Releuko

Generic name: (filgrastim-ayow)

Dosage Form: injection, soln

Medically reviewed by A Rash, MD. Last updated on Mar 23, 2022.

What is Releuko?

Releuko is a granulocyte colony-stimulating factor that has been synthesized by humans (G-CSF). G-CSF is a chemical that the body produces. It promotes the proliferation of neutrophils, a kind of white blood cell vital to the body’s anti-infection defenses.

Mechanism of Action

Colony-stimulating factors are glycoproteins that stimulate hematopoietic cell proliferation, differentiation commitment, and certain end-cell functional activation by binding to particular cell surface receptors.

Monocytes, fibroblasts, and endothelial cells produce endogenous G-CSF, a lineage-specific colony-stimulating factor. G-CSF affects neutrophil progenitor proliferation, differentiation, and selected end-cell functions (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and increased expression of some cell surface antigens) in the bone marrow. G-CSF is not species-specific, and it has been demonstrated to have minimal direct in vivo or in vitro effects on hematopoietic cell types other than neutrophils’ generation or activity.¶

Who should not take Releuko

Do not take Releuko if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.

Before you take Releuko

Talk to your healthcare provider about all of your medical conditions, including if you:

have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are pregnant or plan to become pregnant. It is not known if Releuko will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Releuko passes into your breast milk.

Inform your doctor about all of your medications, including prescription and over-the-counter medications, vitamins, and herbal supplements.

How will I receive Releuko?

These injections can be given intravenously (IV) or subcutaneously by a healthcare professional (subcutaneous injection). Subcutaneous injections may be given at home by you or a caregiver at the discretion of your healthcare practitioner. If you’re giving Releuko at home, follow the thorough “Instructions for Use” that came with your Releuko to learn how to prepare and inject a dose.
Your healthcare practitioner should show you and your caregiver how to prepare and inject Releuko before you use it.
You should not use a Releuko prefilled syringe to inject a dose of less than 0.3 mL (180 mcg). The RELEUKO prefilled syringe cannot correctly measure a dose of less than 0.3 mL.
Your healthcare practitioner will inform you how much and when to inject Releuko. If your healthcare practitioner tells you to, don’t change your dose or stop taking Releuko.
If you’re getting Releuko as part of chemotherapy treatment, your dose should be given at least 24 hours before or after your chemotherapy. Blood tests will be performed by your healthcare practitioner to monitor your white blood cell count and, if necessary, alter your Releuko dose.
If you miss a dose of Releuko, talk to your doctor about when you should take the next one.

Releuko side effects

This may cause serious side effects, including:

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.
A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
Serious allergic reactions. Releuko can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Releuko and call your healthcare provider or get emergency medical help right away.
Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive Releuko. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). Releuko can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
- swelling of your face or ankles
- blood in your urine or dark-colored urine
- you urinate less than usual

Capillary leak syndrome. Releuko can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
- swelling or puffiness and are urinating less than usual o
- trouble breathing
- swelling of your stomach area (abdomen) and feeling of fullness
- dizziness or feeling faint
- a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
- Releuko may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia).
- If you have breast cancer or lung cancer, when Releuko is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML.
- Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding.
- Call your healthcare provider if you develop any of these symptoms during treatment with Releuko.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Releuko. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Releuko. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Releuko.
Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received filgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain or chest pain Call your healthcare provider if you experience these symptoms.

The most common side effects experienced in patients receiving Releuko include:

- Patients with cancer receiving chemotherapy: fever, pain, rash, cough, and shortness of breath, nausea
- Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
- Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
- Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

These are not all the possible side effects of Releuko. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Releuko?

Store Releuko in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze.
Keep in the original pack to protect from light or physical damage. Do not leave RELEUKO in direct sunlight.
Do not shake it.
Take out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
Throw away (dispose of) any Releuko that has been left at room temperature for longer than 24 hours.
After you inject your dose, throw away (dispose of) any unused left in the vials or prefilled syringes. Do not save unused Releuko in the vials or prefilled syringes for later use.

Keep Releuko and all medicines out of the reach of children.

General information about the safety

Medicines are sometimes recommended for reasons not indicated in the Patient Information booklet. Releuko should not be used for any ailment for which it has not been prescribed. Even if they have the same symptoms as you, do not give Releuko to others. It has the potential to hurt them. You can get information on Releuko written for healthcare professionals from your pharmacist or healthcare provider.

Display Panel

10 Single-dose Prefilled Syringes with a Needle Guard
Releuko (filgrastim-ayow) Injection
300 mcg/0.5 mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
Sterile Solution – No Preservative
RX Only

NDC 70121-1568-1 Rx only
Releuko
(filgrastim-ayow)
Injection
300 mcg/0.5 mL
Single-dose Prefilled Syringe
For subcutaneous use only

NDC 70121-1568-1
Releuko
(filgrastim-ayow) Injection RX Only
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli
1 x 300 mcg/0.5 mL single-dose prefilled syringe with needle guard
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F)
in the original carton to protect from light.
DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
Dosage: See Prescribing Information

10 x 1 mL Single-dose Vials
Discard unused portion.
NDC 70121-1569-7
Releuko
(filgrastim-ayow) Injection
300 mcg/mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For subcutaneous or intravenous use only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
RX Only

NDC 70121-1569-1 Rx only
Releuko
(filgrastim-ayow) Injection
300 mcg/mL
single-dose vial
For subcutaneous or intravenous use only

10 Single-dose Prefilled Syringes with a Needle Guard
NDC 70121-1570-7
Releuko
(filgrastim-ayow) Injection
480 mcg/0.8 mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
RX Only

NDC 70121-1570-1 Rx only
Releuko
(filgrastim-ayow)
Injection
480 mcg/0.8 mL
Single-dose Prefilled Syringe
For subcutaneous use only

NDC 70121-1570-1
Releuko
(filgrastim-ayow) Injection RX Only
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli
1 x 480 mcg/0.8 mL single-dose prefilled syringe with needle guard
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F)
in the original carton to protect from light.
DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative