Efbemalenograstim alfa-vuxw Injection

WHY is this medicine prescribed?

Efbemalenograstim alfa-vuxw injection is used to decrease the chance of infection in people who have nonmyeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Efbemalenograstim alfa-vuxw is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Efbemalenograstim alfa-vuxw comes as a solution (liquid) to be injected subcutaneously (under the skin) by a healthcare provider. It is usually given as a single dose for each chemotherapy cycle, no sooner than 24 hours after the last dose of chemotherapy of the cycle is given and more than 14 days before beginning the next chemotherapy cycle.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving efbemalenograstim alfa-vuxw injection,

• tell your doctor and pharmacist if you are allergic to efbemalenograstim alfa-vuxw, filgrastim (Granix, Neupogen, Nivestym, Releuko, Zarxio), pegfilgrastim (Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo), any other medications, latex, or any of the ingredients in efbemalenograstim alfa-vuxw injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had anemia (a lower than normal number of red blood cells), a low platelet (a type of blood cell) count, or kidney problems.

• tell your doctor if you have sickle cell disease (a blood disease that may cause painful crises, a low number of red blood cells, infection, and damage to the internal organs). If you have sickle cell disease, you may be more likely to have a crisis during your treatment with efbemalenograstim alfa-vuxw injection. Call your doctor right away if you have a sickle cell crisis during your treatment.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving efbemalenograstim alfa-vuxw injection, call your doctor.

• you should know that efbemalenograstim alfa-vuxw injection decrease the risk of infection but does not prevent all infections that may develop during or after chemotherapy. Call your doctor if you develop signs of infection such as fever; chills; rash; sore throat; diarrhea; or redness, swelling, or pain around a cut or sore.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive efbemalenograstim alfa-vuxw injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Efbemalenograstim alfa-vuxw injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• pain in the left upper part of the stomach or the tip of your left shoulder
• fever, shortness of breath, trouble breathing, or fast breathing
• rash; hives; itching; swelling of the face, eyes, or mouth; wheezing; shortness of breath; dizziness; or rapid heartbeat
• swelling of your face or ankles, bloody or dark colored urine, decreased urination
• unusual bleeding or bruising, fever, or tiredness
• fever, abdominal pain, back pain, feeling unwell
• swelling of stomach area or other swelling, decreased urination, trouble breathing, dizziness, tiredness

Some people who received efbemalenograstim alfa-vuxw injection developed other forms of cancer such as leukemia (cancer that begins in the white blood cells) and myelodysplastic syndrome (condition in which blood cells do not develop normally). Talk to your doctor about the risks of receiving this medication.

Efbemalenograstim alfa-vuxw injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• bone pain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to efbemalenograstim alfa-vuxw injection.

Before having a bone imaging study, tell your doctor and the technician that you are receiving efbemalenograstim alfa-vuxw injection. Efbemalenograstim alfa-vuxw injection may affect the results of this type of study.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.