Filcad Uses

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

What is Filcad?

Filcad 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. Filcad 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. Filcad is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Filcad 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.

Filcad is available only with your doctor's prescription.

Filcad indications

Established Cytotoxic Chemotherapy: Filcad 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): Filcad 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 Filcad are similar in adults and children receiving cytotoxic chemotherapy. Filcad 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 Filcad is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

HIV Infection: Filcad 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): Filcad is indicated to reduce the duration of neutropenia and related clinical sequelae in patients undergoing induction or consolidation chemotherapy.

How should I use Filcad?

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

• An extra patient leaflet is available with Filcad. Talk to your pharmacist if you have questions about this information.
• Do not shake Filcad. Shaking may damage Filcad. If the vial or syringe has been shaken, the solution may appear foamy and should not be used.
• Filcad is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Filcad at home, a health care provider will teach you how to use it. Be sure you understand how to use Filcad. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Filcad 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 Filcad. 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 Filcad for the full course of treatment. Do not miss any doses.
• Filcad works best if it is used at the same time each day.
• If you use Filcad because you also receive chemotherapy, the last dose of Filcad 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 Filcad, contact your doctor right away.

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

Uses of Filcad in details

Use: Labeled Indications

Chemotherapy-induced myelosuppression in nonmyeloid malignancies:

Filcad and Filcad 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-Filcad: 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 (Filcad and Filcad 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 (Filcad and Filcad 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 (Filcad only): To increase survival in patients acutely exposed to myelosuppressive doses of radiation

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

Severe chronic neutropenia (Filcad and Filcad 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: Filcad (Filcad-aafi) and Zarxio (Filcad-sndz) are approved as biosimilars to Filcad (Filcad). In Canada, Grastofil is a biosimilar to Filcad (Filcad).

Off Label Uses

Alcoholic hepatitis (severe)

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

Filcad 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.

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

Filcad 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.

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

Filcad dosage

Dosage Forms

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

Solution, Injection:

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

Solution, Injection [preservative free]:

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

Solution, Subcutaneous [preservative free]:

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

Solution Prefilled Syringe, Injection [preservative free]:

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

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

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

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Granix: tbo-Filcad 300 mcg/0.5 mL (0.5 mL); tbo-Filcad 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]). Filcad (Filcad-aafi) and Zarxio (Filcad-sndz) are approved as biosimilars to Filcad (Filcad). In Canada, Grastofil is a biosimilar to Filcad (Filcad). International considerations: Dosages below expressed as micrograms; 1 mcg = 100,000 units (Hoglund 1998).

Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Filcad and Filcad 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).

Filcad interactions

See also:
What other drugs will affect Filcad?

The safety and efficacy of Filcad 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 Filcad 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 Filcad 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 Filcad. 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: Filcad should not be diluted with saline solutions. If required, Filcad may be diluted in 5% glucose.

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

Filcad side effects

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

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

The most frequent adverse effect reported during Filcad 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, Filcad-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 Filcad, but is not common.

Filcad contraindications

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

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

Before using Filcad, 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 Filcad. Your liver function will also need to be tested, and you may need bone density scans. Visit your doctor regularly.

Stop using Filcad 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 Filcad:

Filgrastim

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Information checked by Dr. Sachin Kumar, MD Pharmacology