Leucostim Uses

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• Leucostim indications
• Uses of Leucostim in details
• Leucostim description
• Leucostim dosage
• Leucostim interactions
• Leucostim side effects
• Leucostim contraindications

What is Leucostim?

Leucostim injection is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Leucostim helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Leucostim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Leucostim is also used to help the bone marrow recover after a bone marrow transplantation, for a process called peripheral blood progenitor cell collection in cancer patients, and to improve survival in cancer patients who have been exposed to radiation.

Leucostim is available only with your doctor's prescription.

Leucostim indications

Established Cytotoxic Chemotherapy: Leucostim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation.

Peripheral Blood Progenitor Cell Mobilization (PBPC): Leucostim is indicated for the mobilization of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy in order to accelerate hematopoetic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. The safety and efficacy of Leucostim are similar in adults and children receiving cytotoxic chemotherapy. Leucostim is indicated for the mobilization of peripheral blood progenitor cells in normal volunteers for use in allogeneic peripheral blood progenitor cell transplantation.

Severe Chronic Neutropenia (SCN): In patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an ANC of ≤0.5x10⁹/L, and a history of severe or recurrent infections, long-term administration of Leucostim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

HIV Infection: Leucostim is indicated for the treatment of persistent neutropenia (ANC ≤1.0 x 10⁹/L) in patients with advanced HIV infection, in order to reduce risk of bacterial infections, when other options to manage neutropenia are inappropriate.

Patients with Acute Myeloid Leukemia (AML): Leucostim is indicated to reduce the duration of neutropenia and related clinical sequelae in patients undergoing induction or consolidation chemotherapy.

How should I use Leucostim?

Use Leucostim as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Leucostim. Talk to your pharmacist if you have questions about this information.
• Do not shake Leucostim. Shaking may damage Leucostim. If the vial or syringe has been shaken, the solution may appear foamy and should not be used.
• Leucostim is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Leucostim at home, a health care provider will teach you how to use it. Be sure you understand how to use Leucostim. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Leucostim if it contains particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
• Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.
• Choose a new site each time you inject Leucostim. Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.
• Discard any unused portion of medicine left in the vial or syringe.
• Continue to use Leucostim for the full course of treatment. Do not miss any doses.
• Leucostim works best if it is used at the same time each day.
• If you use Leucostim because you also receive chemotherapy, the last dose of Leucostim should be used at least 24 hours before your next dose of chemotherapy.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Leucostim, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Leucostim.

Uses of Leucostim in details

Use: Labeled Indications

Chemotherapy-induced myelosuppression in nonmyeloid malignancies:

Leucostim and Leucostim biosimilars: To decrease the incidence of infection (neutropenic fever) in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a significant incidence of severe neutropenia with fever

Tbo-Leucostim: To decrease the duration of severe neutropenia in adult and pediatric patients ≥1 month of age with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of neutropenic fever

Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Leucostim and Leucostim biosimilars): To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy in adults with AML

Bone marrow transplantation (Leucostim and Leucostim biosimilars): To reduce the duration of neutropenia and neutropenia-related events (eg, neutropenic fever) in patients with nonmyeloid malignancies receiving myeloablative chemotherapy followed by marrow transplantation

Hematopoietic radiation injury syndrome, acute (Leucostim only): To increase survival in patients acutely exposed to myelosuppressive doses of radiation

Peripheral blood progenitor cell collection and therapy (Leucostim and Leucostim biosimilars): Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for apheresis collection

Severe chronic neutropenia (Leucostim and Leucostim biosimilars): Long-term administration to reduce the incidence and duration of neutropenic complications (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital, cyclic, or idiopathic neutropenia

Note: Leucostim (Leucostim-aafi) and Zarxio (Leucostim-sndz) are approved as biosimilars to Leucostim (Leucostim). In Canada, Grastofil is a biosimilar to Leucostim (Leucostim).

Off Label Uses

Alcoholic hepatitis (severe)

Data from a small randomized, non-blinded pilot study suggest Leucostim may be safe and effective therapy and may improve liver function as well as survival in patients with severe alcoholic hepatitis.

Leucostim description

Each powder for injection contains Filgrastim 30 MU and 48 MU.

It also contains the following excipients: Sodium acetate trihydrate, mannitol and polysorbate 80.

Leucostim 30 MU Lyophilized Powder for Injection: Each vial of solvent contains benzyl alcohol 9 mg/mL.

Leucostim 48 MU Lyophilized Powder for Injection: Each vial of solvent contains benzyl alcohol 14.4 mg/1.6 mL.

The reconstituted preparation with 1 mL solvent (containing benzyl alcohol 0.9%) results in a clear, colorless solution.

Each vial of 1 mL and 1.6 mL solution for injection contains Filgrastim 30 MU and 48 MU, respectively.

It also contains the following excipients: Sodium acetate trihydrate, polysorbate 80, benzyl alcohol and water for injection.

Each pre-filled syringe of 0.5 mL and 0.8 mL contains Filgrastim 30 MU and 48 MU, respectively.

