Training Example: Neulasta (Amgen) – Review the Data, Give Your Score & Compare to the Real AI Evaluation

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[H3]

[H3]
Important Safety Information
Do not take Neulasta® if you have had a serious allergic reaction to pegfilgrastim or filgrastim.
[H6] Before you receive Neulasta®, tell your healthcare provider about all of your healthcare conditions, including if you:
Have a sickle cell disorder
Have had severe skin reactions to acrylic adhesives
Are allergic to latex – The needle cap on the prefilled syringe contains dry natural rubber (derived from latex).
Have kidney problems
Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby.
Are breastfeeding or plan to breastfeed. It is not known if Neulasta® 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.
[H6] What are the possible serious side effects of Neulasta®?
Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta®. 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 tip area.
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. Neulasta® 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.
[H6] If you have an allergic reaction during the delivery of Neulasta®, remove the on-body injector for Neulasta® by grabbing the edge of the adhesive pad and peeling off the on-body injector. 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 Neulasta®.
Kidney injury (glomerulonephritis). Neulasta® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: swelling of your face or ankles, blood in your urine or dark colored urine, or you urinate less than usual.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Neulasta®.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neulasta®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Capillary Leak Syndrome. Neulasta® 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 (abdomen) and feeling of fullness
Dizziness or feeling faint
A general feeling of tiredness
Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when Neulasta® 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 may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta®.
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 Neulasta®. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
The most common side effect of Neulasta® is pain in your bones and in your arms and legs.
These are not all the possible side effects of Neulasta®. Call your healthcare provider for medical advice about side effects. You may report negative side effects to the FDA at 1-800-FDA-1088.
Please see Neulasta® Patient Information.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta® (Neulasta® Onpro® kit).

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[H5]

Important Safety Information
Do not take Neulasta® if you have had a serious allergic reaction to pegfilgrastim or filgrastim.
Before you receive Neulasta®, tell your healthcare provider about all of your healthcare conditions, including if you:
• Have a sickle cell disorder
• Have had severe skin reactions to acrylic adhesives

[H5] What is chemotherapy?
Chemotherapy (chemo) is a type of treatment that includes a medication or combination of medications to treat cancer. The goal of chemo is to stop or slow the growth of cancer cells. Chemo is considered a systemic therapy. This means it may affect your entire body.
Chemo medications attack fast-growing cancer cells, but they can also affect healthy cells that grow rapidly. The effect of these medications on normal cells often causes chemo side effects. For example:
A number of blood cells that divide rapidly can be damaged along with cancer cells during chemo:
White blood cells help protect the body from infection. A low white blood cell count is known as neutropenia. If your white blood cell count gets too low, you could get an infection.
Red blood cells carry oxygen throughout your body. A low red blood cell count is known as anemia. Anemia can lead to fatigue, chest pain, and more serious complications.
Platelets are structures in the blood that help stop bleeding. A low platelet cell count is known as thrombocytopenia. A low platelet count can cause bruising and bleeding.

Hair follicles have cells that can be affected by chemo, leading to hair loss, also called alopecia.
Cells lining your stomach can also be affected by chemo. This can cause vomiting and diarrhea, and may be associated with nausea.
[H5] How does chemotherapy work?
The goal of chemotherapy (chemo) is to kill cancer cells or slow the growth of cancer over time. Chemo is often given several times over weeks or months in what is known as a course of treatment. A course of treatment is made up of a series of treatment periods, called cycles. During a cycle, you may get chemo every day for one or more days. Since chemo also kills normal cells, these chemo days are followed by periods of rest when you receive no treatment. This rest lets your body recover and produce new healthy cells.
[H5] What is a chemo regimen?
Your doctor will create a plan, or regimen, that includes the type of chemo medications you will receive. The regimen also includes the medication dose and how often you will receive it. Your doctor will choose certain medications that can best fight your cancer.
[H5] How is chemo given?
Chemotherapy (chemo) treatment plans may use a single medication or a combination (or "cocktail") of medications that can be delivered in more than one way. You may receive chemo in one or more of the following forms:
Injection. Types of injection include:
Subcutaneous (SQ): Chemo given as a shot just under the skin
Intramuscular (IM): Chemo given as a shot directly into a muscle
Intravenous (IV): Chemo given as a shot directly into a vein

