Neupogen Injection Uses, Dosage, Side Effects, Precautions
- 1 [highlight]Important to know about Neupogen Injection ?[/highlight]
- 2 [highlight]Neupogen Injection indication and Uses[/highlight]
- 3 [highlight]Neupogen Injection Dosage[/highlight]
- 4 [highlight]How it works Neupogen Injection[/highlight]
- 5 [highlight]Neupogen Injection Side Effects[/highlight]
- 6 [highlight]Neupogen Injection Interactions[/highlight]
- 7 [highlight]Neupogen Injection Warnings and Precautions[/highlight]
- 8 [highlight]Drive and use machines[/highlight]
- 9 [highlight]Neupogen Injection and PREGNANCY / BREAST FEEDING / FERTILITY[/highlight]
- 10 [highlight]What should I do if I miss a dose?[/highlight]
- 11 [highlight]What happens if I overdose from Neupogen Injection ?[/highlight]
- 12 [highlight]What is Forms and Composition Neupogen Injection?[/highlight]
[highlight]Important to know about Neupogen Injection ?[/highlight]
- Filgrastim injections stimulate the bone marrow to make certain white blood cells. These white blood cells are important in the defense against infections.
- To prevent infections in people with reduced immune system. For example after chemotherapy for cancer, HIV and AIDS and after a bone marrow transplant. Also in healthy persons who are blood donors. They can then donate more white blood cells.
- The number of white blood cells increases within 2 days.
- Do you use filgrastim yourself? Remove the syringe from the refrigerator half an hour before injection to allow it to reach room temperature. Do NOT heat the injection, for example in the hand, it will become less effective.
- How long the treatment takes depends on the condition you have. After chemotherapy: usually 10 to 14 days. After a bone marrow transplant: until the bone marrow produces enough white blood cells. With white blood cell donation: usually 4 to 7 days. HIV infection: usually lifelong.
- Side effects include: bone pain, headache, pain in joints and muscles, gastrointestinal complaints, fatigue, weakness, cough and hair loss. Consult your doctor if you have a lot of side effects.
[highlight]Neupogen Injection indication and Uses[/highlight]
Neupogen Injection is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes), and in the reduction of the duration of neutropenia in patients receiving myelosuppressive therapy followed by bone marrow transplant and with an increased risk of prolonged severe neutropenia.
The safety and efficacy of Neupogen Injection are similar in adults and children receiving cytotoxic chemotherapy.
Neupogen Injection is indicated for the mobilization of progenitor stem cells (CSPs) in circulating blood.
The long-term administration of Neupogen Injection is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with neutrophils ≤ 0.5 x 10 9 / L and a history of severe or in order to increase neutrophil count and reduce the incidence and duration of infectious episodes.
Neupogen Injection is indicated for the treatment of persistent neutropenia (neutrophils less than or equal to 1 x 10 9 / L) in patients with advanced HIV infection to reduce the risk of bacterial infection when other options are available. to correct neutropenia are inadequate.
[highlight]Neupogen Injection Dosage[/highlight]
Neupogen Injection treatment requires the advice of a medical oncology specialist with hematology skills and experience in the use of G-CSFs, and the necessary diagnostic facilities. The mobilization and leukapheresis procedures should be implemented in collaboration with an onco-hematology center with adequate experience, and able to correctly monitor stem cell performance.
After cytotoxic chemotherapy
- The recommended dose of Neupogen Injection is 0.5 MU (5 μg) / kg / day. The first injection of Neupogen Injection should be made at least 24 hours after the end of cytotoxic chemotherapy. In randomized clinical trials, the dose used was 230 μg / m 2 / d (4 to 8.4 μg / kg / day) subcutaneously.
- Daily administration of Neupogen Injection should be continued until the neutrophil count is exceeded and this number has returned to a normal value. After treatment with validated chemotherapy in solid tumors, lymphomas and lymphoid leukaemias, the required duration of Neupogen Injection treatment may be up to 14 days. After induction and consolidation therapy for acute myeloid leukemia, the duration of treatment may be significantly longer (up to 38 days) depending on the type, dose and cytotoxic chemotherapy regimen used.
- In patients treated with cytotoxic chemotherapy, a transient increase in neutrophil count is typically observed 1-2 days after initiation of Neupogen Injection therapy. However, to achieve a lasting response, Neupogen Injection therapy should continue until the expected date of nadir is exceeded and the number of neutrophils has normalized. It is not recommended to prematurely discontinue treatment before the expected date of nadir.
Neupogen Injection should be administered daily subcutaneously or as a 30-minute intravenous infusion, with the Neupogen Injection solution diluted in 5% glucose solution (see section Instructions for Use, Handling and Disposal). ). Preference should be given to the subcutaneous route in the majority of cases. The results of a single-dose study show that intravenous administration may reduce the duration of the Neupogen Injection effect. The clinical significance of these data after multiple administrations has not been clearly established. The choice of route of administration should be made on a case by case basis.
- The recommended dose of Neupogen Injection for the mobilization of CSP, used alone, is 1.0 MU (10 μg) / kg / day for 5 to 7 consecutive days. One or two leukapheresis on days 5 and 6 are often sufficient. In other circumstances, additional leukapheresis may be required. The dose of Neupogen Injection should be maintained until the last leukapheresis.
- After myelosuppressive chemotherapy, the recommended dose of Neupogen Injection is 0.5 MU (5 μg) / kg / day. The first injection should be done the day after the end of chemotherapy. Daily administration of Neupogen Injection should be continued until the expected date of nadir is exceeded and the neutrophil count has normalized. Leukapheresis should be performed in the time interval where neutrophil count is between 0.5 x 10 9 / L and 5.0 x 10 9 / L. A single leukapheresis is usually sufficient for patients who have not received intensive chemotherapy. In other cases, it is recommended to carry out additional leukapheresis.
Neupogen Injection used alone for the mobilization of CSP:
- Neupogen Injection should be given as a continuous subcutaneous infusion over 24 hours or as a subcutaneous injection. If infused, Neupogen Injection should be diluted in 20 mL of 5% glucose solution (see section Instructions for use, handling and disposal ).
- Neupogen Injection used for the mobilization of CSP after myelosuppressive chemotherapy:
- Neupogen Injection should be given as a subcutaneous injection.
Mobilization of progenitor stem cells (CSPs) in circulating blood in healthy donors for allogeneic progenitor stem cell transplantation
- The recommended dose of Neupogen Injection for the mobilization of CSP in healthy donors is 1 MU (10 μg) / kg / day for 4 to 5 consecutive days. Leukapheresis should be started on day 5 and continued until day 6 if necessary, in order to collect 4 x 10 6 CD34 + / kg body weight cells from the recipient.
Neupogen Injection should be given as a subcutaneous injection.
In patients with severe chronic neutropenia (NCS)
Congenital neutropenia: The recommended starting dose is 1.2 MU (12 μg) / kg / day, single dose or divided doses.
Idiopathic or cyclic neutropenia: The recommended starting dose is 0.5 MU (5 μg) / kg / day as a single dose or in divided doses.
Dose Adjustment: Neupogen Injection should be administered daily by subcutaneous injection to increase and maintain average neutrophil counts above 1.5 x 10 9 / L. Once the response has been obtained, the minimum effective dose necessary to maintain the neutrophil level must be sought. Daily long-term administration is necessary to maintain adequate neutrophil levels. After one or two weeks of treatment, the initial dose may be doubled or halved depending on the patient’s response. Thereafter, the dose should be adjusted to each individual every one to two weeks to maintain the average neutrophil count between 1.5 x 10 9 / L and 10 x 10 9/ L. A faster dose escalation protocol may be considered for patients with severe infections. In clinical trials, 97% of responder patients had a complete response at doses ≤ 24 μg / kg / day. The long-term safety of administration of Neupogen Injection at doses> 24 μg / kg / day in patients with severe chronic neutropenia (NCS) has not been established.
Congenital, idiopathic or cyclic neutropenia: Neupogen Injection should be given as a subcutaneous injection.
