What is Neulasta?
Neulasta (pegfilgrastim) can lower your risk of infection during chemotherapy, but it can cause a significant amount of bone pain. This medication reduces the risk of infection in people with tumors who are at risk of developing infections due to chemotherapy.
Neulasta (pegfilgrastim) is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection. Neulasta is used to prevent neutropenia, a lack of certain white blood cells caused by receiving chemotherapy.
Neulasta may also be used for purposes not listed in this medication guide.
Before using Neulasta, tell your doctor if you have sickle cell disorder, chronic myeloid leukemia, myelodysplasia (also called “preleukemia”), or if you are allergic to latex. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Do not self-inject Neulasta if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Neulasta is usually given once per chemotherapy cycle. Neulasta should not be given within 14 days before or 24 hours after you receive chemotherapy.
How does this medication work? What will it do for me?
In the body’s bone marrow (the soft, sponge-like material found inside bones) blood cells are produced. There are three major types of blood cells; white blood cells, which fight infection; red blood cells, which carry oxygen to and remove waste products from organs and tissues; and platelets, which enable the blood to clot.
Cancer treatments such as chemotherapy and radiation therapy can effect these cells which put a person at risk for developing infections, anemia and bleeding problems. Colony-stimulating factors are substances that stimulate the production of blood cells and promote their ability to function.
They do not directly affect tumors but through their role in stimulating blood cells they can be helpful as support of the persons immune system during cancer treatment.
Pegfilgrastim is a growth factor that stimulates the production, maturation and activation of neutrophils. Pegfilgrastim also stimulates the release of neutrophils (a type of white blood cell) from the bone marrow. In patients receiving chemotherapy, pegfilgrastim can accelerate the recovery of neutrophils, reducing the neutropenic phase (the time in which people are susceptible to infections). Pegfilgrastim is a long-acting version of filgrastim.
Pegfilgrastim is filgrastim with a substance called polyethylene glycol (PEG) attached to it. The attachment process is called pegylation, and is used to allow active substances (the filgrastim) to stay in the body longer before they are broken down and eliminated.
Pegfilgrastim belongs to the family of medications known as granulocyte colony stimulating factors (G-CSF). Pegfilgrastim helps the bone marrow produce white blood cells which help the body fight infection.
Pegfilgrastim is used to treat neutropenia (low counts of a certain type of white blood cell known as neutrophils) for people who have certain types of cancer and are receiving a type of chemotherapy that slows down white blood cell production.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
This Drug Is Used For:
- This medicine is used to stimulate the growth of “healthy” white blood cells in the bone marrow, once chemotherapy is given. White blood cells help the body to fight infection. This is not a chemotherapy drug.
- This medication is usually given at least 24 hours after chemotherapy to stimulate the growth of new, healthy, white blood cells (WBC).
- Pegfilgrastim is a longer acting form of filgrastim and the manufacturer recommends that it should not be given within 14 days prior to chemotherapy.
- Pegfilgrastim is given as a single injection.
Before taking this medicine
You should not use Neulasta if you are allergic to pegfilgrastim or filgrastim (Neupogen).
To make sure you can safely use Neulasta, tell your doctor if you have any of these other conditions:
- sickle cell disorder;
- kidney disease;
- chronic myeloid leukemia;
- myelodysplasia (also called “preleukemia”); or
- a latex allergy.
It is not known whether Neulasta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Neulasta on the baby. It is not known whether pegfilgrastim passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Neulasta Side Effects
Important things to remember about the side effects of pegfilgrastim:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and duration.
- Side effects are almost always reversible and will go away after treatment is complete.
- There are many options to help minimize or prevent side effects.
- There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
- Pegfilgrastim is a support medication. The following list includes side effects attributed to pegfilgrastim. Other side effects experienced were attributed to the chemotherapy and/or the disease.
- Pain (bone pain)
- Blood test abnormalities (temporary elevation in lactate dehydrogenase)
- These will return to normal once treatment is discontinued
- Tenderness at the site of injection
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
- Fever of 100.4° F (38° C), chills, sore throat (possible signs of infection)
- Shortness of breath
- Rapid heart beat
- Bleeding that does not stop after a few minutes
- Any new rashes on your skin
How should I use Neulasta?
Neulasta is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Neulasta is usually given once per chemotherapy cycle. This medication should not be given within 14 days before or 24 hours after you receive chemotherapy. Do not shake the prefilled syringe. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
The Neulasta On-body Injector is a special device placed on the skin that delivers your Neulasta dose at a specific time. Read and carefully follow all instructions for using this product.
You will need to wear the device for 27 hours before the dose begins. The timed dose will then be released from the device slowly over a 45-minute period. While wearing the On-body Injector, you or a caregiver will need to check the device to make sure it is working properly.
