NYVEPRIA Patient Counseling Information

(pegfilgrastim-apgf)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Advise patients of the following risks and potential risks with NYVEPRIA:

•
Splenic rupture and splenomegaly
•
Acute Respiratory Distress Syndrome
•
Serious allergic reactions
•
Sickle cell crisis
•
Glomerulonephritis
•
Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive pegfilgrastim products in conjunction with chemotherapy and/or radiation therapy
•
Capillary Leak Syndrome
•
Aortitis

Instruct patients who self-administer NYVEPRIA using the single-dose prefilled syringe of the:

•
Importance of following the Instructions for Use.
•
Dangers of reusing syringes.
•
Importance of following local requirements for proper disposal of used syringes.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Advise patients of the following risks and potential risks with NYVEPRIA:

•
Splenic rupture and splenomegaly
•
Acute Respiratory Distress Syndrome
•
Serious allergic reactions
•
Sickle cell crisis
•
Glomerulonephritis
•
Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive pegfilgrastim products in conjunction with chemotherapy and/or radiation therapy
•
Capillary Leak Syndrome
•
Aortitis

Instruct patients who self-administer NYVEPRIA using the single-dose prefilled syringe of the:

•
Importance of following the Instructions for Use.
•
Dangers of reusing syringes.
•
Importance of following local requirements for proper disposal of used syringes.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
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FDA Medwatch

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