filgrastim (Rx)

Brand and Other Names:G-CSF, Neupogen, more...tbo-filgrastim, Granix, Zarxio, filgrastim-sndz, Nivestym, filgrastim-aafi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution (Neupogen, Nivestym)

  • 300mcg/mL
  • 480mcg/1.6mL

prefilled syringe for SC injection (Neupogen, tbo-filgrastim [Granix], filgrastim-sndz [Zarxio], filgrastim-aafi [Nivestym]))

  • 300mcg/0.5mL
  • 480mcg/0.8mL

Biosimilars to Neupogen

  • Zarxio
  • Granix
  • Nivestym
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Myelosuppressive Chemotherapy Treatment

Neupogen, Granix, Zarxio, Nivestym

Indicated to decrease infection incidence‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever

Obtain a CBC count and platelet count before instituting therapy and monitor twice weekly during therapy

5 mcg/kg SC/IV qDay initially; may increase by 5 mcg/kg according to duration and severity of ANC

Do not administer within the 24-hr period prior to chemotherapy

A transient increase in neutrophil count is typically seen 1-2 days after initiation; therefore, to ensure a sustained therapeutic response‚ administer daily for up to 2 weeks or until the ANC has reached 10‚000/mm³ following the expected chemotherapy-induced neutrophil nadir

Duration of therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen used

Induction or Consolidation Chemotherapy

Neupogen, Zarxio, Nivestym

Indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia

Obtain a CBC count and platelet count before instituting therapy and monitor twice weekly during therapy

5 mcg/kg SC/IV qDay initially; may increase by 5 mcg/kg for each chemotherapy cycle according to duration and severity of ANC

Do not administer within the 24-hr period prior to chemotherapy

A transient increase in neutrophil count is typically seen 1-2 days after initiation; therefore, to ensure a sustained therapeutic response‚ administer daily for up to 2 weeks or until the ANC has reached 10‚000/mm³ following the expected chemotherapy-induced neutrophil nadir

Duration of therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen used

Bone Marrow Transplantation

Neupogen, Zarxio, Nivestym

Indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg‚ febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)

Following BMT: 10 mcg/kg/day IV infusion over 4-24 hr (do not exceed 24-hr infusion)

Administer the first dose at least 24 hr after cytotoxic chemotherapy and at least 24 hr after bone marrow infusion

Monitor CBC counts and platelet counts frequently following marrow transplantation

Dose titration

  • During the period of neutrophil recovery‚ titrate the daily dosage against the neutrophil response
  • ANC >1000/mm³ for 3 consecutive days: Reduce dose to 5 mcg/kg/day, THEN
  • If ANC remains >1000/mm³ for 3 more consecutive days: Discontinue filgrastim, THEN
  • If ANC decreases to <1000mm³: Resume at 5 mcg/kg/day
  • Note: If ANC decreases to <1000mm³ at any time during the 5 mcg/kg/day administration, increase dose to 10 mcg/kg/day and then follow above steps

Peripheral Blood Progenitor Cell Collection

Neupogen, Zarxio, Nivestym

Indicated for the mobilization of autologous peripheral blood progenitor cells (PBPCs) into the peripheral blood for collection by leukapheresis

10 mcg/kg/day SC 

Initiate at least 4 days before first leukapheresis; continue until last day of leukapheresis

Optimal duration of administration and leukapheresis schedule have not been established; administration for 6-7 days with leukaphereses on days 5‚ 6‚ and 7 was found to be safe and effective in clinical studies described in prescribing information

Monitor neutrophil counts after 4 days‚ and discontinue if the WBC count rises to >100‚000/mm³

Severe Chronic Neutropenia

Neupogen, Zarxio, Nivestym

Indicated for long-term administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with severe chronic neutropenia (SCN), including congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

