EFBEMALENOGRASTIM ALFA-VUXW

Other

Brand names: RYZNEUTA

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Efbemalenograstim alfa-vuxw is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Indications

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

as manifested by febrile neutropenia

Contraindications

• 4. CONTRAINDICATIONS RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw
• pegfilgrastim
• or filgrastim products [see Warnings and Precautions ( 5.3 )] . Patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw
• pegfilgrastim
• or filgrastim products. ( 4 )

FDA Warnings

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 RYZNEUTA 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 RYZNEUTA
3 Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products, such as RYZNEUTA

Known Side Effects

9 documented side effects by frequency

Weakness

>10%

Shortness of Breath

>10%

Fever

>10%

Nausea

1-10%

Dizziness

1-10%

Excessive Sweating

1-10%

Heart Palpitations

1-10%

Vomiting

1-10%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous