Dyrupeg: Uses, Side Effects and Dosage

Serious warnings and precautions box

What DYRUPEG is used for:

• DYRUPEG is used to treat neutropenia (nu-tro-peen-ee-ah). Neutropenia is a condition where the body makes too few white blood cells, 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 DYRUPEG for you to increase the number of neutrophils (nu-tro-fils), which will fight infections.
• DYRUPEG is a man-made, long-acting form of granulocyte colony-stimulating factor (G-CSF), a substance naturally produced by the body.

How DYRUPEG works:

DYRUPEG works by stimulating the bone marrow to make white blood cells. To make sure DYRUPEG 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.

The ingredients in DYRUPEG are:

Medicinal ingredient(s): pegfilgrastim

Non-medicinal ingredients: polysorbate 20, sodium acetate, sorbitol, and water for injection.

DYRUPEG comes in the following dosage form(s):

DYRUPEG is available in a single-use prefilled syringe with UltraSafe PlusTM Passive Needle Guard. Each single-use syringe (0.6 mL) of DYRUPEG (10 mg/mL) contains 6 mg of pegfilgrastim, the active substance.

Each blister packaged syringe is provided in a carton. The needle cap on the prefilled syringe is not made with natural rubber latex.

Do not use DYRUPEG if:

• You are allergic to pegfilgrastim (DYRUPEG), filgrastim, or any of the ingredients of DYRUPEG
• You are allergic to other products 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 DYRUPEG. Talk about any health conditions or problems you may have, including if you:

• 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 DYRUPEG, tell your doctor or nurse immediately. DYRUPEG can reduce the risk of infection, but it may not prevent all infections. An infection can still happen in a 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. DYRUPEG 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 DYRUPEG, it is important that you inform yourself about DYRUPEG to know how and when to give the DYRUPEG injection.)
• Make sure your doctor knows about all medications you are taking before starting DYRUPEG injections. Patients taking lithium may need more frequent blood tests.
• More information about DYRUPEG is available in the Product Monograph. Any questions should be discussed with your doctor.

Pregnancy or breastfeeding and DYRUPEG

• DYRUPEG has not been studied in pregnant women, and its effects on developing babies are unknown. It is possible that DYRUPEG can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant or are breastfeeding, you should consult your doctor before using DYRUPEG.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may [also] interact with DYRUPEG:

• Drug interactions between DYRUPEG and other drugs have not been studied. Drugs such as lithium may affect the release of neutrophils into the bloodstream. Patients taking lithium may need more frequent blood tests. You should discuss your treatment with your doctor before using DYRUPEG.

How to take DYRUPEG:

Usual Dose:

The recommended dosage of DYRUPEG is a single subcutaneous injection, just under the skin, of 6 mg

(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 DYRUPEG. DYRUPEG should not be administered less than 14 days before your next chemotherapy cycle.

Overdose:

Missed dose:

As there should be a two-week period between DYRUPEG and your next course of cancer chemotherapy, if you miss a planned dose, consult your doctor before taking the missed dose.

How to take DYRUPEG

This section contains information on how to give yourself an injection of DYRUPEG. It is important that you get special training from your doctor or nurse before you give yourself the injection. If you are not sure about giving yourself the injection or have any questions, please ask your doctor or nurse for help. If you are giving DYRUPEG to someone else, it is important that you know how to inject DYRUPEG.

DYRUPEG is provided in a single-use pre-filled syringe with a BD UltraSafe Plus^TM Passive Needle Guard. The needle guard is a protective mechanism that can prevent syringe re-use and accidental needle pricks after DYRUPEG has been injected. DYRUPEG should be stored in its carton to protect it from light until use.

Before taking the DYRUPEG injection, always check that:

• The name DYRUPEG appears on the carton, blister, and syringe label.
• The expiration date on the label has not passed. Do not use a pre-filled syringe after the expiry date (see EXP) on the label.
• The DYRUPEG liquid should always be clear and colorless. Do not use DYRUPEG if the contents of the pre-filled syringe appear discolored or cloudy or if the pre-filled syringe appears to contain lumps, flakes, or particles.
• Do not use the prefilled syringe if the pack is opened or damaged. Do not shake the prefilled syringe.
• Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
• Do not use the prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.
• Do not attempt to activate the needle safety guard prior to injection.

Important: To help avoid possible infection, you should follow these instructions exactly.

