Patient Medication Information: uses, side effects, how to take - Ziextenzo
What is ZIEXTENZO used for?
ZIEXTENZO is used to treat neutropenia (nu-tro-peen-ee-ah). Neutropenia is a condition where the body makes too few white blood cells and which may be caused by drugs used to treat cancer. Neutropenia is the most serious common side-effect of chemotherapy. Neutropenia predisposes your body to infections and prevents you from fighting them. Your doctor has decided to prescribe ZIEXTENZO for you to increase the number of neutrophils (nu-tro-fils), which will fight infections.
ZIEXTENZO is a man-made, long-acting form of granulocyte colony-stimulating factor (G-CSFF), a substance naturally produced by the body.
How does ZIEXTENZO work?
ZIEXTENZO works by stimulating the bone marrow to make white blood cells. To make sure ZIEXTENZO is working, your doctor may ask that you have regular blood tests to count the number of white blood cells. It is important to follow the doctor's instructions about these tests.
What are the ingredients in ZIEXTENZO?
Medicinal ingredient: Pegfilgrastim.
Non-medicinal ingredients: Acetic acid, polysorbate 20, sorbitol, sodium hydroxide and water for injection, USP.
Serious Warnings and Precautions
|
ZIEXTENZO comes in the following dosage forms:
ZIEXTENZO is available in a single-use pre-filled syringe with BD UltraSafe Passive™ Needle Guard, as a clear, colourless to slightly yellowish liquid solution. Each single-use syringe (0.6 mL) of ZIEXTENZO (10 mg/mL) contains 6 mg of pegfilgrastim (based on protein mass only).
Do not use ZIEXTENZO if:
- You are allergic to pegfilgrastim, filgrastim or any of the ingredients of ZIEXTENZO. Check the section above What are the ingredients in ZIEXTENZO? and the Product Monograph for a list of ingredients in ZIEXTENZO.
- You are allergic to other medicines made using the bacteria Escherichia coli. Ask your doctor if you are not sure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZIEXTENZO. Talk about any health conditions or problems you may have, including:
- If you have common signs of infection, such as fever, chills, rash, sore throat, diarrhea, or redness, swelling, or pain around a cut or sore. If you notice any of these symptoms during treatment with ZIEXTENZO, tell your doctor or nurse immediately. ZIEXTENZO can reduce the risk of infection, but it may not prevent all infections. An infection can still happen during the short time when your white blood cell levels are low.
- If there is a lump, swelling, or bruising at the injection site that does not go away, talk to your doctor. Occasionally a problem may develop at the injection site.
- If you have sickle cell trait or sickle cell disease, tell your doctor prior to treatment. If you develop left upper abdominal pain or pain at the tip of your shoulder, tell your doctor or nurse immediately.
Other warnings you should know about:
Your doctor will decide if you are able to give yourself a subcutaneous (i.e. under the skin) injection. ZIEXTENZO should only be injected on the day the doctor has determined for you, and should not be injected until 24 hours after receiving your last dose of chemotherapy in each cycle.
If you are injecting someone else with ZIEXTENZO, it is important that you inform yourself about ZIEXTENZO to know how and when to give the ZIEXTENZO injection.
ZIEXTENZO has not been studied in pregnant women, and its effects on developing babies are not known. It is possible that ZIEXTENZO can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breast feeding, you should consult your doctor before using ZIEXTENZO.
More information about ZIEXTENZO is available in the Product Monograph. Any questions should be discussed with your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ZIEXTENZO:
Drug interactions between ZIEXTENZO and other drugs have not been studied. Drugs such as lithium may affect the release of neutrophils into the blood stream. You should discuss your treatment with your doctor before using ZIEXTENZO.
How to take ZIEXTENZO:
Usual dose:
The recommended dosage of ZIEXTENZO is a single subcutaneous injection, just under the skin, of 6 mg (the contents of one pre-filled syringe), administered once per cycle of chemotherapy. You must wait at least 24 hours after your course of cancer chemotherapy before injecting ZIEXTENZO.
Overdose:
| If you think you, or a person you are caring for, have taken too much ZIEXTENZO, contact a 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 ZIEXTENZO and your next course of cancer chemotherapy, if you miss a planned dose, consult your doctor before taking the missed dose.
