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[ { "id": "granix_section_S1", "type": "adverse reactions", "text": [ " 6 ADVERSE REACTIONS\n\n The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling:\n\n\n\n Splenic Rupture [ see Warnings and Precautions (5.1) ]\n\n\n\n Acute Respiratory Distress Syndrome [ see Warnings and Precautions (5.2) ]\n\n\n\n Serious Allergic Reactions [ see Warnings and Precautions (5.3) ]\n\n\n\n Use in Patients with Sickle Cell Disease [ see Warnings and Precautions (5.4) ]\n\n\n\n Capillary Leak Syndrome [ see Warnings and Precautions (5.5) ]\n\n\n\n Potential for Tumor Growth Stimulatory Effects on Malignant Cells [ see Warnings and Precautions (5.6) ]\n\n\n\n The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain.\n\n\n\n EXCERPT: * Most common adverse reaction to GRANIX is bone pain ( 6 ) \n To report SUSPECTED ADVERSE REACTIONS, contact TEVA at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. \n \n\n \n\n 6.1 Clinical Trials Experience\n\n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.\n\n\n\n GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin's lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin's lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of >=10,000 x 10 6 /L after nadir was reached.\n\n\n\n Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product).\n\n\n\n Leukocytosis \n\n\n\n In clinical studies, leukocytosis (WBC counts > 100,000 x 10 6 /L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.\n\n\n\n Additional Adverse Reactions\n\n\n\n Other adverse reactions known to occur following administration of human granulocyte colony-stimulating factors include myalgia, headache, vomiting, Sweet's syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis and thrombocytopenia.\n\n\n\n 6.2 Immunogenicity\n\n As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined.\n" ], "offsets": [ [ 0, 3578 ] ] }, { "id": "granix_section_S2", "type": "warnings and precautions", "text": [ " 5 WARNINGS AND PRECAUTIONS\n\n\n\n EXCERPT: * Splenic Rupture: Discontinue GRANIX if suspected ( 5.1 ) \n * Acute Respiratory Distress Syndrome (ARDS): Monitor for and manage immediately. Discontinue GRANIX if suspected ( 5.2 ) \n * Allergic reactions (angioneurotic edema, dermatitis allergic, drug hypersensitivity, hypersensitivity, rash, pruritic rash and urticaria) ( 5.3 ) \n * Sickle cell crisis: Severe and sometimes fatal crisis can occur. Discontinue GRANIX if suspected ( 5.4 ) \n * Capillary Leak Syndrome: Monitor if symptoms develop and administer standard symptomatic treatment (5.5) \n \n \n\n 5.1 Splenic Rupture\n\n\n\n Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture.\n\n\n\n 5.2 Acute Respiratory Distress Syndrome (ARDS)\n\n\n\n Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.\n\n\n\n 5.3 Allergic Reactions\n\n\n\n Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines, steroids, bronchodilators, and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.\n\n\n\n 5.4 Use in Patients with Sickle Cell Disease\n\n\n\n Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis.\n\n\n\n 5.5 Capillary Leak Syndrome\n\n\n\n Capillary leak syndrome (CLS) can occur in patients receiving human granulocyte colony-stimulating factors and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.\n\n\n\n 5.6 Potential for Tumor Growth Stimulatory Effects on Malignant Cells\n\n\n\n The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.\n" ], "offsets": [ [ 3579, 6683 ] ] } ]

