Granix

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Tbo-filgrastim is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Tbo-filgrastim is usually given within 24 hours after your chemotherapy dose. You will receive daily injections until your blood cell counts return to normal.

Do not stop using tbo-filgrastim or change your medication schedule without your doctor's advice.

If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

Do not shake the prefilled syringe. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

You will need frequent medical tests to help your doctor determine how long to treat you with tbo-filgrastim.

Store in the refrigerator, do not freeze. Protect from light.

You may store a prefilled syringe for up to 5 days at room temperature. If you do not use the syringe within 5 days, put it back into the refrigerator.

Do not use a prefilled syringe after the expiration date on the medicine label has passed.

Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Call your doctor for instructions if you miss a dose, or miss an appointment for your tbo-filgrastim injection.

• Teva Oncology

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known whether Granix crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication.Your doctor and you will decide if the benefits outweigh the risk of using Granix.

You should not use this medicine if you are allergic to filgrastim (Neupogen) or pegfilgrastim (Neulasta).

To make sure tbo-filgrastim is safe for you, tell your doctor if:

• you have a hemoglobin blood cell disorder such as sickle cell anemia, thalassemia;

• you have kidney disease; or

• you are scheduled to have a bone scan or other medical tests.

Using a G-CSF such as tbo-filgrastim can cause your spleen to rupture, which can be fatal. Talk with your doctor if you have concerns about this risk.

It is not known whether tbo-filgrastim will harm an unborn baby. Avoid pregnancy while you are being treated with this medicine.

It is not known whether tbo-filgrastim passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin (usually in the abdomen, front of the middle thighs, upper outer areas of the buttocks, or upper back portion of the upper arms).

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

Allow the medicine to warm at room temperature before you inject it. If the medicine in the pen has changed color, looks cloudy, or if you see particles in it, do not use it. Do not shake the syringe.

Each syringe of medicine is good for only one dose. Throw the syringe away after your dose. Do not save unused medicine from an opened syringe.

You should not use this medicine within 24 hours (1 day) before or after receiving cancer medicine or radiation treatments. However, do not use it within 24 hours before you begin another chemotherapy.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form:
  • For neutropenia:
    • Adults—Dose is based on body weight and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Leave the medicine in the carton until you are ready to use it. You may let the medicine warm up to room temperature before you use it. The medicine can stay out of the refrigerator for up to 5 days, and if not used can be returned to the refrigerator. Throw away any unused syringes stored at room temperature for more than 5 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Dark urine.
• A fast heartbeat.
• Dizziness or passing out.
• Sweating a lot.
• Shortness of breath.
• Fast breathing.
• Fever.
• Coughing up blood.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Purple spots or redness of the skin.
• Very bad headache.
• Swelling.
• Enlarged and ruptured spleens have happened with this medicine. Sometimes, ruptured spleens have been deadly. Call your doctor right away if you have left upper stomach pain or left shoulder pain.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain.
• Bone pain.
• Joint pain.
• Cough.
• Headache.
• Upset stomach.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

The efficacy of Granix was evaluated in a multinational, multicenter, randomized and controlled Phase 3 study in 348 chemotherapy-naive patients with high-risk stage II, stage III, or stage IV breast cancer receiving doxorubicin (60 mg/m2) and docetaxel (75 mg/m2) comparing Granix to placebo and a non-US-approved filgrastim product as controls. The median age of the patients was 50 years (range 25 to 75 years) with 99% female and 86% Caucasian.

Granix, placebo, and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.

Granix was superior to placebo in duration of severe neutropenia (DSN) with a statistically significant reduction in DSN (1.1 days vs. 3.8 days, p < 0.0001).

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

Revised: 02/2017

Granix® (tbo-filgrastim) Injection 300 mcg/0.5mL without Safety Needle Guard, 1s Carton Text

Granix®

(tbo-filgrastim)

Injection

300 mcg/0.5 mL

For Subcutaneous Use Only

A recombinant Granulocyte Colony-Stimulating

Factor (rG-CSF) derived from E Coli

1

Single-use prefilled syringe

WITHOUT a safety needle guard

NDC 63459-910-17

Rx only

Discard unused portion

300 mcg/0.5 mL

TEVA

Data not available

Use of tbo-filgrastim is not recommended unless the benefit outweighs the risk to the developing fetus. US FDA pregnancy category: Not Assigned Risk Summary: Limited published data on use during pregnancy are insufficient to inform a drug-associated risk.

Animal studies have revealed evidence of embryolethality and fetotoxicity at doses that produced maternal toxicity. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.