Professional Information

Filgrastim

( G-CSF ) Pronouncation: (fill-GRAH-stim)
Class: Colony-stimulating factor

Trade Names:
Neupogen
- Injection 300 mcg/mL
- Injection 300 mcg per 0.5 mL
- Injection, prefilled SingleJect syringes 300 mcg per 0.5 mL
- Injection, prefilled SingleJect syringes 480 mcg per 0.8 mL

Pharmacology

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Filgrastim is a granulocyte colony-stimulating factor; stimulates neutrophil production within bone marrow.

Pharmacokinetics

Absorption

C _max is 4 to 49 ng/mL (subcutaneous); T _max is 2 to 8 h (subcutaneous).

Distribution

Vd is about 150 mL/kg.

Elimination

The t _½ is about 3.5 h and Cl is 0.5 to 0.7 mL/min/kg.

Indications and Usage

Cancer patients receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; cancer patients receiving bone-marrow transplant; patients with severe chronic neutropenia; peripheral blood progenitor cell (PBPC) collection and therapy in cancer patients.

Contraindications

Hypersensitivity to Escherichia coli -derived proteins, filgrastim, or any component of the product.

Dosage and Administration

Myelosuppressive Chemotherapy

IV/Subcutaneous Administer no earlier than 24 h after cytotoxic chemotherapy 5 mcg/kg/day as single daily injection by subcutaneous bolus, by short (15 to 30 min) IV infusion, or by continuous subcutaneous or IV infusion; may increase in increments of 5 mcg/kg for each chemotherapy cycle daily for up to 2 wk until ANC reaches 10,000/mm ³ .

Discontinuation

Therapy should be continued following chemotherapy until the postnadir ANC reaches 10,000/mm ³ . Discontinue if the ANC surpasses 10,000/mm ³ .

Bone Marrow Transplant

IV/Subcutaneous 10 mcg/kg/day as an IV infusion of 4 or 24 h or as a continuous 24-h subcutaneous infusion. Administer first dose at least 24 h after cytotoxic chemotherapy and at least 24 h after bone marrow infusion.

Dose adjustments

When absolute neutrophil count (ANC) is more than 1,000/mm ³ for 3 consecutive days, reduce dose to 5 mcg/kg/day, then if ANC remains more than 1,000/mm ³ for 3 more consecutive days, discontinue therapy, then if ANC decreases to less than 1,000/mm ³ resume 5 mcg/kg/day; if ANC decreases to less than 1,000/mm ³ at any time during 5 mcg/kg/day administration, increase dose to 10 mcg/kg/day and follow the previous dose adjustment guidelines.

Severe Chronic Neutropenia
Congenital neutropenia Starting dose

6 mcg/kg subcutaneously twice daily.

Idiopathic or Cyclic Neutropenia Starting dose

5ߙmcg/kg as a single subcutaneous injection once daily.

Dose adjustments

Chronic daily administration is required to maintain clinical benefit. Do not use ANC as the sole indication of efficacy. Individually adjust the dose based on the patient's clinical course and ANC.

Peripheral Blood Progenitor Cell Collation/Therapy

Subcutaneous 10 mcg/kg/day as bolus subcutaneous injection or continuous infusion; start 4 days before first leukapheresis and continue until last leukapheresis.

General Advice

Do not give filgrastim 24 h before or 24 h after cytotoxic chemotherapy.

Prefilled Syringe
Must activate the ultra safe needle guard by placing hands behind the needle, grasp the guard with 1 hand and slide the guard forward until needle is completely covered and the guard clicks into place.

For subcutaneous or IV administration only. Not for intradermal, IM, or intra-arterial administration.
May dilute in dextrose 5% injection to concentration between 5 and 15 mcg/mL; protect from absorption to plastic materials by adding albumin (human) to final concentration of 2 mg/mL. Dilution to final concentration of less than 5 mcg/mL is not recommended. Do not dilute filgrastim with saline.
Use only 1 dose per vial or prefilled syringe. Do not reenter vials. Discard unused portions; do not save unused portions for later use.
Do not administer if particulate matter, cloudiness, or discoloration noted.

Storage/Stability

Store vials and prefilled syringes in refrigerator (36° to 46°F). Avoid shaking. May allow injection to reach room temperature for a max of 24 h; discard any vial or syringe left at room temperature for more than 24 h. Protect from direct sunlight.

Drug Interactions

Drugs that may potentiate the release of neutrophils, such as lithium, should be used with caution. Use with caution in conjunction with other drugs known to lower the platelet count.

Incompatibility

Precipitate may form if diluted with saline.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension, hypotension (4%); cardiac events (eg, MI, arrhythmias [3%]).

CNS

Fatigue (11%); headache (7%); generalized weakness (4%).