In patients infected with HIV
Correction of neutropenia:
The recommended initial dose of Neupogen Injection is 0.1 MU (1 μg) / kg / day and may be incrementally increased to a maximum of 0.4 MU (4 μg) / kg / day to achieve and maintain a normal and stable level of neutrophils (PNN> 2 x 10 9 / L). In clinical trials, more than 90% of patients were responders at these doses, with a median duration of 2 days of neutropenia correction.
In a small number of patients (less than 10%), doses up to 1 MU (10 μg) / kg / day were required to correct neutropenia.
Maintaining a normal neutrophil count:
When the correction of neutropenia has been obtained, the minimum effective dose, to maintain the level of neutrophils, must be sought. Dose adjustment: It is recommended to adjust the initial dose by administering every other day 30 MU (300 μg) / day. Depending on the patient’s response, the dosage may be adjusted to maintain the mean level of neutrophils greater than 2 x 10 9 / L. In clinical trials, doses of 30 MU (300 μg) / day, administered 1 to 7 days per week, were required to maintain PNN> 2 x 10 9 / L, with a median frequency of 3 days a week. Long-term administration may be necessary to maintain PNN> 2 x 10 9/ L.
Correction of neutropenia or maintenance of normal neutrophil count: Neupogen Injection should be given as a subcutaneous injection.
Clinical studies with Neupogen Injection included a reduced number of elderly patients. As a result, no specific studies have been performed, so it is not possible to make dosing recommendations for this type of patient.
Patients with renal insufficiency
Studies with Neupogen Injection in patients with severe renal or hepatic impairment demonstrate that pharmacokinetic and pharmacodynamic profiles are similar to those seen in normal subjects. Dose adjustment is not necessary under these conditions.
Pediatric use in oncology and severe chronic neutropenia (NCS)
65% of patients enrolled in the Severe Chronic Neutropenia (NCS) trial program were under 18 years of age. The efficacy of Neupogen Injection treatment was clear for this group, which consisted mainly of patients with congenital neutropenia. There was no difference in the safety profile in children treated for severe chronic neutropenia (NCS).
Data from pediatric clinical studies indicate that the safety and efficacy of Neupogen Injection are comparable in adults and children receiving cytotoxic chemotherapy.
The recommended doses in children are identical to those recommended in adults after cytotoxic myelosuppressive chemotherapy.
[highlight]How it works Neupogen Injection[/highlight]
Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from bone marrow. Neupogen Injection, containing r-metHuG-CSF (filgrastim), causes a marked increase in the number of circulating neutrophils and a minor increase in monocytes within 24 hours of parenteral administration. In some patients with severe chronic neutropenia, filgrastim may also induce a small increase in the number of circulating eosinophils and basophils from baseline. Some of these patients already have eosinophilia or basophilia before treatment. At the recommended dosages, the increase in neutrophils is dose-dependent. Neutrophils produced in response to filgrastim have normal or activated functions as demonstrated by chemotaxis and phagocytosis assays. After discontinuation of filgrastim treatment, the number of circulating neutrophils decreases by 50% within 1 to 2 days and normalizes within 1 to 7 days.
The use of filgrastim in patients treated with cytotoxic chemotherapy results in a significant reduction in the incidence, severity and duration of both neutropenia and associated febrile episodes. Filgrastim treatment significantly reduced the duration of febrile neutropenia, antibiotic use, and hospitalization after induction chemotherapy for acute myeloid leukemia or after myeloablative therapy followed by bone marrow transplantation. The incidence of fever and documented infections has not been reduced under these conditions. The duration of fever was not reduced in patients undergoing myelosuppressive chemotherapy followed by bone marrow transplantation.
Administration of filgrastim either alone or after chemotherapy results in passage of progenitor stem cells (PSC) from the marrow to peripheral circulating blood. These autologous CSPs can be collected by leukapheresis and reinjected after a high-dose chemotherapy regimen, with or without associated bone marrow transplants. CSP injection accelerates hematopoiesis by reducing the risk of hemorrhagic complications and the need for platelet transfusion.
Allogeneic stem cell receptors, obtained after Neupogen Injection mobilization, had a significantly faster haematological reconstitution with, in particular, a shorter platelet recovery time, not supported by platelet transfusion, compared to those receiving an allogeneic bone marrow transplant.
A retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukemia suggested an increased risk of GvHD, treatment-related death, and mortality when G-CSF was administered . In another international retrospective study conducted in patients with acute and chronic myeloid leukemia, no effects on GvHD risk, treatment-related death, and mortality were observed. A meta-analysis of allogeneic transplant studies, including results from nine prospective randomized trials, 8 retrospective studies, and one case-control study, did not demonstrate an effect on the risk of acute GvHD, chronic GvHD or premature mortality related to treatment.
[highlight]Neupogen Injection Side Effects[/highlight]
In addition to the desired effect, this medicine can cause side effects.
The main side effects are the following.
Sometimes (from 10 to 30 people in 100)
- Bone pain . The use of a painkiller can reduce this pain. Consult your doctor about which painkiller is suitable for you.
- Headache .
- Pain in the joints and muscles.
- Gastrointestinal complaints such as nausea, vomiting, constipation, loss of appetite and diarrhea.
- Fatigue and weakness, sometimes also caused by anemia or low blood sugar.
- Cough or sore throat .
- Hair loss .
Rarely (from 1 to 10 in 100 people)
- Pain around the injection site .
- Painful and red oral mucosa .
- Chest pain , consult your doctor if you suffer from this.
- Difficulty with peeing .
- Bleeding and bleeding , such as bloody noses, due to a shortage of platelets. Your doctor will check your blood.
- Red spots and bruises due to inflammation of the blood vessels in the skin.
- Brittle bones due to bone loss when used for several months.
- Damage to the spleen . Consult your doctor if you feel heavy in the left upper part of the abdomen or shoulder. This may indicate enlargement of the spleen.
- Hypersensitivity to filgrastim or latex (rubber) on the syringe. This can be seen, among other things, in inexplicable fatigue, tightness in itching or hives, skin rash, flu-like symptoms, fever, muscle pain, tightness or fainting. Then discontinue use and consult your doctor. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to filgrastim or latex. The pharmacy team can then ensure that you do not get this remedy again.
Very rare (affects less than 1 in 100 people)
- If you have rheumatic symptoms , they can worsen.
- A sickle cell crisis in people with sickle cell disease . Sickle cell disease is a congenital defect of the red blood cells. With a sickle cell crisis, the disease suddenly worsens. You will notice severe pain and swelling around bones and joints, abdominal pain, chest pain and shortness of breath. If you notice this, please contact your doctor immediately.
- Severe skin condition . This can be recognized by purple colored, swollen, sore spots on the limbs or the face with fever. Notify your doctor about these symptoms.
- Respiratory problems . Inform your doctor prior to use if you have a cold, have fever and have breathing difficulties.
- Swelling of the whole body, abdominal distention, difficulty breathing and fatigue. Notify your doctor immediately if you suffer from this. This can indicate a serious side effect.
- Inflammation of the kidneys . You notice this often having to urinate small amounts of blood in the urine or fatigue. Then warn a doctor. This usually disappears when you stop this medication. Sometimes your doctor may reduce the dose or prescribe a different medication that will be less of a problem to you.
Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.
[highlight]Neupogen Injection Interactions[/highlight]
The safety and efficacy of Neupogen Injection and myelosuppressive chemotherapy have not been formally established. The use of Neupogen Injection is not recommended in the 24-hour period before or after myelosuppressive chemotherapy, because of the sensitivity of rapidly dividing myeloid cells to this chemotherapy. In concomitant treatment with Neupogen Injection and 5-fluorouracil, preliminary data from a small number of patients indicate a possible increase in the severity of neutropenia.
Potential interactions with other hematopoietic growth factors and with cytokines have not been studied in clinical trials.
Knowing that lithium promotes the release of neutrophils, it is possible that it potentiates the effect of Neupogen Injection. Although this association has not been specifically studied, no adverse effects due to this interaction have been identified.
[highlight]Neupogen Injection Warnings and Precautions[/highlight]
Neupogen Injection should not be used to increase cytotoxic chemotherapy doses beyond established dosages.
Neupogen Injection should not be administered to patients with severe congenital neutropenia developing leukemia or showing signs of progression to leukemia.
