Neupogen
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Questions & Answers
Side Effects & Adverse Reactions
Allergic Reactions
Allergic-type reactions occurring on initial or subsequent treatment have been reported in less than 1 in 4000 patients treated with NEUPOGEN®. These have generally been characterized by systemic symptoms involving at least 2 body systems‚ most often skin (rash‚ urticaria‚ facial edema)‚ respiratory (wheezing‚ dyspnea)‚ and cardiovascular (hypotension‚ tachycardia). Some reactions occurred on initial exposure. Reactions tended to occur within the first 30 minutes after administration and appeared to occur more frequently in patients receiving NEUPOGEN® IV. Rapid resolution of symptoms occurred in most cases after administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine. Symptoms recurred in more than half the patients who were rechallenged.
SPLENIC RUPTURESPLENIC RUPTURE, INCLUDING FATAL CASES, HAS BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEUPOGEN®. INDIVIDUALS RECEIVING NEUPOGEN® WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE.
Acute Respiratory Distress Syndrome (ARDS)Acute respiratory distress syndrome (ARDS) has been reported in patients receiving NEUPOGEN®, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. Patients receiving NEUPOGEN® who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, NEUPOGEN® should be withheld until resolution of ARDS or discontinued. Patients should receive appropriate medical management for this condition.
Alveolar Hemorrhage and HemoptysisAlveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors undergoing peripheral blood progenitor cell (PBPC) mobilization. Hemoptysis resolved with discontinuation of NEUPOGEN®. The use of NEUPOGEN® for PBPC mobilization in healthy donors is not an approved indication.
Sickle Cell DisordersSevere sickle cell crises, in some cases resulting in death, have been associated with the use of NEUPOGEN® in patients with sickle cell disorders. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disorders should prescribe NEUPOGEN® for such patients, and only after careful consideration of the potential risks and benefits.
Patients With Severe Chronic NeutropeniaThe safety and efficacy of NEUPOGEN® in the treatment of neutropenia due to other hematopoietic disorders (eg‚ myelodysplastic syndrome [MDS]) have not been established. Care should be taken to confirm the diagnosis of SCN before initiating NEUPOGEN® therapy.
MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy.17 Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with NEUPOGEN® for SCN. Based on available data including a postmarketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia (see ADVERSE REACTIONS). Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of NEUPOGEN® on the development of abnormal cytogenetics and the effect of continued NEUPOGEN® administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing NEUPOGEN® should be carefully considered.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cancer Patients Receiving Myelosuppressive Chemotherapy
NEUPOGEN® is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (see CLINICAL EXPERIENCE). A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy‚ and twice per week (see LABORATORY MONITORING) during NEUPOGEN® therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies‚ NEUPOGEN® therapy was discontinued when the ANC was ≥ 10‚000/mm3 after the expected chemotherapy-induced nadir.
Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation ChemotherapyNEUPOGEN® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML.
Cancer Patients Receiving Bone Marrow TransplantNEUPOGEN® is 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 marrow transplantation (see CLINICAL EXPERIENCE). It is recommended that CBCs and platelet counts be obtained at a minimum of 3 times per week (see LABORATORY MONITORING) following marrow infusion to monitor the recovery of marrow reconstitution.
Patients Undergoing Peripheral Blood Progenitor Cell Collection and TherapyNEUPOGEN® is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy‚ the transplantation of an increased number of progenitor cells can lead to more rapid engraftment‚ which may result in a decreased need for supportive care (see CLINICAL EXPERIENCE).
Patients With Severe Chronic NeutropeniaNEUPOGEN® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (see CLINICAL EXPERIENCE). It is essential that serial CBCs with differential and platelet counts‚ and an evaluation of bone marrow morphology and karyotype be performed prior to initiation of NEUPOGEN® therapy (see WARNINGS). The use of NEUPOGEN® prior to confirmation 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.
History
There is currently no drug history available for this drug.
Other Information
Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚ produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for Filgrastim‚ which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF).
NEUPOGEN® is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN® is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NEUPOGEN® has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NEUPOGEN® is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.
NEUPOGEN® is a sterile‚ clear‚ colorless‚ preservative-free liquid for parenteral administration containing Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single use vial or prefilled syringe.
| |
300 mcg/ 1.0 mL Vial |
480 mcg/ 1.6 mL Vial |
300 mcg/ 0.5 mL Syringe |
480 mcg/ 0.8 mL Syringe |
| Filgrastim | 300 mcg | 480 mcg | 300 mcg | 480 mcg |
| Acetate | 0.59 mg | 0.94 mg | 0.295 mg | 0.472 mg |
| Sorbitol | 50.0 mg | 80.0 mg | 25.0 mg | 40.0 mg |
| Polysorbate 80 | 0.04 mg | 0.064 mg | 0.02 mg | 0.032 mg |
| Sodium | 0.035 mg | 0.056 mg | 0.0175 mg | 0.028 mg |
| Water for Injection | |
|
|
|
| USP q.s. ad | 1.0 mL | 1.6 mL | 0.5 mL | 0.8 mL |
Sources
Neupogen Manufacturers
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Physicians Total Care, Inc.
![Neupogen (Filgrastim) Injection, Solution [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Neupogen | Physicians Total Care, Inc.
