GETTING STARTED WITH FULPHILA®

Information brochure for patients

Supporting yourinner strength

This booklet provides answers to the most commonly asked questionsfrom patients like you, who have been prescribed Fulphila® (pegfilgrastim) for the treatment of febrile neutropenia following chemotherapy.

This booklet has been created as a helpful source of informationto support you throughout your treatment, covering topics such as:

Information in this booklet is not a substitute for any professional guidance, advice, or help provided by your doctor, nurse, or pharmacist.

If you have any other questions or concerns about your treatment with Fulphila®, please contact your doctor or nurse.

Meanings of all highlighted words are provided in the glossary at the back of this booklet.

About this booklet

How Fulphila®

helpsWhat youcan expect

When and how you willneed to take Fulphila®

Your body makes white blood cells called

neutrophils, which can sense and fight foreign

organisms.1 They are produced in the bone marrow

and are an important part of your immune system.2

Some forms of chemotherapy used in the treatment

of cancer suppress the production of neutrophils,

leaving you more vulnerable to infections and

fevers.3,4 Febrile means feverish and neutropenia

means an insufficiency of neutrophils.4,5

What isfebrile neutropenia?

Fulphila® is used to treat febrile neutropenia. Neutropenia isa condition where your body makes fewer white blood cells, leaving it vulnerable to infections and fevers. Neutropenia isthe most serious common side-effect of chemotherapy.

Fulphila® helps your body produce more white blood cells, thus boosting your immune system to help protect you from infections.

Fulphila® is given by subcutaneous injection(an injection just under the skin), at least24 hours after you receive chemotherapy.

About Fulphila® 6

Guide to Parts

PlungerRod

Before Use

Finger Grips

Label and Expiration Date

Syringe Barrel

Neulasta® is a product of Amgen Canada Inc.

Syringe Safety Guard

Needle Safety Spring

Gray Needle Cap On

Used SyringeBarrel

After Use

Used PlungerRod

Used Needle

Used NeedleSafety Spring

Gray Needle Cap Off

Fulphila® (pronounced FULL-FILL-A) is a biologic drug to treat febrile neutropenia. It is a biosimilar to the reference drug Neulasta® (pegfilgrastim).6 Biologic drugs are the most advanced medicines currently available, and are made using tiny microorganisms.7,8 Fulphila® is called a biosimilar because it has been shown to work in the same way and has the same benefits as the reference drug.6

Fulphila® comes in a prefilled syringe that contains pegfilgrastim, a protein that stimulates the bone marrow to produce neutrophils. It also contains polysorbate 20, sodium acetate, sorbitol, and water for injection.6

This is what a syringe of Fulphila® looks like:

What is Fulphila®?

Keep prefilled syringes out of the reach of children.

Store Fulphila® in the refrigerator between 2º C to 8º C (36º F to 46º F).Do not freeze.

If Fulphila® is accidentally frozen, allow it to thaw in the refrigerator before injecting. Do not try to warm it by using a heat source such as hot water or a microwave. However, if it is frozen a second time, do not use.

How to store Fulphila® 6

Throw away (dispose of) any Fulphila® that has been left at room temperature, 20º C to 25º C(68º F to 77º F), for more than72 hours.

Keep the prefilled syringe in the original carton to protect fromdirect sunlight or physical damage.

For all questions about storage, contact your doctor, nurse, or pharmacist.

Tell your specialist if:

• You have sickle cell trait or sickle cell disease.

• You are pregnant, plan to become pregnant, think you may be pregnant, or are breast feeding.

• You are taking other medications, including any drugs, vitamins, minerals, natural supplements,or alternative medicines.

Do not use Fulphila® if:

• You are allergic to pegfilgrastim (Fulphila®), filgrastim, any of the ingredients of Fulphila®,or to other products made using the bacteria Escherichia coli. Talk to your doctor if you haveany questions about this information.

Overdose:If you think you have taken too much Fulphila®, contact your healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed dose:As there should be a two-week period between Fulphila® and your next course of cancer chemotherapy, if you miss a planned dose, consult your doctor before taking the missed dose.

Before taking Fulphila® 6

Your doctor will decide if you can give yourself the injection, and will show you or your caregiver how to do it. Do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.

