carton looks damaged. Open the carton and remove one SAPHNELO PEN by gently grasping the middle of the device. Store any remaining SAPHNELO PENS in the carton and return them to the refrigerator.
Let SAPHNELO PEN come to room temperature for 60 minutes before injecting. Do not warm SAPHNELO PEN in any other way. For example, do not warm it in a microwave, hot water, direct sunlight or near other heat sources.
Step 3 – Inspect SAPHNELO PEN
Check the expiration date on SAPHNELO PEN. Do not use if the expiration date has passed.
Check SAPHNELO PEN for damage. Do not use if damaged.
Check the liquid through the viewing window. The liquid should be clear and colorless to slightly yellow. Do not use if the liquid is cloudy, discolored, or contains visible particles. It is normal to see small air bubbles in the liquid. Do not try to remove the air bubbles.
Injecting using your SAPHNELO PEN
Step 4 – Choose an injection site
You or your caregiver can inject in the front of your thigh or the lower part of your stomach (abdomen). A caregiver may also inject you in your upper arm. Do not try to inject yourself in the upper arm. Choose an injection site that is at least 1-inch (3 cm) away from where you last injected. Do not inject: into the 2-inch (5 cm) area around your belly button. where the skin is red, warm, tender, bruised, scaly or hard. into scarred, damaged, discolored or tattooed skin. through clothing.
Step 5 – Wash your hands and clean the injection site
Wash your hands well with soap and water. Clean the injection site with an alcohol wipe or with soap and water. Let the site air dry.
Do not touch the cleaned injection site again or blow on it before injecting.
Step 6 – Pull off the cap
Do not remove the cap until you are ready to inject. Pull off the cap (protective sleeve inside). SAPHNELO PEN is now unlocked and ready to inject. Do not touch the green needle guard or the needle inside. Do not recap SAPHNELO PEN. This could cause the medicine to come out too soon or damage SAPHNELO PEN. Go to Step 7 right away after removing the cap.
Step 7 – Injecting SAPHNELO
Inject the medicine using SAPHNELO PEN by following the steps in figures a, b, c, and d. To deliver a full dose, press and hold SAPHNELO PEN for about 15 seconds until the green plunger fills the viewing window. You may hear a first ‘click’ at the start of the injection and a second ‘click’ at the end of the injection. Do not move or change the position of SAPHNELO PEN after the injection has started.
		Position SAPHNELO PEN. Place the green needle guard flat against the skin (90-degree angle). Make sure you can see the viewing window.

Press down firmly and hold against skin. You may hear the first click right away. This tells you the injection has started. The green plunger will move down in the viewing window.	Hold down firmly for about 15 seconds. The green plunger will fill the viewing window. You may hear the second click at the end of injection.		After you have completed your injection, lift SAPHNELO PEN straight up. The green needle guard will slide down and lock into place over the needle.
Step 8 – Check the viewing window
Check the viewing window to make sure all the medicine has been injected. If the green plunger does not fill the viewing window, you may not have received the full dose. If this happens or if you have any other concerns, contact your healthcare provider.

Step 9 – Check the injection site
There may be a small amount of blood or liquid at the injection site. This is normal. If needed, press a cotton ball or gauze on the area and apply a small bandage. Do not rub the injection site.
Step 10 – Throw away (dispose of) the used SAPHNELO PEN
Put your used SAPHNELO PEN in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) SAPHNELO PEN in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting puncture resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labelled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185 US License No. 2059 Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 ©AstraZeneca 2026 SAPHNELO is a registered trademark of AstraZeneca. For more information, go to https://www.SAPHNELO.com or call 1-800-236-9933.
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: September 2026