Elranatamab

What it is used for

ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response.

Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

The most important thing to know

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 “

Side effects, and when to stop

” 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 step-up dose and the first full treatment dose of ELREXFIO, 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

What to avoid

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.

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: 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 blood 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.