Instructions for Use of the ZIEXTENZO pre-filled syringe with needle guard:
IMPORTANT: TO HELP AVOID A POSSIBLE INFECTION, YOU SHOULD FOLLOW THESE INSTRUCTIONS.
It is important not to try to inject yourself or someone else until you have been trained by your doctor, nurse or pharmacist. Please read all the instructions before injecting. Each sealed blister contains one pre-filled syringe. Each pre-filled syringe contains 6 mg/0.6 mL of ZIEXTENZO drug solution.
ZIEXTENZO pre-filled syringe parts (see Figure A) 6 mg/0.6 mL
Figure A
After the medication has been injected the needle guard will be activated to cover the needle. The needle guard is intended to protect healthcare professionals, caregivers, and patients from accidental needle stick injuries after the injection.
Items you additionally need for your injection:
Figure B
1 Alcohol wipe
- 1 Cotton ball or gauze
- Sharps disposal container
Important safety information
- 1. Do not open the outer box until you are ready to use the ZIEXTENZO pre-filled syringe.
- 2. Do not use the ZIEXTENZO pre-filled syringe if the seal of the blister is broken, as it may not be safe for you to use.
- 3. Do not use the ZIEXTENZO pre-filled syringe if there is liquid in the blister. Do not use the ZIEXTENZO pre-filled syringe if the needle cap is missing or not securely attached. In all these instances, return the entire product pack to the pharmacy.
- 4. Never leave the ZIEXTENZO pre-filled syringe unattended where others might tamper with it.
- 5. Do not shake the ZIEXTENZO pre-filled syringe.
- 6. Be careful not to touch the needle guard wings before use. By touching them, the needle guard may be activated too early.
- 7. Do not remove the needle cap until just before you give the injection.
- 8. The ZIEXTENZO pre-filled syringe cannot be re-used. Please dispose the ZIEXTENZO pre-filled syringe immediately after use in a sharps container.
- 9. Do not use if the syringe has been dropped onto a hard surface or dropped after removing the needle cap.
The Injection Site(s)
| Figure C | The injection site is the place on the body where you are going to use the ZIEXTENZO pre-filled syringe.
|
|---|---|
| Figure D | If a caregiver is giving you the injection, the outer upper arms may also be used. |
Preparing the ZIEXTENZO pre-filled syringe ready for use
- 1. Take the blister containing the ZIEXTENZO pre-filled syringe out of the refrigerator and leave it unopened for approximately 15-30 minutes, so that it can reach room temperature.
- 2. When you are ready to use the ZIEXTENZO pre-filled syringe, open the blister and wash your hands thoroughly with soap and water.
- 3. Clean the injection site with an alcohol wipe.
- 4. Remove the ZIEXTENZO pre-filled syringe from the blister by holding it in the middle as shown below. Do not grab the plunger. Do not grab the needle cap.
 | |
|---|---|
 |
- 5. Check to ensure the plastic transparent needle guard is situated over the barrel of the glass syringe. If the transparent needle guard is covering the needle cap (as shown below in Figure E) the syringe needle guard has been activated, DO NOT use this syringe and take a new syringe. Figure F shows a ready to use syringe.
Figure E DO NOT USE
In this configuration the needle guard is ACTIVATED – DO NOT USE the pre-filled syringe.
Figure F Ready to Use
In this configuration the needle guard is NOT ACTIVATED and the pre-filled syringe is ready for use.
- 6. Inspect the ZIEXTENZO pre-filled syringe. The liquid inside should be clear. The color may be colorless to slightly yellowish. You may see a small air bubble in the liquid. This is normal. DO NOT USE if any other particulates and/or discolorations are observed and return the pre-filled syringe and the package it came in to the pharmacy.
- 7. DO NOT USE if the ZIEXTENZO pre-filled syringe is broken or activated. In all these instances, return the entire product pack to the pharmacy.
