Patient information: uses, side effects, how to take - Sarclisa Escena

What is SARCLISA ESCENA?

SARCLISA ESCENA is a prescription medicine used in combination with:

the medicines pomalidomide and dexamethasone, to treat adults who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
the medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment, and they did not work or are no longer working.
the medicines bortezomib, lenalidomide, and dexamethasone, to treat adults with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).

It is not known if SARCLISA ESCENA is safe and effective in children.

Do not receiveSARCLISA ESCENA if you have a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA ESCENA. See the end of this leaflet for complete list of ingredients in SARCLISA ESCENA.

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

have an infection.
have heart problems, if your healthcare provider prescribes SARCLISA ESCENA in combination with carfilzomib and dexamethasone for you.
have had shingles (herpes zoster).
are pregnant or plan to become pregnant. SARCLISA ESCENA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will check for pregnancy before you start treatment with SARCLISA ESCENA.
- Use an effective birth control (contraception) during treatment and for 7 months after your last dose of SARCLISA ESCENA. Talk to your healthcare provider about birth control methods that you can use during this time.
- Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA ESCENA.
Females and Males:Before receiving SARCLISA ESCENA in combination with either pomalidomide or lenalidomide, females and males must agree to the instructions in the pomalidomide or lenalidomide REMS programs. The pomalidomide and lenalidomide REMS programs have specific requirements about birth control, pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about pomalidomide or lenalidomide.
are breastfeeding or plan to breastfeed. It is not known if SARCLISA ESCENA passes into your breast milk. Do not breastfeed during treatment with SARCLISA ESCENA and for 7 months after your last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA ESCENA?

SARCLISA ESCENA will be given to you by your healthcare provider as an injection under the skin (subcutaneous injection), in the stomach area (abdomen). Your healthcare provider will either use the CirCLIQ™ On-Body Injector or a syringe to inject SARCLISA ESCENA. The injection time is usually 20 minutes with CirCLIQ and over about 6 minutes with a syringe. Your healthcare provider will rotate the injection site for each injection, including for other medicines.
SARCLISA ESCENA in combination with pomalidomide and dexamethasone, or SARCLISA ESCENA in combination with carfilzomib and dexamethasoneis given in treatment cycles of 28 days (4 weeks).
- Cycle 1 (28-day cycle), SARCLISA ESCENA is given weekly.
- Cycle 2 and beyond (28-day cycles), SARCLISA ESCENA is given every 2 weeks.
SARCLISA ESCENA in combination with bortezomib, lenalidomide, and dexamethasoneis given in treatment cycles of 28 days (4 weeks).
- Cycle 1 (28-day cycle), SARCLISA ESCENA is given weekly.
- Cycle 2 to 12 (28-day cycles), SARCLISA ESCENA is given every 2 weeks.
- Cycle 13 and beyond, SARCLISA ESCENA is given every 4 weeks.
Your healthcare provider will decide how many treatments you will receive.
Your healthcare provider will give you medicines before each injection of SARCLISA ESCENA, to help reduce the risk and severity of allergic reactions, for at least Cycle 1 of treatment.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of SARCLISA ESCENA?

SARCLISA ESCENA can cause serious side effects including:

Allergic reactions. SARCLISA ESCENA can cause severe or life-threatening allergic reactions throughout the body (systemic administration reactions). Your healthcare provider may stop your injection and not complete it or completely stop treatment with SARCLISA ESCENA if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you develop any of the following signs and symptoms of an allergic reaction including:

shortness of breath, wheezing or trouble breathing
swelling of the face, mouth, throat or tongue
throat tightness
heart beating faster than usual
dizziness

lightheadedness or fainting
headache
cough
skin rash or itching
nausea
runny or stuffy nose
chills

Injection site reactionscan happen at or near the SARCLISA ESCENA injection site. Symptoms of these local skin reactions include redness, swelling, and pain. Tell your healthcare provider if you develop injection site reactions during treatment with SARCLISA ESCENA.
Decreased white blood cell counts.Decreased white blood cell counts are common and can be severe during treatment with SARCLISA ESCENA. If fever occurs, this may be a sign that you have an infection. Your healthcare provider will check your blood cell counts during treatment with SARCLISA ESCENA and may prescribe medicine to help increase your white blood cell counts. Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA ESCENA.
Infections.SARCLISA ESCENA can cause infections that are severe, life-threatening, or that can lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with SARCLISA ESCENA. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with SARCLISA ESCENA. Tell your healthcare provider right away if you develop a fever or any signs or symptoms of infection during treatment with SARCLISA ESCENA.
Risk of new cancers.New cancers have happened in people during treatment with SARCLISA ESCENA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA ESCENA.
Changes in blood tests.SARCLISA ESCENA may affect the results of blood tests to match your blood type for at least 6 months after your last injection of SARCLISA ESCENA. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA ESCENA. Tell all of your healthcare providers that you are being treated with SARCLISA ESCENA before receiving blood transfusions.

