ELREXFIO Medication Guide

(elranatamab-bcmm)

Medication Guide

MEDICATION GUIDE

ELREXFIOTM (el-reks-fe-o)

(elranatamab-bcmm)
injection, for subcutaneous use

What is the most important information I should know about ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
Cytokine Release Syndrome (CRS). CRS is common during treatment with ELREXFIO and can also be serious, life-threatening, or can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:
o
fever of 100.4 °F (38 °C) or higher
o
trouble breathing
o
chills
o
dizziness or light-headedness
o
fast heartbeat
o
headache
o
increased liver enzymes in your blood. See “What are the possible side effects of ELREXFIO?” for more information about the signs and symptoms of liver problems.
 
Due to the risk of CRS, you will receive ELREXFIO on a “step-up dosing schedule” and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.
o
During the step-up dosing schedule:
▪
for your first dose, you will receive a smaller “step-up” dose of ELREXFIO on Day 1 of your treatment
▪
for your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on Day 4 of your treatment
▪
for your third dose, you will receive the first full “treatment” dose of ELREXFIO, which is usually given on Day 8 of your treatment
o
If your dose of ELREXFIO is delayed for any reason, you may need to repeat the step-up dosing schedule.
o
Before each dose of ELREXFIO you receive during the step-up dosing schedule, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
o
See “How will I receive ELREXFIO?” for more information about how you will receive ELREXFIO.
•
Neurologic problems. ELREXFIO can cause neurologic problems that can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including:
o
headache
o
agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations)
o
trouble speaking, thinking, remembering things, paying attention, or understanding things
o
problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
o
numbness and tingling (feeling like “pins and needles”)
o
burning, throbbing, or stabbing pain
o
changes in your handwriting
•
ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other side effects that are severe.

If you have any questions about ELREXFIO, ask your healthcare provider.

See “What are possible side effects of ELREXFIO?” for more information about side effects.

What is ELREXFIO?

ELREXFIO is a prescription medicine used to treat adults with multiple myeloma who:

•
have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
•
their cancer has come back or did not respond to prior treatment.

It is not known if ELREXFIO is safe and effective in children.

Before receiving ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

•
have an infection.
•
are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start treatment with ELREXFIO.
o
You should use effective birth control (contraception) during treatment and for 4 months after your last dose of ELREXFIO.
o
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO.
•
are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ELREXFIO.

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 ELREXFIO?

•
ELREXFIO will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen). Your thigh or another area of your body may also be used.
•
See “What is the most important information I should know about ELREXFIO?” for more information about how you will receive ELREXFIO.
•
After you receive your first full “treatment” dose, ELREXFIO is usually given 1 time each week through Week 24.
•
Starting on Week 25, your future doses will usually be given 1 time every 2 weeks.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with ELREXFIO.

What should I avoid while receiving ELREXFIO?

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

•
for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and
•
at any time during treatment with ELREXFIO if you develop any new neurologic symptoms such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away.

See “What is the most important information I should know about ELREXFIO?” for more information about signs and symptoms of neurologic problems.

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
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 ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


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

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 ELREXFIO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for more information about ELREXFIO that is written for health professionals.

What are the ingredients in ELREXFIO?

Active ingredient: elranatamab-bcmm

Inactive ingredients: edetate disodium, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection

Manufactured by: Pfizer Inc., NY, NY 10001

US License No. 2001

Logo

LAB-1551-1.0

For more information on ELREXFIO, go to www.ELREXFIO.com

For more information on Pfizer, go to www.Pfizer.com or call 1-800-438-1985

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: August 2023

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Cytokine Release Syndrome (CRS)

Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, tachycardia, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].

Neurologic Toxicity, Including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, encephalopathy, motor dysfunction, sensory neuropathy, and Guillain-Barré Syndrome. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurological toxicity symptoms until symptoms resolve [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].

ELREXFIO REMS

ELREXFIO is available only through a restricted program called ELREXFIO REMS. Inform patients that they will be given an ELREXFIO Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3)].

Infections

Discuss the signs and symptoms of infection [see Dosage and Administration (2.5), Warnings and Precautions (5.4)].

Neutropenia

Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5), Warnings and Precautions (5.5)].

Hepatotoxicity

Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with ELREXFIO and for 4 months after the last dose [see Use in Specific Populations (8.2)].

Manufactured by:
Pfizer Inc.
NY, NY 10001
US License No. 2001
Logo
LAB-1518-1.0

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Find ELREXFIO medical information:

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Health Professional Information

Medication Guide

Medication Guide

MEDICATION GUIDE

ELREXFIOTM (el-reks-fe-o)

(elranatamab-bcmm)
injection, for subcutaneous use

What is the most important information I should know about ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
Cytokine Release Syndrome (CRS). CRS is common during treatment with ELREXFIO and can also be serious, life-threatening, or can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:
o
fever of 100.4 °F (38 °C) or higher
o
trouble breathing
o
chills
o
dizziness or light-headedness
o
fast heartbeat
o
headache
o
increased liver enzymes in your blood. See “What are the possible side effects of ELREXFIO?” for more information about the signs and symptoms of liver problems.
 
