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Onbevzi is a brand name for Bevacizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to…
Verbatim from this product's EMA label. Tap a section to expand.
Do not shake the vial. Onbevzi must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. 5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Metastatic breast cancer (mBC) The recommended dose of Onbevzi is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Non-small cell lung cancer (NSCLC) First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy Onbevzi is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Onbevzi as a single agent until disease progression.
5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 1). It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity. First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib EGFR mutation testing should be performed prior to initiation of treatment with the combination of Onbevzi and erlotinib.
It is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations. The recommended dose of Onbevzi when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that the treatment with Onbevzi in addition to erlotinib is continued until disease progression. For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
Advanced and/or metastatic renal cell cancer (mRCC) The recommended dose of Onbevzi is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Epithelial ovarian, fallopian tube and primary peritoneal cancer Front-line treatment Onbevzi is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Onbevzi as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
Summary of the safety profile The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy in clinical trials.
4). 4). 4). The most frequently observed adverse reactions across clinical trials in patients receiving bevacizumab were hypertension, fatigue or asthenia, diarrhoea and abdominal pain. Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizumab therapy are likely to be dose-dependent.
Medicinal product no longer authorised 11 Tabulated list of adverse reactions The adverse reactions listed in this section fall into the following frequency categories: 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).
Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications, by MedDRA system organ class. Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through: • comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions, • post-authorisation safety studies, • spontaneous reporting, • epidemiological studies\non-interventional or observational studies, • or through an evaluation of individual case reports.
Table 2 provides the frequency of severe adverse reactions. Severe reactions are defined as adverse reactions with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions. Table 2 also includes adverse reactions which are considered by the MAH to be clinically significant or severe.
4. 6. Onbevzi infusions should not be administered or mixed with glucose solutions. 6. 1. • Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. 6). 4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab. Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution Medicinal product no longer authorised 6 should be exercised when treating these patients.
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with bevacizumab and all patients with GI perforation had a history of prior radiation. Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
GI-vaginal fistulae in study GOG-0240 Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI-vaginal fistulae had a history of prior radiation. Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
8) Patients may be at increased risk for the development of fistulae when treated with bevacizumab. 3)]. Limited information is available on the continued use of bevacizumab in patients with other fistulae. In cases of internal fistula not arising in the gastrointestinal tract, discontinuation of Onbevzi should be considered.
1. • Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The recommended dose of Onbevzi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. Treatment of platinum-sensitive recurrent disease Onbevzi is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of Onbevzi as single agent until disease progression.
The recommended dose of Onbevzi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. Treatment of platinum-resistant recurrent disease Onbevzi is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
The recommended dose of Onbevzi is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. When Onbevzi is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Onbevzi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
1, study MO22224). Cervical Cancer Onbevzi is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan. The recommended dose of Onbevzi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
1). Special populations Elderly patients No dose adjustment is required in the patients ≥ 65 years of age. 2). 2). Paediatric population The safety and efficacy of bevacizumab in children aged less than 18 years old have not been established.
2 but no recommendation on a posology can be made. There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Method of administration Onbevzi is for intravenous use. The initial dose should be delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. It should not be administered as an intravenous push or bolus. Dose reduction for adverse reactions is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section
Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable. Detailed information about these post-marketing reactions are provided in Table 3. Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Within each frequency category, adverse reactions are presented in the order of decreasing seriousness. Some of the adverse reactions are reactions commonly seen with chemotherapy; however, bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents.
Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel, and paronychia with erlotinib.
Table 1. Adverse reactions by frequency System organ class Very common Common Uncommon Rare Very rare Frequency not known Infections and infestations Sepsis, Abscessb,d, Cellulitis, Infection, Urinary tract infection Necrotising fasciitisa Blood and lymphatic system disorders Febrile neutropenia, Leucopenia, Neutropeniab, Thrombocytopenia Anaemia, Lymphopenia Immune system disorders Hypersensitivity, Infusion reactionsa,b,d Anaphylactic shock Metabolism and nutrition disorders Anorexia Hypomagnesaemia Hyponatraemia Dehydration Medicinal product no longer authorised 12 System organ class Very common Common Uncommon Rare Very rare Frequency not known Nervous system disorders Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia Cerebrovascular accident, Syncope, Somnolence Posterior reversible encephalopathy syndromea,b,d Hypertensive encephalopathya Eye disorders Eye disorder, Lacrimation increased Cardiac disorders Congestive heart failureb,d, Supraventricular tachycardia Vascular disorders Hypertensionb,d, Thromboembolism (venous)b,d Thromboembolism (arterial)b,d, Haemorrhageb,d, Deep vein thrombosis Renal thrombotic microangiopathya,b, Aneurysms and artery dissections Respiratory, thoracic and mediastinal disorders Dyspnoea, Rhinitis Epistaxis Cough Pulmonary haemorrhage/ Haemoptysisb,d, Pulmonary embolism, Hypoxia, Dysphoniaa Pulmonary hypertensiona, Nasal septum perforationa Gastrointestinal disorders Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea, Vomiting, Abdominal pain Gastrointestinal perforationb,d, Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaed,e, Gastrointestinal disorder, Proctalgia Gastrointestinal ulcera Hepatobiliary disorders Gallbladder perforationa,b Skin and subcutaneous tissue disorders Wound healing complicationsb,d, Exfoliative dermatitis, Dry skin, Skin discoloration Palmar-plantar erythrodysaesthesia syndrome Musculoskeletal and connective tissue disorders Arthralgia, Myalgia Fistulab,d, Muscular weakness, Back pain Osteonecrosis of the jawa,b, Non-mandibular osteonecrosisa,f Renal and urinary disorders Proteinuriab,d Reproductive system and breast disorders Ovarian failureb,c,d Pelvic pain Medicinal product no longer authorised 13 System organ class Very common Common Uncommon Rare Very rare Frequency not known Congenital, familial, and genetic disorder Foetal abnormalitiesa,b General disorders and administration site conditions Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation Lethargy Investigations Weight decreased When events were noted as both all grade and grade 3-5 adverse drug reactions in clinical trials, the highest frequency observed in patients has been reported.
Data are unadjusted for the differential time on treatment. a For further information please refer to Table 3 ‘Adverse reactions reported in post-marketing […]
8) Bevacizumab may adversely affect the wound healing process. Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported. Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed. Therapy should be withheld for elective surgery. Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab.
This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation. Onbevzi therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
8) An increased incidence of hypertension was observed in bevacizumab-treated patients. Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent. Pre-existing hypertension should be adequately controlled before starting Onbevzi treatment.
There is no information on the effect of bevacizumab in patients with uncontrolled hypertension at the time of initiating therapy. Monitoring of blood pressure is generally recommended during therapy. In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen. Onbevzi should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
8) There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Onbevzi.
The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known. 8) Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
3]) proteinuria may be related to the dose. Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy. 4% of patients treated with bevacizumab. […]