Quest for the right Drug
סטימופיל 480 מק"ג/0.5 מ"ל STIMOFIL 480 MCG/0.5 ML (FILGRASTIM)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי, תוך-ורידי : S.C, I.V
צורת מינון:
תמיסה להזרקהאינפוזיה : SOLUTION FOR INJECTION / INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects a. Summary of the safety profile The most serious adverse reactions that may occur during Filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease. The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anemia, vomiting, and nausea. In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients. b. Tabulated summary of adverse reactions The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting. Within each frequency grouping undesirable effects are presented in order of decreasing seriousness. MedDRA Adverse reactions system organ Very common Common Uncommon Rare class (≥1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to < (1/10,000 to < 1/100) 1/1,000) Infections Sepsis and Bronchitis infestations Upper respiratory tract infection Urinary tract infection MedDRA Adverse reactions system organ Very common Common Uncommon Rare class (≥1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to < (1/10,000 to < 1/100) 1/1,000) Blood and Thrombocytopeni Splenomegalya Leukocytosisa Splenic rupturea lymphatic a Haemoglobin Sickle cell anemia system Anemiae decreasede with crisis disorders Immune Hypersensitivity Anaphylactic system Drug reaction disorders hypersensitivitya Graft versus Host Diseaseb Metabolism Decreased Hyperuricaemia Blood glucose and nutrition Appetitee Blood uric acid decreased disorders Blood lactate increased Pseudogouta dehydrogenase (Chondrocalcinosis increased Pyrophosphate) Fluid volume disturbances Psychiatric Insomnia disorders Nervous Headachea Dizziness, system Hypoaesthesia disorders Paraesthesia Vascular Hypotension Veno-occlusive Capillary leak Disorders Hypertension diseased syndromea Aortitis Respiratory, Haemoptysis Acute respiratory thoracic and Dyspnoea distress mediastinal Cougha syndromea disorders Oropharyngeal Respiratory paina,e failurea Epistaxis Pulmonary edemaa Pulmonary hemorrhage Interstitial lung diseasea Lung infiltrationa Hypoxia Gastrointesti Diarrhoeaa,e Oral Pain nal disorders Vomitinga,e Constipatione Nauseaa Hepatobiliary Hepatomegaly Aspartate disorders Blood alkaline aminotransferase phosphatase increased increased Gamma-glutamyl transferase increased MedDRA Adverse reactions system organ Very common Common Uncommon Rare class (≥1/10) (≥ 1/100 to < 1/10) (≥ 1/1,000 to < (1/10,000 to < 1/100) 1/1,000) Skin and Rasha Rash Cutaneous a subcutaneous Alopecia maculopapular vasculitisa tissue Erythema Sweets syndrome disorders (acute febrile neutrophilic dermatosis) Musculoskele Musculoskeletal Muscle spasms Osteoporosis Bone density tal and painc decreased connective Exacerbation of tissue rheumatoid arthritis disorders Renal and Dysuria Glomerulonephritis urinary Haematuria Proteinuria Urine abnormality disorders General Fatiguea Chest paina Injection site disorders and Mucosal reaction administratio inflammationa Paina n site Pyrexia Astheniaa conditions Malaisee Edema peripherale Injury, Transfusion poisoning and reactione procedural complications a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy c. Description of selected adverse reactions Hypersensitivity Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angiedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience. Overall, reports were more common after IV administration. In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction. Pulmonary adverse events In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary edema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4). Splenomegaly and splenic rupture Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim. Some cases of splenic rupture were fatal (see section 4.4). Capillary leak syndrome Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4). Cutaneous vasculitis Cutaneous vasculitis has been reported in patients treated with Filgrastim. The mechanism of vasculitis in patients receiving Filgrastim is unknown. During long term use cutaneous vasculitis has been reported in 2% of SCN patients. Leukocytosis Leukocytosis (WBC > 50 x 109/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4). Sweets syndrome Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim. Pseudogout (chondrocalcinosis pyrophosphate) Pseudogout has been reported in cancer patients treated with filgrastim. GvHD There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1). d. Pediatric population Data from clinical studies in pediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim. The only consistently reported adverse event was musculoskeletal pain, which is no different from the experience in the adult population. There is insufficient data to further evaluate filgrastim use in pediatric subjects. e. Other special populations Geriatric use No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients. There is insufficient data to evaluate StimoFil use in geriatric subjects for other approved StimoFil indications. Pediatric SCN patients Cases of decreased bone density and osteoporosis have been reported in pediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
הפחתת משך וחומרה של נויטרופניה בחולים העוברים השתלת מח עצם או המטופלים בכימוטרפיה המדכאת את מח העצם. | 01/01/1995 | LIPEGFILGRASTIM, FILGRASTIM, PEGFILGRASTIM, LENOGRASTIM | ||
טיפול לצורך העלאת הספירה הנויטרופילית והפחתת זיהומים בילדים ומבוגרים הסובלים מנויטרופניה מולדת חמורה, נויטרופניה ציקלית או נויטרופניה אידיופאתית ושסבלו מזיהומים משמעותיים מבחינה קלינית ומ-3 אירועים של נויטרופניה בשנה האחרונה. | 01/01/1995 | LIPEGFILGRASTIM, FILGRASTIM, PEGFILGRASTIM, LENOGRASTIM | ||
טיפול בנויטרופניה כרונית חמורה. | 01/01/1995 | LIPEGFILGRASTIM, FILGRASTIM, PEGFILGRASTIM, LENOGRASTIM |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף