Patient Medication Information: uses, side effects, how to take - Niopeg
What is Niopeg used for?
Niopeg 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 Niopeg for you to increase the number of neutrophils, which will fight infections.
Niopeg is a man-made, long-acting form of granulocyte colony-stimulating factor (G-CSF), a substance naturally produced by the body.
How does Niopeg work?
Niopeg works by stimulating the bone marrow to make white blood cells. To make sure Niopeg 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 Niopeg?
Medicinal ingredients: pegfilgrastim
Non-medicinal ingredients: acetic acid, polysorbate 20, sodium hydroxide, sorbitol, and water for injection
Serious Warnings and Precautions
- Your spleen may become enlarged and can rupture while taking Niopeg. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area.
- If you have a sickle cell trait or sickle cell disease, make sure that you tell your doctor before you start taking Niopeg so that the potential risks and benefits can be discussed. In patients with sickle cell trait or sickle cell disease, severe sickle cell crises have been associated with the use of pegfilgrastim. Severe sickle cell crises, in some cases resulting in death, have also been associated with filgrastim, the parent compound of pegfilgrastim.
Niopeg comes in the following dosage forms:
Prefilled syringe with a BD UltraSafe Plus™ Passive Needle Guard containing 6 mg / 0.6 mL (10 mg/mL) of pegfilgrastim.
The Niopeg syringe plunger stopper and needle cover are not made with natural rubber latex.
Do not use Niopeg if you are:
- allergic to pegfilgrastim (Niopeg), filgrastim, or any of the ingredients of Niopeg. Check the section above called, “What are the ingredients in Niopeg?” and the Product Monograph for the list of ingredients in Niopeg.
- allergic to other medicine made using the bacteria Escherichia coli. Talk to your doctor if you have any questions about this information.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Niopeg. 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 Niopeg, tell your doctor or nurse immediately. Niopeg 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. Niopeg 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 Niopeg, it is important that you inform yourself about Niopeg to know how and when to give the Niopeg injection.)
Make sure your doctor knows about all medications you are taking before starting Niopeg injections. Patients taking lithium may need more frequent blood tests.
More information about Niopeg is available in the Product Monograph. Any questions should be discussed with your doctor.
Pregnancy or breast-feeding and Niopeg
Niopeg has not been studied in pregnant women, and its effects on developing babies are not known. It is possible that Niopeg 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 Niopeg.
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 Niopeg:
Drug interactions between Niopeg 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 Niopeg.
How to take Niopeg:
Niopeg is available in a prefilled syringe. Niopeg should be stored in its carton to protect it from light until use. If you are giving someone else Niopeg injections, it is important that you know how to inject Niopeg.
Before a Niopeg injection is given, always check to see that:
- The name Niopeg appears on the carton and prefilled syringe label.
- The expiration date on the prefilled syringe has not passed. You should not use a prefilled syringe after the expiry date on the label.
- The Niopeg liquid should always be clear and colourless. Do not use Niopeg if the contents of the prefilled syringe appear discoloured or cloudy, or if the prefilled syringe appears to contain lumps, flakes, or particles.
IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, FOLLOW THESE INSTRUCTIONS EXACTLY.
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| Guide to parts | ||
|---|---|---|
| Syringe before administration | ||
| Caution: Avoid contact with the plunger and needle during the preparation of the syringe. The safety device is normally activated by pressure from the plunger on the syringe. | ||
Syringe after administration (Guard is released and covers the needle) | ||
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Instructions for use:
Important: The needle is covered by the needle cover before use.