IV infusion: Chemo medications are dripped through a tube that is attached to a needle and put into a vein
Oral: Chemo taken by mouth as a pill or liquid
Topical: A cream containing the chemo medication that is rubbed into the skin
Intra-arterial (IA): Chemo delivered into an artery that is connected to the tumor
Intraperitoneal (IP): Chemo given directly into the area that contains the intestines, stomach, liver, ovaries, etc. This area is called the peritoneal cavity.
[H5] What are the most common side effects of chemo?
Most people undergoing chemotherapy (chemo) will have chemo side effects. These can vary from person to person. Common chemo side effects include:
Hair loss, also called alopecia
Nausea and vomiting
Fatigue
Neutropenia, a low number of white blood cells. White blood cells help you fight infections.
Anemia, caused by a low number of red blood cells. Red blood cells carry oxygen throughout the body.
Thrombocytopenia, a low number of platelets. Platelets help the blood to clot to stop bleeding.
Trouble with memory
Mouth sores
Learn more about neutropenia and white blood cells here.
[H5] What are the most serious side effects of chemotherapy?
Some chemo side effects can be serious. These may include febrile neutropenia, anemia, thrombocytopenia, fatigue, and nausea and vomiting. You can learn more about these serious chemo side effects by talking to your doctor.
Learn more about how febrile neutropenia can disrupt your treatment plan here.
[H5] What can happen to white blood cells during strong chemotherapy?
White blood cells are a key part of your immune system. At natural levels, white blood cells help protect your body against infection. Strong chemotherapy can lower the number of infection-fighting white blood cells in your body, which may weaken your immune system and increase your risk for infection.
Learn more about the role of white blood cells here.
[H5] How will I know if my white blood cell counts are low?
Your doctor may routinely use a test called a complete blood count (a CBC) before and during your chemotherapy treatment. A CBC can help tell if a patient is at increased risk of or has an infection.
[H5] What are the signs of an infection?
If you’re getting strong chemo, watch for these signs of infection. It’s very important to tell your doctor or nurse if you experience the following:
Fever
Chills, cough, or sore throat
Constipation, loose stools, or diarrhea
Painful or frequent urination
Mouth ulcers or sores in the throat
Unusual vaginal discharge or itching
Redness, swelling, or soreness in the skin around an implanted port
Shortness of breath, chest pain
Irregular or rapid heartbeat
Blood in urine or stool
[H5] What can I do to avoid getting an infection during strong chemo?
During strong chemo, you may be at risk for infection. There may be ways you can help protect yourself.
Here are some things you can do:
Wash your hands frequently with soap and water. This is especially important after you use the toilet and before cooking and eating.
Avoid people who have diseases—such as colds or the flu—that you can catch.
Clean cuts and scrapes right away with warm water and soap. Cover with a bandage. Ask your doctor and care team if using antibiotic creams is right for you.
Avoid crowds where germs can be rampant.
Be careful not to cut or nick yourself. Use an electric shaver instead of a razor. Wear protective gloves when gardening or cleaning to avoid cuts and scrapes.

