Elrexfio

What is Elrexfio?

Elrex Fio (elranatamab-bcmm) from Pfizer can be used for treating the condition known as multiple myeloma (MM), that is a blood cancer that targets plasma cells found in the bone marrow. Elrex Fio is prescribed to those who have had a relapse or have refractory myeloma (RRMM) and who have had at least four options of treatment, including a proteasome inhibitor, an immunomodulatory agent and anti-CD38 monoclonal antibodies.Elrex Fio is an antigen for B-cell maturation (BCMA)-specific antibody that targets CD3 (BsAb). Elrex Fio is administered by subcutaneous injections every week with two doses stepped up for 24 weeks, after which treatment is given every two weeks.Elrexfio was granted FDA approval on August 14, 2023. The FDA's approval was based on good results in the Phase 2 study MagnetisM-3 (NCT04649359), which demonstrated a positive objective rate of response (ORR) in the range of 57.7 percent.

Side effects of Elrexfio

Common Elrex Fio side effects

• Reduced white blood cells as well as red blood cells and platelets.
• Tiredness
• Reactions at the injection site reactions at the injection site, including itching, redness, swelling, bruising tenderness, and swelling
• Diarrhea
• Bone and muscle discomfort
• Diminished appetite
• Rash
• Cough
• Nausea
• The fever

Serious Elrex Fio side effects include:

infections. Upper respiratory tract infections and pneumonia are very common in the treatment of this medication. The medicine may cause infections caused by viruses and bacteria that are life-threatening and severe or could result in death.Your doctor might prescribe medications to prevent infections and also treat you in the event of an infection while receiving treatment.Inform your doctor immediately if you experience any symptoms or signs of infection during treatment with this medicine, such as the following:

• High fever of 100.4 degrees Fahrenheit (38 degrees Celsius) or greater
• Chills
• Cough
• Breathiness
• Chest pain
• Sore throat
• Pain during urination
• Being weak, or feeling generally weak.

Reduced white blood cell count. Decreased white blood cell counts are commonplace when you are treated with Elrex Fio, which may be serious. It can occur when there are low white blood cell counts. This could indicate that you are suffering from an infection. Your doctor will take care of you if needed.

Liver issues. This medicine can increase liver enzymes and the presence of bilirubin in the blood. This can occur regardless of whether you are diagnosed with Cytokine Release Syndrome (CRS). Inform your doctor in the event that you experience any of the following symptoms or signs of liver issues:

• Tiredness
• Loss of appetite
• Pain in your right upper stomach region (abdomen)
• Dark urine that is dark
• The skin's color is becoming yellow, or the white portion of your eyes.

Your doctor will examine your blood count and look for any signs or signs of serious side effects prior to you beginning treatment and throughout your treatments with Elrexfio. Your healthcare provider could temporarily or completely stop the treatment when you experience certain adverse symptoms.These aren't all the possible adverse effects that could result from this medication.Also see 'Warnings."Contact your doctor for advice from a medical professional regarding adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Elrexfio may cause serious side effects, including

Cytokine Release Disorder (CRS) CRS is a common occurrence during treatment with Elrexfio, but it could be serious and life-threatening and could result in death. Talk to your healthcare professional or seek medical attention whenever you experience any symptoms or signs of CRS. These include:

• A fever that is 100.4 degrees Fahrenheit (38 degrees Celsius) or more
• Trouble breathing
• Chills
• Lightheadedness or dizziness
• Fast heartbeat
• Headache
• Increased levels of liver enzymes that are present in the blood.

Check out 'Side Effects' for more information on the symptoms and signs of liver disorders.Due to the possibility of CRS, you'll be given Elrex Fio according to a "step-up dosing schedule" and must be admitted to the hospital for 48 hours following the first "step-up" dose and for 24 hours following taking the next "step-up" dose.In the step-up dosing schedule:

• For your first dose, you will be given a lower "step-up" dose of Eprex Rio on Day 1 of your treatment.
• For your second dose, you'll be given a bigger "step-up" dose of this medication. It is usually delivered on the fourth day of your treatment.
• For your third dose, you will be given the first complete "treatment" dose of Elrexfio normally on the 8th day of your treatment.
• If you experience a delay in your dose due to any reason, it is possible to repeat the step-up dosage program.
• Prior to each dose in the dosing step-up schedule You will be given medicine to reduce the CRS risk. Your doctor will determine whether you should receive medications to reduce the chance of contracting CRS by the next dose.