| Important | |
|---|---|
Before you use a Niopeg pre-filled syringe with automatic needle guard, read this important information:
Call your doctor or healthcare provider if you have any questions. | |
| Step 1: Prepare | |
| A. | Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included). |
For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. Do not try to warm the syringe by using a heat source such as hot water or microwave. Do not leave the pre-filled syringe exposed to direct sunlight. Do not shake the pre-filled syringe. Keep pre-filled syringes out of the sight and reach of children. | |
| B. | Warning/Precaution: Check to ensure there is no loose fragment or fluid inside the pack. In case of doubt, DO NOT open this pack and take another pack instead. Open the blister by peeling back the top layer all the way off the blister as shown. |
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| C. | Warning/Precaution: DO NOT lift the product by the plunger or needle cover. Remove the pre-filled syringe from blister as shown. |
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| D. | Inspect the medicine content through the viewing window of the pre-filled syringe. |
Do not use the pre-filled syringe if:
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| Step 2: Get ready | |
| A. | Wash your hands thoroughly. Prepare and clean your injection site. |
 You can use:
 Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. |
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| B. | Warning/Precaution: DO NOT twist the needle cover or touch the needle or plunger. Pull the needle cover straight off as shown and handle the guard to avoid injuries or bending the needle. |
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| C. | Pinch your injection site to create a firm surface. |
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 It is important to keep the skin pinched when injecting. | |||||
| Step 3: Inject | |||||
| A. | INSERT the needle into skin. Push the plunger while grasping the finger flanges. Push the plunger all the way down as far as it will go to inject all of the solution. | ||||
 Do not touch the injection site before injecting. | |||||
| B. | The entire dose has to be administered to trigger the guard. | ||||
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| C. | After the injection is complete, one of the below alternatives can be followed: -Remove the needle from the injection site and release the plunger until the entire needle is covered by the guard. -Release the plunger until the needle is covered and then remove the syringe from the injection site. | |
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 Warning/Precaution: If the guard is not activated or only partially activated, discard the syringe without replacing the needle cover. | ||
Healthcare professionals only The brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied should be clearly recorded in the patient file. |
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 Turn the plunger to move the label into a position where you can remove the syringe label. | |
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| Step 4: Finish | |
| A. | Dispose of the used medicine immediately in a sharps container or as instructed by your healthcare provider. |
 Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Keep the syringe and sharps disposal container out of sight and reach of children. Do not reuse the pre-filled syringe. Do not recycle pre-filled syringes or throw them away via household waste. | |
| B. | Examine the injection site. |
| If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed. | |
Usual dose:
The recommended dosage of Niopeg is a single subcutaneous injection, just under the skin, of 6 mg / 0.6 mL (the contents of one prefilled syringe), administered once per cycle of chemotherapy. You must wait at least 24 hours after your course of cancer chemotherapy before injecting Niopeg.
Overdose:
Missed Dose:
As there should be a two-week period between Niopeg and your next course of cancer chemotherapy, if you miss a planned dose, consult your doctor before taking the missed dose.
What are possible side effects from using Niopeg?
These are not all the possible side effects you may feel when taking Niopeg. If you experience any side effects not listed here, contact your healthcare professional.
- Spleen Rupture. Your spleen may become enlarged and can rupture while taking Niopeg. 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 Niopeg, 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 have shortness of breath, trouble breathing or a fast rate of breathing.
- Kidney injury (glomerulonephritis) has been seen in patients who received Niopeg. 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.
What are the most common side effects of Niopeg?
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 Niopeg, or it may be a local reaction. If you notice any of these signs or symptoms, call your doctor.
If you think you have taken too much Niopeg, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
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 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) | √ | ||
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 | ||
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, talk to your healthcare professional.
Storage:
Do not use Niopeg after the expiry date which is stated on the outer carton and the label of the prefilled syringe.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp- mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
- Niopeg should be stored in the refrigerator between 2˚C to 8˚C but not in the freezer. Avoid shaking.
- If Niopeg is accidentally frozen, allow it to thaw in the refrigerator before giving the next dose. However, if it is frozen for a second time, do not use it and contact your doctor or nurse for further instructions.
- Niopeg can be left out at room temperature (not above 25ºC) for a single period of up to 4 days that ends within the labeled expiry date. Once Niopeg has been out at room temperature, it should not be placed back into the refrigerator. Any Niopeg syringes that have been out of the refrigerator for longer than 4 days should not be used and should be disposed of in accordance with local requirements.
- Keep Niopeg in the carton to protect from light or physical damage. Do not leave Niopeg in direct sunlight. Do not use if you notice it is cloudy or there are particles in it.
- If you have any questions about storage or how to carry Niopeg when you travel, contact your doctor, nurse, or pharmacist.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
Keep out of reach and sight of children.
If you want more information about Niopeg:
- 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 (http://hc-sc.gc.ca/index-eng.php); or by calling 1-888-270-9874.
Nora Pharma Inc.
1565, boul. Lionel-Boulet
Varennes, Quebec J3X 1P7 Canada
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BD UltraSafe Plus is a trademark of Becton Dickinson and Company.