Training Example: NEUPOGEN – Review the Data, Give Your Score & Compare to the Real AI Evaluation

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[H3]

[H2] Important Safety Information

Do not take NEUPOGEN®
if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.

Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:

have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.

are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.

are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.

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

How will I receive NEUPOGEN®?

NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.

You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.

Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.

If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.

What are possible side effects of NEUPOGEN®?

NEUPOGEN 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 left shoulder.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.

Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

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 NEUPOGEN®. 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 experienced in patients receiving NEUPOGEN®:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.

Please see the NEUPOGEN® Patient Information for additional information.

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[H5]

[H2] Important Safety Information
Do not take NEUPOGEN®
if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.
Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:
have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.

are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.

are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NEUPOGEN®?

NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.

You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.

Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.

If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.
What are possible side effects of NEUPOGEN®?
NEUPOGEN 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 left shoulder.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.

Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

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 NEUPOGEN. 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 experienced in patients receiving NEUPOGEN:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss
These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.
Please see the NEUPOGEN® Patient Information for additional information.

[H2] What is NEUPOGEN® used for?
[H3] NEUPOGEN® is approved for several uses to help boost the production of white blood cells

[H4] Patients with Cancer Receiving Strong Chemotherapy

NEUPOGEN® is a prescription medicine used to help the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.
[H4] Important Safety Information
Do not take NEUPOGEN® if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.
Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:
have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.
are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.
are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NEUPOGEN®?
NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.
You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.
Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.
If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.
What are possible side effects of NEUPOGEN®?
NEUPOGEN 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 left shoulder.
A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.
Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.
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 NEUPOGEN. 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 experienced in patients receiving NEUPOGEN:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss
These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.
Please see the NEUPOGEN® Patient Information for additional information.
USA-003-80219

[H4] Patients with Acute Myeloid Leukemia (AML) Receiving Chemotherapy

NEUPOGEN® is a prescription medicine used to help the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.
[H4] Important Safety Information
Do not take NEUPOGEN® if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.
Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:
have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.
are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.
are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NEUPOGEN®?
NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.
You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.
Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.
If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.
What are possible side effects of NEUPOGEN®?
NEUPOGEN 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 left shoulder.
A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.
Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.
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 NEUPOGEN. 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 experienced in patients receiving NEUPOGEN:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss
These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.
Please see the NEUPOGEN® Patient Information for additional information.
USA-003-80219

[H4] Patients with Cancer Undergoing Bone Marrow Transplantation (BMT)

NEUPOGEN® is a prescription medicine used to help the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.
[H4] Important Safety Information
Do not take NEUPOGEN® if you have had a serious allergic reaction to human G-

[H1] Glossary
Bacteria — Among the smallest forms of life. Bacteria are the most common causes of infections in people with cancer. Some examples of bacterial infection include food poisoning, pneumonia, and strep throat.Chemotherapy — The use of drugs to destroy cancer cells. A person on chemotherapy may take one drug or a combination of drugs. These drugs are often given by vein using intravenous (IV) infusion. Some can be taken by mouth or given as a shot.Co-pay — A flat fee for specified medical services required by some insurers. For example, your insurance provider may require you to pay a $10 co-pay for a doctor visit or a $50 co-pay for a hospital stay.Cycle — A period of chemotherapy treatment followed by a period of rest. For example, you may receive chemotherapy over 1 week followed by a week without treatment. These 2 weeks are one cycle of chemotherapy.Febrile neutropenia — A condition marked by fever and a lower than normal number of neutrophils in the blood. A neutrophil is a type of white blood cell that helps fight infection. Having too few neutrophils increases that risk of infection.Infection — An invasion of microorganisms such as bacteria or viruses that have the ability to multiply and cause disease.Intravenous (IV) infusion — The delivery of medicine directly into a vein.Neutropenia — A lower-than-normal number of neutrophils (infection-fighting white blood cells) in the blood. It is a common side effect of some chemotherapy treatments. Doctors check the number of neutrophils when they measure the white blood cell count, to monitor the risk of infection.Neutrophil — The most common type of white blood cell. Neutrophils help the body fight infection. A low white blood cell count usually indicates that the neutrophil count is low. It is easier to get an infection and harder to recover from an infection when the number of neutrophils in the bloodstream is low.Placebo — A dummy treatment used in some clinical trials. In these studies, a group of patients who are given a placebo treatment are compared to another group of patients who are given the actual treatment. The difference in results between the actual treatment group and the placebo group is considered the result of giving the medicine.Side effect — A secondary and usually undesired action or effect of a drug or treatment. For example, common side effects of chemotherapy include fatigue, nausea, vomiting, and hair loss.Subcutaneous injection — A shot given in the layer of fatty tissue just under the skin.White blood cell — A white blood cell is one of the three main types of blood cells. They are produced in the bone marrow and released into the blood. White blood cells are responsible for fighting infection. There are several kinds of white blood cells, including monocytes, lymphocytes, neutrophils, and macrophages.

