Pegfilgrastim

Pegfilgrastim is a prescription medication used to reduce the risk of infection in people receiving strong chemotherapy that decreases the number of infection-fighting white blood cells known as neutrophils. Pegfilgrastim belongs to a group of drugs called colony stimulating factors, which stimulate the body to produce neutrophils.

This medication comes in an injectable form and is injected just under the skin, usually once per chemotherapy cycle.

Common side effects of pegfilgrastim include muscle and bone pain.

Pegfilgrastim is a prescription medication used to reduce the risk of infection in people receiving strong chemotherapy that decreases the number of infection-fighting white blood cells known as neutrophils.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pegfilgrastim may be found in some form under the following brand names:

• Neulasta

Pegfilgrastim may cause serious side effects (see "Drug Precautions".) These side effects include:

• Spleen rupture
• Acute Respiratory Distress Syndrome (ARDS)
• Serious allergic reactions
• Sickle cell crisis

More common side effects of Pegfilgrastim include:

• Aching in the bones and muscles-this can often be relieved with a non-aspirin pain reliever, such as acetaminophen.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• lithium (Eskalith, Lithobid)

This is not a complete list of pegfilgrastim drug interactions. Ask your healthcare provider for more information.

Do not take pegfilgrastim if you have had a serious allergic reaction to pegfilgrastim or filgrastim.

Occasionally pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor.

Pegfilgrastim should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy.

The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

Pegfilgrastim may cause serious side effects including:

• Spleen rupture: Your spleen may become enlarged and can rupture while taking pegfilgrastim. 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.

• 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.

• Serious Allergic Reactions. Pegfilgrastim can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of pegfilgrastim, stop the injection. Call your doctor right away.

• Sickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take pegfilgrastim. Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, a medicine similar to pegfilgrastim. Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pegfilgrastim there are no specific foods that you must exclude from your diet when receiving pegfilgrastim

Before receiving pegfilgrastim, tell your healthcare provider if you:

• are allergic to pegfilgrastim, filgrastim, or any other medications
• are being treated with radiation therapy
• have or have ever had cancer of the blood or bone marrow or sickle cell disease. Call your healthcare provider right away if you have a sickle cell crisis during your treatment.
• are pregnant
• are breastfeeding

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

If you become pregnant during use of pegfilgrastim, you are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pegfilgrastim can get into human breast milk.

Pegfilgrastim is provided in a prefilled syringe. Pegfilgrastim should be stored away from light until use. If you are giving someone else pegfilgrastim injections, it is important that you know how to inject pegfilgrastim. Before getting your pegfilgrastim injection, always check to see that:

• The name pegfilgrastim 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 date on the label.
• The pegfilgrastim liquid should always be clear and colorless. Do not use prefilled syringes that appear discolored or cloudy, or if it appears to contain lumps, flakes, or particles.

IMPORTANT: THE BELOW IS SPECIFCALLY ABOUT pegfilgrastim prefilled syringe

Setting up for an injection

Note: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

1. Find a clean, flat working surface, such as a table.
2. Remove the carton containing the prefilled syringe of pegfilgrastim from the refrigerator. Allow the prefilled syringe to reach room temperature (this takes about 30 minutes). Remove the syringe from the carton before injection. Each prefilled syringe should be used only once. DO NOT SHAKE THE PREFILLED SYRINGE. Shaking may damage pegfilgrastim. If the prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.
3. Assemble the supplies you will need for an injection:
   • Pegfilgrastim prefilled syringe with transparent (clear) plastic blue needle guard attached
   • An alcohol swab and a cotton ball or gauze
   • Puncture-proof disposal container

  4.  Wash your hands with soap and warm water.

HOW TO PREPARE FOR INJECTION

• Remove the syringe from the package and the tray. Check to see that the plastic blue needle guard is covering the barrel of the glass syringe. DO NOT push the blue needle guard over the needle cover before injection. This may activate or lock the needle guard. If the blue needle guard is covering the needle that means it has been activated. Do NOT use that syringe. Dispose of that syringe in the puncture-proof disposal container. Use a new syringe. Do not activate the needle guard prior to injection.
• Hold the syringe barrel through the needle guard windows with the needle pointing up. Holding the syringe with the needle pointing up helps to prevent medicine from leaking out of the needle. Carefully pull the needle cover straight off.
• Check the syringe for air bubbles. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.
• Gently place the prefilled syringe with the window flat on your clean working surface so that the needle does not touch anything.

Selecting and preparing the injection site

• Choose an injection site. Four recommended injection sites are:
  • The outer area of the upper arms
  • The abdomen, except for the two-inch area around the navel
  • The front of the middle thighs
  • The upper outer areas of the buttocks
• Clean the injection site with an alcohol swab. 

Injecting the dose 

• Pick up the prefilled syringe from your clean, flat working surface by grabbing the sides of the needle guard with your thumb and forefinger.
• Hold the syringe in the hand you will use to inject. Use the other hand to pinch a fold of skin at the cleaned injection site. Note: Hold the syringe barrel through the needle guard windows when giving the injection.
• Holding the syringe like a pencil, use a quick “dart-like” motion to insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degrees) into the skin.
• After the needle is inserted, let go of the skin. Pull the plunger back slightly. If no blood appears, slowly push down on the plunger all the way, until all the medication is injected. If blood comes into the syringe, do not inject, because the needle has entered a blood vessel. Withdraw the syringe and discard it in the puncture-proof container. Repeat the steps to prepare a new prefilled syringe and choose and clean a new injection site. Remember to check again for blood before injecting pegfilgrastim.
• When the syringe is empty, pull the needle out of the skin and place a cotton ball or gauze over the injection site and press for several seconds.
• Use a prefilled syringe with the needle guard only once.

Activating the Needle Guard after the injection has been given

• After injecting pegfilgrastim from the prefilled syringe, do not recap the needle. Keep your hands behind the needle at all times. While holding the clear plastic finger grip of the syringe with one hand, grasp the blue needle guard with your free hand and slide the blue needle guard over the needle until the needle is completely covered and the needle guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated.
• Place the prefilled syringe with the activated needle guard into a puncture-proof container for proper disposal as described below.

Disposal of prefilled syringes and needle guards

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

The recommended dosage of pegfilgrastim is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer pegfilgrastim between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

If you receive too much pegfilgrastim, call your local Poison Control Center or seek emergency medical attention right away.

• Do not throw the container in the household trash. Do not recycle.
• DO NOT put the needle cover (the cap) back on the needle.
• Place all used needle covers and syringes in a hard plastic container with a screw-on cap or in 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 container is full, tape around the cap or lid to make sure the cap or lid does not come off.
• Always keep the container out of the reach of children.