Pronunciation:

el-ra-NAT-a-mab - bcmm

Brand Names:

• Elrexfio

Dosage Forms:

• Solution

Warnings:

Warning: Cytokine Release Syndrome and Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving elranatamab-bcmm. Initiate treatment with elranatamab-bcmm step-up dosing schedule to reduce the risk of CRS. Withhold elranatamab-bcmm until CRS resolves or permanently discontinue based on severity.Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving elranatamab-bcmm. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold elranatamab-bcmm until the neurologic toxicity resolves or permanently discontinue based on severity.Because of the risk of CRS and neurologic toxicity, including ICANS, elranatamab-bcmm is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Elranatamab

Uses of This Medicine:

Elranatamab-bcmm injection is used to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma in patients who have received at least 4 previous treatments. These previous treatments include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This medicine is available only under a restricted distribution program called Elrexfioi™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of elranatamab-bcmm injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elranatamab-bcmm injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver problems or
• Serious infections—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as a shot under your skin, usually in the stomach or thigh.

It is very important that you understand the requirements of the Elrexfio™ REMS program, and become familiar with the Elrexfio™ medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

You will receive this medicine on a "step-up dosing schedule" on Days 1 and 4, followed by the first treatment dose on Day 8. After you receive your first treatment dose, this medicine is usually given once a week through Week 24. Starting at Week 25, your dose is usually given once every 2 weeks. Your doctor will ask you to stay for 24 to 48 hours after receiving the step-up doses.

You may also receive other medicines (eg, allergy medicine, fever medicine, steroid) 1 hour before receiving this medicine to help prevent unwanted reactions to the injection.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

Ask your doctor for a patient wallet card. This card will list the symptoms of cytokine release syndrome and nervous system problems. Carry the card with you at all times during treatment. You will need to show the card to any doctor who treats you.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious liver problems. Check with your doctor right away if you have clay colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause dizziness, confusion, sleepiness, or tremors. Do not drive or do anything else that could be dangerous during and for 48 hours after receiving this medicine until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

back pain

being forgetful

bladder pain

bleeding gums

bloody or cloudy urine

blurred or double vision

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain, discomfort, or tightness

coma

confusion

confusion as to time, place, or person

cough

coughing up blood

diarrhea

difficult, burning, or painful urination

dizziness

drowsiness

ear congestion

fainting

fast heartbeat

fever or chills

frequent urge to urinate

hallucinations

headache

holding false beliefs that cannot be changed by fact

increased menstrual flow or vaginal bleeding

irritability

lightheadedness

loss of taste or smell

loss of voice

lower back or side pain

mental depression or anxiety

mood or mental changes

muscle or bone pain

nightmares or unusually vivid dreams

nosebleeds

paralysis

pounding or rapid pulse

prolonged bleeding from cuts

rapid or irregular heartbeat

red or black, tarry stools

red or dark brown urine

seizures

shakiness and unsteady walk

sleepiness or unusual drowsiness

sneezing

sore throat

stiff neck

stuffy or runny nose

swelling

trembling and shaking of the hands

trouble breathing

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, or restlessness

vomiting

Less common

Decreased urine output

hostility

muscle twitching

nausea

pale skin

rapid weight gain

stupor

swelling of the face, ankles, or hands

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

Rare

Cool, sweaty skin

inability to move the arms and legs

sudden numbness and weakness in the arms and legs

Incidence not known

Dark urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

loss of appetite

stomach pain, severe

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

constipation

dry skin

fall

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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