See Less

[H3]

[H2] Important Safety Information

Do not take NEUPOGEN®
if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.

Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:

have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.

are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.

are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.

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

How will I receive NEUPOGEN®?

NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.

You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.

Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.

If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.

What are possible side effects of NEUPOGEN®?

NEUPOGEN 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 left shoulder.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.

Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

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 NEUPOGEN®. 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 experienced in patients receiving NEUPOGEN®:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.

Please see the NEUPOGEN® Patient Information for additional information.

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[H5]

[H2] Important Safety Information
Do not take NEUPOGEN®
if you have had a serious allergic reaction to human G-CSFs such as (filgrastim) or (pegfilgrastim) products.
Before you take NEUPOGEN®, tell your healthcare provider all about your medical conditions, including if you:
have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give NEUPOGEN® using the prefilled syringe if you have latex allergies. Ask your healthcare provider about using the vial if you have latex allergies.

are pregnant, or plan to become pregnant. It is not known if NEUPOGEN® will harm your unborn baby.

are breastfeeding, or plan to breastfeed. It is not known if NEUPOGEN® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NEUPOGEN®?

NEUPOGEN® injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If NEUPOGEN® is given at home, see the detailed "Instructions for Use" that comes with your NEUPOGEN® for information on how to prepare and inject a dose of NEUPOGEN®.

You and your caregiver should be shown how to prepare and inject NEUPOGEN® before you use it, by your healthcare provider.

Your healthcare provider will tell you how much NEUPOGEN® to inject and when to inject it. Do not change your dose or stop NEUPOGEN® unless your healthcare provider tells you to.

If you are receiving NEUPOGEN® because you are also receiving chemotherapy, your dose of NEUPOGEN® should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your NEUPOGEN dose.
If you are receiving NEUPOGEN because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with NEUPOGEN to check your white blood cell count.
If you miss a dose of NEUPOGEN, talk to your healthcare provider about when you should be given your next dose.
What are possible side effects of NEUPOGEN®?
NEUPOGEN 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 left shoulder.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical 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. NEUPOGEN® 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 NEUPOGEN®, and call your healthcare provider or get emergency 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 NEUPOGEN®. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). NEUPOGEN® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
swelling of your face and ankles
blood in your urine or dark colored urine
you urinate less than usual

Capillary Leak Syndrome. NEUPOGEN® 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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). NEUPOGEN® may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia). If you have breast cancer or lung cancer, when NEUPOGEN® is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop any of these symptoms during treatment with NEUPOGEN®.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NEUPOGEN®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NEUPOGEN®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NEUPOGEN®.

Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.

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 NEUPOGEN. 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 experienced in patients receiving NEUPOGEN:
Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath
Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
Patients who are having their own blood cells collected: bone pain, fever, and headache
Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss
These are not all the possible side effect of NEUPOGEN®. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.
Please see the NEUPOGEN® Patient Information for additional information.