The most common side effects of SARCLISA ESCENA in combination with pomalidomide and dexamethasone include:

upper respiratory tract infection
lung infection (pneumonia)
tiredness
muscle and joint pain
diarrhea

trouble sleeping
COVID-19
constipation
swelling of the hands, legs, ankles, and feet

The most common side effects of SARCLISA ESCENA in combination with carfilzomib and dexamethasone include:

upper respiratory tract infection
muscle and joint pain
lung infection (pneumonia)
high blood pressure

COVID-19
trouble sleeping
diarrhea
fever

The most common side effects of SARCLISA ESCENA in combination with bortezomib, lenalidomide and dexamethasone include:

tingling or numbness of the arms or legs
constipation
diarrhea
tiredness
muscle and joint pain
upper respiratory tract infection
reaction at the injection site
trouble sleeping
nausea and vomiting
skin rash
skin redness
swelling throughout the body (edema)

COVID-19
back pain
low blood pressure
lung infection (pneumonia)
bronchitis
muscle spasm
weight decreased
flu
urinary tract infection
fever
stomach (abdomen) pain

The most common abnormal blood tests results during treatment with SARCLISA ESCENA combination therapies include:

decreased white blood cell counts

decreased red blood cell counts

decreased platelet counts

Heart failurecan happen during treatment with SARCLISA ESCENA in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:

trouble breathing

cough

swelling of your ankles, feet, and legs

These are not all of the possible side effects of SARCLISA ESCENA.

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

General information about the safe and effective use of SARCLISA ESCENA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about SARCLISA ESCENA that is written for health professionals.

What are the ingredients in SARCLISA ESCENA?

Active ingredient:isatuximab-irfc

Inactive ingredients:arginine hydrochloride, histidine, histidine hydrochloride monohydrate, poloxamer 188, sucrose, and water for injection.

Manufactured by: sanofi-aventis U.S. LLC, Morristown, NJ 07960, A SANOFI COMPANY. U.S. License No. 1752.

For more information, go to www.sanofi-aventis.us or call 1-800-633-1610.

Healthcare Provider

INSTRUCTIONS FOR USE

CirCLIQ™ On-Body Delivery System

for use with SARCLISA ESCENA™

[sar-cli-sa es-SEEN-ah]

(isatuximab-irfc)

injection, for subcutaneous use

Single-use CirCLIQ™ On-Body Delivery System

Rx only

This Instructions for Use contains information on how to use the CirCLIQ On-Body Delivery System to inject SARCLISA ESCENA.

Read this Instructions for Use carefully before using the SARCLISA ESCENA vial and CirCLIQ On-Body Delivery System (OBDS).

Important Information You Need to Know Before Injecting SARCLISA ESCENA.

See United States Prescribing Information (USPI) for information on SARCLISA ESCENA.
The CirCLIQ OBDS contains one 10 mL single-use On-Body Injector and one Filling Base. Device must be filled prior to use.
The CirCLIQ OBDS is intended for abdominal subcutaneous injection of SARCLISA ESCENA single dose by a healthcare provider in adult patients.
SARCLISA ESCENA is indicated for the treatment of adult patients with multiple myeloma. The SARCLISA ESCENA vial is not included in the CirCLIQ OBDS packaging.
For abdominal subcutaneous injection only. Administer directly into fatty layer under skin.
Only use the CirCLIQ OBDS with SARCLISA ESCENA. The CirCLIQ OBDS should not be used with any other medicines.
Do notuse the CirCLIQ OBDS if the expiration date has passed or its packaging was previously opened.
Do notuse the CirCLIQ OBDS components if they have been dropped on a hard surface because they could be damaged. Start again with a new CirCLIQ OBDS.

Do notuse the CirCLIQ OBDS if the wearer has an acrylic allergy. The CirCLIQ On-Body Injector adhesive contains acrylic.

Use the CirCLIQ On-Body Injector as soon as possible after filling it with SARCLISA ESCENA.

The injection should be completed within 4 hours once the vial is punctured.

Do notattempt to reapply CirCLIQ On-Body Injector once attached to the abdomen.

Storing CirCLIQ OBDS

Keep CirCLIQ OBDS away from children of 3 years and younger. Contains small parts.