How to use the ZIEXTENZO pre-filled syringe
Figure G
 | Carefully pull the needle cap straight off to remove it from the ZIEXTENZO pre-filled syringe (see Figure G). Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal. |
|---|
Figure H  | Gently pinch the skin at the injection site and insert the needle into your skin as shown (see Figure H). Push the needle all the way in to ensure that the medication can be fully administered. |
|---|---|
Figure I  | Holding the ZIEXTENZO pre-filled syringe as shown (see Figure I), slowly depress the plunger as far as it will go so that the plunger head is completely between the needle guard wings. Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds. |
Figure J  | Keep the plunger fully depressed while you carefully pull the needle straight out from the injection site and let it come out of your skin (see Figure J). |
Figure K  | Slowly release the plunger and allow the needle guard to automatically cover the exposed needle (see Figure K). There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed. |
Disposal Instructions Figure L | Dispose of the used syringe in a sharps container (closable, puncture-resistant container). For the safety and health of you and others, needles and used syringes must never be re-used. |
|---|
What are possible side effects from using ZIEXTENZO?
These are not all the possible side effects you may have when taking ZIEXTENZO. If you experience any side effects not listed here, tell your healthcare professional. Please also see Serious Warnings and Precautions.
- Spleen Rupture. Your spleen may become enlarged and can rupture while taking ZIEXTENZO. A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured.
- Serious Allergic Reactions. Serious allergic reactions can also happen. These reactions may cause a rash over the whole body, shortness of breath, wheezing, a drop in blood pressure (usually causing dizziness or lightheadedness), swelling around the mouth or eyes, fast pulse, or sweating. If you experience an allergic reaction during the injection of ZIEXTENZO, the injection should be stopped immediately. If at any time a serious allergic reaction occurs, immediately call a doctor or emergency services (for example, call 911).
- A serious lung problem called acute respiratory distress syndrome (ARDS). Call your doctor or seek emergency care right away if you or your child has shortness of breath, trouble breathing or a fast rate of breathing.
- Kidney injury (glomerulonephritis) has been seen in patients who received ZIEXTENZO. Call your doctor immediately if you experience puffiness in your face or ankles, blood in your urine or brown coloured urine, or if you notice that you urinate less often than usual.
 |
|---|
The most common side effect that you may experience is aching in the bones and muscles. If this occurs, it can usually be relieved with a non-acetylsalicylic acid over-the-counter pain reliever. Ask your doctor which is the most suitable one for you.
Some patients experience redness, swelling, or itching at the site of injection. This may be an allergy to the ingredients in ZIEXTENZO, or it may be a local reaction. If you notice any of these signs or symptoms, call your doctor.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON: ≥ 0.1% and < 1% | |||
| Bone Pain. | ✓ | ||
| Low platelet counts (thrombocytopenia) (including the following symptoms: easy bruising and increased bleeding). | ✓ | ||
| 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). | ✓ | ✓ | |
| Acute respiratory distress syndrome (including the following symptoms: fever, shortness of breath, cough, or congestion in your lungs). | ✓ | ✓ | |
| VERY RARE < 0.01% | |||
| Splenomegaly (including the following symptoms: pain in the left upper stomach area or left shoulder tip area). | ✓ | ||
| *FREQUENCY NOT KNOWN | |||
| 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 | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| surface that looks like purple or red spots or bumps, clusters of small dots, splotches or hives. Your skin may also be itchy). | |||
| 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 the face or ankles, blood in urine or brown coloured urine, or urinating less often than usual). | ✓ | ✓ | |
| **Abnormal number of immature bone marrow cells (myelodysplastic syndrome) that could lead to a type of cancer (acute myeloid leukemia) (including the following symptoms: fever, bone pain, bruising, difficulty breathing, bleeding and a general feeling of tiredness). | ✓ | ✓ | |
* Reported in the post-marketing setting where the incidence is not known.
** Adverse events in breast and lung cancer patients receiving chemotherapy and/or radiotherapy
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store the ZIEXTENZO pre-filled syringe in its outer carton box to protect it from light. Store it in a refrigerator between 2°C and 8°C (36°F and 46°F). DO NOT FREEZE.
- Remember to take the ZIEXTENZO blister out of the refrigerator and let it warm up for 15-30 minutes to allow it to reach room temperature before preparing it for the injection.
Keep ZIEXTENZO out of reach and sight of children.
Do not use ZIEXTENZO pre-filled syringe after the expiration date shown on the outer box and on the pre-filled syringe label. If it has expired, return the entire pack to the pharmacy.
If you want more information about ZIEXTENZO:
- 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: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.