Before initiating therapy in patients with suspected chronic neutropenia, confirm the diagnosis of severe chronic neutropenia SCN by evaluating serial CBC counts with differential and platelet counts‚ and evaluating bone marrow morphology and karyotype; initiating therapy prior to confirmation of a correct diagnosis of SCN may impair diagnostic efforts and may thus impair or delay evaluation and treatment of an underlying condition‚ other than SCN‚ causing the neutropenia

Congenital: Initial 6 mcg/kg SC q12hr 

Idiopathic/cyclic: Initial 5 mcg/kg/day SC

Dosage modifications (SCN)

  • Long-term daily administration is required to maintain clinical benefit
  • Individualize dose based on the clinical course as well as ANC
  • Postmarket analysis showed median daily doses of 6 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia)
  • In rare instances, patients with congenital neutropenia have required doses ≥100 mcg/kg/day

Monitoring (SCN)

  • Monitor CBC count (with differential and platelet counts) during the initial 4 weeks and during the 2 weeks following any dosage adjustment
  • Once a patient is clinically stable‚ monitor monthly during the first year of treatment
  • Thereafter, if the patient is clinically stable, less frequent routine monitoring is recommended

Acute Exposure to Myelosuppressive Radiation Doses

Neupogen

Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

10 mcg/kg SC as a single daily injection for patients exposed to myelosuppressive doses of radiation

Administer as soon as possible after suspected or confirmed exposure to radiation doses >2 Gy

Estimate a patient’s absorbed radiation dose based on information from public health authorities, biodosimetry if available, or clinical findings (eg, time to onset of vomiting, lymphocyte depletion kinetics)

Obtain baseline CBC count and then serial CBC counts ~q3days until the ANC remains >1,000/mm³ for 3 consecutive CBC counts

Do not delay administration if a CBC count is not readily available

Continue administration until the ANC remains >1,000/mm³ for 3 consecutive CBC counts or is >10,000/mm³ after a radiation-induced nadir

Dosing Considerations

Prefilled syringe with BD UltraSafe Plus 9 Passive Needle Guard may not accurately measure volumes <0.3 mL due to needle spring mechanism design; direct administration of a volume <0.3 mL using prefilled syringe is not recommended due to potential for dosing errors; for direct administration of doses <0.3 mL (180 mcg) use single-dose vial

Orphan Designations

Ganciclovir-related neutropenia: Treatment of patients with AIDS who, in addition, are afflicted with cytomegalovirus retinitis and are being treated with ganciclovir

Treatment of amyotrophic lateral sclerosis (ALS)

tbo-filgrastim (Granix): Orphan designation for mobilization of peripheral blood progenitor cells (PBPCs) in healthy donors prior to allogeneic PBPC transplantation

Sponsors

  • Amgen, Inc; One Amgen Center Dr; Thousand Oaks, CA 91320-1799
  • Neurovision Pharma GmbH; Emil-Geis Str. 4; Grunwald82031, Germany
  • Sicor Biotech UAB; 5 Moletu pl. 5, Vilnius; Lithuania

Dosage Forms & Strengths

injectable solution (Neupogen, Nivestym)

  • 300mcg/mL
  • 480mcg/1.6mL

prefilled syringe for SC injection (Neupogen, tbo-filgrastim [Granix], filgrastim-aafi [Nivestym])

  • 300mcg/0.5mL
  • 480mcg/0.8mL
more...

Peripheral Blood Progenitor Cell Collection

As adults; 10 mcg/kg/day SC 

Initiate 4 days before leukapheresis; continue until last day of leukapheresis

Myelosuppressive Chemotherapy Treatment (Off-label)

5-10 mcg/kg qDay IV/SC for14 days

Give daily until ANC >10,000/mm³

Congenital Neutropenia or Agranulocytosis (Off-label)

As adults; Initial 6 mcg/kg SC q12hr

Dosage range: 3-15 mcg/kg/day SC qDay or divided q12hr

Dosing Considerations

Prefilled syringe with BD UltraSafe Plus Passive Needle Guard may not accurately measure volumes <0.3 mL due to needle spring mechanism design; direct administration of a volume <0.3 mL using prefilled syringe is not recommended due to potential for dosing errors; for direct administration of doses <0.3 mL (180 mcg) use single-dose vial

