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Eflapegrastim: Side Effects, Uses, Dosage, Interactions, Warnings

Eflapegrastim

Reviewed on 6/19/2023

What Is Eflapegrastim and How Does It Work?

Eflapegrastim is a prescription medication indicated to decrease incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.

  • Eflapegrastim is available under the following different brand names: Rolvedon, eflapegrastim-xnst

What Are Side Effects Associated with Using Eflapegrastim?

Common side effects of Eflapegrastim include:

  • fatigue
  • nausea
  • diarrhea
  • bone pain
  • headache
  • fever
  • anemia
  • rash
  • muscle pain
  • joint pain
  • back pain

Serious side effects of Eflapegrastim include:

  • hives
  • difficulty breathing
  • swelling of the face, lip, tongue, or throat
  • decreased appetite
  • swelling in the arms and legs
  • abdominal pain
  • dizziness
  • shortness of breath
  • cough
  • low platelet levels
  • pain or discomfort
  • pain in the arms and legs
  • injection site reaction

Rare side effects of Eflapegrastim 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.

What Are the Dosages of Eflapegrastim?

Adult dosage

Injection, solution

  • 13.2 mg/0.6 mL prefilled syringe

Chemotherapy-induced neutropenia

Adult dosage

  • 13.2 mg SC as a single dose once per chemotherapy cycle approximately 24 h after cytotoxic chemotherapy
  • Do not administer during the period from 14 days before to 24 h after administration of cytotoxic chemotherapy

Dosage Considerations – Should be Given as Follows:

  • See "Dosages"

What Other Drugs Interact with Eflapegrastim?

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, healthcare provider, or pharmacist first.

  • Eflapegrastim has no noted severe interactions with any other drugs.
  • Eflapegrastim has no noted serious interactions with any other drugs.
  • Eflapegrastim has no noted moderate interactions with any other drugs.
  • Eflapegrastim 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 with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

What Are Warnings and Precautions for Eflapegrastim?

Contraindications

  • History of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products

Effects of drug abuse

  • None

Short-Term Effects

  • See "What Are Side Effects Associated with Using Eflapegrastim?"

Long-Term Effects

  • See "What Are Side Effects Associated with Using Eflapegrastim?"

Cautions

  • Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products; evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after administration
  • Acute respiratory distress syndrome (ARDS) can occur; evaluate patients who develop fever and lung infiltrates or respiratory distress; discontinue in patients with ARDS
  • Serious allergic reactions, including anaphylaxis, are reported; permanently discontinue if serious allergic reaction occurs; contraindicated with a history of serious allergic reaction
  • Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products; discontinue if sickle cell crisis occurs
  • Leukocytosis reported; monitor complete blood count; discontinue if WBC count increases 100 × 109/L and more
  • Thrombocytopenia reported; monitor platelet counts
  • Possibly acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which eflapegrastim is not approved
  • Increased hematopoietic activity of bone marrow in response to growth factor therapy associated with transient positive bone imaging findings; consider this when interpreting bone imaging results
  • Capillary leak syndrome
    • Capillary leak syndrome reported and characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
    • If symptoms occur, closely monitor and receive standard symptomatic treatment, which may include the need for intensive care
    • Episodes may become life-threatening if treatment is delayed
    • Instruct patients to contact emergency services if they experience swelling or puffiness and urinate less than usual and have trouble breathing, abdominal swelling and feeling of fullness, dizziness or feeling faint, or a general feeling of tiredness
  • Glomerulonephritis
    • Glomerulonephritis reported; generally resolves after dose reduction or discontinuation
    • If glomerulonephritis is suspected, evaluate for a cause; if causality is likely, consider dose reduction or interruption
    • Instruct patients to contact their healthcare provider if they experience swelling of the face or ankles, have blood in the urine or dark-colored urine, or urinate less than usual
  • MDS and AML
    • Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) have been associated with 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 these settings
    • Instruct patients to contact their healthcare professional if they experience tiredness, fever, and easy bruising or bleeding
  • Aortitis
    • Aortitis may occur as early as the first week after initiation
    • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, C-reactive protein, WBC count)
    • Discontinue if aortitis is suspected
    • Instruct patient to contact a healthcare provider if they experience fever, abdominal pain, tiredness, or back pain

Pregnancy and Lactation

  • Data are not available regarding use in pregnant women; however, data from published studies with the use of other rhG-CSF products during pregnancy have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
  • Lactation
    • Data are not available regarding the presence of human milk, its effects on breastfed children, or its effects on milk production
    • Endogenous G-CSF is present in human milk; other rhG-CSF products are present in human milk at low levels and are not orally absorbed by infants
References
https://reference.medscape.com/drug/rolvedon-eflapegrastim-4000053#0