Setting up for an Injection

1. 1. Find a comfortable, well-lit working place for injecting DYRUPEG.
2. 2. Remove the prefilled syringe of DYRUPEG from the refrigerator and check the date on the prefilled syringe to be sure that the DYRUPEG has not expired. Do not use a prefilled syringe of DYRUPEG after the date on the label.
3. 3. Allow DYRUPEG to reach room temperature (this takes about 30 minutes). DYRUPEG should not be left at room temperature for more than 72 hours. Each prefilled syringe is designed to be used only once. DO NOT SHAKE THE PREFILLED SYRINGE. Shaking too hard or for too long may damage the DYRUPEG. If the prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.
4. 4.

   Assemble the supplies needed for an injection:

   • DYRUPEG pre-filled syringe, which has a plunger and a transparent (clear) plastic needle guard attached, as shown in the image below

• alcohol swab and a cotton ball or gauze

• puncture-proof disposal container, as discussed with your doctor/nurse.
• Clean the work area.
• Wash your hands thoroughly with soap and water before preparing for the injection.

Selecting and preparing the injection site

1. 7.

   Find a site for injection prior to preparing the prefilled syringe. Alternate the injection site each time you inject DYRUPEG. The usual sites for injections are:

   • Back of the upper arms
   • Abdomen, except for the navel and waist
   • Upper thighs
   • Upper outer areas of the buttocks

Front Back

1. 8. Clean the injection site with an alcohol swab. Use a circular motion from the inside to the outside of the injection site.
2. 9. Remove the syringe from the blister pack by the body and hold the prefilled syringe by the barrel, as shown below.

• Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
• Do not twist or bend the gray needle cap.
• Do not hold the prefilled syringe by the plunger rod.
• Do not put the gray needle cap back onto the prefilled syringe.
• Carefully pull the gray needle cap straight off and away from the body. Throw away the needle cap into the sharps disposal container. Take care not to touch the needle. Holding the syringe with the needle pointing up helps reduce the amount of medicine that may leak out of the needle.

1. 11. Check the syringe for air bubbles. If there are bubbles, hold the syringe with the needle pointing upward and pull back on the plunger slightly to remove any DYRUPEG that may be inside the needle. Gently tap the syringe until the bubbles rise to the top of the syringe barrel. Then slowly push the plunger, forcing the bubbles but not the liquid out of the syringe.
2. 12. Do not lay the syringe down or allow the needle to touch anything.
3. 13. Pinch the injection site to create a firm surface. Keep skin pinched while injecting.

1. 14. Hold the pinch. Insert the needle into the skin at 45 to 90 degrees.

1. 15. Using slow and constant pressure, push the plunger rod until it reaches the bottom and the plunger head is completely between the needle guard wings. The needle guard will not be activated unless the entire dose has been administered and you remove downward pressure on the plunger.

1. 16. When the syringe is emptied of all the medication, slowly lift your thumb from the plunger which will release the needle guard. As you let go of the plunger head, the needle will automatically slide into the clear safety guard until the needle is completely covered.
2. 17. If the clear safety guard does not activate, remove the needle from the skin and throw away the used prefilled syringe as instructed right away. Keep your hands away from the needle at all times.

1. 18. When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare professional right away.

Disposing of syringes and needles

1. 19. Dispose of the entire prefilled syringe as directed by your doctor, or by following these steps:

1. 20. Put the used prefilled syringe in a sharps disposal container right away after use.
2. 21.

   Put used syringes into an appropriate puncture-proof container as instructed by your doctor/nurse. you may use a container that is mentioned below:

   • 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.
3. 22. Please check with your healthcare professional for instructions on how to properly dispose of the sharps disposal container.
4. 23. Do not reuse the prefilled syringe.
5. 24. Do not recycle the prefilled syringe or sharps disposal container or throw them into the household trash.
6. 25. Always keep the sharps disposal container out of the reach of children.

Examine the injection site

If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

Possible side effects from using DYRUPEG:

These are not all the possible side effects you may have when taking DYRUPEG. If you experience any side effects not listed here, tell your healthcare professional.

• Spleen Rupture. Your spleen may become enlarged and can rupture while taking DYRUPEG. 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 DYRUPEG, 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 pegfilgrastim. 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 DYRUPEG?

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 DYRUPEG, 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

* 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

Storage:

DYRUPEG should be stored in the refrigerator at 2° to 8°C. Keep the container in the outer carton to protect from light. Avoid shaking DYRUPEG.

If accidently frozen, allow DYRUPEG to thaw in the refrigerator before injecting. However, if frozen a second time, DO NOT use it and contact your doctor or nurse for further instructions.

DYRUPEG can be removed from the refrigerator and left at room temperature for up to 72 hours.

Keep out of reach and sight of children.

For any questions about storage, contact your doctor or nurse.

If you want more information about DYRUPEG:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website [website]; or by calling [phone number].

Canadian Distributor: Auro Pharma Inc.

Date of Authorization: [2026-01-06]