Store and transport CirCLIQ OBDS in its unopened plastic packaging inside of the original carton.
Store CirCLIQ OBDS in a clean, dry area away from heat and sunlight at 36°F to 86°F (2°C to 30°C).
Use CirCLIQ OBDS where the temperature is 64°F to 82°F (18°C to 28°C).

Storing SARCLISA ESCENA vial

Store SARCLISA ESCENA vial in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until 20 minutes prior to use. Do notfreeze. Do notshake.
Unpunctured vials may be stored at ambient temperature 64°F to 82°F (18°C to 28°C) for a single period of up to 24 hours. Once the vial has been taken out of the refrigerator, it must not be returned to the refrigerator.

Parts of the CirCLIQ OBDS (Filling Base and Wearable On-Body Injector) and SARCLISA ESCENA vial:

For single use only

Vial(not included in OBDS packaging)

See SARCLISA ESCENA USPI for information on SARCLISA ESCENA.

Part 1 – Getting ready to inject SARCLISA ESCENA (vial packaged separately from OBDS)

1 Get and inspect vial and CirCLIQ OBDS

a) Take SARCLISA ESCENA vial out of the refrigerator.

Do notshake SARCLISA ESCENA vial.

b) Allow the vial and OBDS to come to ambient temperature 64°F to 82°F (18°C to 28°C) for 20 minutes prior to use.
c) Check SARCLISA ESCENA vial label to make sure it is the correct medication. The label should say : "SARCLISA ESCENA for subcutaneous use". Vial cap should be green.

Do notuse SARCLISA ESCENA vial if the expiration date has passed.
The medicine in SARCLISA ESCENA vial should be clear to slightly opalescent, colorless to slightly yellow. The solution may contain a few translucent to white particles.

d) Check CirCLIQ OBDS.

Do notuse CirCLIQ OBDS if the expiration date has passed or its packaging was previously opened.

2 Gather supplies

Place the following on a flat clean surface:
Vial filled with 1,400 mg dose of SARCLISA ESCENA (packaged separately)
CirCLIQ OBDS in packaging
Two alcohol wipes (not included in carton)
Single-use gloves (not included in carton)
FDA-cleared sharps container (not included in carton)
Medical disposal container (not included in carton)

Part 2 – Fill CirCLIQ On-Body Injector

Remove cap and clean SARCLISA ESCENA vial
- Remove green cap from SARCLISA ESCENA vial.
- Wipe rubber at the top of SARCLISA ESCENA vial with an alcohol wipe and allow to air dry.

Unpack CirCLIQ OBDS
- Peel away white seal from package.

Do notuse if sealed plastic packaging was already opened or damaged because CirCLIQ OBDS may be contaminated. Use a new one.
- Remove CirCLIQ OBDS from plastic packaging and place on a clean, flat surface.

Do notremove the On-Body Injector from Filling Base.
Do notremove the Gray Retainer Strap.
- Discard plastic packaging.

Fill CirCLIQ On-Body Injector
- Confirm again the cap is removed from the SARCLISA ESCENA vial.
- Place SARCLISA ESCENA vial top-first into Green Vial Port on the Filling Base.

The injection should be completed within 4 hours once the vial is punctured.

Firmly push SARCLISA ESCENA vial down until a burst of bubbles quickly forms. This means filling has started.

Leave on flat surface until filling is complete.
Do notlift or tilt device while it is filling.
Note: The Red Fill Gauge will move as the device fills. Filling may take up to 2 minutes.
Gray Retainer Strap will automatically open when SARCLISA ESCENA vial is empty.

Part 3 – Preparing the injection site

Clean the injection site on abdomen
- 1. a) Choose a flat injection site on bare skin around abdomen.
- Avoid injecting within 2 inches (5 cm) around the belly button or in folded skin.

Note:The injection site should be changed (rotated) at least 1 inch (2.5 cm) from previous injection site - with every injection to avoid accumulation of fatty tissue.
- Clean injection site with an alcohol wipe. Then allow the skin to completely air dry; this should take about 30 seconds.
- Do notapply the On-Body Injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the On-Body Injector.
- Do notinject into areas where the skin is injured, tender, red, hot, has scars, or is excessively hairy. If hair on injection site might prevent secure adhesive attachment, carefully trim hair to clear a patch of skin large enough for the On-Body Injector.

Continue to Part 4

Flip over these instructions for use.

If you have read and followed all of the instructions for use on this side, proceed to:

Part 4 "Preparing to inject SARCLISA ESCENAon the back side of this page.

Confirm Parts 1 to 3 are completed.

Flip over for Parts 1 to 3.

