EFLAPEGRASTIM-XNST

Other

Brand names: Rolvedon

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.

Indications

1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection

as manifested by febrile neutropenia

Contraindications

• 4 CONTRAINDICATIONS Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim
• pegfilgrastim
• pegfilgrastim or filgrastim products. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture
2 ) • Serious allergic reactions, including anaphylaxis: Permanently discontinue Rolvedon in patients with serious allergic reactions
1 Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products, such as Rolvedon
3 Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products, such as Rolvedon

Known Side Effects

7 documented side effects by frequency

Weakness

1-10%

Diarrhea

1-10%

Abdominal Pain

1-10%

Constipation

1-10%

Fatigue

1-10%

Nausea

1-10%

Vomiting

1-10%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous