Understanding how GRANIX® (tbo-filgrastim) Injection may help you

Understanding how GRANIX® (tbo-filgrastim) Injection may help you during chemotherapy

Approved use of GRANIXGRANIX is a prescription medication given to people with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

It is not known if GRANIX is safe and effective in children under 18 years of age.

Please see Important Safety Information on pages 6–7 and accompanying Full Prescribing Information.Please contact your healthcare treatment team with any questions that you may have.

A guide for patients

Normal white blood cell count

Low white blood cell count

2

Your chemotherapy treatment may cause a condition called severe neutropeniaChemotherapy helps treat cancer, but sometimes it can cause unwanted side effects. One of those potential side effects is called severe neutropenia (nu-tro-PEEN-ee-ah), a low level of neutrophils (nu-tro-fils), a type of white blood cell that helps fight infection in the body.

Chemotherapy attacks the fast-growing cells in your body, including cancer cells. It can also attack other cells that grow quickly, like hair and red blood cells. Some types of chemotherapy attack the bone marrow, where white blood cells are made. When that happens, your body produces fewer white blood cells, which exposes you to the risk of infection and neutropenia.

Counting white blood cellsYour healthcare provider may perform blood tests the day before you begin chemotherapy and every 3 days or so during treatment. One of these tests, called an absolute neutrophil count (or ANC), tells your doctor how many neutrophils (a type of white blood cell) your body is making. Talk to your doctor about your test results. Depending on your white blood cell count, you might have neutropenia or be at risk for infection.

Symptoms of infectionIf you are neutropenic, you may experience the symptoms below (some of which you might normally have with a cold or flu):

» A fever greater than 100.4 degrees F

» Shaking or sweating chills

» Sore throat or sores in your mouth

» Cough

» Burning with urination or frequent urination

» Shortness of breath

» Diarrhea

» Skin changes

» Redness, swelling, or drainage around an injury, or entry wound to the body such as a port or IV line

Please see accompanying Full Prescribing Information.

What is severe neutropenia?Neutropenia is a low level of neutrophils (nu-tro-fils), a type of white blood cell that helps fight infection in the body. When your level of neutrophils gets low, your body has fewer white blood cells, and your risk of getting sick increases. If your neutrophil count falls below a certain level, you may have severe neutropenia.

Severity of neutropenia and degree of risk*†

ANC SEVERITY OF NEUTROPENIA RISK OF INFECTION

1000–1500 Mild Low

500–1000 Moderate Moderate

less than 500 Severe High

*Based on accepted ANC ranges published in Clinical Cornerstone. 2006;8[suppl 5]:S5-S11. †National Neutropenia Network. Understanding Severe Chronic Neutropenia Handbook. 2010.

Why has my doctor prescribed GRANIX® (tbo-filgrastim) Injection?Doctors may prescribe GRANIX when their patients are at risk for severe neutropenia while they receive chemotherapy. GRANIX helps decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

Are there side effects with GRANIX?Yes–it is important to discuss potential side effects with your doctor. You can also find some of the side effects throughout this brochure and on page 6-7.

Please see Important Safety Information on pages 6–7 and accompanying Full Prescribing Information.4

GRANIX® (tbo-filgrastim) Injection helps support your body’s efforts to make white blood cellsDoctors may prescribe GRANIX to people with certain types of cancer who are receiving chemotherapy that affects the bone marrow. GRANIX helps decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

Severe neutropenia can put you at risk for infectionsThe lower your white blood cell count gets and the longer it stays low, the greater your chances for developing potentially serious infections. GRANIX may help limit periods of very low white blood cell counts (severe neutropenia), so your body is better able to fight off infections that might otherwise interfere with your chemotherapy schedule.

GRANIX may help limit periods of severe neutropenia In a clinical study, GRANIX reduced the time patients had severe neutropenia to a little more than a day. As part of the study, a group of patients not treated with GRANIX had severe neutropenia for almost 4 days.

What should I tell my doctor before I receive GRANIX? Before you take GRANIX, tell your doctor if you have sickle cell anemia or other blood problems, plan to have bone scans or tests, are allergic to filgrastim (Neupogen®) or pegfilgrastim (Neulasta®), or have any other medical conditions. It is not known if GRANIX will harm an unborn baby or passes into breast milk; tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

GRANIX® (tbo-filgrastim) Injection may help you during your chemotherapy If you are undergoing chemotherapy, it’s important to do what you can to prevent infection and stay on track with your treatment. In addition to taking GRANIX, here are some things you can do: wash your hands frequently; avoid large crowds at places like schools and malls; stay away from anyone with a cold or the flu; don’t wade or swim in rivers, lakes, or water parks—just to name a few. Ask your doctor about other ways to prevent infection.

