Armlupeg: Uses, Side Effects and Dosage

What is Armlupeg used for?

Armlupeg 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 Armlupeg for you to increase the number of neutrophils (nu-tro-fils), which will fight infections.

Armlupeg is a long-acting form of granulocyte colony-stimulating factor (G-CSF), a substance naturally produced by the body.

How does Armlupeg work?

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

Medicinal ingredients: pegfilgrastim

Non-medicinal ingredients: sorbitol, glacial acetic acid, sodium acetate trihydrate, polysorbate 20, and water for injection

The needle cover on the prefilled syringe contains a derivative of latex (dry natural rubber). If you

Serious Warnings and Precautions

• Your spleen may become enlarged and can rupture while taking Armlupeg. 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 Armlupeg 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 Armlupeg. Severe sickle cell crises, in some cases resulting in death, have also been associated with filgrastim, the parent compound of pegfilgrastim.

know you are allergic to latex, talk to your healthcare provider before using Armlupeg.

Armlupeg comes in the following dosage forms:

Armlupeg comes in a single-use pre-filled syringe with BD UltraSafe^® Plus Passive Needle Guard, as a clear, colourless liquid solution. Each single-use syringe (0.6 mL) of Armlupeg (10 mg/mL) contains 6 mg of pegfilgrastim, the active substance.

Do not use Armlupeg if:

• You are allergic to pegfilgrastim, filgrastim, or any of the ingredients of Armlupeg. Check the section above What are the ingredients in Armlupeg and the Product Monograph for a list of ingredients in Armlupeg.
• 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 Armlupeg. 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 Armlupeg, tell your doctor or nurse immediately. Armlupeg 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 (ie, under the skin) injection. Armlupeg 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 Armlupeg, it is important that you inform yourself about Armlupeg to know how and when to give the Armlupeg injection.

Make sure your doctor knows about all medications you are taking before starting Armlupeg injections. Patients taking lithium may need more frequent blood tests.

More information about Armlupeg is available in the Product Monograph. Any questions should be discussed with your doctor.

Pregnancy or breast feeding and Armlupeg

Armlupeg has not been studied in pregnant women, and its effects on developing babies are not known. It is possible that Armlupeg 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 Armlupeg.

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 Armlupeg:

Drug interactions between Armlupeg 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 Armlupeg.

How to take Armlupeg:

Armlupeg is available in a prefilled syringe. Armlupeg should be stored in its carton to protect it from light until use. If you are giving someone else Armlupeg injections, it is important that you know how to inject Armlupeg.

Before a Armlupeg injection is given, always check to see that:

• The name Armlupeg appears on the dispensing pack 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 Armlupeg liquid should always be clear and colourless. Do not use Armlupeg 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.

Guide to parts

Figure 1

Figure 2

Important: The needle is covered by the gray needle cap before use.

Important

Read the Patient Information for important information you need to know about Armlupeg before using these Instructions for Use.

Before you use a Armlupeg prefilled syringe, read this important information.

Storing the prefilled syringe

• Store Armlupeg in the refrigerator between 36°F to 46° F (2°C to 8°C).
• Do not freeze.
• Keep the prefilled syringe in the original carton to protect from light or physical damage.
• Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away (dispose of) any Armlupeg that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours.
• Keep the Armlupeg prefilled syringe out of the reach of children.

Using the prefilled syringe

• It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
• Make sure that the name Armlupeg appears on the carton and prefilled syringe label.
• Check the carton and prefilled syringe label to make sure the dose strength is 6 mg.

• You should not inject a dose of Armlupeg to children weighing less than 45 kg from a Armlupeg prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Armlupeg prefilled syringe.

• Do not use a prefilled syringe after the expiration date on the label.
• 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 the carton is open or damaged.
• Do not use a 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.
• The gray needle cap on the prefilled syringe contains dry natural rubber (made from latex). Tell your healthcare provider if you are allergic to latex. You should not give Armlupeg using the prefilled syringe if you have latex allergies

Call your healthcare provider if you have any questions.

1. A. Remove the prefilled syringe carton from refrigerator.

Put the original carton with any unused prefilled syringes back in the refrigerator.

Check the expiration date printed on the carton.

Important: Do not use if the expiration date has passed.

Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.

• Do not remove the prefilled syringe from the original carton until you are ready to inject
• Do not use the prefilled syringe if the carton is damaged.

• Do not try to warm the prefilled syringe by using a heat source such as hot water or

  microwave.

• Do not leave the prefilled syringe in direct sunlight.

• Do not shake the prefilled syringe.