Cases of hypersensitivity, including anaphylactic reactions, have been observed in patients treated with Neupogen Injection during the initial treatment or subsequent treatments. Neupogen Injection treatment should be permanently discontinued in patients with clinically significant hypersensitivity. Do not administer Neupogen Injection in patients with a history of hypersensitivity to filgrastim and pegfilgrastim.
As with all therapeutic proteins, there is a potential risk of immunogenicity. Anti-filgrastim antibody production rates are generally low. Binding antibodies can be present as with all biological drugs; however, so far they have not been associated with neutralizing activity.
Malignant cell growth
Granulocyte growth factor (G-CSF) can promote myeloid cell growth in vitro and similar effects have been observed on some non-myeloid cells in vitro .
The safety and efficacy of Neupogen Injection in patients with myelodysplastic syndrome or chronic myeloid leukemia have not been established.
Neupogen Injection is not indicated in these pathologies.
It is important to differentiate between blast transformation of chronic myeloid leukemia and acute myeloid leukemia (AML).
Due to limited safety and efficacy data, Neupogen Injection should be administered with caution in patients with secondary AML.
The safety and efficacy of Neupogen Injection have not been established in de novo AML patients younger than 55 years of age with favorable cytogenetics (t (8; 21); t (15; 17); and inv (16)).
It is desirable to monitor bone density in patients with osteoporotic sites who are scheduled to be treated with Neupogen Injection for more than 6 months.
Following administration of G-CSFs, pulmonary adverse events have been reported, particularly interstitial lung diseases. The risks may be increased in patients with a recent history of pulmonary infiltration or pneumonia. The onset of pulmonary signs such as cough, fever and dyspnea associated with radiological evidence of pulmonary infiltration with deterioration of lung function may be preliminary signs of acute respiratory distress syndrome (ARDS). Neupogen Injection should be stopped and appropriate treatment initiated.
Capillary leak syndrome has been observed following growth factor administration of the granulocyte line and is characterized by hypotension, hypoalbuminemia, edema and haemoconcentration. Patients developing symptoms of capillary leak syndrome should be closely monitored for standard symptomatic treatment, which may include intensive care (see section 4.8 ).
Glomerulonephritis has been reported in patients treated with filgrastim and pegfilgrastim. Generally, episodes of glomerulonephritis have been resolved after dose reduction or discontinuation of filgrastim and pegfilgrastim. Urine monitoring is recommended.
Special precautions in patients with cancer
Cases of splenomegaly and splenic rupture have been observed infrequently following the administration of filgrastim. Cases of splenic rupture have been fatal. Patients receiving filgrastim who complain of left-sided pain and / or shoulder-top pain should be evaluated for increased spleen volume or splenic rupture.
Leukocytosis greater than or equal to 100 x 10 9 / L was observed in less than 5% of subjects receiving Neupogen Injection dosages greater than 0.3 MU (3 μg) / kg / day. No adverse effects directly attributable to this level of leukocytosis have been reported. However, because of the potential risks associated with leukocytosis, it is recommended to perform a leukocyte count at regular intervals during treatment with Neupogen Injection. If the number of leukocytes exceeds 50 x 10 9 / L after the expected date of nadir, Neupogen Injection should be stopped immediately. However, when Neupogen Injection is used for stem cell mobilization, Neupogen Injection treatment should be discontinued or dosage reduced if the leukocyte count exceeds 70 x 10 9/ L.
Risks associated with intensive chemotherapy
Special precautions should be taken for the treatment of patients with doses of chemotherapy above the recommended doses because the beneficial effect on tumor progression has not been demonstrated and intensive chemotherapy may involve increased toxic effects, in particular cardiac, pulmonary, neurological and dermatological (please refer to the information on the chemotherapy used).
Neupogen Injection treatment does not act per se for thrombocytopenia or anemia due to cytotoxic chemotherapy. Due to the administration of higher doses of chemotherapy, the risk of thrombocytopenia and anemia may be increased. Regular monitoring of platelet counts and hematocrit is recommended. Special care should be taken when administering chemotherapy known to be thrombopenic.
Use of Neupogen Injection-mobilized stem cells has been shown to reduce the depth and duration of thrombocytopenia associated with myelosuppressive or myeloablative chemotherapy.
