Neupogen (Amgen Inc.)
Neupogen (Amgen Inc.) - General Information
Recombinant human G-CSF (Granulocyte colony stimulating factor), 175 residues, expressed in E. coli. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E coli.
Pharmacology of Neupogen (Amgen Inc.)
Used in the treatment of chemotherapy-induced neutropenia by enhancing the production of neutrophils. Neupogen (Amgen Inc.) acts on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Neupogen (Amgen Inc.) for patients
Patients should be referred to the "Information for Patients and Caregivers" labeling included with the package insert in each dispensing pack of NEUPOGEN vials or NEUPOGEN prefilled syringes. The "Information for Patients and Caregivers" labeling provides information about neutrophils and neutropenia and the safety and efficacy of NEUPOGEN. It is not intended to be a disclosure of all known or possible effects
INFORMATION FOR PATIENTS AND CAREGIVERS
This patient package insert provides information and instructions for people who will be receiving NEUPOGEN and their caregivers. This patient package insert does not tell you everything about NEUPOGEN. You should discuss any questions you have about treatment with NEUPOGEN with your doctor.
What is NEUPOGEN?
NEUPOGEN 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. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body's fight against infection.
What is NEUPOGEN used for?
NEUPOGEN is used to treat neutropenia (nu-tro-peen-ee-ah), a condition where the body makes too few white blood cells. Neutropenia may be a long-standing condition where your body does not make enough white blood cells, or it may be caused by drugs used to treat cancer. In some cases, your body may make enough white blood cells, but as part of your treatment for cancer, your doctor may want to increase the number of white blood cells your body makes 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 your treatment for cancer.
How does NEUPOGEN work?
NEUPOGEN works by stimulating the growth of neutrophils, a type of white blood cell. To make sure NEUPOGEN is working, your doctor will ask that you have regular blood tests to count the number of white blood cells you have. It is important that you follow your doctor's instructions about getting these tests.
Who should not take NEUPOGEN?
Do not take NEUPOGEN® if you are:
- Allergic to NEUPOGEN (Filgrastim) or any of its ingredients. See the end of this leaflet for a list of ingredients in NEUPOGEN .
- Allergic to other medicines made using the bacteria E coli. Ask your doctor if you are not sure.
What important information do I need to know about taking NEUPOGEN?
NEUPOGEN may reduce your risk of getting an infection, but may not prevent all infections. An infection can still happen during the short time when your/your child's white blood cell levels are low. You must be alert and look for some of the common signs 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 symptoms during treatment with NEUPOGEN, tell your doctor or nurse immediately.
There is a possibility that you could have a reaction at an injection site.
If there is a lump, swelling, or bruising at an injection site that does not go away, call your doctor.
If you have sickle cell disease, make sure that you tell your doctor before you start taking NEUPOGEN. If you do receive NEUPOGEN, it is important that you drink plenty of fluids. If you have a sickle cell crisis after getting NEUPOGEN, you need to tell your doctor right away.
Make sure your doctor knows about all medicines, and herbal or vitamin supplements you are taking before starting NEUPOGEN injections. If you are taking lithium you may need more frequent blood tests.
If you/your child are receiving NEUPOGEN injections because you are also receiving chemotherapy, your doctor or nurse will usually inject your first dose of NEUPOGEN the day after the last dose of chemotherapy in each cycle. The last dose of NEUPOGEN should be injected at least 24 hours before your next dose of chemotherapy.
There is more information about NEUPOGEN in the Physician Package Insert. If you have any questions, you should talk to your doctor.
What are possible side effects of NEUPOGEN?
Your spleen may become enlarged and, in rare instances, may rupture while taking NEUPOGEN. 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 your or your child's spleen is enlarged or ruptured.
NEUPOGEN can cause serious allergic reactions. These reactions can cause a rash over the whole body, shortness of breath, wheezing, dizziness (a drop in blood pressure), swelling around the mouth or eyes, fast pulse, and/or sweating. If you or your child gets these symptoms, stop using NEUPOGEN and call your doctor or get emergency care right away. If you or your child has an allergic reaction during the injection of NEUPOGEN, stop the injection right away.
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-aspirin 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 NEUPOGEN, 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.
What about pregnancy or breastfeeding?
NEUPOGEN has not been studied in pregnant women, and its effects on unborn babies are not known. If you take NEUPOGEN while you are pregnant, it is possible that small amounts of it may get into your baby's blood.
It is not known if NEUPOGEN 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 tell your doctor before using NEUPOGEN.
How to prepare and give a NEUPOGEN injection
NEUPOGEN should be injected at the same time each day. If you miss a dose contact your doctor or nurse.
