Filra: Uses, Side Effects and Dosage

Serious warnings and precautions box

What Filra is used for:

Filra is used to treat neutropenia (nu-tro-peen-ee-ah), a condition where the body makes too few neutrophils. Neutropenia predisposes your body to infections and prevents you from fighting them. Your doctor has decided to prescribe Filra for you to increase the number of neutrophils (nu-tro-fils), which will fight infections.

Neutropenia may be a long-standing condition where your body does not make enough neutrophils, or it may be caused by drugs used to treat cancer. In some cases, your body may make enough neutrophils, but as part of your treatment for cancer, your doctor may want to increase the number of certain blood cells (CD34 cells) and collect them. The cells are collected using a process called apheresis (ay-fer-ree-sis). These collected cells are given back to you after you receive very high doses of treatment for cancer to make your blood counts get back to normal more quickly.

Filra is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria E coli. G-CSF is a substance naturally produced by the body.

How Filra works:

Filra works by helping your body make more neutrophils. To make sure Filra is working, your doctor will ask that you have regular blood tests to count the number of neutrophils you have. It is important that you follow your doctor’s instructions about getting these tests.

• Your spleen may become enlarged and can rupture while taking Filra. A ruptured spleen can cause death. Call your healthcare professional right away if you or your child has pain in the left upper stomach area or left shoulder tip area.
• If you have sickle cell trait or sickle cell disease, make sure that you tell your healthcare professional before you start taking Filra 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 filgrastim injection, resulting in death in some cases.

The ingredients in Filra are:

Medicinal ingredient: filgrastim

Non-medicinal ingredients: acetate, polysorbate 80, sodium, sorbitol, water for injection

The prefilled syringe plunger and needle cap are not made with natural rubber latex.

Filra comes in the following dosage forms:

Filra is available in 2 prefilled syringe sizes: 0.5 mL and 0.8 mL. The preservative-free single use prefilled syringes contain 600 mcg/mL of filgrastim.

Do not use Filra if:

• You are allergic to Filra (filgrastim) or any of its ingredients.
• You are allergic to other medicines made using the bacteria E. coli. Ask you doctor if you are not sure.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Filra. Talk about any health conditions or problems you may have, including:

• If you have common signs or symptoms of infection, such as fever, chills, rash, sore throat, diarrhea, or redness, swelling, or pain around a cut or sore. If you/your child has any of these signs or symptoms during treatment with Filra, tell your doctor or nurse immediately. Filra may reduce your chance of getting an infection but does not prevent all infections. An infection can still happen during the short time when you/your child's neutrophil levels are low.
• If there is a lump, swelling, or bruising at an injection site that does not go away, call your doctor. There is a possibility that you could have a reaction at an injection site.
• If you have a sickle cell trait or sickle cell disease, make sure that you tell your doctor before you start taking Filra. If you have a sickle cell crisis after getting Filra, tell your doctor right away.

Other warnings you should know about:

Make sure your doctor knows about all medicines, and herbal or vitamin supplements you are taking before starting Filra. If you are taking lithium you may need more frequent blood tests.

If you/your child are receiving Filra because you are also receiving chemotherapy, the last dose of Filra should be injected at least 24 hours before your next dose of chemotherapy.

Talk to your doctor if you experience unusual bleeding or bruising while taking Filra following chemotherapy, as this could mean a decrease of platelets which reduces the ability of blood to clot.

If you have any questions, you should talk to your doctor.

Pregnancy or breastfeeding and Filra:

Filra has not been studied in pregnant women, and its effects on unborn babies are not known. If you take Filra while you are pregnant, it is possible that small amounts of it may get into your baby’s blood. It is not known if Filra can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should tell your doctor before using Filra.

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 Filra:

Drug interactions between Filra 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 Filra.

How to take Filra:

You should not inject a dose of Filra less than 0.3 mL from a Filra prefilled syringe. A dose of less than 0.3 mL cannot be accurately measured using the Filra prefilled syringe.

PREFILLED SYRINGES

Guide to parts

Important: The needle is covered by the gray needle cap before use. Read the complete Patient Medication Information for important information you need to know about Filra before using it.

Storing your prefilled syringe

• Store Filra in the refrigerator between 2°C and 8°C.
• Do not freeze.
• Keep the prefilled syringe in the original pack 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.
• If needed, individual Filra pre-filled syringes may be kept at room temperature up to 25°C for a single period of up to 14 days in the original carton with protection from light.
• Once a syringe has been stored at room temperature, it should not be returned to the refrigerator.
• Throw away any Filra that has been left at room temperature for more than 14 days.
• After you inject your dose, throw away any unused Filra left in the prefilled syringe. Do not save unused Filra in the prefilled syringe for later use.
• Keep the Filra prefilled syringe out of the reach of children.

Using your 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 professional.
• Make sure the name Filra appears on the pack and the prefilled syringe label.
• 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 pack is open or damaged.
• 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.

Call your healthcare professional if you or your caregiver have any questions.

Step 1: Prepare

1. A.

   Remove the prefilled syringe pack from the refrigerator.

