Ryzneuta 20 mg/mL subcutaneous syringe

Generic name:
Efbemalenograstim alfa - injection

Brand name(s)
Ryzneuta

Efbemalenograstim alfa is a human-made version of a certain natural substance made by your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Efbemalenograstim alfa is given to people whose ability to make white blood cells is reduced due to chemotherapy.

Read the Patient Information Leaflet if available from your pharmacist before you start using efbemalenograstim alfa and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once during each chemotherapy cycle. However, it should not be given within 14 days before or less than 24 hours after chemotherapy.

Nausea may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• pink/bloody urine
• easy bleeding/bruising
• fever
• fast heartbeat
• purple/red spots on your skin
• back pain

Get medical help right away if you have any very serious side effects, including:

• breathing problems (such as shortness of breath, fast breathing)
• unusual decrease in urination
• unusual tiredness
• swelling/puffiness of the body

Rarely, serious (possibly fatal) damage to the spleen may occur. Get medical help right away if you develop stomach/abdominal pain or shoulder pain.

Rarely, this medication may increase the risk of developing a certain bone marrow disorder (myelodysplastic syndrome-MDS) or blood cancer (acute myeloid leukemia-AML) in people with breast or lung cancer who are receiving chemotherapy/radiation. Ask your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using efbemalenograstim alfa, tell your doctor or pharmacist if you are allergic to it; or to pegfilgrastim or filgrastim products; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the needle cap of the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• sickle cell disease
• spleen problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.