[H5] What is Neulasta®?
Neulasta® is a prescription medicine used to help reduce 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 low blood cell count.
To learn more about how Neulasta® works, watch the video here.
[H5] Who should receive Neulasta®?
Neulasta® is a prescription medication used to help reduce 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 low blood cell count. Talk to your doctor to see if Neulasta® may be appropriate for you.
[H5] Who should not take Neulasta®?
Do not take Neulasta® if you have had a serious allergic reaction to Neulasta® (pegfilgrastim) or to NEUPOGEN® (filgrastim). Talk to your doctor to see if Neulasta® may be appropriate for you.
[H5] What should I tell my healthcare provider before taking Neulasta®?
Before you receive Neulasta®, tell your healthcare provider if you:
Have sickle cell trait or sickle cell disease
Have had severe skin reactions to acrylic adhesives
Are allergic to latex
Have problems with your kidneys
Have any other medical problems
Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby.
Are breastfeeding or plan to breastfeed. It is not known if Neulasta® 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.
Learn more about what to discuss with your doctor with our doctor discussion guide here.
[H5] How does strong chemotherapy result in low white blood cell counts?
While chemotherapy is fighting cancer cells, it can also harm normal cells in the body that divide rapidly. Strong chemotherapy described as myelosuppressive (my-eh-lo-suh-press-iv) can lower the number of infection-fighting white blood cells called neutrophils in your body. White blood cells are a key part of your immune system.
Learn more about the role of white blood cells here.
[H5] What kind of drug is Neulasta®?
Medications like Neulasta® may be called white blood cell boosters because they help your body produce more infection-fighting white blood cells during strong chemotherapy. These medications are man-made forms of a substance called granulocyte (gran-yoo-loh-site) colony-stimulating factor (G-CSF) that is naturally produced by the body. They stimulate the growth of a type of white blood cell called neutrophils, which are important in the body's fight against infection.
[H5] What if I'm prescribed a biosimilar to Neulasta?
A biosimilar is a highly similar version of an approved biologic medicine. Biologics and biosimilars are both made from living cells. Biosimilars must provide the same treatment benefit as the original biologic.
Only Neulasta has an FDA approved on-body injector called Neulasta Onpro.
[H5] How does Neulasta® work?
Neulasta® works like a natural protein in your body to promote the growth of new white blood cells. Neulasta® helps protect against the risk of infection and is a prescription medication given approximately 24 hours after you receive chemotherapy treatment to help protect you through that cycle.
To learn more about how Neulasta® works, watch the video here.
[H5] What are the study results for Neulasta®?
In a key study of 928 patients with breast cancer who received up to 4 cycles of strong chemotherapy, one group of patients received Neulasta® (the study group), while the other group did not receive Neulasta® (the placebo group). Neulasta® was shown to help protect against the risk of infection with fever (sometimes called febrile neutropenia or neutropenic fever) through strong chemo treatment. The most common side effect experienced with Neulasta® was aching in the bones or muscles.
To see more data, view the information here.
[H5] What are the possible serious side effects of Neulasta®?
The possible serious side effects of Neulasta® include:
Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta®. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured.
A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of ARDS: fever, shortness of breath, trouble breathing, or a fast rate of breathing.
Serious Allergic Reactions. Get emergency medical help right away if you get any of these symptoms of a serious allergic reaction with Neulasta®: shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives.
If you have an allergic reaction during the delivery of Neulasta®, remove the on-body injector for Neulasta® by grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency medical help right away.
Sickle Cell Crises. Severe sickle cell crises, and sometimes death, can happen in people with sickle cell trait or disease who receive filgrastim, a medicine similar to Neulasta®.
Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neulasta®. You should notify your healthcare provider right away if you experience puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.
Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta®.
Capillary Leak Syndrome. Neulasta® 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 often
Trouble breathing
Swelling of your stomach-area (abdomen) and feeling of fullness
Dizziness or feeling faint
A general feeling of tiredness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Neulasta®. For more information, ask your doctor or pharmacist.
[H5] What are the most common side effects of Neulasta®?
The most common side effect of Neulasta® is pain in the bones and in your arms and legs. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Neulasta®. For more information, ask your doctor or pharmacist.
For additional Important Safety Information, see below.
[H5] Do I need to be aware of any drug interactions with Neulasta®?
No formal drug interaction studies have been conducted. When discussing your treatment options, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
[H5] What are the ingredients in Neulasta®?
The active ingredient in Neulasta® is pegfilgrastim. Inactive ingredients in Neulasta® include acetate, sorbitol, polysorbate 20, and sodium in water for injection.
[H5] Are there any co-pay and reimbursement resources available for patients prescribed Neulasta®?
Amgen Assist 360™ can help patients with insurance benefit verification and put them in touch with programs that may help them afford their prescribed medication, such as Neulasta FIRST STEP® or other independent nonprofit organizations.
Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Amgen has no control over these programs and provides referrals as a courtesy only. Call 1-844-MYNEULASTA (1-844-696-3852) to learn more visit the Paying For Neulasta® Onpro® page here.
[H5] How will I receive Neulasta®?
Neulasta® is given as an injection under the skin at least 24 hours after you receive chemotherapy treatment to provide protection through that cycle. There are two ways in which you may receive your Neulasta®— either Neulasta® by manual injection or Neulasta® Onpro®. Your healthcare provider will choose with you which one is most appropriate.
[H5] Do I have to return to the doctor’s office the day after chemotherapy to get my Neulasta® injection?
Neulasta® is given as an injection under the skin at least 24 hours after you receive chemotherapy treatment to provide protection through that cyc

