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What is the most important information I should know about Neupogen (Amgen Inc.)?
You should not use this medication if you are allergic to Neupogen (Amgen Inc.) or to other medicines that contain the E. coli bacteria.
Before using Neupogen (Amgen Inc.), 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 Neupogen (Amgen Inc.). Your liver function will also need to be tested, and you may need bone density scans. Visit your doctor regularly.
Stop using Neupogen (Amgen Inc.) 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).
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What are the possible side effects of Neupogen (Amgen Inc.)?
During clinical studies 183 cancer patients and 96 healthy volunteers were exposed to Neupogen (Amgen Inc.).
The safety profile of Neupogen (Amgen Inc.) observed in these clinical studies was consistent with that reported with the reference product used in these studies.
The following undesirable effects and their frequencies have been observed under treatment with Neupogen (Amgen Inc.) based on published information.
The assessment of undesirable effects is based on the following frequency data: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
In Cancer Patients: In clinical trials, the most frequent undesirable effects attributable to Neupogen (Amgen Inc.) at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10%, and severe musculoskeletal pain in 3% of patients. Musculoskeletal pain is usually controlled with standard analgesics. Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.
In randomised, placebo-controlled clinical trials, Neupogen (Amgen Inc.) did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy. Undesirable effects reported with equal frequency in patients treated with Neupogen (Amgen Inc.) chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase, alkaline phosphatase, serum uric acid, and gamma-glutamyl transpeptidase occurred with Neupogen (Amgen Inc.) in approximately 50%, 35%, 25%, and 10% of patients, respectively at recommended doses.
Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation.
Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation. The causal association with Neupogen (Amgen Inc.) has not been established.
Very rare events of cutaneous vasculitis have been reported in patients treated with Neupogen (Amgen Inc.). The mechanism of vasculitis in patients receiving Neupogen (Amgen Inc.) is unknown.
Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis. Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥1/1,000 to <1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors.
The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally. However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with Neupogen (Amgen Inc.) has not been established.
Exacerbation of rheumatoid arthritis has been observed in individual cases.
Rare pulmonary adverse events including interstitial pneumonia, pulmonary oedema, and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS), which may be fatal.
Allergic Reactions: Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment have been reported in patients receiving Neupogen (Amgen Inc.). Overall, reports were more common after intravenous administration. In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Neupogen (Amgen Inc.) should be permanently discontinued in patients who experience a serious allergic reaction.
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease.
Pseudogout has been reported in patients with cancer treated with Neupogen (Amgen Inc.).
In Peripheral Blood Progenitor Cell Mobilisation in Normal Donors: The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain. Leukocytosis [White Blood Cell (WBC) >50 x 109/L] was observed in 41% of donors and transient thrombocytopenia (platelets <100 x 109/L) following Neupogen (Amgen Inc.) and leukapheresis was observed in 35% of donors.
Transient, minor increases in alkaline phosphatase, LDH, SGOT and uric acid have been reported in normal donors receiving Neupogen (Amgen Inc.); these were without clinical sequelae.
Exacerbation of arthritic symptoms has been observed very rarely.
Symptoms suggestive of severe allergic reactions have been reported very rarely.
Headaches, believed to be caused by Neupogen (Amgen Inc.), have been reported in PBPC donor studies.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience with other Neupogen (Amgen Inc.)-containing medicinal products.
In Severe Chronic Neutropenia (SCN) Patients: Undesirable effects related to Neupogen (Amgen Inc.) therapy in SCN patients have been reported and for some their frequency tend to decrease with time.
The most frequent undesirable effects attributable to Neupogen (Amgen Inc.) were bone pain, and general musculoskeletal pain.
Other undesirable effects seen include splenic enlargement, which may be progressive in a minority of cases and thrombocytopenia. Headache and diarrhoea have been reported shortly after starting Neupogen (Amgen Inc.) therapy, typically in less than 10% of patients. Anaemia and epistaxis have also been reported.
Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase, and alkaline phosphatase. Transient, moderate decreases in non-fasting blood glucose have also been seen.
Undesirable effects possibly related to Neupogen (Amgen Inc.) therapy and typically occurring in <2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis, and rash.
During long term use cutaneous vasculitis has been reported in 2% of SCN patients. There have been very few instances of proteinuria/haematuria.
In Patients with HIV: In clinical studies, the only undesirable effects that were consistently considered to be related to Neupogen (Amgen Inc.) administration were musculoskeletal pain, predominantly mild to moderate bone pain and myalgia. The incidence of these events was similar to that reported in cancer patients.
Splenic enlargement was reported to be related to Neupogen (Amgen Inc.) therapy in <3% of patients. In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy. As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to Neupogen (Amgen Inc.) treatment is unclear.