Other special precautions
The effects of Neupogen Injection in patients with a significant decrease in myeloid precursors have not been studied. Neupogen Injection acts primarily on the precursors of neutrophils to lead to an increase in the number of neutrophils. As a result, the response to treatment may be reduced in patients with reduced neutrophil precursors (eg in patients treated with extensive radiotherapy or prolonged chemotherapy, as well as in patients with tumor infiltration of the bone marrow).
Vascular disorders such as veno-occlusive disease and fluid volume disturbances have occasionally been reported in patients receiving intensive chemotherapy followed by transplantation.
There have been reports of graft-versus-host disease (GvHD) and death in patients who received G-CSF after allogeneic bone marrow transplantation (see section 4.8 Undesirable effects and Pharmacodynamic properties ).
The increase in bone marrow hematopoietic activity in response to growth factor treatment has been associated with observable transient changes in bone scintigraphy. These must be taken into account when interpreting the results of the bone scintigraphy.
Special precautions for patients with a stem cell collection
There is no prospective randomized comparison of the two recommended collection methods (Neupogen Injection alone or in combination with myelosuppressive chemotherapy) in the same patient populations. The degree of variation in CD34 + cell levels between patients and between assays makes direct comparison between studies difficult. It is therefore difficult to recommend an ideal method. The choice of the method must take into account the overall therapeutic goal for each patient.
With prior exposure to cytotoxic agents
Patients who have previously received intensive myelosuppressive chemotherapy may not have sufficient stem cell mobilization to achieve the recommended yield (CD34 + cells ≥ 2 x 10 6 / kg) or acceleration of platelet count normalization .
Some cytotoxic agents are particularly toxic to progenitor stem cells and may decrease their mobilization. Agents such as melphalan, carmustine (BCNU) and carboplatin may reduce the yield of stem cells if administered for long periods of time before initiation of mobilization. Nevertheless, the administration of these products associated with that of Neupogen Injection, has been effective for the mobilization of stem cells. If a stem cell transplant is envisaged, it is desirable to provide early for a procedure for mobilizing these cells in the patient’s treatment regimen. Special attention should be given in these patients to the number of stem cells collected prior to administration of high-dose chemotherapy.
Estimate of stem cell yields
Particular attention should be paid to the quantification method used to estimate the level of stem cells collected in patients treated with Neupogen Injection. The results of quantification of CD34 + cells by flow cytometry vary according to the method used. Rate recommendations based on studies from other laboratories should therefore be interpreted with caution.
Statistical analysis shows that there is a complex but continuous relationship between the number of reinjected CD34 + and the rapidity of platelet recovery after high dose chemotherapy.
The recommendation of a minimum yield of CD34 + cells ≥ 2 x 10 6 / kg is based on the experience published in the literature, demonstrating a correct hematological reconstitution. It seems that CD34 + yields above this norm are related to faster recovery and lower yields than slower recovery.
Special precautions for healthy donors for progenitor stem cell mobilization
CSP mobilization is of no direct benefit to healthy donors and should be considered only in the context of allogeneic stem cell transplantation.
The mobilization of CSP can only be considered in donors who meet the clinical and biological criteria for stem cell donation, with particular attention to hematological values and infectious diseases.
The safety and efficacy of Neupogen Injection have not been evaluated in healthy donors under 16 years of age or over 60 years of age.
Thrombocytopenia has been observed very frequently in patients treated with Neupogen Injection. The platelet count should therefore be closely monitored.
Transient thrombocytopenia (platelet count <100 x 10 9 / L) following filgrastim administration and leukapheresis was observed in 35% of the subjects studied. Of these subjects, two reported cases of platelet count <50 x 10 9 / L were attributed to the leukapheresis procedure.
If more than one leukapheresis is required, special attention should be paid to donors with platelet counts <100 x 10 9 / L before leukapheresis; in general, this should not be performed if the platelet count is <75 x 10 9 / L.
Leukapheresis should not be performed in donors receiving anticoagulant therapy or recognized as having abnormal hemostasis.
Administration of Neupogen Injection should be discontinued or the dosage reduced if the number of leukocytes exceeds 70 x 10 9 / L.