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"granix_entity_M8", "type": "AdverseReaction", "text": [ "bone pain" ], "offsets": [ [ 894, 903 ] ], "normalized": [] }, { "id": "granix_entity_M9", "type": "AdverseReaction", "text": [ "bone pain" ], "offsets": [ [ 971, 980 ] ], "normalized": [] }, { "id": "granix_entity_M10", "type": "AdverseReaction", "text": [ "Bone pain" ], "offsets": [ [ 2448, 2457 ] ], "normalized": [] }, { "id": "granix_entity_M11", "type": "AdverseReaction", "text": [ "bone pain" ], "offsets": [ [ 2711, 2720 ] ], "normalized": [] }, { "id": "granix_entity_M12", "type": "AdverseReaction", "text": [ "leukocytosis" ], "offsets": [ [ 2870, 2882 ] ], "normalized": [] }, { "id": "granix_entity_M13", "type": "AdverseReaction", "text": [ "WBC counts > 100,000 x 10 6 /L" ], "offsets": [ [ 2884, 2916 ] ], "normalized": [] }, { "id": "granix_entity_M14", "type": "AdverseReaction", "text": [ "leukocytosis" ], "offsets": [ [ 3037, 3049 ] ], "normalized": [] }, { "id": "granix_entity_M15", "type": "DrugClass", "text": [ "human granulocyte colony-stimulating factors" ], "offsets": [ [ 3189, 3233 ] ], "normalized": [] }, { "id": "granix_entity_M16", "type": "AdverseReaction", "text": [ "myalgia" ], "offsets": [ [ 3242, 3249 ] ], "normalized": [] }, { "id": "granix_entity_M17", "type": "AdverseReaction", "text": [ "headache" ], "offsets": [ [ 3251, 3259 ] ], "normalized": [] }, { "id": "granix_entity_M18", "type": "AdverseReaction", "text": [ "vomiting" ], "offsets": [ [ 3261, 3269 ] ], "normalized": [] }, { "id": "granix_entity_M19", "type": "AdverseReaction", "text": [ "Sweet's syndrome" ], "offsets": [ [ 3271, 3287 ] ], "normalized": [] }, { "id": "granix_entity_M20", "type": "AdverseReaction", "text": [ "acute febrile neutrophilic dermatosis" ], "offsets": [ [ 3289, 3326 ] ], "normalized": [] }, { "id": "granix_entity_M21", "type": "AdverseReaction", "text": [ "cutaneous vasculitis" ], "offsets": [ [ 3329, 3349 ] ], "normalized": [] }, { "id": "granix_entity_M22", "type": "AdverseReaction", "text": [ "thrombocytopenia" ], "offsets": [ [ 3354, 3370 ] ], "normalized": [] }, { "id": "granix_entity_M23", "type": "AdverseReaction", "text": [ "Splenic Rupture" ], "offsets": [ [ 3633, 3648 ] ], "normalized": [] }, { "id": "granix_entity_M24", "type": "AdverseReaction", "text": [ "Acute Respiratory Distress Syndrome" ], "offsets": [ [ 3699, 3734 ] ], "normalized": [] }, { "id": "granix_entity_M25", "type": "AdverseReaction", "text": [ "ARDS" ], "offsets": [ [ 3736, 3740 ] ], "normalized": [] }, { "id": "granix_entity_M26", "type": "AdverseReaction", "text": [ "Allergic reactions" ], "offsets": [ [ 3828, 3846 ] ], "normalized": [] }, { "id": "granix_entity_M27", "type": "AdverseReaction", "text": [ "angioneurotic edema" ], "offsets": [ [ 3848, 3867 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10002471" } ] }, { "id": "granix_entity_M28", "type": "AdverseReaction", "text": [ "dermatitis allergic" ], "offsets": [ [ 3869, 3888 ] ], "normalized": [] }, { "id": "granix_entity_M29", "type": "AdverseReaction", "text": [ "drug hypersensitivity" ], "offsets": [ [ 3890, 3911 ] ], "normalized": [] }, { "id": "granix_entity_M30", "type": "AdverseReaction", "text": [ "hypersensitivity" ], "offsets": [ [ 3913, 3929 ] ], "normalized": [] }, { "id": "granix_entity_M31", "type": "AdverseReaction", "text": [ "rash" ], "offsets": [ [ 3931, 3935 ] ], "normalized": [] }, { "id": "granix_entity_M32", "type": "AdverseReaction", "text": [ "pruritic rash" ], "offsets": [ [ 3937, 3950 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10037085" } ] }, { "id": "granix_entity_M33", "type": "AdverseReaction", "text": [ "urticaria" ], "offsets": [ [ 3955, 3964 ] ], "normalized": [] }, { "id": "granix_entity_M34", "type": "AdverseReaction", "text": [ "Sickle cell crisis" ], "offsets": [ [ 3983, 4001 ] ], "normalized": [] }, { "id": "granix_entity_M35", "type": "Severity", "text": [ "Severe" ], "offsets": [ [ 4003, 4009 ] ], "normalized": [] }, { "id": "granix_entity_M36", "type": "AdverseReaction", "text": [ "fatal" ], "offsets": [ [ 4024, 4029 ] ], "normalized": [] }, { "id": "granix_entity_M37", "type": "Factor", "text": [ "can" ], "offsets": [ [ 4037, 4040 ] ], "normalized": [] }, { "id": "granix_entity_M38", "type": "AdverseReaction", "text": [ "Capillary Leak Syndrome" ], "offsets": [ [ 4097, 4120 ] ], "normalized": [] }, { "id": "granix_entity_M39", "type": "AdverseReaction", "text": [ "Splenic rupture" ], "offsets": [ [ 4239, 4254 ] ], "normalized": [] }, { "id": "granix_entity_M40", "type": "AdverseReaction", "text": [ "fatal" ], "offsets": [ [ 4266, 4271 ] ], "normalized": [] }, { "id": "granix_entity_M41", "type": "Factor", "text": [ "can" ], "offsets": [ [ 4279, 4282 ] ], "normalized": [] }, { "id": "granix_entity_M42", "type": "AdverseReaction", "text": [ "Acute respiratory distress syndrome" ], "offsets": [ [ 4577, 4612 ] ], "normalized": [] }, { "id": "granix_entity_M43", "type": "AdverseReaction", "text": [ "ARDS" ], "offsets": [ [ 4614, 4618 ] ], "normalized": [] }, { "id": "granix_entity_M44", "type": "DrugClass", "text": [ "human granulocyte colony-stimulating factors" ], "offsets": [ [ 4652, 4696 ] ], "normalized": [] }, { "id": "granix_entity_M45", "type": "Severity", "text": [ "Serious" ], "offsets": [ [ 4890, 4897 ] ], "normalized": [] }, { "id": "granix_entity_M46", "type": "AdverseReaction", "text": [ "allergic reactions" ], "offsets": [ [ 4898, 4916 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10001718" } ] }, { "id": "granix_entity_M47", "type": "AdverseReaction", "text": [ "anaphylaxis" ], "offsets": [ [ 4927, 4938 ] ], "normalized": [] }, { "id": "granix_entity_M48", "type": "DrugClass", "text": [ "human granulocyte colony-stimulating factors" ], "offsets": [ [ 4971, 5015 ] ], "normalized": [] }, { "id": "granix_entity_M49", "type": "AdverseReaction", "text": [ "fatal" ], "offsets": [ [ 5452, 5457 ] ], "normalized": [] }, { "id": "granix_entity_M50", "type": "AdverseReaction", "text": [ "sickle cell crises" ], "offsets": [ [ 5458, 5476 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10040643" } ] }, { "id": "granix_entity_M51", "type": "Factor", "text": [ "can" ], "offsets": [ [ 5477, 5480 ] ], "normalized": [] }, { "id": "granix_entity_M52", "type": "AdverseReaction", "text": [ "Capillary leak syndrome" ], "offsets": [ [ 5840, 5863 ] ], "normalized": [] }, { "id": "granix_entity_M53", "type": "AdverseReaction", "text": [ "CLS" ], "offsets": [ [ 5865, 5868 ] ], "normalized": [] }, { "id": "granix_entity_M54", "type": "DrugClass", "text": [ "human granulocyte colony-stimulating factors" ], "offsets": [ [ 5902, 5946 ] ], "normalized": [] }, { "id": "granix_entity_M55", "type": "AdverseReaction", "text": [ "hypotension" ], "offsets": [ [ 5971, 5982 ] ], "normalized": [] }, { "id": "granix_entity_M56", "type": "AdverseReaction", "text": [ "hypoalbuminemia" ], "offsets": [ [ 5984, 5999 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10020943" } ] }, { "id": "granix_entity_M57", "type": "AdverseReaction", "text": [ "edema" ], "offsets": [ [ 6001, 6006 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10014210" } ] }, { "id": "granix_entity_M58", "type": "AdverseReaction", "text": [ "hemoconcentration" ], "offsets": [ [ 6011, 6028 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10019479" } ] }, { "id": "granix_entity_M59", "type": "Factor", "text": [ "possibility" ], "offsets": [ [ 6501, 6512 ] ], "normalized": [] }, { "id": "granix_entity_M60", "type": "AdverseReaction", "text": [ "growth factor for", "tumor" ], "offsets": [ [ 6535, 6552 ], [ 6557, 6562 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10028994" } ] }, { "id": "granix_entity_M61", "type": "AdverseReaction", "text": [ "myeloid malignancies" ], "offsets": [ [ 6579, 6599 ] ], "normalized": [] }, { "id": "granix_entity_M62", "type": "AdverseReaction", "text": [ "myelodysplasia" ], "offsets": [ [ 6604, 6618 ] ], "normalized": [ { "db_name": "MedDRA v18.1", "db_id": "llt_10028532" } ] } ]

[]

[]

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