How to prepare andgive a Fulphila® injection6

The recommended dosage of Fulphila® is a single subcutaneous injection,just under the skin, of 6 mg (the contents of one prefilled syringe), administered once per cycle of chemotherapy. You must wait at least 24 hours after your course of cancer chemotherapy before injecting Fulphila®.

The following instructions are not intended to take the place of your doctor’s advice, but can be helpful. You can also find an instructional video at

IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, FOLLOW THESE INSTRUCTIONS EXACTLY AS PROVIDED.

www.fulphila.ca

A. Find a clean, well-lit and flat working surface, such as a table.

B. Take the prefilled syringe out of the refrigerator30 minutes before use and allow it to reach room temperature before giving an injection.

C. Make sure the name Fulphila® appears on the carton and prefilled syringe label and that the dose strength is 6 mg/0.6 mL.

D. Remove the prefilled syringe tray from the carton.

E. Gather the supplies for the injection: alcohol wipes, a cotton ball or gauze pad and an approved sharps disposal container.

F. Wash hands thoroughly with soap and water.

Step 1: Gather supplies

A. Open the tray by peeling away the cover.Grab the prefilled syringe safety guard to remove the prefilled syringe from the tray.

FOR SAFETY REASONS:

� Do not grab the plunger rod.

� Do not grasp the gray needle cap.

� Do not shake the prefilled syringe. If the prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.

B. Inspect the medicine and prefilled syringe.The liquid contents should be clear and colorless.

Do not use the prefilled syringe if:

• The medicine is cloudy or discolored,or contains flakes or particles.

• The prefilled syringe has been dropped.

• Any part appears cracked or broken.

• The gray needle cap is missing ornot securely attached.

• The expiration date printed on the labelhas passed.

In all cases, use a new prefilled syringe andcall your healthcare provider.

Step 2: Prepare for injection

Upper OuterArea of Buttocks

Upper Arms

Stomach Area(Abdomen)

Thighs

Upper Arms

C. Choose an injection site and clean it with an alcohol wipe. Let the skin dry.

There are four recommended injection sites:The thigh; the stomach area (abdomen), except fora 2-inch area right around the navel (belly button); the upper outer area of the buttocks (only if someone else is giving you the injection); andthe outer area of the upper arm (only if someone else is giving you the injection).

D. Hold the prefilled syringe by the safety guard. When ready, carefully pull the gray needle cap straight off and away from the body.

If you want to use the same injection site,make sure it is not the same spot you usedfor a previous injection.

� Do not touch this area again before injecting.� Do not inject into areas where the skin is tender,

bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

� Do not twist or bend the gray needle cap.� Do not hold the prefilled syringe by the plunger rod.� Do not put the gray needle cap back onto the

prefilled syringe.

A. Pinch the cleaned injection site to create a firm surface. Keep skin pinched while injecting.

B. Holding the pinched skin, insert the needle into the skin between 45 and 90 degrees.

C. Using slow and constant pressure, push the plunger rod until it reaches the bottom. The plunger must be pushed fully in order to administer the full dose.

D. Once the entire dose has been delivered, the needle safety guard will be triggered and either of the following actions can be followed:Release the plunger until the entire needle is covered and then remove the needle from the injection site. Or gently remove the needle from

Step 3: Inject the dose

� Do not touch the cleaned area of the skin.

the injection site and release the plunger until the entireneedle is coveredby the needlesafety guard.

After releasing the plunger, the prefilled syringe safety guard will safely cover the injection needleOnce the needle has been removed from the injection site dispose of the syringe as per Step 4.

• If the guard is not activated or only partially activated, discard the product (without replacing the needle cap) as in Step 4.

• If your injection is given by another person,he or she should also be careful when removing the needle from your skin in order to prevent accidental needlestick injury andpossible infections.

• When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received the full dose. Call your healthcare provider right away.

E. Examine the injection site. If there is blood, press a cotton ball or gauze pad on theinjection site. Do not rub the injection site.Apply an adhesive bandage if needed.

A. Put the used prefilled syringe and other supplies in an approved sharps disposal container right away after use. Do not throwthe syringe in the household garbage.

Step 4: Dispose of supplies

If you do not have an approved sharpsdisposal container, you may use a household container that is:

• Made of heavy-duty plastic

• Can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out

• Upright and stable during use

• Leak-resistant

• Properly labeled to warn of hazardous waste inside the container

Do not use glass or clear plastic containers.

