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GRANIX- tbo-filgrastim injection, solution


  1. Patient Information
  2. Granix Is A Prescription Medicine:
  3. Before You Receive Granix, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. Granix Is Given By An Injection Under Your Skin (subcutaneous) By A Healthcare Provider. Your Healthcare Provider May Decide Injections Can Be Given At Home By You Or Your Caregiver. If Granix Is Given At Home, Granix Can Cause Serious Side Effects, Including:
  5. How Should I Store Granix?
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Manufactured By:
  9. Distributed By:

Patient Information 

Availability of Patient Information and Instructions for Use

Advise all patients and/or caregivers to read the FDA-approved Patient Information. For patients that are candidates for self-administration, assist patients and caregivers in understanding the contents of the Patient Information as well as the GRANIX Instructions for Use that are included with the product, and give them the opportunity to ask questions prior to initiating therapy.

Patient Training

Once it is determined that a patient is an appropriate candidate for self-administration or administration by a caregiver, instruct the patient or caregivers on the proper storage, preparation, and administration technique for GRANIX. Patients should be advised not to skip or change their dose or stop taking GRANIX without talking to their healthcare provider first. Advise the patients to read the FDA-approved Patient Information and Instructions for Use for further information.

Bone Pain

Bone pain is common. Analgesics such as acetaminophen or NSAIDS may be necessary[seeAdverse Reactions (6.1)].

Rupture or Enlargement of Spleen

Rupture or enlargement of the spleen may occur, which may be signaled by abdominal pain, left upper quadrant pain, or left shoulder pain. Advise patients to report onset of pain in these areas to their doctor immediately[seeWarnings and Precautions (5.1)].

Dyspnea

Dyspnea with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur. Advise patients to report dyspnea immediately to their doctor[seeWarnings and Precautions (5.2)].

Allergic Reactions

Serious allergic reactions, including anaphylaxis, rash, and urticaria: Patients should report such reactions immediately to their doctor[seeWarnings and Precautions (5.3)].

Sickle Cell Disorders

In patients with sickle cell disorders, sickle cell crisis and death has occurred. Discuss the potential risks and benefits for patients with sickle cell disorders prior to the administration of GRANIX[seeWarnings and Precautions (5.4)].

Glomerulonephritis

Symptoms may include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately[seeWarnings and Precautions (5.5)].

Infections

GRANIX is used in circumstances where the risk of infection is increased. Patients should be alert for signs of infection such as fever, redness or swelling, and should report these findings to their doctor immediately.

Pregnancy

Inform patients not to become pregnant while receiving GRANIX. If pregnancy occurs, advise patients of the possibility of fetal harm[seeUse in Specific Populations (8.1)].

Lactation

Inform lactating women that filgrastim was detected in breast milk for up to 3 days after dosing[seeUse in Specific Populations (8.2)].

See FDA-approved Patient Labeling (Patient Information) and Instructions for Use.

TBO-008

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2014-2019 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

Granix Is A Prescription Medicine: 

  • used in people with certain types of cancer (non-myeloid malignancies), who are receiving chemotherapy that affects the bone marrow
  • given to help decrease the length of time that the number of certain white blood cells (neutrophils) are very low (severe neutropenia). Neutrophils are white blood cells that are important in fighting bacterial infections.
It is not known if GRANIX is safe and effective in children younger than 1 month of age.Do not take GRANIXif you have had a serious allergic reaction to filgrastim products or pegfligrastim products.

Before You Receive Granix, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have a sickle cell disorder
  • have kidney problems
  • plan to have bone scans or tests
  • are pregnant or plan to become pregnant. It is not known if GRANIX will harm your unborn baby. You should not become pregnant during treatment with GRANIX.
  • are breastfeeding or plan to breastfeed. It is not known if GRANIX 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.

Granix Is Given By An Injection Under Your Skin (subcutaneous) By A Healthcare Provider. Your Healthcare Provider May Decide Injections Can Be Given At Home By You Or Your Caregiver. If Granix Is Given At Home, Granix Can 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 your left upper stomach (abdomen)-area or your left shoulder during treatment with GRANIX.
  • 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 fever, trouble breathing, or a fast rate of breathing.
  • Serious allergic reactions.GRANIX 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 GRANIX and call your healthcare provider or get emergency help right away.
  • Sickle cell crisis.You may have a serious sickle cell crisis if you have a sickle cell disorder and use GRANIX. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
  • Kidney injury (glomerulonephritis).GRANIX 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
    • you urinate less than usual
  • Capillary Leak Syndrome.GRANIX 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
  • 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 another filgrastim product. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

Your healthcare provider may decrease your dose, temporarily stop, or permanently stop treatment with GRANIX if you have certain side effects.

The most common side effect of GRANIX is bone pain.

Other possible side effects of other filgrastim products that may also happen with GRANIX may include muscle aches (myalgia), headache, weakness, diarrhea, fatigue, vomiting, inflamed blood vessels in the skin (cutaneous vasculitis), low platelet count (thrombocytopenia), and Sweet s syndrome (a rare skin condition that mainly includes fever and painful skin lesions that appear mostly on the arms, neck, head and trunk).

These are not all the possible side effects of GRANIX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Granix? 

  • Store GRANIX in the refrigerator between 36 F to 46 F (2 C to 8 C).
  • Keep GRANIX way from light to protect it. If your GRANIX prefilled syringe or vial comes in a carton, keep it in the carton until you are ready to use it, to protect from light.
  • Do notshake.
  • Take GRANIX out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
  • GRANIX can be left at room temperature for up to 5 days. If not used within 5 days, return GRANIX back to the refrigerator. Throw away (dispose of) GRANIX that has been left at room temperature for more than 5 days.
  • After you inject your dose, throw away (dispose of) any unused GRANIX left in the syringe or the vial. Do not save unused GRANIX in the syringe or vial for later use.

Keep GRANIX and all medicines out of the reach of children.

General information about the safe and effective use of GRANIX

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use GRANIX for a condition for which it was not prescribed. Do not give GRANIX to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about GRANIX that is written for health professionals.

Active Ingredient: 

tbo-filgrastim

Inactive Ingredients: 

glacial acetic acid, polysorbate 80, sorbitol, sodium hydroxide, and Water for Injection

Manufactured By: 

Sicor Biotech UAB

Vilnius, Lithuania

U.S. License No. 1803

Distributed By: 

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454


Product of Israel

Teva logo


TBOPL-006

2014-2018 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

For more information, call 1-800-896-5855.

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

Revised:07/2018



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