Due to the risk of CRS, you will receive ELREXFIO on a “step-up dosing schedule” and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.
o
During the step-up dosing schedule:
▪
for your first dose, you will receive a smaller “step-up” dose of ELREXFIO on Day 1 of your treatment
▪
for your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on Day 4 of your treatment
▪
for your third dose, you will receive the first full “treatment” dose of ELREXFIO, which is usually given on Day 8 of your treatment
o
If your dose of ELREXFIO is delayed for any reason, you may need to repeat the step-up dosing schedule.
o
Before each dose of ELREXFIO you receive during the step-up dosing schedule, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
o
See “How will I receive ELREXFIO?” for more information about how you will receive ELREXFIO.
•
Neurologic problems. ELREXFIO can cause neurologic problems that can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including:
o
headache
o
agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations)
o
trouble speaking, thinking, remembering things, paying attention, or understanding things
o
problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
o
numbness and tingling (feeling like “pins and needles”)
o
burning, throbbing, or stabbing pain
o
changes in your handwriting
•
ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other side effects that are severe.

If you have any questions about ELREXFIO, ask your healthcare provider.

See “What are possible side effects of ELREXFIO?” for more information about side effects.

What is ELREXFIO?

ELREXFIO is a prescription medicine used to treat adults with multiple myeloma who:

•
have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
•
their cancer has come back or did not respond to prior treatment.

It is not known if ELREXFIO is safe and effective in children.

Before receiving ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

•
have an infection.
•
are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start treatment with ELREXFIO.
o
You should use effective birth control (contraception) during treatment and for 4 months after your last dose of ELREXFIO.
o
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO.
•
are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ELREXFIO.

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 ELREXFIO?

•
ELREXFIO will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen). Your thigh or another area of your body may also be used.
•
See “What is the most important information I should know about ELREXFIO?” for more information about how you will receive ELREXFIO.
•
After you receive your first full “treatment” dose, ELREXFIO is usually given 1 time each week through Week 24.
•
Starting on Week 25, your future doses will usually be given 1 time every 2 weeks.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with ELREXFIO.

What should I avoid while receiving ELREXFIO?

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

•
for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and
•
at any time during treatment with ELREXFIO if you develop any new neurologic symptoms such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away.

See “What is the most important information I should know about ELREXFIO?” for more information about signs and symptoms of neurologic problems.

What are the possible side effects of ELREXFIO?

ELREXFIO may cause serious side effects, including:

•
See “What is the most important information I should know about ELREXFIO?”
•
Infections. Upper respiratory tract infections and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
o
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 ELREXFIO.
o
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
▪
fever of 100.4 °F (38 °C) or higher
▪
chills
▪
cough
▪
shortness of breath
▪
chest pain
▪
sore throat
▪
pain during urination
▪
feeling weak or generally unwell
•
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. Fever can happen with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
•
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
o
tiredness
o
loss of appetite
o
pain in your right upper stomach-area (abdomen)
o
dark urine
o
yellowing of your skin or the white part of your eyes

Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

•
tiredness
•
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, tenderness
•
diarrhea
•
muscle and bone pain
•
decreased appetite
•
rash
•
cough
•
nausea
•
fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.


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

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 ELREXFIO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for more information about ELREXFIO that is written for health professionals.

What are the ingredients in ELREXFIO?

Active ingredient: elranatamab-bcmm

Inactive ingredients: edetate disodium, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection

Manufactured by: Pfizer Inc., NY, NY 10001

US License No. 2001

Logo

LAB-1551-1.0

For more information on ELREXFIO, go to www.ELREXFIO.com

For more information on Pfizer, go to www.Pfizer.com or call 1-800-438-1985

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: August 2023

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Cytokine Release Syndrome (CRS)

Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, tachycardia, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].

Neurologic Toxicity, Including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, encephalopathy, motor dysfunction, sensory neuropathy, and Guillain-Barré Syndrome. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurological toxicity symptoms until symptoms resolve [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].

ELREXFIO REMS

ELREXFIO is available only through a restricted program called ELREXFIO REMS. Inform patients that they will be given an ELREXFIO Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3)].

Infections

Discuss the signs and symptoms of infection [see Dosage and Administration (2.5), Warnings and Precautions (5.4)].

Neutropenia

Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5), Warnings and Precautions (5.5)].

Hepatotoxicity

Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with ELREXFIO and for 4 months after the last dose [see Use in Specific Populations (8.2)].

Manufactured by:
Pfizer Inc.
NY, NY 10001
US License No. 2001
Logo
LAB-1518-1.0
Medication Guide

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