Therapeutic Action: Human factor granulocyte colony stimulating recombinant (Filgrastim or rHuG-CSF).
Directions: So the main uses of Neupogen (G-CSF) at present are: treatment of febrile neutropenia induced by cancer chemotherapy standard. Neupogen (G-CSF) reduces the intensity and duration of neutropenia straight to anticancer chemotherapy and reduces the incidence, duration and severity of infections that accompany the neutropenia in these patients. Treatment of neutropenia from chemotherapy with autologous bone marrow transplantation. Treatment of chronic congenital neutropenia, idiopathic, cyclic neutropenia in children and caused by radiation therapy, steroids, antiinflammatory, antithyroid drugs, AZT, and drugs in general. In patients with infection and leucopenia Neupogen can help bone marrow recovery.
Properties: Neupogen (G-CSF) is the human factor granulocyte colony stimulating, it is a soluble glycoprotein, glycosylated not have the specific ability to powerfully stimulate the development of neutrophils and slightly monocytes (macrophages). Neupogen, containing recombinant G-CSF, causes marked increases in neutrophil counts in peripheral blood within 24 hours, with minimal increases in monocytes. Elevations in neutrophil counts are dose dependent recommended doses. Neutrophils produced in response to Neupogen have a normal or praised, as was shown by tests of chemotactic and phagocytic function. After treatment with Neupogen circulating neutrophil counts decrease by 50% in 1-2 days and normal levels in 2-7 days. In bone marrow, Neupogen (RHGuG-CSF) stimulates the proliferation of stem cells "forming units granulocyte" UFC-G and differentiation of granulocytes.
Dosage: The recommended dose of Neupogen is 0.5 million IU (5 mcg / kg / day). The first dose of Neupogen should be administered at least 24 hours after cytotoxic chemotherapy. Neupogen may be administered daily by subcutaneous injection or IV infusion diluted in 5% glucose solution for 30 minutes. The daily administration of Neupogen should continue to exceed the minimum level of neutrophils and once reached the normal rate, it is considered that the duration of treatment under this criterion is up to 14 days depending on the type, dose and schedule of cytotoxic chemotherapy used. In patients receiving cytotoxic chemotherapy shows a transient increase neutrolitos which is characteristic of the first 2 days of treatment with Neupogen. However, for a sustained therapeutic response, treatment with Neupogen should be kept to the minimum level expected and recover the normal number of neutrophils. Not recommended for premature discontinuation of Neupogen before reaching the minimum level of neutrophils. High-dose cytotoxic chemotherapy on bone marrow transplantation: The recommended dose of Neupogen is 20 mcg / kg / day given as continuous subcutaneous infusion or 30 mcg / kg / day IV infusion continuous. Neupogen is diluted in 25-50 ml of 5% glucose solution. The first dose is not administered within 24 hours after an infusion of bone marrow. Once past the minimum level of neutrophils, the daily dose of Neupogen is determined according to the response of neutrophils, as the following scheme: RAN neutrophil count> 1000 cells/mm3. Neupogen dosage adjustment: Reduce to 5.0 mcg / kg / day. If ANC> 1000 cells/mm3 3 more consecutive days, reduced to 1.0 mcg / kg / day. If ANC> 1000 cells/mm3 other 3 more consecutive days, discontinue treatment. ANC = absolute neutrophil count. If ANC decreases to less than 1,000 elements per mm3 during the treatment period, the dose of Neupogen should be modified in steps as the previous scheme. Neupogen has proved effective and well tolerated in this treatment at doses of 70 mcg / kg / day. Not yet established the safety and efficacy of Neupogen in treatment exceeding 28 days. Clinical trials conducted with Neupogen include the small number of elderly patients and have not been studied with this special population group, therefore, there can be no specific regimen. In children has not been established safety and efficacy of Neupogen. Dilutions: Neupogen may be diluted if necessary, in glucosal solution 5%, not saline. Diluted Neupogen can be absorbed in glass and plastic materials. Not recommended in any case, dilution to a final concentration less than 0.2 MIU / ml (2 mcg / ml). For patients treated with Neupogen diluted to a concentration of less than 1.5 MIU / ml (15 mcg / ml) human serum albumin be added to a concentration of 2 mg / ml. Example: in a shot whose final volume is 20 ml for doses below 300 mcg Neupogen, one should add 0.2 ml of human serum albumin. Neupogen diluted in glucose solution 5% is compatible with various plastics such as PVC, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Side Effects: In clinical trials, the most common adverse effect attributed to Neupogen administered at recommended doses, it was a mild to moderate musculoskeletal pain in 10% of patients and severe in 3% of cases. Musculoskeletal pain is usually controlled with common analgesics. Less common side effects were urinary tract symptoms (mainly mild or moderate dysuria). In randomized controlled trials with placebo, Neupogen caused no increased adverse effects associated with cytotoxic chemotherapy. The adverse effects detected with equal frequency in patients treated with chemotherapy and Neupogen and those treated with placebo and chemotherapy, including nausea, vomiting, alopecia, diarrhea, fatigue, anorexia, mucositis, headache, cough, rash, chest pain generalized weakness, sore throat, constipation and unspecified pain. Elevations were reversible, mild to moderate and dose-dependent lactate dehydrogenase, alkaline phosphatase, blood uric acid and gamma-glutamyltranspeptidase in approximately 50%, 35%, 25% and 10% respectively of patients treated with Neupogen at recommended doses. Are seldom detected transient decreases in blood pressure that did not need medical treatment. Also, occasionally, there are reports of vascular disorders, veno-occlusive disease and circulatory volume changes in patients treated with high doses of chemotherapy followed by autologous bone marrow transplantation. No causal relationship has been established with Neupogen.