Please see accompanying Full Prescribing Information.6

Approved use & Important Safety Information

What is GRANIX® (tbo-filgrastim) Injection?GRANIX is a prescription medication given to people with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

It is not known if GRANIX is safe and effective in children under 18 years of age.

What should I tell my doctor before I receive GRANIX? Before you take GRANIX, tell your doctor if you have sickle cell anemia or other blood problems, plan to have bone scans or tests, are allergic to filgrastim (Neupogen®) or pegfilgrastim (Neulasta®), or have any other medical conditions. It is not known if GRANIX will harm an unborn baby or passes into breast milk; tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

What are the possible side effects of GRANIX?Spleen rupture, which can cause death. Call your doctor right away if you have pain in your left upper stomach area or left shoulder area while taking GRANIX. This pain could mean your spleen is enlarged or ruptured.

A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Get medical help right away if you have any of these symptoms of ARDS: fever, shortness of breath, trouble breathing.

Serious allergic reactions. If you have a serious allergic reaction during a GRANIX® (tbo-filgrastim) Injection, stop giving yourself the injection and call your doctor right away. Symptoms of serious allergic reaction can occur during or after your injection and include: a rash over the whole body, shortness of breath, trouble breathing (wheezing), dizziness, swelling around the mouth or eyes, fast heart rate, sweating.

Severe Sickle Cell Crisis in people with sickle cell disease. If you have sickle cell disease, talk to your doctor about the risks of taking GRANIX.

The most common side effect of GRANIX is bone pain. Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of GRANIX. For a complete list, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch, or call 1-800-FDA-1088.


How GRANIX® (tbo-filgrastim) Injection is taken

GRANIX is delivered by an injection under your skin (called a “subcutaneous” injection). This can be given by a doctor or a nurse. Or, you may be able to take GRANIX at home, either by yourself or with the help of a friend or loved one.

» Follow the detailed Instructions for Use included with your GRANIX package for information about the right way to:

– store GRANIX

– read the syringe markings and adjust the amount of medicine

– prepare and administer an injection

» GRANIX injections can be given by a doctor or nurse, or your doctor may decide that your injections can be given at home by you or your caregiver

» Your doctor will tell you how much GRANIX to inject and the timing of when to inject it. Inject GRANIX exactly as prescribed.

» Do not change your dose unless your doctor tells you to

» GRANIX is given by an injection under your skin (subcutaneous injection)

» Your doctor will show you or your caregiver how to prepare for an injection and how to inject GRANIX before you use it for the first time

» Your first dose of GRANIX is given at least 24 hours after you receive your chemotherapy

» GRANIX injections are usually given 1 time each day until your white blood cell count returns to normal

» If you miss a dose or forget to take your dose of GRANIX® (tbo-filgrastim) Injection, speak to your doctor about when to take your next dose

» If you use too much GRANIX, call your doctor right away

» If you or your caregiver get GRANIX on your skin, wash the area with soap and water

» If you or your caregiver get GRANIX in your eyes, flush your eyes with water and call your doctor right away

» Your doctor will test your blood before your chemotherapy and during your GRANIX treatment until your white blood cell count returns to normal

» Keep all of your appointments for your GRANIX injections and blood tests

» Do not stop taking GRANIX without talking to your doctor

5

Instructions for UseGRANIX (GRAN-icks)

(tbo-filgrastim)Injection, for subcutaneous use

Important: Keep the GRANIX syringe out of the reach of children.About the GRANIX syringeDepending on the prescription that your doctor gave you, you will receive a syringe that provides a dose of either 0.1mL to 0.5mL or 0.1mL to 0.8mL. If you are prescribed a dose over 0.8mL, two syringes will be required to reach your prescribed dose. Your doctor will determine how many syringes and the correct dose in milliliters (mL) you will need to give based on your body weight. You should continue to give GRANIX daily until your doctor informs you that your white blood cell count has returned to normal.

Make sure you understand the following:• How to store your syringes.• How to read the syringe markings.• How to adjust the amount of GRANIX in the syringe for your pre-

scribed dose.• How to prepare and give the injection.