Get to know the CirCLIQ On-Body Injector

Underside of CirCLIQ On-Body Injector

Part 4 – Preparing to inject SARCLISA ESCENA

Remove the CirCLIQ On-Body Injector from Filling Base
- Confirm the Gray Retainer Strap has opened on its own and has risen away from Filling Base.
- Do notuse force to open the Gray Retainer Strap.
- Hold the sides of the On-Body Injector and pull it straight up from the Filling Base to expose the White Sticky Adhesive underneath.
- Do nottouch the White Sticky Adhesive. The Needle is inside the center.
- Do notremove Red Safety Tab until the On-Body Injector is attached to body and you are ready to inject. The Red Safety Tab prevents accidental Needle sticks.
- Note:The Clear Liner will remain attached to Filling Base.

Apply the CirCLIQ On-Body Injector to abdomen (injection site)
Position the On-Body Injector where you can see the Fill Window. This allows a clear view of the Red Fill Gauge as it moves.
Do notmove the On-Body Injector once attached to the abdomen.
Note:The On-Body Injector will continue to work properly no matter which way the Fill Window is facing.
Once on the skin, press the On-Body Injector firmly onto injection site to attach adhesive to abdomen.
Do notremove the Red Safety Tab until ready to inject. The Red Safety Tab prevents the start of the injection.

Part 5 – Injecting SARCLISA ESCENA

Remove Red Safety Tab and inject
- Hold the On-Body Injector with one hand. Use the other hand to pull the Red Safety Tab off to the side.

Note:The injection cannot start until the Red Safety Tab is removed.

Push Button in firmly.

The Button will stay in place when you let go.
The Button pushes the Needle into the skin. This starts the injection.

Do notbump or knock On-Body Injector or Button during the injection.

Keep injection site dry during injection.

The patient should notsleep or bathe during injection.

Wait for injection to finish
- Leave the On-Body Injector on body until the Button pops out.

After a 1 to 2 minute delay, the Red Fill Gauge will begin to move toward the other end of the Fill Window.

Do notremove the On-Body Injector before the Button pops out. The Needle may be exposed. Sticking yourself with an exposed Needle may result in infection.

Check the Button to see if it has popped out. This means the injection is complete.

Note:The injection could take up to 20 minutes. If the Button has not popped out after 20 minutes, allow the injection to complete (wait for the Button to pop out up to 60 minutes, if not, refer to FAQ).

Part 6 – Removing and disposing of the CirCLIQ On-Body Injector and Filling Base

Remove the CirCLIQ On-Body Injector
- 1. a) Confirm again that the Button on the On-Body Injector has popped out. This means the Needle has retracted and is locked inside the On-Body Injector.
- 1. b) Slowly peel off the On-Body Injector with the Adhesive Tab.
  - Lift the Adhesive Tab.
  - Hold the Adhesive Tab against the On-Body Injector and slowly peel away from skin.
Dispose of the CirCLIQ On-Body Injector and Filling Base
- 1. a) Put the On-Body Injector in an FDA-cleared sharps disposal container. The On-Body Injector is a single-use device.
- 1. b) Dispose the Filling Base with attached SARCLISA ESCENA vial in an approved medical disposal container in accordance with local guidelines.

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 labeled 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.

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.

FAQ

How long should delivery take after the Button is pressed?

The injection typically takes up to 20 minutes but may be slower based on local absorption of medication. If the Button has not popped out after 60 minutes, slowly remove the On-Body Injector from skin. Do not touch the Needle or any medicine that may be on the Injector. Call Sanofi at 1-800-633-1610 for help or assistance.

Can the injection be paused if necessary?

Yes, holding down the Button will stop the flow of medicine. Delivery will resume when the Button is released.

What activities can the patient perform during injection?

The patient may move around and perform light or non-strenuous routine activities during injection. Refer also to Part 5 – Injecting SARCLISA ESCENA.

What if the On-Body Injector falls off?

If the On-Body Injector falls off the body, pick it up carefully. Do nottouch the Needle or any medicine that may be on the On-Body Injector. Put the On-Body Injector in an FDA-cleared sharps disposal container. Call Sanofi at 1-800-633-1610 for help or assistance.

Have Questions?

If you have questions, concerns, or are in need of assistance, please call Sanofi: 1-800-633-1610.

The CirCLIQ OBDS is not made with natural rubber latex.

Manufactured for:

sanofi-aventis U.S. LLC

Morristown, NJ 07960 USA

A SANOFI COMPANY

Manufactured by:

Enable Injections

2863 E. Sharon Road

Cincinnati, OH 45241 USA

Manufactured in the USA

Issued: 07 2026

Patent:

Enableinjections.com/patent

Sarclisa Escena (Isatuximab): Uses, Side Effects and Dosage