It also contains the following excipients: Sodium acetate trihydrate, polysorbate 80, benzyl alcohol and water for injection.

Leucostim (recombinant human granulocyte-colony stimulating factor, rH G-SCF) is produced by r-DNA technology in Escherichia coli.

Leucostim dosage

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Leucostim: Leucostim 300 mcg/mL (1 mL); Leucostim 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]

Solution, Injection [preservative free]:

Leucostim: Leucostim-aafi 300 mcg/mL (1 mL); Leucostim-aafi 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]

Solution, Subcutaneous [preservative free]:

Granix: tbo-Leucostim 300 mcg/mL (1 mL); tbo-Leucostim 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Injection [preservative free]:

Leucostim: Leucostim 300 mcg/0.5 mL (0.5 mL); Leucostim 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]

Leucostim: Leucostim-aafi 300 mcg/0.5 mL (0.5 mL); Leucostim-aafi 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]

Zarxio: Leucostim-sndz 300 mcg/0.5 mL (0.5 mL); Leucostim-sndz 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Granix: tbo-Leucostim 300 mcg/0.5 mL (0.5 mL); tbo-Leucostim 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]

Dosing: Adult

Note: Do not administer in the period 24 hours before to 24 hours after cytotoxic chemotherapy. May round the dose to the nearest vial size for convenience and cost minimization (ASCO [Ozer 2000]). Leucostim (Leucostim-aafi) and Zarxio (Leucostim-sndz) are approved as biosimilars to Leucostim (Leucostim). In Canada, Grastofil is a biosimilar to Leucostim (Leucostim). International considerations: Dosages below expressed as micrograms; 1 mcg = 100,000 units (Hoglund 1998).

Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Leucostim and Leucostim biosimilars): SubQ, IV: 5 mcg/kg/day; doses may be increased by 5 mcg/kg (for each chemotherapy cycle) according to the duration and severity of the neutropenia; continue for up to 14 days until the ANC reaches 10,000/mm (Díaz 2000; Wagner 2001).

Leucostim interactions

See also:
What other drugs will affect Leucostim?

The safety and efficacy of Leucostim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established. In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of Leucostim is not recommended in the period from 24 hrs before to 24 hrs after chemotherapy. Preliminary evidence from a small number of patients treated concomitantly with Leucostim and 5-fluorouracil indicate that the severity of neutropenia may be exacerbated. Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.

Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of Leucostim. Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.

Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.

Incompatibilities: Leucostim should not be diluted with saline solutions. If required, Leucostim may be diluted in 5% glucose.

Diluted Leucostim may be adsorbed to glass and plastic materials. However, when diluted in 5% glucose solution, Leucostim is compatible with glass and a variety of plastic including PVC, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.

Leucostim side effects

See also:
What are the possible side effects of Leucostim?

Leucostim usually does not cause serious or life-threatening adverse effects and it only rarely has required discontinuance. Because most patients who receive Leucostim have recently undergone cytotoxic chemotherapy, many of the adverse effects reported with Leucostim therapy may actually result from the actions of the previously administered antineoplastic agents.

The most frequent adverse effect reported during Leucostim therapy is deep, throbbing medullary bone pain, most often in the lower back, pelvis, ribs or sternum (eg, sites containing bone marrow). Sternal pain can imitate the pain of an acute myocardial infarction. The severity of the pain usually is increased in patients with more extensive leukocytosis. Non-opiate analgesics can alleviate this effect, and bone pain may spontaneously resolve with continued therapy.

Dose- or route-dependent, Leucostim-induced leukocytosis (leukocyte count >100,000/mm³) can occur during therapy, and the drug should be discontinued if the absolute neutrophil count (ANC) rises >10,000/mm³ after the nadir is achieved. An ANC >10,000/mm³ will not increase the effectiveness of the drug, but can increase its toxicity.

Splenomegaly has been observed in both children and adults during therapy with Leucostim, but is not common.

Leucostim contraindications

See also:
What is the most important information I should know about Leucostim?

You should not use this medication if you are allergic to Leucostim or to other medicines that contain the E. coli bacteria.

Before using Leucostim, tell your doctor if you have a blood cell disorder (such as sickle cell anemia), chronic myeloid leukemia, myelodysplasia (also called "preleukemia"), or if you are receiving chemotherapy or radiation treatment.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with Leucostim. Your liver function will also need to be tested, and you may need bone density scans. Visit your doctor regularly.

Stop using Leucostim and call your doctor at once if you have a serious side effect such as sudden or severe pain in your left upper stomach spreading up to your shoulder, rapid breathing or feeling short of breath, or signs of infection (fever, chills, sore throat, flu symptoms, easy bruising or bleeding, loss of appetite, nausea and vomiting, mouth sores, or unusual weakness).

Active ingredient matches for Leucostim:

Filgrastim in Peru, South Korea, Turkey.

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Information checked by Dr. Sachin Kumar, MD Pharmacology