Do not shake syringes. Do not remove the needle cap until you are ready to inject.Do not re-use a syringe. The syringe is for single-use only.Do not use earlier than 24 hours following the end of your chemo-therapy cycle.Dosing schedule Inject your total daily dose 1 time each day as prescribed by your doctor, starting at least 24 hours (1 day) after the end of your chemotherapy cycle. You should continue to give GRANIX daily until your white blood cell count returns to normal.

How to store your GRANIX syringes • Always store the GRANIX syringes in a refrigerator at a tem-

perature between 36°F to 46°F (2°C to 8°C). • Always store the syringes in the carton to protect them from

light. • GRANIX syringes can be left unrefrigerated for a single period

of up to 5 days, and if not used can be returned to the refriger-ator.

• When preparing to inject, you will need to let the syringe(s) adjust to room temperature for 30 minutes.

• Throw away (dispose of) your syringes if stored at room tem-perature for more than 5 days.

GRANIX® (tbo-filgrastim) injection GRANIX® (tbo-filgrastim) injection

Determining how many syringes you need for your daily dose • If your prescribed daily dose is 0.5mL or less, use 1 syringe.• If your prescribed daily dose is

0.8mL or less, use 1 syringe.• If your prescribed daily dose is

more than 0.8mL you will need to prepare 2 syringes in order to match your prescribed dose:

◦ Adjust your first syringe to 0.8mL.

◦ Adjust your second syringe to the additional amount required to make up your total prescribed dose.

◦ Make sure the amounts in both syringes add up to your prescribed dose (See the table to the right to determine how much medicine should be in each syringe).

For example: If your prescribed dose is 1mL you would prepare 1 syringe with 0.8mL and a second syringe with 0.2mL.

Important: When using two syringes always adjust the first syringe to 0.8mL.How to read the syringe markings What the markings on the syringe mean:The syringe is labeled in 0.1mL unit increments from 0.1mL to 0.8mL. There is a line next to each 0.1mL unit increment.To read the dose scale always hold the syringe with the needle-end facing up so that 0.1mL is at the top and 0.8mL is at the bottom.

How to adjust the medicine level for your prescribed dose • When setting your dose, (See 2C) you will line up the top edge

of the grey rubber stopper with the line on the syringe scale that matches your prescribed dose.

0.1mL - 0.5mL0.1mL - 0.8mL

0.9mL - 1.6mL

1 Syringe

2 Syringes

DOSE NUMBER OF SYRINGES

medication and includes an air gap. As part of the preparation process you will need to carefully remove the air gap and some of the medication in order to match your prescribed dose.

EXP: MO / YR0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

mLGraduation 0.1 mL

EXP: MO / YR0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

mLGraduation 0.1 mL

EXP: MO / YR0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

mLGraduation 0.1 mL

Note: Each syringe comes over�lled with

EXP

: M

O / Y

R0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

mLGraduation 0.1 mL

Needle Cap

Needle Label Plunger

Thumb PadDose Scale

Syringe Body

CALENDARSu Mo Tu We Th Fr Sa

One time each day

EXP: MO / YR

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8mL

Gra

du

ati

on

0.1

mL

0.8mL + 0.2mL = 1.0mL

EXP: MO / YR

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8mL

Gra

du

ati

on

0.1

mL

Use the table below to calculate if you will need to administer one or two injections for your prescribed dose.

Dose

0.1mL0.2mL0.3mL0.4mL0.5mL0.6mL0.7mL0.8mL0.9mL1.0mL1.1mL1.2mL1.3mL1.4mL1.5mL1.6mL

0.1mL0.2mL0.3mL0.4mL0.5mL0.6mL0.7mL0.8mL0.8mL 0.1mL+

0.2mL+0.3mL+0.4mL+0.5mL+0.6mL+0.7mL+0.8mL+

0.8mL0.8mL0.8mL0.8mL0.8mL0.8mL0.8mL

1st InjectionAmount

2nd InjectionAmount

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8mL

Gra

du

ati

on

0.1

mL

DosageFill

Lines

Syringe Label(0.1mL-0.5mL)

0.1

0.2

0.3

0.4

0.5

0.6

0.7

Gra

du

ati

on

0.1

mL

Align Top Edge of Stopper

to Dosage Fill Line

0.8mL0.8mL

DosageFill

Lines

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8mL

Gra

du

ati

on

0.1

mL

Syringe Label(0.1mL-0.8mL)


Learn about CORE» GRANIX® (tbo-filgrastim) Injection is part of the Teva Oncology Comprehensive

Oncology Reimbursement Expertise (CORE) program

CORE can help you understand your insurance benefits and may help you identify alternative funding sources for your treatment

Look for more information about CORE on page 14.

