Efbemalenograstim Alfa

Efbemalenograstim Alfa is a prescription medication indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies who are receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

• Efbemalenograstim Alfa is available under the following different brand names: Ryzneuta, Efbemalenograstim Alfa-vuxw

Common side effects of Efbemalenograstim Alfa include:

• tiredness
• fever
• nausea
• decreased red blood cell count
• diarrhea
• rash
• bone pain
• muscle and joint pain
• headache
• back pain
• abdominal pain
• increased inflammatory markers (eg, C-reactive protein, WBC count)

Serious side effects of Efbemalenograstim Alfa include:

• not available

Rare side effects of Efbemalenograstim Alfa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable SC solution

• 20 mg/ML single-dose prefilled syringe

Febrile neutropenia

Adult dosage

• 20 mg SC administered once per chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy
• Do not administer within 14 days before and less than 24 hours after the administration of chemotherapy

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Efbemalenograstim Alfa has no noted severe interactions with any other drugs
• Efbemalenograstim Alfa has no noted serious interactions with any other drugs
• Efbemalenograstim Alfa has no noted moderate interactions with any other drugs
• Efbemalenograstim Alfa has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• A history of serious allergic reactions to granulocyte-colony stimulating factors (G-CSFs) such as Efbemalenograstim Alfa, pegfilgrastim and filgrastim

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Efbemalenograstim Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Efbemalenograstim Alfa?”

Cautions

• Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture
• Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress; discontinue in patients with ARDS
• Serious allergic reactions, including anaphylaxis: Permanently discontinue
• Sickle cell crises in patients with sickle cell disorders: Discontinue if sickle cell crisis occurs
• Glomerulonephritis: Evaluate and consider dose reduction or interruption if causality is likely
• Leukocytosis: WBC counts of 100 ×109/L and more observed in patients receiving rhG-CSF products; monitor complete blood count (CBC) count during therapy; discontinue if WBC count exceeds 100 × 109/L
• Thrombocytopenia: Monitor platelet counts
• Capillary leak syndrome: Monitor patients with symptoms; consider intensive care
• Potential for tumor growth
  • The G-CSF receptor, through which Efbemalenograstim Alfa acts, has been found on tumor cell lines
  • Cannot exclude the possibility that Efbemalenograstim Alfa acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which it is not approved
• MDS and AML
  • Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer
  • Monitor patients with breast and lung cancer receiving Efbemalenograstim Alfa in conjunction with chemotherapy and radiotherapy for signs and symptoms of MDS/AML
• Aortitis
  • Aortitis reported in patients receiving rhG-CSF products
  • It may occur as early as the first week after starting therapy
  • Manifestations may include generalized signs and symptoms (eg, fever, abdominal pain, malaise, back pain, and increased inflammatory markers such as C-reactive protein, WBC count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology
  • Discontinue if aortitis is suspected
• Nuclear imaging
  • Increased hematopoietic activity of bone marrow in response to growth factor therapy associated with transient positive bone imaging changes
  • Consider this when interpreting bone imaging results

Pregnancy and Lactation

• Although available data on Efbemalenograstim Alfa use in pregnant women are insufficient to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies with exposure to other human G-CSF products
• These studies have not established an association between the use of G-CSF product during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Data are unavailable on the presence of Efbemalenograstim Alfa or its metabolite in either human or animal milk and its effects on breastfed children or milk production