Neurologic issues. This medicine can cause neurologic disorders that can be life-threatening or serious. Talk to your doctor or seek medical assistance immediately if you notice any symptoms or signs of neurologic issues, such as:

• Headache
• Anxiety, insomnia, and confusion or disorientation: experiencing or hearing things that aren't real (hallucinations)
• Difficulty with speaking, thinking, recalling items, becoming attentive, or understanding what you read.
• Difficulties walking or standing, muscle weakness, shaking (tremors), difficulty walking, muscle spasms
• Numbness and tingling (feeling like "pins and needles")
• Burning, burning,
• Handwriting changes

Elrex Fio is only available via the Elrex Fio Risk Evaluation and Mitigation Strategies (REMS) because of the possibility of CRS and neurological problems. You will receive an Elrexfio Patient Wallet Card from your healthcare provider. Take your Elrex Fio Patient Wallet Card with you at all times and provide it to all your health care providers. This patient wallet card lists the symptoms of CRS and neurologic issues. Seek medical attention immediately in the event that you exhibit any of the symptoms mentioned within the wallet card. You might require treatment in a hospital.Your healthcare provider will watch your symptoms and signs of neurologic and CRS issues while you are receiving treatment with Elrexfio, along with other adverse effects, and will be able to treat you if necessary. Your doctor may temporarily or permanently end your treatment with Elrex Fio should you develop neurologic issues or other adverse side effects that are severe.

Before you take this drug

Inform your doctor about all medical conditions you suffer from, for example, if you:

• Have an infection.

Pregnancy

Contact your healthcare professional when you're pregnant or are planning to become pregnant. Elrexfio could harm the unborn baby.If you're able to be pregnant, your healthcare professional will require an examination for pregnancy before starting treatments with Elrex Fio. It is recommended to use an effective method of contraception (contraception) throughout treatment as well as for the four months following your last dose of this medication.

Breastfeeding

Inform your doctor whether you are nursing or planning to breastfeed. It is unclear whether Elexio is absorbed into breast milk. Don't breastfeed during treatment or for four months after the last dose of Eprex Fio.

How to take Elrexfio?

Elrexfio will be administered by your physician by injecting it underneath the skin (subcutaneous injection), generally within your stomach area (abdomen), your thigh, or any other region of your body.You begin Elrex Fio with the "step-up dosing schedule".The dose is given on the first day, Day 4, Day 5, and typically Day 8. Then, after that, you will typically be administered once a week until Week 24. After Week 25, the next doses will typically be repeated every 2 weeks.The hospitalization period will last for 48 hours following the first dose and for 24 hours following the second dose of Eprex Fio.The first dose of day 1 is a smaller "step-up" dose. Your second dose is normally delivered on Day 4 and is a more substantial "step-up" dose. For the third dose, which is usually administered on the 8th day of your treatment, you will be given the first fully "treatment" dose of this medication.

Details on dosage

Usual adult dose of Eprex Fio:

• Step-up dose 1 is 12 mg on Day 1, Step-up dose 2 is 32 mg on Day 4.
• First treatment dose: 76 mg on Day 8
• Then 76 mg a week thereafter, up to 24
• After 24 weeks, 76 mg twice a week.

Comments

• Dosing after 24 weeks of treatment should only be done if the patient has had a positive reaction (partial response or greater) and has maintained that response for a minimum of 2 months.
• Keep treatment going with Eltrexfio until the disease progresses or toxicity is unacceptable.
• Take pre-treatment medicines prior to every dose in the Eltrexfio step-up dose schedule that includes step-up dose 1, step-up dose 2, and the initial treatment dose, as directed by the doctor.

Elrex Fios is available.

• 76 mg/1.9 mL (40 mg/mL) single-dose vial.
• 44 mg/1.1 mL (40 mg/mL) single-dose vial

What happens if I miss the dose?

If you are unable to attend any appointments, contact your healthcare provider immediately to make a new appointment. It is crucial that you are monitored closely for any side effects that may occur when you are taking Elrex Fio.

What happens if I overdose?

Elrex Fio is an antibody with specificity that functions in a similar way to binding on the surfaces of myeloma cancer cells. It also adheres to the surface of cancerous cells. which activates T-cells to kill myeloma cells.Elrex Fio is a B-cell receptor agonist. maturation antigen skin (BCMA) of myeloma cells. It is able to bind to the receptor CD3 on T cells.

What should be avoided?

Avoid operating machines that are heavy or possibly dangerous, or engage in other risky actions while you are receiving your treatment, Elrexfio.

• For a period of 48 hours following completion of each dose that forms part of your "step-up dosing schedule" and your first dose of full treatment in the following 48 hours.
• Anytime during treatment with elrex fio in the event that you experience new neurologic symptoms, such as dizziness and confusion, shakes (tremors), sleepiness, or any other sign that affects your consciousness, and you wait until the symptoms disappear.

Interaction with other drug

Talk to your healthcare professional about every medication you are taking, such as prescription and over-the-counter medications such as vitamins and herbal supplements.