Efbemalenograstim Alfa-vuxw (Monograph)

Drug class: Hematopoietic Agents

Medically reviewed by Drugs.com on Sep 10, 2024. Written by ASHP.

Introduction

Leukocyte growth factor; recombinant fusion protein consisting of human granulocyte colony-stimulating factor (G-CSF) and the Fc portion of human IgG₂.

Uses for Efbemalenograstim Alfa-vuxw

Chemotherapy-induced Neutropenia

Used to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

American Society of Clinical Oncology (ASCO) guidelines state that hematopoietic colony-stimulating factors (CSFs) are indicated for certain patients with solid tumors or lymphoma undergoing chemotherapy; choice of CSF should be based on convenience, cost, and the clinical situation. Consult guidelines for further details.

Efbemalenograstim Alfa-vuxw Dosage and Administration

General

Patient Monitoring

• Monitor for left upper abdominal pain or shoulder pain (may indicate enlarged spleen or splenic rupture).

• Monitor for symptoms of acute respiratory distress syndrome (ARDS), which may present with fever, lung infiltrates, or respiratory distress.

• Monitor CBC and platelet counts during therapy.

• In patients with breast or lung cancer receiving efbemalenograstim alfa-vuxw in conjunction with chemotherapy and/or radiotherapy, monitor for signs and symptoms of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

Other General Considerations

• Do not administer efbemalenograstim alfa-vuxw within 14 days before and <24 hours after administration of cytotoxic chemotherapy.

Administration

Sub-Q Administration

Administer via sub-Q injection by a healthcare professional.

Available in single-dose prefilled syringes. Prefilled syringes do not have graduation marks, and are only intended to deliver the full contents of the syringe. Needle caps contain natural rubber; people with latex allergies should not administer this product.

Prior to administration, remove carton from the refrigerator (keeping the syringe in the carton); let stand for at least 30 minutes to allow the drug to come to room temperature. Discard any product left at room temperature for >48 hours.

Administer sub-Q injection by pinching skin and holding; administer into the abdomen, back or side of the upper arm, or thighs. Rotate injection sites. If injecting into the abdominal area, avoid injecting within a 2-inch diameter circle around the navel. Avoid injecting into scar tissue or areas that are reddened, inflamed, or swollen.

Dosage

Adults

Chemotherapy-induced Neutropenia

Sub-Q

20 mg injection once per chemotherapy cycle.

Administer ≥24 hours after chemotherapy. Do not administer within 14 days before or <24 hours after chemotherapy administration.

Special Populations

Hepatic Impairment

No dosage recommendations at this time.

Renal Impairment

No dosage recommendations at this time.

Geriatric Patients

No dosage recommendations at this time.

Cautions for Efbemalenograstim Alfa-vuxw

Contraindications

• History of serious allergic reactions to granulocyte stimulating factors (e.g., efbemalenograstim alfa-vuxw, pegfilgrastim, filgrastim products).

Warnings/Precautions

Splenic Rupture

Cases of splenic rupture, some fatal, reported. Evaluate patients for enlarged spleen or splenic rupture if left upper abdominal or shoulder pain reported.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) reported. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS; discontinue therapy if confirmed.

Serious Allergic Reactions

Hypersensitivity

Serious allergic reactions, including anaphylaxis, reported. Permanently discontinue if serious allergic reactions occur. Efbemalenograstim alfa-vuxw contraindicated in patients with a history of serious allergic reactions to the drug or other recombinant human granulocyte colony-stimulating factor (rhG-CSF) products (e.g., pegfilgrastim, eflapegrastim, filgrastim).

Latex Sensitivity

Needle cap of prefilled syringe contains natural rubber, which may cause allergic reactions; people with latex allergies should not administer the product.

Sickle Cell Crisis

Severe sickle cell crises, some fatal, reported in patients with sickle cell disorders. Discontinue therapy if a sickle cell crisis occurs.

Glomerulonephritis

Glomerulonephritis reported with rhG-CSF products. Cases generally resolved after dosage reduction or discontinuation of the rhG-CSF product.

If glomerulonephritis occurs, evaluate for the underlying cause; consider efbemalenograstim alfa-vuxw dosage reduction or interruption if efbemalenograstim alfa-vuxw is a likely cause.

Leukocytosis

Elevated WBC counts ≥100,000/mm³ reported. Monitor CBC and discontinue therapy if WBC count increases to ≥100,000/mm³.

Thrombocytopenia

Thrombocytopenia reported. Monitor platelet counts during therapy.

Capillary Leak Syndrome

Capillary leak syndrome reported; may become life-threatening if treatment is delayed.

Closely monitor patients who develop symptoms of capillary leak syndrome and administer symptomatic treatment in accordance with current standard of care. Intensive care may be warranted.

Potential for Tumor Growth Stimulation

Possibility that efbemalenograstim alfa-vuxw may act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be ruled out.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

MDS and AML associated with use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor for signs and symptoms of MDS/AML in patients with breast or lung cancer.

Aortitis

Aortitis reported as early as 1 week after initiation. Discontinue if aortitis suspected.

Nuclear Imaging

Transient positive bone imaging changes observed in association with increased hematopoietic activity of the bone marrow in response to growth factor therapy. Consider such changes when interpreting bone imaging results.