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Adverse Effects

>10%

Nausea (57%)

Vomiting (57%)

Bone pain (22%-33%)

Alopecia (18%)

Diarrhea (14%)

Fever (12%)

Fatigue (11%)

1-10%

Headache

Anorexia

Chest pain

Cough

Dyspnea

Constipation

Stomatitis

Sore throat

Rash

Frequency Not Defined

Elevated uric acid

Elevated lactate dehydrogenase

Elevated alkaline phosphatase

Postmarketing Reports

Splenic rupture

ARDS

Asthenia

Glomerulonephritis

Alveolar hemorrhage and hemoptysis

Sickle cell crisis

Cutaneous vasculitis

Sweet syndrome (acute febrile neutrophilic dermatosis)

Decreased bone density and osteoporosis in children with severe chronic neutropenia receiving long-term treatment

Aortitis

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Warnings

Contraindications

History of serious allergic reactions to filgrastim or pegfilgrastim products

Cautions

Allergic reactions reported (angioneurotic edema, dermatitis-allergic, hypersensitivity, rash, pruritic rash, and urticaria); allergic reactions can recur within days after discontinuation of initial antiallergic treatment; permanently discontinue therapy in patients with serious allergic reactions

Associated with rare cases of potentially fatal splenic rupture; evaluate if patient experiences left upper abdominal and/or shoulder tip pain

Rare cases of ARDS reported; evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS; discontinue therapy in patients with ARDS

Monitor for thrombocytopenia

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders; discontinue therapy if sickle cell crisis occurs

Glomerulonephritis reported; if suspected, evaluate for cause; if causality likely, consider dose-reduction or interruption

Increased hematopoietic 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

WBC counts ≥100‚000/mm³ were observed in ~2% of patients receiving filgrastim at dosages >5 mcg/kg/day

Off-label use for PBPC mobilization has resulted in alveolar hemorrhage, resulting in pulmonary infiltrates and hemoptysis

Cutaneous vasculitis has been reported; hold therapy in patients with cutaneous vasculitis; therapy may be started at a reduced dose when the symptoms resolve and the ANC has decreased

Capillary leak syndrome (CLS) can occur in patients receiving filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration; patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

In patients with cancer receiving the drug as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ recommended that therapy be discontinued if the ANC surpasses 10‚000/mm³ after the chemotherapy-induced ANC nadir has occurred; monitor CBC counts at least twice weekly during therapy; dosages that increase the ANC beyond 10‚000/mm³ may not result in any additional clinical benefit

During period of administration of therapy for PBPC mobilization in patients with cancer, discontinue therapy if leukocyte count rises to >10‚000/mm³

Simultaneous use with chemotherapy and radiation therapy not recommended

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes; consider when interpreting bone-imaging results

Increased hematopoietic 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

Aortitis

  • Aortitis has been reported; may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, C-reactive protein and WBC)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology
  • Discontinue if aortitis is suspected

Severe chronic neutropenia

  • Confirm if patients have severe chronic neutropenia (SCN)
  • Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy
  • Effect of filgrastim on the development of abnormal cytogenetics and the effect of continued administration in patients with abnormal cytogenetics or MDS are unknown
  • If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits should be carefully considered before continuing treatment

Drug interaction overview

  • Drugs that may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution
  • Safety and efficacy of concomitantly using filgrastim with cytotoxic chemotherapy or radiation therapy have not been established; because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ do not use in the period 24 hr before through 24 hr after the administration of cytotoxic chemotherapy
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Pregnancy & Lactation

Pregnancy

Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes

Reports in scientific literature have described transplacental passage of drug in pregnant women when administered less than or equal to 30 hours prior to preterm delivery (less than or equal to 30 weeks' gestation)

In animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits; no malformations were observed in either species; no maternal or fetal effects were observed in pregnant rats at doses up to 58 times the human doses; drug has been shown to have adverse effects in pregnant rabbits at doses 2 -10 times higher than the human doses

Lactation

There is published literature documenting transfer of filgrastim into human milk; there are a few case reports describing use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants; there are no data on effects of filgrastim on milk production; other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
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Pharmacology

Mechanism of Action

Recombinant human G-CSF; acts on hematopoietic cells to stimulate production, maturation, and activation of neutrophils; increases migration and cytotoxicity of neutrophils.