Dermatologic

Alopecia (18%); petechiae (17%); rash 12%; cutaneous vasculitis; exacerbation of preexisting skin disorders (eg, psoriasis).

EENT

Epistaxis (15%); sore throat (4%).

GI

Nausea/vomiting (57%); diarrhea (14%); mucositis (12%); anorexia (9%); stomatitis, constipation (5%); peritonitis (2%).

Genitourinary

Hematuria/proteinuria; renal insufficiency.

Hematologic-Lymphatic

Increased neutrophil count (100%); decreased platelet counts (97%); mild to moderate anemia (65%); thrombocytopenia, increased WBC (12%); severe hemorrhage (7%); capillary leak syndrome.

Hepatic

Hepatomegaly.

Lab Tests

Reversible elevations is alkaline phosphatase, lactate dehydrogenase, uric acid (27% to 58%).

Musculoskeletal

MUSC symptoms (44%); medullary bone pain, mild to moderate bone pain (33%); skeletal pain (22%); arthralgia; osteoporosis.

Respiratory

Dyspnea (9%); cough (6%).

Miscellaneous

Splenomegaly (30%); neutropenic fever (13%); fever (12%); transfusion reactions (10%); chest pain (5%); pain (2%); injection-site reaction; acute myeloid leukemia, myelodysplastic syndrome (postmarketing [2% annually]).

Precautions

Monitor

Myelosuppressive chemotherapy

Obtain CBC, WBC, and platelet count prior to chemotherapy and 2 times/wk during filgrastim therapy.

Bone marrow transplant

Obtain CBC and platelet count at least 3 times/wk following marrow transplantation.

Severe chronic neutropenia

Obtain CBC with differential and platelet count 2 times/wk during first 4 wk of filgrastim therapy, and during the 2 wk following any dose adjustment; once stable, obtain once monthly for first year then at least quarterly thereafter. Perform bone marrow and cytogenetic evaluations annually in patients with congenital neutropenia.

Peripheral blood progenitor cell collection/therapy

Obtain neutrophil count after 4 days of filgrastim. Consider dose modification if WBC count greater than 100,000/mm ³ .

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in neonates and patients with autoimmune neutropenia of infancy not established.

Adult Respiratory Distress Syndrome

Has been reported in neutropenic patients with sepsis.

Bone marrow transplant

Do not administer filgrastim until at least 24 h after cytotoxic chemotherapy and at least 24 h after bone marrow infusion.

Cardiac events

MI and arrhythmias have been reported. Use with caution in patients with preexisting cardiac conditions.

Chemotherapy and radiation therapy

Do not use filgrastim in the period 24 h before through 24 h after administration of cytotoxic chemotherapy.

Immunogenicity

May occur.

Severe chronic neutropenia

Confirm diagnosis before initiating therapy.

Sickle cell disease

Use with caution; may cause sickle cell crisis.

Splenic rupture

Has been reported rarely. Evaluate patients reporting left upper abdominal and/or shoulder tip pain for enlarged spleen or splenic rupture.

Overdosage

Symptoms

Leukocytosis.

Patient Information

Advise patient or caregiver to read the patient information leaflet before starting therapy and with each refill.
Ensure patient or caregiver who is administering filgrastim understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health care professional.
Advise patient or caregiver to inject filgrastim at the same time each day.
Caution patient or caregiver not to shake the vial or prefilled syringe of filgrastim because shaking may damage the filgrastim.
Caution patient or caregiver not to use any filgrastim that is foamy, clouding, discolored, or contains particulate matter.
Instruct patient to take exactly as prescribed and not to change or stop taking the dose unless advised by health care provider. Caution patient that taking too little filgrastim may not protect against infections, and taking too much may cause too many WBCs to be produced.
Remind patient to rotate injection sites and never to inject into tissue that is tender, red, bruised, or hard, or has scars or stretch marks.
Advise patient or caregiver that aching in the bones and muscles is the most common side effect, but can usually be relieved by taking non-aspirin pain reliever (eg, acetaminophen). Advise patient or caregiver to notify health care provider if bone or muscle aches are severe or are not relieved by acetaminophen.
Instruct patient or caregiver to immediately notify health care provider if any of the following occur: signs or symptoms of infection (eg, fever, chills, rash, sore throat, diarrhea, or redness, swelling, or pain around a cut or open sore; pain in left upper stomach area or left shoulder tip area; rash; unexplained shortness of breath; wheezing; fast pulse; swelling around mouth or eyes.
Advise patient or caregiver to notify health care provider if any of the following occur: persistent or recurrent nausea with or without vomiting; persistent or severe injection site reactions (eg, redness, swelling, bruising, itching); any unexplained symptoms or feelings.
Advise patient with sickle cell disease to drink plenty of fluids while using filgrastim and to report any signs of sickle cell crisis to health care provider.