Donors who have received G-CSF for CSP mobilization should be monitored until the hematological parameters return to normal.
Transient cytogenetic abnormalities have been observed in healthy donors after G-CSF administration. The meaning of these changes is unknown.
Nevertheless, the risk of developing a clone of malignant myeloid cells can not be ruled out. It is recommended that each donation be systematically recorded and monitored by leukapheresis centers for at least 10 years in order to monitor long-term tolerance.
Following administration of granulocyte granulocyte growth factors (G-CSFs) in healthy donors (and in patients), frequent but generally asymptomatic cases of increased spleen volume and infrequent splenic rupture were observed. Some cases of splenic rupture have been fatal. Therefore, clinical monitoring of spleen volume should be instituted (eg clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in healthy donors and / or in patients with left hypochondrial pain or shoulder pain.
In healthy donors cases of dyspnea have been reported frequently and other pulmonary adverse events (haemoptysis, pulmonary hemorrhage, pulmonary infiltration and hypoxia) have been infrequently reported. In the event of a suspected or suspected adverse pulmonary event, discontinuation of Neupogen Injection should be considered, with appropriate medical management.
Special precautions for allogeneic stem cell recipients obtained after mobilization by Neupogen Injection
Current evidence indicates that immunological interactions between the allogeneic CSP graft and the recipient’s immune system may be associated with an increased risk of GvHD, as compared to bone marrow transplantation.
Special precautions for patients with severe chronic neutropenia (NCS)
Thrombocytopenia has been observed frequently in patients treated with Neupogen Injection. Platelet count should be closely monitored, especially during the first few weeks of Neupogen Injection therapy. Intermittent discontinuation or reduction of Neupogen Injection dose should be considered in patients who develop thrombocytopenia (ie platelets regularly <100,000 / mm 3 ).
Other changes may occur, such as anemia and transient increases in myeloid precursors, requiring close monitoring of blood counts.
Transformation into leukemia or myelodysplastic syndrome
Before making a diagnosis of severe chronic neutropenia, care should be taken to distinguish this condition from other hematological disorders such as bone marrow suppression, myelodysplasia and myeloid leukemia. A blood count with platelet count and a myelogram and karyotype should be performed before treatment.
Rare cases (about 3%) of myelodysplastic syndrome (MDS) or leukemia have been observed in patients with severe congenital neutropenia treated with Neupogen Injection. These observations have only been made in cases of congenital neutropenia. However, SMD or leukemia are natural complications of the disease and the responsibility for treatment with Neupogen Injection has not been demonstrated in their occurrence. A subset of approximately 12% of patients whose cytogenetic formula was initially normal, developed abnormalities (including monosomy 7) during routine assessments. It is still unclear whether long-term Neupogen Injection treatment of patients with severe chronic neutropenia promotes the development of cytogenetic abnormalities, MDS, or leukemic transformation.
Other special precautions
Causes of transient neutropenia, such as viral infections, should be ruled out.
Cases of splenomegaly have been observed very frequently and cases of splenic rupture have been observed frequently after the administration of filgrastim. Patients receiving filgrastim who complain of left-sided pain and / or shoulder-top pain should be evaluated for increased spleen volume or splenic rupture.
Splenomegaly is a direct effect of Neupogen Injection treatment. In 31% of patients studied, palpable splenomegaly was noted. Volume increases, measured radiographically, appeared early during Neupogen Injection treatment and evolved into a plateau. Dose reduction resulted in slowing or stopping the progression of splenomegaly and in 3% of patients splenectomy was required. Abdominal palpation is a sufficient method to look for an abnormal increase in splenic volume and should be performed regularly.
Hematuria was frequently observed and proteinuria occurred in a small number of patients. Regular urine tests should be performed to monitor these effects.
The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Special precautions for patients with HIV infection
Cases of splenomegaly have been observed frequently after administration of Neupogen Injection. Patients receiving filgrastim who complain of left-sided pain and / or shoulder-top pain should be evaluated for increased spleen volume or splenic rupture.
