VEGZELMA CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/ML

INFUSION, SOLUTION CONCENTRATE

**3.2 Dosage and Method of Administration** Substitution by any other biological medicinal product requires the consent of the prescribing physician. The safety and efficacy of alternating or switching between Vegzelma and products that are biosimilar but not deemed interchangeable to Vegzelma has not been established. Therefore, the benefit/risk of alternating or switching need to be carefully considered. Vegzelma should be prepared by a healthcare professional using aseptic technique. Withdraw the volume of Vegzelma equivalent to the required dose per body weight and dilute in a total volume of 100 ml of sterile, pyrogen-free 0.9% sodium chloride. For further instructions, see section 5.4 Special Remarks – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. No incompatibilities between Vegzelma and polyolefin bags have been observed. _Vegzelma infusions should not be administered or mixed with dextrose or glucose solutions (see section 5.2 Incompatibilities – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ _Do not administer as an intravenous push or bolus._ The initial Vegzelma 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. The initial dose of Vegzelma should be administered following chemotherapy, all subsequent doses can be given before or after chemotherapy. Vegzelma is not formulated for intravitreal use. _(see section 3.4 Special Warnings and Special Precautions for Use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_ **3.2.1 Standard Dosage** **Metastatic carcinoma of the colon or rectum (mCRC)** The recommended dose of Vegzelma, administered as an intravenous infusion, is as follows: First-line treatment: 5 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg of body weight given once every 3 weeks. Second-line treatment: 10 mg/kg of body weight given every 2 weeks with FOLFOX-4. 5mg/kg every 2 weeks or 7.5mg/kg every 3 weeks when used in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen in patients who have progressed on a first-line Vegzelma-containing regimen (see section 4.1.2 study ML18147 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is recommended that Vegzelma treatment be continued until progression of the underlying disease. Patients previously treated with Vegzelma can continue with Vegzelma treatment following first progression (see section 4.1.2 study ML18147 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Metastatic breast cancer (mBC)** The recommended dose of Vegzelma, administered as an intravenous infusion, is as follows: In combination with paclitaxel: 10 mg/kg of body weight given once every 2 weeks In combination with capecitabine: 15 mg/kg of body weight given once every 3 weeks It is recommended that Vegzelma treatment be continued until progression of the underlying disease. **Non-small cell lung cancer (NSCLC)** First-line treatment of NSCLC in combination with platinum-based chemotherapy Vegzelma is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Vegzelma as a single agent until disease progression. The recommended dose of Vegzelma is 15mg/kg of body weight given once every 3 weeks as an intravenous infusion. First-line treatment of NSCLC with EGFR activating mutations in combination with erlotinib The recommended dose of Vegzelma 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 Vegzelma in addition to erlotinib is continued until disease progression. Please refer to the full prescribing information for erlotinib for patient selection and posology. **Advanced and/or metastatic Renal Cell Cancer (mRCC)** The recommended dose of Vegzelma is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. It is recommended that Vegzelma treatment be continued until progression of the underlying disease. **Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer** The recommended dose of Vegzelma administered as an intravenous infusion is as follows. _Front-line treatment:_ 15 mg/kg of body weight given once every 3 weeks when administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Vegzelma as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier. _Treatment of recurrent disease:_ Platinum sensitive: 15 mg/kg of body weight given once every 3 weeks when administered in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles followed by continued use of Vegzelma as a single agent until disease progression. Alternatively, 15 mg/kg every 3 weeks when administrated in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Vegzelma as single agent until disease progression. Platinum resistant: 10 mg/kg body weight given once every 2 weeks when administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin (see section 4.1.2 Study MO22224 for chemotherapy regimens – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Alternatively, 15 mg/kg every 3 weeks when administered in combination with topotecan given on days 1 – 5, every 3 weeks (see section 4.1.2 Study MO22224 for chemotherapy regimen – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is recommended that treatment be continued until disease progression. **Cervical Cancer** The recommended dose of Vegzelma is 15 mg/kg every 3 weeks as an intravenous infusion administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin, or paclitaxel and topotecan (see section 4.1.2 study GOG-0240 for further details on the chemotherapy regimens – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is recommended that Vegzelma treatment be continued until progression of the underlying disease. **3.2.2 Special Dosage Instructions** _Pediatric Use:_ The safety and efficacy of Vegzelma in children and adolescents (<18 years) have not been established (see section 3.5 Use in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Vegzelma is not recommended for use in children and adolescents due to a lack of data on safety and efficacy (see also section 4.2.6 Nonclinical Safety – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Geriatric Use:_ No dose adjustment is required in patients ≥ 65 years of age. However, there was an increased risk of adverse events in patients above 65 years of age (See section 3.7.1 Elderly patients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment:_ The safety and efficacy of Vegzelma have not been studied in patients with renal impairment. _Hepatic impairment:_ The safety and efficacy of Vegzelma have not been studied in patients with hepatic impairment.