Releuko (filgrastim-ayow) for Neutropenia

RELEUKO is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

It is used to treat:

• Patients with Cancer Receiving Myelosuppressive Chemotherapy

• Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

• Patients with Cancer Undergoing Bone Marrow Transplantation

• Patients with Severe Chronic Neutropenia

RELEUKO is contraindicated in patients who have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.

Before you take RELEUKO, tell your doctor about all of your medical conditions, including if you:

• have a sickle cell disorder.

• have kidney problems.

• are receiving radiation therapy.

• are pregnant or planning to become pregnant. It is not known if RELEUKO can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known if RELEUKO can pass into your breast milk.

Tell your doctor about all the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.

RELEUKO injections can be given by a doctor by intravenous infusion or under your skin. Your doctor may decide whether subcutaneous injections can be given at home by you or your caregiver.

• You and your caregiver should be shown how to prepare and inject RELEUKO before you use it, by your doctor.

• You should not inject a dose of RELEUKO less than 0.3 mL (180 mcg) from a RELEUKO prefilled syringe.

• A dose less than 0.3 mL cannot be measured using the RELEUKO prefilled syringe.

• Your doctor will tell you how much RELEUKO to inject and when to inject it. Do not change your dose or stop RELEUKO unless your doctor tells you to.

• If you are receiving RELEUKO because you are also receiving chemotherapy, your dose of RELEUKO should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your doctor will do blood tests to monitor your white blood cell count, and if necessary, adjust your RELEUKO dose.

• If you miss a dose of RELEUKO, talk to your doctor about when you should give your next dose.

The recommended starting dosage of RELEUKO is 5 mcg/kg/day‚ administered as a single daily injection by subcutaneous injection‚ by continuous intravenous infusion, or by short intravenous infusion (15 to 30 minutes)

The recommended dosage of RELEUKO following BMT is 10 mcg/kg/day given as an intravenous (into the vein) infusion no longer than 24 hours.

Before starting treatment with RELEUKO in patients with suspected chronic neutropenia, your doctor will confirm the diagnosis of severe chronic neutropenia (SCN) by evaluating serial complete blood count (CBC) with differential and platelet counts‚ and evaluating bone marrow morphology and karyotype.

The recommended starting dosage in patients with Congenital Neutropenia is 6 mcg/kg as a twice daily
subcutaneous injection.

The recommended starting dosage in patients with Cyclic or Idiopathic Neutropenia is 5 mcg/kg as a single daily subcutaneous injection.

Chronic daily administration is required to maintain clinical benefit. Individualize the dosage based on the patient’s clinical course as well as absolute neutrophil count ANC. In the SCN postmarketing surveillance study, the reported median daily doses of filgrastim were: 2.1 mcg/kg (cyclic neutropenia), 6 mcg/kg (congenital neutropenia), and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses of filgrastim greater than or equal to 100 mcg/kg/day.

During the initial 4 weeks of RELEUKO therapy and during the 2 weeks following any dosage adjustment‚ your doctor monitor CBCs with differential and platelet counts. Once you are clinically stable‚ your doctor will monitor CBCs with differential and platelet counts monthly during the first year of treatment. Thereafter, if you are clinically stable, then less frequent routine monitoring is recommended.

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

• Patients with cancer receiving chemotherapy: rash, cough, fever, pain, and shortness of breath

• Patients with acute myeloid leukemia receiving chemotherapy: nose bleed, pain, and rash

• Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash

• Patients with severe chronic neutropenia: pain, nose bleed, diarrhea, decreased red blood cells, reduced sensation, and hair loss

• Spleen rupture: Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or your left shoulder.

• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS): Call your doctor 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 may 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 doctor right away.

• Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage and hemoptysis have been reported in healthy donors treated with filgrastim products for peripheral blood progenitor cell (PBPC) mobilization. Hemoptysis resolved with discontinuation of filgrastim products.

• Sickle cell crises: You may get a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive RELEUKO. Call your doctor right away if you have symptoms of sickle cell crisis such as difficulty breathing or pain.

• Kidney injury (glomerulonephritis): RELEUKO can cause kidney injury. Call your doctor 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

• Increased white blood cell count (leukocytosis): Your doctor will check your blood during treatment with RELEUKO.

• Decreased platelet count (thrombocytopenia): Your doctor will check your blood during treatment with RELEUKO. Tell your doctor if you have unusual bleeding or bruising during treatment with RELEUKO.

• Capillary Leak Syndrome (CLS): RELEUKO can cause fluid to leak from blood vessels into your body’s tissues. This condition is called CLS or Capillary Leak Syndrome. CLS can cause 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
  • trouble breathing
  • swelling of your stomach area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness

• Inflammation of your blood vessels (cutaneous vasculitis): Tell your doctor right away if you develop purple spots or redness of your skin.

• Myelodysplastic syndrome and acute myeloid leukemia: If you have lung cancer or breast cancer, when RELEUKO is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called MDS or myelodysplastic syndrome or a blood cancer called AML or acute myeloid leukemia. Symptoms of MDS and AML may include fever, tiredness, and easy bruising or bleeding. Call your doctor if you develop these symptoms during treatment with RELEUKO.

• Inflammation of the aorta (aortitis): Inflammation of the aorta has been reported in patients who received pegfilgrastim products. Symptoms may include fever, feeling tired, abdominal pain, and back pain. Call your doctor if you experience these symptoms.

• Potential Effect on Malignant Cells: The granulocyte-colony stimulating factor (GCSF) receptor through which RELEUKO acts has also been found on tumor cell lines. The possibility that RELEUKO acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in myelodysplasia and chronic myeloid leukemia (CML) has not been established.

• Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes.

• Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended: Avoid the simultaneous use of RELEUKO with chemotherapy and radiation therapy.

• Store RELEUKO in the refrigerator between 2°C to 8°C.

• Do not freeze.

• Keep RELEUKO in the original packaging to protect from light or physical damage. Do not leave RELEUKO in direct sunlight.

• Do not shake RELEUKO.

• Take RELEUKO out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.

• Throw away any RELEUKO that has been left at room temperature for longer than 24 hours.

• After you inject your dose, throw away any unused RELEUKO left in the vials or prefilled syringes.

• Do not save unused RELEUKO in the vials or prefilled syringes for later use.

Active ingredient: filgrastim-ayow
Inactive ingredients: acetic acid, sodium hydroxide, polysorbate 80, sorbitol, and water for injection