NYVEPRIA Medication Guide

(pegfilgrastim-apgf)

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: March 2023    

Patient Information
NYVEPRIA™ (Nigh-VEP ree-ah)
(pegfilgrastim-apgf)
injection
Single-Dose Prefilled Syringe

What is NYVEPRIA?
NYVEPRIA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.

Before you receive NYVEPRIA, tell your healthcare provider about all of your medical conditions, including if you:

•
have a sickle cell disorder.
•
have kidney problems.
•
are pregnant or plan to become pregnant. It is not known if NYVEPRIA will harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if NYVEPRIA passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive NYVEPRIA?

•
NYVEPRIA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" that comes with your NYVEPRIA for information on how to prepare and inject a dose of NYVEPRIA.
•
You and your caregiver will be shown how to prepare and inject NYVEPRIA before you use it.
•
You should not inject a dose of NYVEPRIA to children weighing less than 45 kg from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe.
•
If you are receiving NYVEPRIA because you are also receiving chemotherapy, the last dose of NYVEPRIA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
•
If you miss a dose of NYVEPRIA, talk to your healthcare provider about when you should give your next dose.

What are possible side effects of NYVEPRIA?
NYVEPRIA may cause serious side effects, including:

•
Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
•
A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
•
Serious allergic reactions. NYVEPRIA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using NYVEPRIA and call your healthcare provider or get emergency medical help right away.
•
Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive NYVEPRIA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
•
Kidney injury (glomerulonephritis). NYVEPRIA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
o
swelling of your face or ankles
o
blood in your urine or dark colored urine
o
you urinate less than usual
•
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NYVEPRIA.
•
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NYVEPRIA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NYVEPRIA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
•
Capillary Leak Syndrome. NYVEPRIA can cause fluid to leak from blood vessels into your body's tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
o
swelling or puffiness and are urinating less than usual
o
trouble breathing
o
swelling of your stomach area (abdomen) and feeling of fullness
o
dizziness or feeling faint
o
a general feeling of tiredness
•
Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when NYVEPRIA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with NYVEPRIA.
•
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
 
The most common side effects of NYVEPRIA are pain in the bones, arms, and legs. These are not all the possible side effects of NYVEPRIA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NYVEPRIA?

•
Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C).
•
Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
•
Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Use a new NYVEPRIA prefilled syringe.
•
Keep the prefilled syringe in the original carton to protect from light or physical damage.
•
Do not shake the prefilled syringe.
•
Take NYVEPRIA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
•
Throw away (dispose of) any NYVEPRIA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 15 days.

Keep the NYVEPRIA prefilled syringe out of the reach of children.

General information about the safe and effective use of NYVEPRIA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NYVEPRIA for a condition for which it was not prescribed. Do not give NYVEPRIA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NYVEPRIA that is written for health professionals.

What are the ingredients in NYVEPRIA?
Active ingredient: pegfilgrastim-apgf.
Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in water for injection.
Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA
US License No. 1974
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

Logo

LAB-1187-4.0
For more information go to www.pfizer.com or call 1-800-438-1985.

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Find NYVEPRIA medical information:

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Prescribing Information
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Health Professional Information

Medication Guide

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: March 2023    

Patient Information
NYVEPRIA™ (Nigh-VEP ree-ah)
(pegfilgrastim-apgf)
injection
Single-Dose Prefilled Syringe

What is NYVEPRIA?
NYVEPRIA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.

Before you receive NYVEPRIA, tell your healthcare provider about all of your medical conditions, including if you:

•
have a sickle cell disorder.
•
have kidney problems.
•
are pregnant or plan to become pregnant. It is not known if NYVEPRIA will harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if NYVEPRIA passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive NYVEPRIA?

•
NYVEPRIA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" that comes with your NYVEPRIA for information on how to prepare and inject a dose of NYVEPRIA.
•
You and your caregiver will be shown how to prepare and inject NYVEPRIA before you use it.
•
You should not inject a dose of NYVEPRIA to children weighing less than 45 kg from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe.
•
If you are receiving NYVEPRIA because you are also receiving chemotherapy, the last dose of NYVEPRIA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
•
If you miss a dose of NYVEPRIA, talk to your healthcare provider about when you should give your next dose.

What are possible side effects of NYVEPRIA?
NYVEPRIA may cause serious side effects, including:

•
Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
•
A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
•
Serious allergic reactions. NYVEPRIA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using NYVEPRIA and call your healthcare provider or get emergency medical help right away.
•
Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive NYVEPRIA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
•
Kidney injury (glomerulonephritis). NYVEPRIA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
o
swelling of your face or ankles
o
blood in your urine or dark colored urine
o
you urinate less than usual
•
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NYVEPRIA.
•
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NYVEPRIA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NYVEPRIA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
•
Capillary Leak Syndrome. NYVEPRIA can cause fluid to leak from blood vessels into your body's tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
o
swelling or puffiness and are urinating less than usual
o
trouble breathing
o
swelling of your stomach area (abdomen) and feeling of fullness
o
dizziness or feeling faint
o
a general feeling of tiredness
•
Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when NYVEPRIA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with NYVEPRIA.
•
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
 
The most common side effects of NYVEPRIA are pain in the bones, arms, and legs. These are not all the possible side effects of NYVEPRIA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NYVEPRIA?

•
Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C).
•
Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
•
Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Use a new NYVEPRIA prefilled syringe.
•
Keep the prefilled syringe in the original carton to protect from light or physical damage.
•
Do not shake the prefilled syringe.
•
Take NYVEPRIA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
•
Throw away (dispose of) any NYVEPRIA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 15 days.

Keep the NYVEPRIA prefilled syringe out of the reach of children.

General information about the safe and effective use of NYVEPRIA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NYVEPRIA for a condition for which it was not prescribed. Do not give NYVEPRIA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NYVEPRIA that is written for health professionals.

What are the ingredients in NYVEPRIA?
Active ingredient: pegfilgrastim-apgf.
Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in water for injection.
Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA
US License No. 1974
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

Logo

LAB-1187-4.0
For more information go to www.pfizer.com or call 1-800-438-1985.
Medication Guide

Health Professional Information

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