Neutrophil polynuclear (PNN) counts should be closely monitored, particularly during the first few weeks of Neupogen Injection therapy. Some patients can respond very quickly to treatment, with a sharp increase in neutrophil count from the beginning. It is recommended that the PNN level be monitored on a daily basis during the first 2 or 3 days of Neupogen Injection therapy. Subsequently, it is recommended that the PNN rate be set at least twice a week during the first two weeks and then once a week or every other week, during the continuation of treatment. During intermittent doses of 30 MU (300 μg) / day Neupogen Injection, there can be significant fluctuations in PNN levels.
Risks of administering higher doses of myelosuppressive drugs
Neupogen Injection does not prevent thrombocytopenia and anemia due to myelosuppressive drugs. Due to the potential for higher doses or combinations of these drugs with Neupogen Injection therapy, the risk of thrombocytopenia and anemia may be increased. Regular monitoring of blood counts is recommended (see above).
Myelosuppression due to opportunistic infections and malignancies
Opportunistic infections such as M Mycobacterium avium complex or malignancies such as lymphoma, affecting the bone marrow, can also cause neutropenia. In patients with infectious or malignant bone marrow involvement, it is appropriate to specifically treat the underlying pathology, in addition to the administration of Neupogen Injection for the treatment of neutropenia. The effects of Neupogen Injection on neutropenia due to bone marrow infection or malignancy have not been accurately determined.
Special precautions in healthy patients with sickle cell trait or Sickle Cell Disease
Sickle cell crises, which have been fatal in some cases, have been reported with the use of Neupogen Injection in healthy patients with sickle cell trait or Sickle Cell Disease. The doctor should be careful when prescribing Neupogen Injection in healthy patients with sickle cell trait or sickle cell anemia.
In all patients
Neupogen Injection contains sorbitol (E420). Patients with rare hereditary fructose intolerance should not take this medicine.
Neupogen Injection contains less than 1 mmol (23 mg) of sodium per 0.3 mg / mL, that is, it can be considered essentially free of sodium.
In order to improve traceability of granulocyte growth factors (G-CSFs), the brand name of the administered product should be clearly recorded in the patient’s chart.
[highlight]Drive and use machines[/highlight]
[highlight]Neupogen Injection and PREGNANCY / BREAST FEEDING / FERTILITY[/highlight]
There is little or no data on the use of filgrastim in pregnant women. Animal studies have shown reproductive toxicity. In rabbits exposed to several multiples of clinical exposure, an increased incidence of embryonal loss was observed in the presence of maternal toxicity (see section 5.3 ). Transplacental passages of filgrastim have been reported in the literature in pregnant women.
Neupogen Injection is not recommended during pregnancy.
Women who become pregnant during treatment with Neupogen Injection should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The coordinates are at the end of the instructions.
There are no data on the passage of filgrastim / metabolites in breast milk. The risk for newborns / infants can not be ruled out. The decision to discontinue breastfeeding or to discontinue Neupogen Injection should be made with consideration to the benefit of breastfeeding for the child and the benefit of treatment for the woman.
Women who are breastfeeding during treatment should be encouraged to enroll in the Amgen Breastfeeding Surveillance Program. The coordinates are at the end of the instructions.
Filgrastim had no effect on reproductive performance or fertility in male or female rats (see Preclinical safety data).
[highlight]What should I do if I miss a dose?[/highlight]
If you inject yourself: have you forgotten the injection and are you not more than 4 hours late? Then administer the injection. Do you discover it later? Consult your doctor right away.
[highlight]What happens if I overdose from Neupogen Injection ?[/highlight]
The effects of an overdose of Neupogen Injection have not been established. Discontinuation of Neupogen Injection therapy is usually followed by a 50% drop in circulating neutrophils within 1 to 2 days and normalization of their level within 1 to 7 days.
[highlight]What is Forms and Composition Neupogen Injection?[/highlight]
Solution for injection (SC, or concentrate for IV infusion, clear and colorless) at 30 MU (0.3 mg / mL): 1 mL vials, 5 mL solution for injection (SC, or for dilution for IV infusion; and colorless) at 30 MU / 0.5 mL (0.6 mg / mL) or 48 MU / 0.5 mL (0.96 mg / mL): 0.5 mL pre-filled syringes * , single cartons. * The cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) or synthetic rubber: see Warnings and Precautions for use .
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