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ZARXIO- filgrastim-sndz injection, solution


  1. What Is Zarxio?
  2. Before You Take Zarxio, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  3. How Will I Receive Zarxio?
  4. General Information About The Safe And Effective Use Of Zarxio:
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Important:
  8. About The Zarxio Prefilled Syringe:
  9. If You Do Not Have An Fda-cleared Sharps Disposal Container, You May Use A Household Container That Is:
  10. Manufactured By:
  11. Patient Information
  12. Advise Patients Of The Following Risks And Potential Risks With Zarxio:
  13. Instruct Patients Who Self-administer Zarxio Using The Prefilled Syringe Of The:

What Is Zarxio? 

ZARXIO is a man-made form of granulocyte colony-stimulating factor (G CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body s fight against infection.

Do not take ZARXIOif you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.

Before You Take Zarxio, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give ZARXIO using the prefilled syringe if you have latex allergies.
are pregnant or plan to become pregnant. It is not known if ZARXIO will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ZARXIO 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.

How Will I Receive Zarxio? 

ZARXIO injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If ZARXIO is given at home,

Store ZARXIO in the refrigerator between 36 F to 46 F (2 C to 8 C).
Donotfreeze.
Store ZARXIO in the original pack to protect it from light.
Donotshake ZARXIO.
Take ZARXIO out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
ZARXIO may be allowed to reach room temperature for up to 24 hours. Throw away (dispose of) any ZARXIO that has been left at room temperature for longer than 24 hours.
After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe.Do notsave unused ZARXIO in the prefilled syringe for later use.

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

General Information About The Safe And Effective Use Of Zarxio: 

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

Active Ingredient: 

filgrastim-sndz

Inactive Ingredients: 

glutamic acid, polysorbate 80, sorbitol, sodium hydroxide, water for injection

Manufactured by: Sandoz Inc., Princeton, NJ 08540, US License No. 2003

At: Sandoz GmbH, Langkampfen, Austria, Product of Austria

For more information visit www.zarxio.com or call 1-800-525-8747.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2019

Instructions for Use

ZARXIO(zar-zee-oh)

(filgrastim-sndz)

injection

Important: 

Do not inject yourself or someone else until you have been shown how to inject ZARXIO.Your healthcare provideror nurse will show you how to prepare and inject ZARXIO properly using the ZARXIO prefilled syringe with UltraSafe PassiveNeedle Guard. Talk to your healthcare provider or nurse if you have any questions.
You should not inject a dose of ZARXIO less than 0.3 mL (180 mcg) from a ZARXIO prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the ZARXIO prefilled syringe.
Do not usethe ZARXIO prefilled syringe if either the seal on the outer pack or the seal of the blister are broken.
Keep the ZARXIO prefilled syringe in the sealed pack until you are ready to use it.
The needle cap on the prefilled syringe contains natural rubber (derived from latex). Do not handle the prefilled syringe if you are allergic to latex.
The prefilled syringe has a needle guard that will be activated to cover the needle after the injection is given. The needle guard will help prevent needle stick injuries to anyone who handles the prefilled syringe.
Avoid touching the syringe needle guard wings before use. Touching them may cause the syringe needle guard to be activated too early.
Do not remove the needle cap until just before you give the injection.
Throw away (dispose of) the used ZARXIO prefilled syringe right away after use.Do not re-use a ZARXIO prefilled syringe.

Store ZARXIO in the refrigerator between 36 F to 46 F (2 C to 8 C).
Protect from freezing ZARXIO. If frozen, thaw in the refrigerator before use. Throw away (dispose of) if it has been frozen more than 1 time.
Store ZARXIO in the original pack to protect it from light.
Avoid shaking ZARXIO.
Take ZARXIO out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
ZARXIO may be allowed to reach room temperature for up to 24 hours.Throw away (dispose of) any ZARXIO that has been left at room temperature for longer than 24 hours.
After you inject your dose, throw away (dispose of) any unused ZARXIO left in the prefilled syringe. Do not save unused ZARXIO in the prefilled syringe for later use.

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

About The Zarxio Prefilled Syringe: 

ZARXIO prefilled syringes come in two strengths. Depending on your prescription, you will receive ZARXIO prefilled syringes that contain 300 mcg/0.5 mL or 480 mcg/0.8 mL of medicine. Your healthcare provider will determine the dose in milliliters (mL) that you will need to give based on your body weight.
When you receive your ZARXIO prefilled syringes, always check to at the end of this Instructions for Use.

Preparing the ZARXIO prefilled syringe

Step 1. Find a clean, well-lit, flat work surface.

Step 2. Take the pack containing the ZARXIO prefilled syringe out of the refrigerator and leave itunopened on your work surfacefor about 30 minutes so that it reaches room temperature.

Step 3. Wash your hands well with soap and water.

Step 4. Remove the ZARXIO prefilled syringe from the outer pack and take it out of the blister.

Step 5. Check the expiration date.Do not usethe ZARXIO prefilled syringe if the expiration date has passed.

Step 6. Look through the viewing window on the ZARXIO prefilled syringe. The liquid inside should be clear. The color may be colorless to slightly yellow. You may

Put your used prefilled syringes in a FDA-cleared sharps disposal container right away after use(see Figure N). Do not throw away (dispose of)ZARXIO prefilled syringes in your household trash.

Figure N

Fig-N

If You Do Not Have An Fda-cleared Sharps Disposal Container, You May Use A Household Container That Is: 

made of a 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, and
properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA s website at:http://www.fda.gov/safesharpsdisposal.

Do not reuse the prefilled syringe.

Do not recycle the syringe, or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured By: 

Sandoz Inc., Princeton, NJ 08540,

US License No. 2003

At:

Sandoz GmbH. Langkampfen, Austria,

Product of Austria

Revised: April 2018

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of ZARXIO prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of ZARXIO.

Advise Patients Of The Following Risks And Potential Risks With Zarxio: 

Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their physician immediately[see Warnings and Precautions (5.1)].
Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur. Advise patients to report dyspnea to their physician immediately[see Warnings and Precautions (5.2)].
Serious allergic reactions may occur, which may be signaled by rash facial edema wheezing dyspnea hypotension or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur[see Warnings and Precautions (5.3)].
In patients with sickle cell disease, sickle cell crisis and death have occurred. Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors[see Warnings and Precautions (5.4)].
Glomerulonephritis may occur. Symptoms 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[see Warnings and Precautions (5.5)].
Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Advise patients to report signs or symptoms of vasculitis to their physician immediately[see Warnings and Precautions (5.11)].
Aortitis may occur. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately[see Warnings and Precautions (5.15)].

Instruct Patients Who Self-administer Zarxio Using The Prefilled Syringe Of The: 

Importance of following the applicable Instructions for Use.
Dangers of reusing needles, and syringes.
Importance of following local requirements for proper disposal of used syringes.
Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the ZARXIO prefilled syringe.

ZARXIO(filgrastim-sndz)

ZARXIO is a registered trademark of Novartis AG

UltraSafe Passive is a registered trademark of Safety Syringes, Inc.



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