Nypozi: Uses, Side Effects and Dosage

What is NYPOZI used for?

NYPOZI 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 NYPOZI 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.

NYPOZI 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 does NYPOZI work?

NYPOZI works by helping your body make more neutrophils. To make sure NYPOZI 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.

Serious Warnings and Precautions

• Your spleen may become enlarged and can rupture while taking NYPOZI. A ruptured spleen can cause death. Call your doctor 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 doctor before your start taking NYPOZI 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 NYPOZI, resulting in death in some cases.

What are the ingredients in NYPOZI?

Medicinal ingredients: filgrastim

Non-medicinal ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for injection. The syringe plunger and stopper and needle cover are not made with natural latex rubber.

NYPOZI comes in the following dosage forms:

NYPOZI is available in single-use graduated prefilled syringes with an UltraSafe Passive^® Needle Guard, as a clear, colourless injection in two sizes of 300 µg/0.5 mL and 480 mcg/0.8 mL. These are available in cartons of 1 and 10 individually blistered pre-filled syringes per carton.

Do not use NYPOZI if you are:

• allergic to filgrastim or any of its ingredients.
• allergic to other medicines made using the bacteria E. 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 NYPOZI. 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 NYPOZI, tell your doctor or nurse immediately. NYPOZI 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 NYPOZI. If you have a sickle cell crisis after getting NYPOZI, 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 NYPOZI. If you are taking lithium, you may need more frequent blood tests.

If you/your child are receiving NYPOZI because you are also receiving chemotherapy, the last dose of NYPOZI 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 NYPOZI 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 NYPOZI

NYPOZI has not been studied in pregnant women, and its effects on unborn babies are not known. If you take NYPOZI while you are pregnant, it is possible that small amounts of it may get into your baby’s blood. It is not known if NYPOZI 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 NYPOZI.

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 NYPOZI:

Interactions between NYPOZI 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 NYPOZI.

How to take NYPOZI:

If you are giving someone else NYPOZI injections, it is important that you know how to inject NYPOZI, how much to inject, and how often to inject NYPOZI.

NYPOZI is available as a liquid in prefilled syringes. When you receive your NYPOZI, always check to see that:

• The name NYPOZI appears on the package and prefilled syringe label.
• The expiration date on the prefilled syringe label has not passed. Do not use a prefilled syringe after the date on the label.
• The NYPOZI liquid in the prefilled syringe is clear and colourless. Do not use NYPOZI if the contents of the prefilled syringe appear discoloured or cloudy, or if the prefilled syringe appears to contain lumps, flakes, or particles.

You should not inject a dose of NYPOZI of less than 0.3 mL from a NYPOZI graduated prefilled single-use syringe. A dose of less than 0.3 mL cannot be accurately measured using the NYPOZI prefilled single-use syringe.

Information on How to Inject NYPOZI:

This section contains information on how to give an injection of NYPOZI. It is important that you do not try to give the injection unless you have received training from your healthcare provider or nurse. If you are not sure about giving the injection or you have any questions, please ask your healthcare professional or nurse for help.

Injecting with NYPOZI:

IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, YOU SHOULD FOLLOW THESE INSTRUCTIONS.

You will need to give an injection into the tissue under the skin, known as subcutaneous injection. Your healthcare provider or nurse will tell you how frequently it should be injected.

Step 1: Before Injection with NYPOZI:

Wash your hands thoroughly with soap and water. Gather the materials you will need for an injection (Figure A):

• A new prefilled syringe of NYPOZI with an UltraSafe Passive Needle Guard.

• Alcohol wipes or similar.

• Cotton or gauze.
• Adhesive bandage

• A puncture-proof container for disposing of used syringes, as discussed with your healthcare provider/nurse.

  Figure A

Note the needle is covered by the needle cap before use.

Figure B

Step 2: Setting up for the Injection:

On a clean, well-lit, flat surface, place the NYPOZI syringe blister pack and leave it unopened on your working surface for about 30 minutes so that it reaches room temperature. Confirm on the syringe and carton that it is the correct dose as prescribed by your healthcare provider (300 mcg/0.5 mL or 480 mcg/0.8 mL). Put the original carton with any unused prefilled syringes back in the refrigerator. 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.
• Keep the prefilled syringe in the blister pack until you are ready to use it.
• Do not shake the prefilled syringe.

Step 3. Remove and Inspect the NYPOZI prefilled syringe (See Figure C)

Remove the NYPOZI syringe from the blister. Follow directions for correct handling technique as shown below when removing the pre-filled syringe with the UltraSafe Passive^® Needle Guard from the packaging, otherwise, the needle’s safety mechanism may be triggered, making the syringe unusable. For safety reasons, do not grab the plunger head or the needle cap. Do not touch the needle guard activation clips at any time during use. This may trigger the needle's safety mechanism causing the needle to retract (pull back) before your injection is given. This will make the syringe unusable.

Figure C

Turn the prefilled syringe so you can see through the viewing window. The liquid inside should be clear and colorless.

Check to make sure that the plastic transparent needle guard is covering the barrel of the glass syringe. If the transparent needle guard is covering the needle cap (illustrated below), the needle guard has already been activated. Do not use the prefilled syringe if the needle guard has been activated (See Figure D).

Figure D

Syringe with Activated Needle Guard

Do not use the prefilled syringe if:

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

In these cases, use a new prefilled syringe and call your healthcare provider or return to your pharmacy.