NEUPOGEN® is supplied in either vials or in prefilled syringes with UltraSafe® Needle Guards. Following administration of NEUPOGEN® from the prefilled syringe, the UltraSafe® Needle Guard should be activated to prevent accidental needle sticks. To activate the UltraSafe® Needle Guard, place your hands behind the needle, grasp the guard with one hand, and slide the guard forward until the needle is completely covered and the guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated. The prefilled syringe should be disposed of by placing the entire prefilled syringe with guard activated into an approved puncture-proof container.
Cancer Patients Receiving Myelosuppressive ChemotherapyThe recommended starting dose of NEUPOGEN® is 5 mcg/kg/day‚ administered as a single daily injection by SC bolus injection‚ by short IV infusion (15 to 30 minutes)‚ or by continuous SC or continuous IV infusion. A CBC and platelet count should be obtained before instituting NEUPOGEN® therapy‚ and monitored twice weekly during therapy. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle‚ according to the duration and severity of the ANC nadir.
NEUPOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. NEUPOGEN® should not be administered in the period 24 hours before the administration of chemotherapy (see PRECAUTIONS). NEUPOGEN® should be administered daily for up to 2 weeks‚ until the ANC has reached 10‚000/mm3 following the expected chemotherapy-induced neutrophil nadir. The duration of NEUPOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. NEUPOGEN® therapy should be discontinued if the ANC surpasses 10‚000/mm3 after the expected chemotherapy-induced neutrophil nadir (see PRECAUTIONS). In phase 3 trials‚ efficacy was observed at doses of 4 to 8 mcg/kg/day.
Cancer Patients Receiving Bone Marrow TransplantThe recommended dose of NEUPOGEN® following BMT is 10 mcg/kg/day given as an IV infusion of 4 or 24 hours‚ or as a continuous 24-hour SC infusion. For patients receiving BMT‚ the first dose of NEUPOGEN® should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
During the period of neutrophil recovery‚ the daily dose of NEUPOGEN® should be titrated against the neutrophil response as follows:
Absolute Neutrophil Count
NEUPOGEN® Dose Adjustment When ANC greater than 1000/mm3 for
3 consecutive days
Reduce to 5 mcg/kg/day* then:
If ANC remains greater than 1000/mm3
for 3 more consecutive days
Discontinue NEUPOGEN® then:
If ANC decreases to less than 1000/mm3
Resume at 5 mcg/kg/day* If ANC decreases to less than 1000/mm3 at any time during the 5 mcg/kg/day administration‚ NEUPOGEN® should be increased to 10 mcg/kg/day‚ and the above steps should then be followed.
Peripheral Blood Progenitor Cell Collection and Therapy in Cancer PatientsThe recommended dose of NEUPOGEN® for the mobilization of PBPC is 10 mcg/kg/day SC‚ either as a bolus or a continuous infusion. It is recommended that NEUPOGEN® be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. Although the optimal duration of NEUPOGEN® administration and leukapheresis schedule have not been established‚ administration of NEUPOGEN® for 6 to 7 days with leukaphereses on days 5‚ 6‚ and 7 was found to be safe and effective (see CLINICAL EXPERIENCE for schedules used in clinical trials). Neutrophil counts should be monitored after 4 days of NEUPOGEN®, and NEUPOGEN® dose modification should be considered for those patients who develop a WBC count greater than 100‚000/mm3.
In all clinical trials of NEUPOGEN® for the mobilization of PBPC‚ NEUPOGEN® was also administered after reinfusion of the collected cells (see CLINICAL EXPERIENCE).
Patients With Severe Chronic NeutropeniaNEUPOGEN® should be administered to those patients in whom a diagnosis of congenital‚ cyclic‚ or idiopathic neutropenia has been definitively confirmed. Other diseases associated with neutropenia should be ruled out.
Starting Dose:
Congenital Neutropenia: The recommended daily starting dose is 6 mcg/kg BID SC every day.
Idiopathic or Cyclic Neutropenia: The recommended daily starting dose is 5 mcg/kg as a single injection SC every day.
Dose Adjustments:
Chronic daily administration is required to maintain clinical benefit. Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients’ clinical course as well as ANC. In the SCN postmarketing surveillance study, the reported median daily doses of NEUPOGEN® were: 6.0 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 of NEUPOGEN® greater than or equal to 100 mcg/kg/day.
DilutionIf required‚ NEUPOGEN® may be diluted in 5% dextrose. NEUPOGEN® diluted to concentrations between 5 and 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% dextrose or 5% dextrose plus Albumin (Human)‚ NEUPOGEN® is compatible with glass bottles‚ PVC and polyolefin IV bags‚ and polypropylene syringes.
Dilution of NEUPOGEN® to a final concentration of less than 5 mcg/mL is not recommended at any time. Do not dilute with saline at any time; product may precipitate.
StorageNEUPOGEN® should be stored in the refrigerator at 2° to 8°C (36° to 46°F). Avoid shaking. Prior to injection‚ NEUPOGEN® may be allowed to reach room temperature for a maximum of 24 hours. Any vial or prefilled syringe left at room temperature for greater than 24 hours should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration‚ whenever solution and container permit; if particulates or discoloration are observed‚ the container should not be used.
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Amgen Inc
Neupogen | Walgreens
do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose adults and children 12 years and older: take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8- to 12-hour period do not exceed 3 caplets in a 24-hour period children under 12 years: ask a doctor
![Neupogen (Filgrastim) Injection, Solution [Amgen Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=01a13827-8256-49c3-9721-8cdad491a641&name=naproxen-sodium-220-mg-caplet--aml-1.jpg)
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