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[H3]

[H3]
Important Safety Information
Do not take Neulasta® if you have had a serious allergic reaction to pegfilgrastim or filgrastim.
[H6] Before you receive Neulasta®, tell your healthcare provider about all of your healthcare conditions, including if you:
Have a sickle cell disorder
Have had severe skin reactions to acrylic adhesives
Are allergic to latex – The needle cap on the prefilled syringe contains dry natural rubber (derived from latex).
Have kidney problems
Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby.
Are breastfeeding or plan to breastfeed. It is not known if Neulasta® 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.
[H6] What are the possible serious side effects of Neulasta®?
Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta®. 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 tip area.
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. Neulasta® 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.
[H6] If you have an allergic reaction during the delivery of Neulasta®, remove the on-body injector for Neulasta® by grabbing the edge of the adhesive pad and peeling off the on-body injector. 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 Neulasta®.
Kidney injury (glomerulonephritis). Neulasta® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: swelling of your face or ankles, blood in your urine or dark colored urine, or you urinate less than usual.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Neulasta®.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neulasta®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Capillary Leak Syndrome. Neulasta® 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 (abdomen) and feeling of fullness
Dizziness or feeling faint
A general feeling of tiredness
Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when Neulasta® 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 may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta®.
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 Neulasta®. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
The most common side effect of Neulasta® is pain in your bones and in your arms and legs.
These are not all the possible side effects of Neulasta®. Call your healthcare provider for medical advice about side effects. You may report negative side effects to the FDA at 1-800-FDA-1088.
Please see Neulasta® Patient Information.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
Neulasta® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta® (Neulasta® Onpro® kit).

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[H5]

Important Safety Information
Do not take Neulasta® if you have had a serious allergic reaction to pegfilgrastim or filgrastim.
Before you receive Neulasta®, tell your healthcare provider about all of your healthcare conditions, including if you:
• Have a sickle cell disorder
• Have had severe skin reactions to acrylic adhesives

[H2] How the Neulasta® Onpro®
on-body injector works
Right after your strong chemo treatment, your healthcare provider will apply the on-body injector to your skin. The on-body injector is designed to automatically deliver your Neulasta® dose over 45 minutes, approximately 27 hours after application. Once your dose is complete, remove the injector and dispose of it according to the Patient Instructions for Use.
The summary does not replace the Patient Instructions for Use. If you are using Neulasta® Onpro®, it’s
important that you review the patient instructions and call your doctor if you have any questions.
[IMG: On Body Injector]

Fill indicator
The black line should be at “FULL” until dose
delivery starts. Check your instructions for
use for more information.

Adhesive pad
The pad attaches the on-body injector directly on
the skin on the back of your arm or abdomen.

Cannula window
Allows you to view the cannula
(a short, soft tube) that your
Neulasta® passes through during
the 45-minute dose delivery.

Audio
When you hear a beep, check the status light
and fill indicator. See your instructions for useto understand what these signals mean.

Status light
Flashing green: On-body injector is working properly.
Solid green (or turned off): Medication delivery should be complete. Check to see if the fill indicator reads “empty” and there is no noticeably wet adhesive.
Flashing red: On-body injector error—call your healthcare provider immediately.

[H2] Applying and removing the on-body injector
Watch this overview video to learn more about how your healthcare provider will apply the Neulasta® Onpro® on-body injector, how it is removed, and what to expect the next day.
This video does not replace the instructions for use. Please consult the instructions for
use when using the Neulasta® Onpro® kit.

To watch this video in Spanish, click here.
[H2] A PodPal™ adds extra adhesion
[IMG: PodPals Image]
For a more secure fit, an adhesive extender that fits around the on-body injector called a PodPal™ may be added by your doctor or nurse if they deem it appropriate. You can also ask your doctor or nurse about adding a PodPal™ when they put your Onpro® on-body injector in place.