  

  Figure 3

Open the tray by peeling away the cover. Grab the safety guard to remove the prefilled syringe from the tray. (See Figure 3)

STEP 1: Prepare

For Safety reasons:

• Do not grab the plunger rod.
• Do not grab the gray needle cap.

B. Inspect the medicine and prefilled syringe.

Figure 4

Make sure the medicine in prefilled syringe is clear and colorless (See Figure 4). It is normal to see one or more air bubbles in the syringe.

Do not use the prefilled syringe if:

• The medicine is cloudy or discolored or contains flakes or particles.
• Any part appears cracked or broken.
• The prefilled syringe has been dropped.
• The gray needle cap is missing or not securely attached.
• The expiration date printed on the label has passed.

In all cases, use a new prefilled syringe and call your healthcare provider.

C. Gather all materials needed for injection (See Figure 5)

Wash your hands thoroughly with soap and water

On a clean, well-lit work surface, place the:

• Prefilled syringe

• Alcohol swab

• Cotton ball or gauze pad
• Adhesive bandage
• Sharps disposal container

Figure 5

D. Prepare and clean the injection site (s).

Figure 6

You can use:

• Thigh
• Stomach area (abdomen), except for a 2-inch area right around the navel (belly button)
• Upper outer area of the buttocks (only if someone else is giving you the injection)
• Outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol swab. Let the skin dry.

Figure 7

• Do not touch this area again before injecting.
• If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

STEP 2: Get ready

E. Hold the prefilled syringe by the syringe barrel. Carefully pull the gray needle cap straight off and away from the body.

Figure 8

Remove the air bubble by tapping the syringe, if any. (See Figure 8)

• Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
• Do not twist or bend the needle cap.
• Do not hold the prefilled syringe by the plunger rod
• Do not put the gray needle cap back onto the syringe or never recap. In case, if the needle cap is removed accidently and you are not ready for the injection, discard the opened syringe and use a new syringe when ready.
• Do not use the prefilled syringe if it has been dropped with the needle cap removed

Important: Throw the gray needle cap into the sharps disposal container.

F. Pinch the injection site to create a firm surface.

Figure 9

Important: Keep skin pinched while injecting

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

• Do not touch the plunger rod or grasp the syringe above the finger grips.

STEP 3: Subcutaneous (under the skin) injection

Figure 10

H. Using slow and constant pressure, push the plunger head until it reaches the bottom. This will ensure that you receive the full dose (injection is completed). (See Figure 11)

Figure 11

Figure 12

While the needle is still inserted, slowly move your thumb back, allowing the plunger rod to rise. This will release the needle safety guard to safely cover the needle. Then remove the syringe from the injection site. (See Figure 12)

Important: After the removal of the syringe if needle safety guard is not activated and/or if it appears that some medicine is still left in the syringe, this means you have not received a full dose. Call your healthcare provider right away.

I. For your safety, ensure that the needle safety guard is activated i.e. needle is fully covered by needle safety guard.

Once the needle safety guard is extended, it will lock into position and will not slide back over the needle.

Important: Keep your hands away from the needle at all times.

J. Discard (throw away) the used prefilled syringe.

Figure 13

• Put the used prefilled syringe into a sharps disposal container right away after use (See Figure 13). Do not throw away (dispose of) the syringe in the household trash.

• If you do not have a 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
  • 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.
• Do not reuse the prefilled syringe.
• Do not recycle prefilled syringes or sharps disposal container or throw them into household trash.

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

K. 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.

STEP 4: Finish

Usual dose:

The recommended dosage of Armlupeg 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 Armlupeg.

Overdose:

Missed dose:

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

What are possible serious side effects of Armlupeg?

These are not all the possible side effects you may experience when taking Armlupeg. 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 Armlupeg. 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 Armlupeg, 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 Armlupeg. 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 Armlupeg?

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 Armlupeg, or it may be a local reaction. If you notice any of these signs or symptoms, call your doctor.

If you think you, or a person you are caring for, have taken too much Armlupeg, contact a 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

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.

Storage:

Armlupeg should be stored in the refrigerator at 2° to 8°C (36° to 46°F), but not in the freezer. Keep the container in the outer carton to protect from light. Avoid shaking Armlupeg. If Armlupeg is accidentally frozen, allow it to thaw in the refrigerator before giving the next dose. However, if it is frozen a second time, do not use it and contact your doctor or nurse for further instructions. Armlupeg can be left out at room temperature for up to 48 hours. Keep out of reach of children. For any questions about storage, contact your doctor or nurse.

Keep out of reach and sight of children.

If you want more information about Armlupeg:

• 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 web site www.lupinpharma.ca, or by calling 514.866.3863.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect- canada.html) 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.