DO NOT:

� Do not throw the container in the household garbage.

� Do not recycle.

� Do not reuse the prefilled syringe.

� Do not recycle prefilled syringes or throw them into household waste.

B. When your sharps disposal container isalmost full, you will need to tape around thecap or lid and:

• Check with your doctor, nurse, or pharmacist for instructions on how to properly dispose of the filled container.

Important: Keep the syringe and sharps disposal container out of the reach of children.

Tell your specialist if:

• You develop signs of infection, such as fever, chills, rash, sore throat, diarrhea, or redness, swelling, or pain around a cut or sore.

• There is a lump, swelling, orbruising at the injection site that does not go away.

IMMEDIATELY tell your specialist if:

• You develop any symptoms ofsevere side effects.

After taking Fulphila® 6

Below are some of the serious side effects from using Fulphila®. This is not a complete list.

VERY COMMON (≥10%)Bone pain.

UNCOMMON (≥ 0.1% and < 1%)Allergic reactions including the following symptoms: rash over the whole body, shortness of breath, a drop-in blood pressure (usually causing dizziness or lightheadedness), swelling around the mouth or eyes, fast pulse, weakness, sweating; severe redness or swelling or itching at injection site.

*Splenic rupture (including the following symptoms: left upper abdominal pain or pain at the tip of your shoulder).

*Cutaneous vasculitis (including the following symptoms:a rash in the skin surface that looks like purple or red spots or bumps, clusters of small dots, splotches or hives. Your skin may also be itchy).

What are possible side effects from using Fulphila®?6

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Symptom/Effect Talk to your healthcare professional Stop taking drug and getimmediate medical helpOnly if severe In all cases

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RARE (≥ 0.01% and < 0.1%)Acute respiratory distress syndrome (including the following symptoms: fever, shortness of breath, cough, or congestion in your lungs).

Capillary leak syndrome (including the following symptoms: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness).

Kidney injury (glomerulonephritis) (including the following symptoms: puffiness in your face or ankles, blood in your urine or brown colored urine, or if you notice that you urinate less often than usual).

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Symptom/Effect Talk to your healthcare professional Stop taking drug and getimmediate medical helpOnly if severe In all cases

*No serious events were reported in clinical trials, frequency reflects all adverse events.

If you have a troublesome symptom or side effect that is not listed here, or becomes bad enough to interferewith your daily activities, talk to your healthcare professional.

�

�

�

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You can report any suspected side effects associated with the use of health productsto Health Canada by:

Visiting the web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or by

Calling toll-free at 1-866-234-2345

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Reporting side effects6

If you want more information about Fulphila®:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/indexeng.php);Mylan’s website (www.mylan.ca),or by calling 1-844-596-9526

During and after the treatment• Anything you can do to reduce your stress and to

enhance your comfort, joy, and satisfaction can have a major effect on your well-being.9

• Meditation, yoga, and visualization exercisesmay be valuable additions to your daily orweekly routine.10

• Healthy eating means eating a variety of foods that give you the nutrients you need. These nutrients include protein, carbohydrates, fiber, fat, water, vitamins, and minerals.10

• Studies have shown that exercises and maintenance of body weight in a healthy range may also reduce the risk of recurrences.9

• Although it can be difficult, try to engage in 20 minutes of physical activity per day. Moderate

exercises include walking, stretching, dancing, water aerobics, and yoga. If you are able, vigorous exercises include biking, hiking, jogging, running, and swimming.10

• Please consult your healthcare professionalon regular exercise, maintaining a healthy diet,and weight.

List all the medicines you take, including all over-the-counter medicines, vitamins, and supplements.Talk with your doctor before taking any new over-the-counter medicines, vitamins, or supplements.