Call 1.888.587.3263 Fax 1.866.676.4073 Visit TevaCORE.com

Find helpful resources at GRANIXrx.com Go to GRANIXrx.com anytime day or night for information on GRANIX® (tbo-filgrastim) Injection and neutropenia.

Helpful resources and tools to help you with everything from preparation to injection to storage.

Downloadable self-injection instructions for taking GRANIX at home. If you need additional instructions, or have questions, contact your doctor’s office.

GRANIXrx.comAvailable anytime 24/7


The GRANIX® (tbo-filgrastim) Injection Patient Savings Program

Offers financial support for cash-paying and commercially insured patients

Up to $14,000 savings per calendar year.

Please see terms and conditions on right.

$0Pay No

More Than

Terms and Conditions» Patients are not eligible if prescriptions are paid for in part or full by any state or federally

funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD, TRICARE, or by private health benefit programs which reimburse patients for the entire cost of prescription drugs

» This offer is not valid for patients who are Medicare eligible and are enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (ie, patients who are eligible for Medicare Part D but receive a prescription drug benefit through a former employer)

» No enrollment form required

» This is not an insurance program

» Up to $14,000 savings per calendar year

» Patients must be 18 years of age or older to participate

» Offer may not be used with any other discount, coupon, or offer

» Void if copied, transferred, purchased, altered, or traded and where prohibited or restricted by law

» Teva Pharmaceuticals reserves the right to rescind, revoke, or amend this offer at any time without notice

» Patients must show the pharmacist their primary insurance card and GRANIX prescription to participate in this offer

» By redeeming this offer, patients acknowledge that they agree with the terms and conditions of this offer

To find out more about the GRANIX Patient Savings Program or other available financial assistance, call Teva CORE at 1-888-587-3263, Monday through Friday 9 am to 8 pm ET. If you wish to discontinue participation in this program, please speak to your pharmacist.


Resources for patients and caregiversAs a patient with cancer, you and your loved ones have a wide range of resources and support organizations that are ready to assist you.

This is a list of helpful resources. Please note that this information was accurate at the time of publication, but it is subject to change without notice. Ask your healthcare team to recommend more resources.

GRANIX® (tbo-filgrastim) Injection website Information about severe neutropenia and your treatment with GRANIX. GRANIXrx.com

Teva Oncology CORE A convenient reimbursement resource that provides a support program along with online tools to help make it easier to understand the reimbursement process. 1-888-587-3263, Monday–Friday, 9 AM–8 PM ET TevaCORE.com

American Cancer Society® (ACS) Education, news, and networks. 1-800-227-2345 cancer.org

CancerCare® A national organization offering free information and support services to cancer patients, their loved ones, caregivers, and the bereaved. CancerCare provides access to educational publications and workshops, financial assistance programs, support groups, and individual counseling with oncology social workers. 1-800-813-HOPE (4673) cancercare.org

Cancer Hope Network Free and confidential one-on-one support for cancer patients and their families. 1-877-HOPENET (467-3638) cancerhopenetwork.org

Cancer Support CommunityProvides support, education, and hope to people affected by cancer. 1-888-793-9355 cancersupportcommunity.org

Cancer Wellness CenterFree services and resources for cancer patients in most states across the country. cancerwellnesscenter.org

National Coalition for Cancer Survivorship (NCCS)A nationwide network of independent organizations and individuals working in the area of cancer support and information. 1-877-NCCS-YES (622-7937) canceradvocacy.org

This is a list of sources that you may find helpful. Please note that this information was accurate at the time of publication, but subject to change without notice. Ask your healthcare team to recommend additional resources.


Talking to your doctor is importantHere are some questions to consider asking your healthcare provider before and during your cancer treatment:

» Am I at risk of developing severe neutropenia?

» If I have a very low white blood cell count, how might it affect my treatment plan?

» What can I do to lower my risk of severe neutropenia?

» How will I know if I have severe neutropenia?

» What should I do if I think I have severe neutropenia?

» If I get a fever, does that mean I have a very low white blood cell count?

» How will you decide whether to treat my severe neutropenia?

» What will you do if the treatment doesn’t help raise my white blood cell count?

» What are some of the side effects that I should be aware of?

Notes

©2016 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a registered trademark of Teva Pharmaceutical Industries Ltd.All rights reserved. GRX-40984 October 2016.

NEUPOGEN® and Neulasta® are registered trademarks of Amgen Inc.

For more information, visit GRANIXrx.com

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Understanding how GRANIX® (tbo-filgrastim) Injection may help you