Immunogenicity

Treatment-emergent anti-drug antibodies and treatment-emergent antibodies to G-CSF reported; no evidence of altered pharmacokinetics or allergic-type reactions in patients who developed such antibodies after 6 months of follow-up.

Specific Populations

Pregnancy

Data insufficient to establish drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with efbemalenograstim alfa-vuxw. Data with other human granulocyte colony-stimulating factor (G-CSF) products have not established a link between human G-CSF products and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation

Not known if efbemalenograstim alfa-vuxw or metabolite present in human milk. Effects on the breast-fed child and milk production unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Insufficient number of patients ≥65 years of age in clinical studies to assess differences in response compared to younger adults. No differences identified with other clinical experience.

Hepatic Impairment

Pharmacokinetics in hepatic impairment not known.

Renal Impairment

Pharmacokinetics in renal impairment not known.

Common Adverse Effects

Adverse effects reported in ≥10% of patients receiving efbemelanograstim alfa-vuxw include nausea, anemia, and thrombocytopenia.

Drug Interactions

Formal drug interaction studies not conducted. Expected to undergo metabolism into small peptides via catabolic pathways.

Efbemalenograstim Alfa-vuxw Pharmacokinetics

Absorption

Bioavailability

Exhibits non-linear and time-dependent pharmacokinetics over the dosage range of 30—360 mcg/kg.

Median ANC in patients with breast cancer receiving EC (epirubicin and cyclophosphamide) chemotherapy peaked on day 4 (about 24 hours after efbemalenograstim alfa-vuxw administration) for the 240 and 320 mcg/kg doses, declined to nadir on days 8—9, then recovered to ≥2000/mm³ by day 11. Absolute neutrophil count levels tended to be higher during cycles 2, 3, and 4 compared to cycle 1.

Median ANC in patients with breast cancer receiving TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy peaked on day 3 (about 24 hours after efbemalenograstim alfa-vuxw administration) during cycles 1 and 3, and declined to nadir on day 8, then recovered to 2000/mm³ on days 9 and 10.

Special Populations

Age (20—83 years) and body weight (40—137 kg) do not affect pharmacokinetics.

Distribution

Extent

Not known if efbemalenograstim alfa-vuxw or its metabolite distribute into human milk.

Elimination

Metabolism

Expected to undergo metabolism into small peptides via catabolic pathways.

Elimination Route

Neutrophil receptor binding important for serum clearance; clearance is directly related to the neutrophil count.

Half-life

Mean elimination half-life of 35.6 hours during cycle 1 and 36.9 hours during cycle 3.

Stability

Storage

Parenteral

Injection, for sub-Q use

Store at 2—8°C in carton to protect from light. Discard if frozen.

May be left at room temperature in carton for a maximum of 48 hours.

Actions

• Leukoctye growth factor; recombinant fusion protein consisting of human granulocyte colony-stimulating factor (G-CSF), a 16 amino-acid linker, and the Fc portion of human IgG₂.

• Colony-stimulating factor; binds to specific hematopoietic cell surface receptors to stimulate proliferation, differentiation, commitment, and end cell functional activation.

Advice to Patients

• Advise the patient to read the FDA-approved patient labeling (Patient Information).

• Inform patients that rupture or enlargement of the spleen can occur, and that symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their healthcare provider immediately.

• Inform patients receiving efbemelanograstim alfa-vuxw that dyspnea, with or without fever, can occur and progress to acute respiratory distress syndrome. Advise patients to immediately contact their healthcare provider if they develop dyspnea.

• Inform patients receiving efbemelanograstim alfa-vuxw that serious allergic reactions can occur during therapy. Signs of serious allergic reactions may include rash, facial edema, wheezing, dyspnea, hypotension, or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction develop.

• Inform patients with sickle cell disease that sickle cell crisis and death have occurred with use of human granulocyte colony-stimulating factors. Discuss the potential risks and benefits of efbemalenograstim alfa-vuxw therapy prior to initiation in patients with sickle cell disease.

• Inform patients receiving efbemelanograstim alfa-vuxw that glomerulonephritis can occur during therapy. Advise patients to report signs or symptoms of glomerulonephritis (e.g., swelling of the face or ankles, dark colored urine or blood in the urine, decreased urine production) to their healthcare provider immediately.

• Inform patients receiving efbemelanograstim alfa-vuxw that capillary leak syndrome can occur. Advise patients to immediately report signs and symptoms of capillary leak syndrome (e.g., hypotension, edema) to their healthcare provider immediately.

• Inform patients of the increased risk of myelodysplastic syndrome (MDS) and/or acute myeloid leukemia (AML) when efbemalenograstim alfa-vuxw is used in conjunction with chemotherapy and/or radiation therapy for breast or lung cancer. Advise patients to report signs and symptoms of MDS/AML (e.g., tiredness, fever, easy bruising or bleeding) to their healthcare provider.

• Inform patients that aortitis can occur and advise patients to immediately report signs and symptoms of aortitis (e.g., fever, abdominal pain, malaise, back pain, increased inflammatory markers) to their healthcare provider immediately.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Reload page with references included

Efbemalenograstim alfa Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for efbemalenograstim alfa.

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