Elranatamab-bcmm (Subcutaneous)

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 through a special distribution program called Elrexfioi™ REMS (Risk Evaluation and Mitigation Strategy) Program.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working correctly. Blood tests are necessary 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 conduct tests to confirm you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy during treatment and for 4 months after the last dose. If you think you may be pregnant while using this medicine, inform your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system issues, including immune effector cell-associated neurotoxicity syndrome (ICANS). These can be life-threatening and need immediate attention. Tell your doctor right away if you experience agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, restlessness, 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 issues. 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. Contact 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 reduces 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 issues, avoid close contact with people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or situations where you could get 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. Contact 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 it affects you.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not been done to understand how elranatamab-bcmm injection affects children. Safety and effectiveness have not been established in this age group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of elranatamab-bcmm injection.

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Check with your doctor or nurse right away 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 about 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
• severe stomach pain
• yellow eyes or skin

Some side effects may happen 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, 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.

In the U.S.

• Elrexfio

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Elranatamab

Find detailed information on biosimilars for this medication.

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.