Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands, bioepis.mi@medinformation.co.uk
Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.
Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).
Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).
Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see section 5.1).
Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Aybintio must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
The recommended dose of Aybintio, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 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.
The recommended dose of Aybintio 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.
Aybintio is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Aybintio as a single agent until disease progression.
The recommended dose of Aybintio is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
EGFR mutation testing should be performed prior to initiation of treatment with the combination of Aybintio 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 Aybintio 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 Aybintio 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.
The recommended dose of Aybintio 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.
Aybintio is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Aybintio as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier. The recommended dose of Aybintio is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Aybintio 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 Aybintio as single agent until disease progression. The recommended dose of Aybintio is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Aybintio is administered in combination with one of the following agents – topotecan (given weekly) or pegylated liposomal doxorubicin. The recommended dose of Aybintio is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. When Aybintio is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Aybintio is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. It is recommended that treatment be continued until disease progression or unacceptable toxicity (see section 5.1, study MO22224).
Aybintio is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
The recommended dose of Aybintio is 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 (see section 5.1).
No dose adjustment is required in the patients ≥ 65 years of age.
The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
The safety and efficacy of bevacizumab in children aged less than 18 years old have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 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.
Aybintio 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 4.4.
For instructions on dilution of the medicinal product before administration, see section 6.6. Aybintio infusions should not be administered or mixed with glucose solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Unopened vial: 3 years.
The unopened vial may be stored at temperatures not exceeding 30°C for up to 35 days. The vial must be discarded if not used within 35 days after removal from refrigerated storage, even if it has been returned to the refrigerator during this period.
Diluted medicinal product: Chemical and physical in-use stability has been demonstrated for up to 45 days at 2°C to 8°C plus an additional 72 hours at temperatures not exceeding 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the unopened vial outside the refrigerator, see section 6.3.
For storage conditions after dilution of the medicinal product, see section 6.3.
4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Pack of 1 vial.
Aybintio should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution. A sterile needle and syringe should be used to prepare Aybintio.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection. The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml. In the majority of the occasions the necessary amount of Aybintio can be diluted with 0.9 % sodium chloride solution for injection to a total volume of 100 ml.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
No incompatibilities between Aybintio and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Aybintio is for single-use only, as the product contains no preservatives. Any unused medicinal product or waste material should be disposed in accordance with local requirements.
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