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

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

   • Do not use the prefilled syringe if the pack is damaged.
   • Do not 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.

Open the tray by peeling away the cover. Grab the clear safety guard to remove the prefilled syringe from the tray.

For safety reasons:

• Do not grab the plunger rod.
• Do not grab the gray needle cap.
• Inspect the medicine and prefilled syringe.

Turn the prefilled syringe so you can see the medicine window and markings. Make sure the medicine in the prefilled syringe is clear and colourless.

Do not use the prefilled syringe if:

• The medicine is cloudy or discoloured 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 professional.

1. C.

   Gather all materials needed for the injection.

   Wash your hands thoroughly with soap and water.

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

   • Prefilled syringe

   • Alcohol wipe

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

Step 2: Get ready

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

You can use:

• Thigh
• Stomach area (abdomen), except for a 5 cm area 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 wipe.

• Let the skin dry.
• 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.
• Hold the prefilled syringe by the barrel. Carefully pull the gray needle cap straight off and away from the body.

• 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.

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

1. F. Check your prescription before you inject your dose.

Your healthcare provider has prescribed either a “full” syringe dose or a “partial” syringe dose of Filra.

• If you are prescribed a full dose, you will inject all of the medicine from your prefilled syringe. For a full dose, proceed with Step G below and then go to Step 3: Subcutaneous (under the skin) injection.
• If you are prescribed a partial dose of Filra, start with Step G below. You should not inject a dose of Filra less than 0.3 mL (180 mcg) from a Filra prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the Filra prefilled syringe.
• Point the needle up and tap gently until the air bubbles rise to the top.

1. H. Slowly push the plunger rod up to the line on the syringe barrel that matches your prescribed dose.

As you push the plunger rod up, air and extra medicine is removed. Check to make sure the top edge of plunger stopper lines up with the syringe markings for your prescribed dose. If you remove too much medicine, get a new prefilled syringe and start again at Step 1.

• See figure above for an example of a dose of 0.4 mL. Your dose may be different than the example shown.
• Call your healthcare professional if you have problems measuring your prescribed dose.

Step 3: Subcutaneous (under the skin) injection

1. I. Pinch your injection site to create a firm surface.

Important: keep skin pinched while injecting.

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

1. K.

   Using slow and constant pressure, push the plunger rod until it reaches the bottom.

   1. • Do not pull back the plunger rod while the needle is inserted.
   2. • Press down slowly on the plunger as far as it will go so that the plunger head is completely between the needle guard wings.

Step 4: Finish

Important: If you were prescribed a full dose, if it looks like the medicine is still in the syringe barrel when you remove the syringe, this means you may have not received a full dose. Call your healthcare professional right away.

1. L.

   Finish your injection.

   1. • While you continue to hold the syringe, slowly let go of the plunger head.
   2. • As you let go of the plunger head, the needle will automatically slide into the clear safety guard until the needle is completely covered.

Important: If the clear safety guard does not activate after Step L, remove the needle from the skin and throw away the used prefilled syringe as instructed in Step M right away. Keep your hands away from the needle at all times.

1. M. Discard (throw away) the used prefilled syringe.

• Put the used prefilled syringe in a sharps disposal container right away after use. Do not throw away the syringe in the household trash.

• If you do not have a sharps disposal container, you may use a household container with the following characteristics:

  • 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.
• Please check with your healthcare professional for instructions on how to properly dispose of the sharps disposal container.
• Do not reuse the prefilled syringe.
• Do not recycle the prefilled syringe or sharps disposal container or throw them into the household trash.

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

1. N.

   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.

Usual dose:

Your doctor will determine your/your child’s correct dose based on your/your child's body weight.

Overdose:

You must always use the correct dose of Filra. Too little Filra may not protect you against infections, and too much Filra may cause too many neutrophils to be in your blood.

If you think you, or a person you are caring for, have taken too much Filra, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

Filra should be injected at the same time each day. If you miss a dose, contact your healthcare professional.

Possible side effects from using Filra:

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

The most common side effect you/your child may experience is aching in the bones and muscles. This aching can usually be relieved by taking a non-acetylsalicylic acid pain reliever such as acetaminophen.

Some people experience redness, swelling, or itching at the site of injection. This may be an allergy to the ingredients in Filra, or it may be a local reaction. If you are giving an injection to a child, look for signs of redness, swelling, or itching at the site of injection because they may not be able to tell you they are experiencing a reaction. If you notice any signs of a local reaction, call your doctor. If at any time a serious allergic reaction occurs, immediately call a doctor or emergency services (for example, call 911).

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

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://canada.ca/drug-device-reporting) 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.

Storage:

Filra should be stored in the refrigerator at 2°C to 8°C. Take Filra out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing and injection.

Filra can be left out at room temperature for up to 14 days.

Keep Filra in the carton to protect from light and do not leave in direct sunlight. Do not shake. After you inject your dose, throw away any unused Filra; do not save for later use.

Keep out of reach and sight of children.

If you want more information about Filra:

• 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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.

Date of Authorization: July 2, 2026