Contraindications: Neupogen should not be administered to patients with known hypersensitivity to the drug or any of its components.
Precautions: The colony stimulating factor can induce in vitro growth of myeloid and non-myeloid cells. Not established the safety and efficacy of the administration of Neupogen in patients with myelodysplasia, acute myelogenous leukemia or chronic myelogenous leukemia. Therefore, Neupogen will be administered with caution in any myeloid malignancy. Clinical trials have not shown yet, if Neupogen influences the evolution of MDS to acute myeloid leukemia. Therefore, extreme caution is recommended when used in any situation myeloid Neupogen preneoplastic. Leukocytosis: white blood cell counts of 100,000 cubic mm elements appear in less than 5% of patients treated with Neupogen at doses above the 0.3 MIU / kg / day (3 mcg / kg / day). No adverse effects have been directly related to the degree of leukocytosis. However, considering the potential risks associated with a severe leukocytosis, leukocyte counts should be performed regularly during treatment with Neupogen. If after reaching the minimum level of neutrophils as expected, the leukocyte count exceeds 50,000 cubic mm elements, discontinue immediately the Neupogen. High-dose chemotherapy: patients treated with high doses of chemotherapy should be treated with special caution as there is no evidence of tumor remission and high doses of chemotherapy may cause more toxicity, including effects on the heart, pulmonary, neurological and dermatological (see Information specific chemotherapeutic agents used). Neupogen can not exclude thrombocytopenia and anemia induced by cytotoxic chemotherapy. In these patients, because of the possibility of receiving higher doses of chemotherapy (dose prescribed complete program), there is increased risk of thrombocytopenia and anemia, as recommended periodic platelet counts and hematocrit. Special care should be taken when administering chemotherapy, alone or associated with thrombocytopenic effect shown. Other special precautions is advised to monitor bone density in patients with osteoporosis who underwent treatment with Neupogen for more than 6 meses.No have studied the effect of Neupogen in patients with myeloid precursors levels substantially reduced. Neupogen acts initially on neutrophil precursors leading to increasing them. Thus, patients with low neutrophil precursors (eg.: Patients treated with extensive radiation therapy or chemotherapy) show lower response to treatment. Pregnancy and lactation: Do not use during pregnancy because the safety of Neupogen in pregnant women has not been established. As is clear from studies in rats and rabbits, there is no evidence that Neupogen is teratogenic. In rabbits has been observed an increased incidence of embryo loss, but has not appreciated any malformation. Lactation: It is not known whether Neupogen is excreted in breast milk, therefore not recommended for breastfeeding women.
Overdose: Not established the effect of an overdose of Neupogen. Discontinuation of treatment usually produces a 50% reduction in circulating neutrophils within 1 to 2 days with a return to normal in 1-7 days.
Storage: Neupogen 30 is stored at 2-8 ° C. Do not freeze. The roads which have been frozen should not be used. The exposure of the vials at room temperature up to 37 º C for a short period of time (maximum 7 days), does not affect the stability of Neupogen. Under the special conditions indicated storage, Neupogen is stable up to 24 months. Do not use after expiration date exceeded. Diluted solutions of Neupogen should not be prepared within 24 hours after administration and stored refrigerated at 2-8 º C. Neupogen vials are used only once.
Presentation: Vials: package containing 5 vials. Prefilled syringes: a pack containing 1 pre-filled syringe.