Established Cytotoxic Chemotherapy: Neupogen (Amgen Inc.) 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): Neupogen (Amgen Inc.) 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 Neupogen (Amgen Inc.) are similar in adults and children receiving cytotoxic chemotherapy. Neupogen (Amgen Inc.) 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 Neupogen (Amgen Inc.) is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
HIV Infection: Neupogen (Amgen Inc.) 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): Neupogen (Amgen Inc.) is indicated to reduce the duration of neutropenia and related clinical sequelae in patients undergoing induction or consolidation chemotherapy.
Neupogen (Amgen Inc.) 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. Neupogen (Amgen Inc.) 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. Neupogen (Amgen Inc.) is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Neupogen (Amgen Inc.) 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.
Neupogen (Amgen Inc.) is available only with your doctor's prescription.
Each powder for injection contains Filgrastim 30 MU and 48 MU.
It also contains the following excipients: Sodium acetate trihydrate, mannitol and polysorbate 80.
Neupogen (Amgen Inc.) 30 MU Lyophilized Powder for Injection: Each vial of solvent contains benzyl alcohol 9 mg/mL.
Neupogen (Amgen Inc.) 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.
Neupogen (Amgen Inc.) (recombinant human granulocyte-colony stimulating factor, rH G-SCF) is produced by r-DNA technology in Escherichia coli.
Use Neupogen (Amgen Inc.) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Neupogen (Amgen Inc.).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsChemotherapy-induced myelosuppression in nonmyeloid malignancies:
Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) 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-Neupogen (Amgen Inc.): 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 (Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) 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 (Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) 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 (Neupogen (Amgen Inc.) only): To increase survival in patients acutely exposed to myelosuppressive doses of radiation
Peripheral blood progenitor cell collection and therapy (Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) biosimilars): Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for apheresis collection
Severe chronic neutropenia (Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) 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: Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)-aafi) and Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)-sndz) are approved as biosimilars to Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)). In Canada, Grastofil is a biosimilar to Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)).
Off Label UsesAlcoholic hepatitis (severe)
Data from a small randomized, non-blinded pilot study suggest Neupogen (Amgen Inc.) may be safe and effective therapy and may improve liver function as well as survival in patients with severe alcoholic hepatitis.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Neupogen (Amgen Inc.): Neupogen (Amgen Inc.) 300 mcg/mL (1 mL); Neupogen (Amgen Inc.) 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution, Injection [preservative free]:
Neupogen (Amgen Inc.): Neupogen (Amgen Inc.)-aafi 300 mcg/mL (1 mL); Neupogen (Amgen Inc.)-aafi 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution, Subcutaneous [preservative free]:
Neupogen (Amgen Inc.): tbo-Neupogen (Amgen Inc.) 300 mcg/mL (1 mL); tbo-Neupogen (Amgen Inc.) 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Injection [preservative free]:
Neupogen (Amgen Inc.): Neupogen (Amgen Inc.) 300 mcg/0.5 mL (0.5 mL); Neupogen (Amgen Inc.) 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Neupogen (Amgen Inc.): Neupogen (Amgen Inc.)-aafi 300 mcg/0.5 mL (0.5 mL); Neupogen (Amgen Inc.)-aafi 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Neupogen (Amgen Inc.): Neupogen (Amgen Inc.)-sndz 300 mcg/0.5 mL (0.5 mL); Neupogen (Amgen Inc.)-sndz 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Neupogen (Amgen Inc.): tbo-Neupogen (Amgen Inc.) 300 mcg/0.5 mL (0.5 mL); tbo-Neupogen (Amgen Inc.) 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]). Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)-aafi) and Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)-sndz) are approved as biosimilars to Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)). In Canada, Grastofil is a biosimilar to Neupogen (Amgen Inc.) (Neupogen (Amgen Inc.)). International considerations: Dosages below expressed as micrograms; 1 mcg = 100,000 units (Hoglund 1998).
Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Neupogen (Amgen Inc.) and Neupogen (Amgen Inc.) 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).
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What other drugs will affect Neupogen (Amgen Inc.)?
The safety and efficacy of Neupogen (Amgen Inc.) 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 Neupogen (Amgen Inc.) 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 Neupogen (Amgen Inc.) 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 Neupogen (Amgen Inc.). 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: Neupogen (Amgen Inc.) should not be diluted with saline solutions. If required, Neupogen (Amgen Inc.) may be diluted in 5% glucose.
Diluted Neupogen (Amgen Inc.) may be adsorbed to glass and plastic materials. However, when diluted in 5% glucose solution, Neupogen (Amgen Inc.) is compatible with glass and a variety of plastic including PVC, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