Medicines I'm taking

List of medications Dose, frequency and time

• Reimbursement navigation

• Insurance coverage assistance for public and private drug plans

• Help with necessary paperwork

• Ongoing updates on patient reimbursement status

• Primary point of contact for all Healthcare Professionals and Drug Access Coordinators

• Easy to use portal to enroll patients

• Patient-centric approach to meet patient needs to minimize access barriers

Additional supportfor patients:

• Injection services

• Ongoing updates on patient infusion status

• Information on Fulphila®

and Biosimilars

Providing patient support for Fulphila®

Monday to Friday

Phone:

Fax:

Email:

website:

8:00 AM to 8:00 PM EST

1-833-847-4323

1-833-794-2382

BiosimilarsCanada@innomar-strategies.com

www.BiosimilarsCanadaPSP.com

For more information onMylan’s biosimilars go to

mylanbiosimilars.ca

For more information aboutFulphila® please visit

www.fulphila.ca

Providing patient support for Fulphila®

Biologic drug: A drug produced from living organisms or contains a component of living organisms. A biologic drug may contain a wide variety of products from human, animal,or microorganisms.Examples: vaccines, recombinant proteins, etc.11

Biosimilar: A biological medical product which possesses a high similarity to another already approved medicine. It also has a similar pharmaceutical quality, efficacy and safety profileas a biologic drug that was already authorizedfor sale.12

Cancer: It is a group of diseases causing abnormal and uncontrolled growth of cells in the body, mostly resulting in tumors. Tumors can be benign

Glossary(non-cancerous) or malignant (cancerous).Cancer cells from malignant tumor (primary site) can travel to invade other healthy tissues. This process of spreading is called metastasis.13,14

Chemotherapy: Treatment with powerful chemicals (drugs) to kill fast-growing cancer cells, preventing cancer from spreading or to treat recurred cancer. Chemotherapy is often used either alone or with surgery and or radiation.14

1. Healthdirect. White Blood Cells. Available from: https://www.healthdirect.gov.au/white-blood-cells Accessed on: Dec 20th, 2019.

2. AboutKidsHealth. Bone marrow and the immune system. Available from: https://www.aboutkidshealth.ca/Article?contentid=1511&language=English Accessed on: Dec 20th, 2019.

3. Willis-Knighton Cancer Center. Chemotherapy for cancer treatment. Available from: https://www.wkhs.com/cancer/cancer-treatment-services/hematology-medical-oncology/chemotherapy Accessed on: Dec 20th, 2019.

4. Hassan BA, Yusoff ZB, Othman SB. A Close Look at Neutropenia among Cancer Patients—Risk Factor and Management. Updates on Cancer Treatment. 2015:201. DOI: 10.5772/60794.

5. National Cancer Institute. NCI Dictionary of Cancer Terms: Febrile Neutropenia. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/febrile-neutropenia Accessed on: Dec 20th, 2019.

6. Fulphila® (pegfilgrastim) Product Monograph, BGP Pharma ULC.PDF copy available at mylan.ca.

7. Introduction to Biologics. Available from: https://www.iapo.org.uk /sites/default/files/files/factsheet1.pdf Accessed on: Jan 23rd, 2020.

8. GoodRx. What Are Biologics? 5 Examples of Biological Drugs You May Already Be Taking. Available from: https://www.goodrx.com/blog/ biologics-biological-drugs-examples/ Accessed on: Jan 23rd, 2020.

9. ESMO. What is breast cancer? Available at: https://www.esmo.org/content/download/6593/114959/file/EN-Breast-Cancer-Guide-for-Patients.pdf Accessed on: 3 February, 2020.

References10. ESMO. What does survivorship mean? Available at:

https://www.esmo.org/content/download/117593/2061518/file/ESMO-Patient-Guide-Survivorship.pdf Accessed on: 3 February, 2020.

11. Biologics (Biologic Drug Class). Available at: https://www.medicinenet.com/ biologics_biologic_drug_class/article.htm Accessed on: 11 February, 2020.

12. Biologics, Radiopharmaceuticals and Genetic Therapies. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies.html Accessed on: 11 February, 2020.

13. Understanding Cancer: Metastasis, Stages of Cancer, and More. Available at: https://www.medicinenet.com/cancer_101_pictures_slideshow/article.htm Accessed on: 11 February, 2020.

14. Glossary: Definitions & Phonetic Pronunciations. Available at: https://www.cancer.org/cancer/glossary.html#alpha-c Accessed on:11 February, 2020.

The FULPHILA® Product Monograph is also available upon request by calling 1-844-596-9526.

FULPHILA® is a registered trademark of Mylan Institutional Inc.,used under permission by BGP Pharma ULC, a Mylan company.

Mylan® is a registered trademark of Mylan Inc., used under permission by BGP Pharma ULC, a Mylan company.

Copyright© 2020 BGP Pharma ULC, a Mylan company. All rights reserved.

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