Each prefilled Neulasta syringe or On-body Injector is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets. You may need frequent medical tests to help your doctor determine how long to treat you with Neulasta. Store Neulasta in the refrigerator, do not freeze. Protect from light and do not shake.
Take the medicine out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not leave the medicine at room temperature for longer than 48 hours.
Throw away any unused syringes after the expiration date on the label has passed.
What should I tell my health care provider before taking Neulasta®?
Before you receive Neulasta®, tell your healthcare provider if you:
- Have sickle cell trait or sickle cell disease
- Have had severe skin reactions to acrylic adhesives
- Are allergic to latex
- Have problems with your kidneys
- Have any other medical problems
- Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if Neulasta® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
Usual Adult Dose for Neutropenia Associated with Chemotherapy:
6 mg subcutaneously once per chemotherapy cycle, beginning 24 to 72 hours after completion of chemotherapy
Usual Pediatric Dose for Neutropenia Associated with Chemotherapy:
Based on limited studies:
1 to 12 years old: 100 mcg/kg (maximum dose: 6 mg) once per chemotherapy cycle, beginning 24 to 72 hours after completion of chemotherapy
13 to 18 years old and greater than 45 kg: 6 mg once per chemotherapy cycle, beginning 24 to 72 hours after completion of chemotherapy.
Neulasta side effects
Get emergency medical help if you have signs of an allergic reaction to Neulasta: hives, skin rash, flushing (warmth, redness, or tingly feeling); wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.
A rare but serious side effect of Neulasta is called capillary leak syndrome. Call your doctor right away if you have signs of this condition, which may include: decreased urination, tiredness, dizziness or light-headed feeling, and sudden swelling, puffiness, or feeling of fullness.
Call your doctor at once if you have:
- sudden or severe pain in your left upper stomach spreading up to your shoulder;
- rapid breathing, feeling short of breath;
- bruising, swelling, or a hard lump where the medicine was injected;
- kidney problems – little or no urination, pink or dark urine, swelling in your feet or ankles, feeling tired or short of breath; or
- low white blood cell counts – fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough.
Common Neulasta side effects may include:
- bone pain, muscle aches;
- pain in your arms or legs; or
- pain and redness where the injection was given.
- Before starting pegfilgrastim treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- The manufacturer recommends that the first dose of pegfilgrastim be given no sooner than 24 hours after chemotherapy. Your doctor will discontinue therapy with pegfilgrastim when your white blood cell count has reached acceptable levels.
- Pegfilgrastim may be inadvisable if you have had a hypersensitivity (allergic) reaction to filgrastim, pegfilgrastim or E. coli-derived proteins.
- Do not receive any kind of immunization or vaccination without your doctor’s approval while taking pegfilgrastim.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
- For both men and women: Do not conceive a child (get pregnant) while taking pegfilgrastim. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking this medication.
- Pegfilgrastim should be used with caution in people taking lithium.
Neulasta Pregnancy Warnings
AU, US: This drug should be used during pregnancy only if the benefit outweighs the risk. UK: Use is not recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comment: -Some manufacturers have surveillance programs for pregnant women who are receiving this drug. Consult the manufacturer product information for further detail.
This drug was embryotoxic and increased pregnancy loss in animal studies at cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. There are no controlled data in human pregnancy.
It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
precautions or warnings for this medication?
The safety of using pegfilgrastim at the same time as cytotoxic chemotherapy (a type of chemotherapy that kills cells, especially cancer cells) has not been established. Pegfilgrastim should not be used within 14 days before or 24 hours after chemotherapy. In addition, it is not known whether is is safe and effective to use pegfilgrastim after certain chemotherapy medications (e.g., mitomycin C, 5-flurouracil, and nitrosoureas such as carmustine and lomustine).
Pegfilgrastim may cause adult respiratory distress syndrome (ARDS), a serious lung condition, when people with neutropenia have sepsis (bacterial infection in the blood). If ARDS occurs, this medication should be stopped until the ARDS resolves.
It is nnot known whether it is safe and effective to use pegfilgrastim with radiation therapy. Pegfilgrastim should not be used during radiation therapy.
Sickle cell disease:
Pegfilgrastim may cause sickle cell crisis when used by people who have sickle cell disease. You and your doctor should carefully consider the benefits and risks of using pegfilgrastim in these circumstances.
This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.
It is not known whether pegfilgrastim passes into breast milk. Pegfilgrastim is not recommended by breast-feeding mothers.
The safety and effectiveness of pegfilgrastim have not been established for children.
Neulasta Breastfeeding Warnings
AU, US: Caution is recommended. UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Other recombinant G-CSF products are poorly secreted in breast milk, and G-CSF is not orally absorbed by neonates. -The effects in the nursing infant are unknown. -Some manufacturers have surveillance programs for nursing mothers who are receiving this drug. Consult the manufacturer product information for further detail.
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