You must always use the correct dose of NEUPOGEN. Too little NEUPOGEN
may not protect you against infections, and too much NEUPOGEN may cause too many neutrophils to be in your blood. Your doctor will determine your/your child's correct dose based on your/your child's body weight.
If you are giving someone else NEUPOGEN injections, it is important that you know how to inject NEUPOGEN, how much to inject, and how
often to inject NEUPOGEN.
NEUPOGEN is available as a liquid in vials or in prefilled syringes.
When you receive your NEUPOGEN, always check to see that:
- The name NEUPOGEN appears on the package and vial or prefilled syringe label.
- The expiration date on the vial or prefilled syringe label has not passed. You should not use a vial or prefilled syringe after the date on the label.
- The strength of the NEUPOGEN (number of micrograms in the colored dot on the package containing the vial or prefilled syringe) is the same as your doctor prescribed.
- The NEUPOGEN liquid in the vial or in the prefilled syringe is clear and colorless. Do not use NEUPOGEN if the contents of the vial or prefilled syringe appear discolored or cloudy, or if the vial or prefilled syringe appears to contain lumps, flakes, or particles.
If you are using vials of NEUPOGEN only use the syringe that your doctor prescribes.
Your doctor or nurse will give you instructions on how to measure the correct dose of NEUPOGEN. This dose will be measured in milliliters. You should only use a syringe that is marked in tenths of milliliters, or mL (for example, 0.2 mL). The doctor or nurse may refer to an mL as a cc (1 mL = 1 cc).
If you do not use the correct syringe, you or your child could receive too much or too little NEUPOGEN.
Only use disposable syringes and needles. Use the syringes only once and dispose of them as instructed by your doctor or nurse.
IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, YOU SHOULD FOLLOW THESE INSTRUCTIONS.
Setting up for an injection
- Find a clean flat working surface, such as a table.
- Remove the vial or prefilled syringe of NEUPOGEN from the refrigerator. Allow NEUPOGEN to reach room temperature (this takes about 30 minutes). Vials or prefilled syringes should be used only once. DO NOT SHAKE THE VIAL OR PREFILLED SYRINGE. Shaking may damage the NEUPOGEN. If the vial or prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.
- Assemble the supplies you will need for an injection:
- NEUPOGEN vial and disposable syringe and needle
- Or NEUPOGEN prefilled syringe with transparent (clear)
plastic orange needle guard attached
- two alcohol swabs and one cotton ball or gauze pad
- puncture-proof disposal container
- NEUPOGEN vial and disposable syringe and needle
- Wash your hands with soap and warm water.
HOW TO PREPARE THE DOSE OF NEUPOGEN IN VIALS OR PREFILLED SYRINGES
If you are using NEUPOGEN in a vial, follow the instructions in Section A. If you are using NEUPOGEN in a prefilled syringe, go to Section B.
Section A. Preparing the dose of NEUPOGEN® in a vial
- Take the cap off the vial. Clean the rubber stopper with one alcohol swab.
- Check the package containing the syringe. If the package has been opened or damaged, do not use that syringe. Dispose of that syringe in the puncture-proof disposal container. If the syringe package is undamaged, open the package and remove the syringe.
- Pull the needle cover straight off the syringe. Then, pull back the plunger and draw air into the syringe. The amount of air drawn into the syringe should be the same amount (mL or cc) as the dose of NEUPOGEN
that your doctor prescribed.
- Keep the vial on your flat working surface and insert the needle straight down through the rubber stopper. Do not put the needle through the rubber stopper more than once.
- Push the plunger of the syringe down and inject the air from the syringe into the vial of NEUPOGEN.
- Keeping the needle in the vial, turn the vial upside down. Make sure that the NEUPOGEN liquid is covering the tip of the needle.
- Keeping the vial upside down, slowly pull back on the plunger to fill the syringe with NEUPOGEN liquid to the number (mL or cc) that matches the dose your doctor prescribed.
- Keeping the needle in the vial, check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Then slowly push the plunger up to force the air bubbles out of the syringe.
- Keeping the tip of the needle in the liquid, once again pull the plunger back to the number on the syringe that matches your dose. Check again for air bubbles. The air in the syringe will not hurt you, but too large an air bubble can reduce your dose of NEUPOGEN. If there are still air bubbles, repeat the steps above to remove them.
- Check again to make sure that you have the correct dose in the syringe. It is important that you use the exact dose prescribed by your doctor. Remove the syringe from the vial but do not lay it down or let the needle touch anything. (Go to "Injecting the Dose of Neupogen®").