Absorption

100% (SC)

Peak Plasma Time: 2-8 hr

Distribution

Vd: 0.15 L/kg

Metabolism

Degraded systemically

Elimination

Duration: Neutrophil counts decrease to baseline in approximately 4 days

Half-life elimination: 1.8-3.5 hr

Clearance: 0.5-0.7 mL/min/kg

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Administration

IV Incompatibilities

Y-site: amphotericin B, cefepime, cefoperazone, cefotaxime, cefoxitin, ceftizoxime, ceftriaxone, cefuroxime, clindamycin, dactinomycin, etoposide, fluorouracil, furosemide, heparin, mannitol, methylprednisolone sodium succinate, metronidazole, mitomycin, piperacillin, prochlorperazine, thiotepa

IV Compatibilities

Y-site (partial list): acyclovir, ampicillin, bleomycin, carboplatin, carmustine, cyclophosphamide, diphenhydramine, daunorubicin, doxorubicin, fluconazole, metoclopramide, morphine SO4, KCl, Na-bicarb

IV Preparation

Vials may be diluted in D5W to >15 mcg/mL for infusion

5-15 mcg/mL dilution: Protect from adsorption to plastic materials by the addition of human albumin to a final concentration of 2 mg/mL

Do not dilute with saline at any time, because the product may precipitate

IV Administration

Short IV infusion over 15-30 min, OR

Continuous IV infusion

SC Administration

SC injection may be administered by healthcare professional, caregiver, or patient

Patient self-administration and administration by a caregiver may benefit from training by a healthcare professional; training should aim to demonstrate to those patients and caregivers how to measure the dose using the prefilled syringe; the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for use of prefilled syringe with BD UltraSafe Plus Passive Needle Guard; if a patient or caregiver is not able to demonstrate he or she can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration

Prefilled syringe with BD UltraSafe Plus Passive Needle Guard is not designed to allow for direct administration of doses of <0.3 mL (180 mcg); the spring mechanism of the needle guard apparatus affixed to the prefilled syringe interferes with the visibility of the graduation markings on the syringe barrel corresponding to 0.1 mL and 0.2 mL; the visibility of these markings is necessary to accurately measure doses <0.3 mL (180 mcg) for direct administration; the direct administration to patients requiring doses <0.3 mL (180 mcg) is not recommended owing to potential for dosing errors; for direct administration of doses <0.3 mL (180 mcg) use single-dose vial

Prior to use‚ remove vial or prefilled syringe from refrigerator and allow to reach room temperature for a minimum of 30 minutes and a maximum of 24 hr; discard any vial or prefilled syringe left at room temperature for >24 hr; visually inspect for particulate matter and discoloration prior to administration (the solution is clear and colorless); do not administer dose if particulates or discoloration are observed

Discard unused portion in vials or prefilled syringes; do not reenter the vial; do not save unused drug for later administration

If the patient or caregiver misses a dose, instruct them to contact their healthcare provider

Administer undiluted by SC in the outer area of upper arms, abdomen (except for the 2-inch area around the navel), thighs, or upper outer areas of the buttock

Rotate injection site daily

Do not inject into an area that is tender, red, bruised or hard, or that has scars or stretch marks

Storage

Clear, colorless solution

Store refrigerated and protect from light

Diluted solution: Can be stored at room temperature for up to 24 hr (includes infusion time)

Do not shake

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.