Step 4: Select and clean the injection site (See Figure E)

Figure E

Areas that you can use for injection include:

• Front of your thighs
• Lower stomach area (abdomen), but not the area 2 inches right around your navel (belly button)
• Upper outer area of your buttocks if someone else is giving you the injection
• Outer area of upper arm if someone else is giving you the injection

Choose a different injection site for each injection of NYPOZI.

Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

Clean your injection site with an alcohol wipe.

• Let your skin dry.
• Do not touch this cleansed area again before injecting

Step 5: Prepare the NYPOZI syringe for injection

Do not remove the needle cap from the syringe until you are ready to inject.

Hold the prefilled syringe by the barrel (the clear plastic needle guard) with the needle pointing up (See Figure F). Holding the syringe with the needle pointing up helps to prevent medicine from leaking out of the needle.

Carefully pull the needle cap straight off and away from your body. Throw away the needle cap.

Figure F

Check the syringe for an air bubble. Point the needle up and gently tap the syringe with your fingers until the air bubble rises to the top of the syringe (See Figure G).

Figure G

Slowly push the plunger up to push any air out of the syringe and stop when you see a small drop start to appear at the needle

Check your prescription before you inject your dose (See Figure HError! Reference source not found.)

Your healthcare provider has prescribed either a “full” syringe dose or a “partial” syringe dose of NYPOZI. If a partial dose is prescribed, hold the syringe as shown below and press slowly on the plunger to push out the excess medicine until the edge of the conical base of the plunger stopper lines up with the syringe marking for your prescribed dose. If you remove too much medicine, get a new prefilled syringe, and start again at Step 1.

You should not inject a dose of NYPOZI less than 0.3 mL (180 mcg) from a NYPOZI prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the NYPOZI prefilled syringe.

Figure H

Step 6. Inject NYPOZI dose (See Figure I)

With one hand gently pinch the skin at the injection site. With your other hand insert the needle into your skin as shown. Push the needle all the way in to make sure that you inject your full dose.

Figure I

Hold the NYPOZI prefilled syringe as shown (See Figure J). Slowly press down on the plunger as far as it will go so that the plunger head is completely between the needle guard wings.

Figure J

Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds. Do not pull back the plunger rod while the needle is inserted.

When done, keep the plunger fully pressed down while you carefully pull the needle straight out from the injection site (See Figure K).

Figure K

Step 7 After injection (See Figure L)

Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.

Figure L

Step 8 Examine the injection site

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over 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.

Do not use NYPOZI that is left in the syringe.

Place the pre-filled syringe with the needle guard covered needle into a Sharps puncture-proof container for proper disposal as described below. Use each pre-filled syringe only for one injection. (See Figure M).

Figure M

Remember:

Do not hesitate to consult your healthcare provider or nurse for help or if you have any concerns.

Disposal of Used Syringes:

You should always follow the instructions given by your doctor, nurse, or pharmacist on how to properly dispose of containers with used syringes, needles, and needle guards. There may be special provincial or local laws for disposal of used needles and syringes. The used syringes should be disposed of in accordance with local requirements.

• Place all used needles, needle covers, syringes, into a “Sharps” container given to you by your doctor or pharmacist or in a hard-plastic container with a screw-on cap, or a metal container with a plastic lid, such as a coffee can, labeled “used syringes.” If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard-plastic container is used, always screw the cap on tightly after each use.
• Do not use glass or clear plastic containers.

• When the puncture-proof container is full, tape around the cap or lid to make sure the

  • cap or lid does not come off. It should be disposed as instructed by your healthcare professional, nurse, or pharmacist.
• Do not throw the container in the household trash. Do not recycle.

Always keep the container out of reach and sight of children.

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 NYPOZI. Too little NYPOZI may not protect you against infections, and too much NYPOZI may cause too many neutrophils to be in your blood.

Missed Dose:

NYPOZI should be injected at the same time each day. If you miss a dose, contact your doctor or nurse.

What are possible serious side effects from using NYPOZI?

These are not all the possible side effects you may experience when taking NYPOZI. 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 NYPOZI. 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 or your child has pain in the left upper stomach area or left shoulder tip area. This pain could mean you or your child’s spleen is enlarged or ruptured.

Serious Allergic Reactions: NYPOZI can cause serious allergic reactions. These reactions can cause a rash over the whole body, shortness of breath, wheezing, dizziness, swelling around mouth or eyes, fast pulse, and sweating. If you or your child starts to have any of these symptoms, stop using NYPOZI and call your doctor or seek emergency care right away. If you or your child has an allergic reaction during the injection of NYPOZI, stop the injection right away.

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.

Sickle Cell Crisis: Call your doctor or seek emergency care right away if you or your child experiences severe pain in bones, chest, gut, or joints.

Kidney injury (glomerulonephritis) has been seen in patients who received Nypozi. Call your doctor right away 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 NYPOZI?

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 NYPOZI 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

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:

Do not use NYPOZI after the expiry date which is stated on the outer carton and on the pre-filled syringe.

• Store in a refrigerator (2°C - 8°C). Do not freeze. Do not shake.
• If NYPOZI 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 healthcare provider or nurse for further instructions.
• NYPOZI can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period of up to 15 days that ends within the labelled expiry date. Once NYPOZI has been out at room temperature it should not be put back into the refrigerator. Any NYPOZI syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.
• Keep the pre-filled syringe in the carton in order to protect from light. Do not use if you notice it is cloudy or there are particles in it.

Keep out of reach and sight of children.

If you want more information about NYPOZI:

• 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 <To Be Determined>, or by calling 1-800-<To Be Determined>.

Last Revised: October 8, 2021