Section B. Preparing the dose of NEUPOGEN® in a prefilled syringe
- Remove the syringe from the package and the tray. Check to see that the plastic orange needle guard is covering the barrel of the glass syringe.
DO NOT push the orange needle guard over the needle cover before injection.
This may activate or lock the needle guard. If the orange 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 from the package.
- 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.
- Push the plunger up to the number (mL) on the syringe that matches the dose of NEUPOGEN that your doctor prescribed.
- Check again to make sure the correct dose of NEUPOGEN is in 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 for NEUPOGEN
are:
- The outer area of your upper arms
- The abdomen, except for the two inch area around your navel
- The front of your middle thighs
- The upper outer areas of your buttocks
- Clean the injection site with a new alcohol swab.
Choose a new site each time you inject NEUPOGEN. Choosing a new
site can help avoid soreness at any one site. Do not inject NEUPOGEN
into an area that is tender, red, bruised, or hard or that has scars or stretch marks.
Injecting the dose of NEUPOGEN
- For injecting the dose of NEUPOGEN from a vial, remove the syringe and needle from the vial. For injecting the dose of NEUPOGEN from a prefilled syringe, 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 NEUPOGEN.
Use the other hand to pinch a fold of skin at the cleaned injection site.
Note: If using a prefilled syringe with a needle guard, 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 NEUPOGEN is injected. If blood comes into the syringe, do not inject NEUPOGEN, 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 syringe (or get a new prefilled syringe) and choose and clean a new injection site. Remember to check again for blood before injecting NEUPOGEN.
- 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 or a syringe and vial only once. If you are using a syringe, DO NOT put the needle cover (the cap) back on the needle. Discard the vial with any remaining NEUPOGEN liquid.
Activating the Needle Guard for the prefilled syringe after the injection has been given
- After injecting NEUPOGEN 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 orange needle guard with your free hand and slide the orange 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 syringes, needles, vials 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, needles, vials and needle guards. There may be special state and local laws for disposal of used needles and syringes.
- Place all used needles, needle covers, syringes, and vials (empty or unused contents) 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 container is full, tape around the cap or lid to make sure the cap or lid does not come off. Do not throw the container in the household trash. Do not recycle.
- Always keep the container out of the reach of children.
How should NEUPOGEN be stored?
NEUPOGEN should be stored in the refrigerator at 2� to 8�C (36�
to 46�F), but not in the freezer. Avoid shaking NEUPOGEN. If NEUPOGEN
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. NEUPOGEN can be left out at room temperature for up to 24 hours. Do not leave NEUPOGEN in direct sunlight. If you have any questions about storage or how to carry NEUPOGEN when you travel, contact your doctor, nurse, or pharmacist.
What are the ingredients in NEUPOGEN®?
Each syringe and vial contains Filgrastim in a sterile, clear, colorless, preservative-free solution containing acetate, sorbitol, polysorbate 80, and sodium.
Neupogen (Amgen Inc.) Interactions
Drug interactions between NEUPOGEN and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium, should be used with caution.
Neupogen (Amgen Inc.) Contraindications
NEUPOGEN is contraindicated in patients with known hypersensitivity to E coli-derived proteins, Filgrastim, or any component of the product.
Additional information about Neupogen (Amgen Inc.)
Neupogen (Amgen Inc.) Indication: Increases leukocyte production, for treatment in non-myeloid cancer,neutropenia and bone marrow transplant
Mechanism Of Action: Neupogen (Amgen Inc.) binds to the G-CSF receptor. As a G-CSF analog, it controls proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Neupogen (Amgen Inc.) also stimulates the release of neutrophils from bone marrow storage pools and reduces their maturation time. Neupogen (Amgen Inc.) acts to increase the phagocytic activity of mature neutrophils. In patients receiving cytotoxic chemotherapy, Neupogen (Amgen Inc.) can accelerate neutrophil recovery, leading to a reduction in duration of the neutropenic phase
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Filgrastim
Synonyms: G-CSF; Granulocyte colony-stimulating factor precursor; Lenograstim; Pluripoietin
Drug Category: Anti-Infective Agents; Antineutropenic Agents; Immunomodulatory Agents
Drug Type: Biotech; Approved
Other Brand Names containing Filgrastim: Neupogen (Amgen Inc.);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: Not Available
Dosage Forms of Neupogen (Amgen Inc.): Solution Intravenous
Chemical IUPAC Name: Human granulocyte colony stimulating factor
Chemical Formula: C845H1343N223O243S9
Filgrastim on Wikipedia: https://en.wikipedia.org/wiki/Filgrastim
Organisms Affected: Not Available