AVASTIN
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AVASTIN
Package(a):
VIAL (concentrate for I.V. infusion): 1 x 100 mg/4 ml.
Dosage(a):
The initial dose should be delivered over 90 minutes as an I.V. 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.
Metastatic carcinoma of the colon or rectum (mCRC): Either 5 mg/kg or 10 mg/kg body weight once every two weeks or 7.5 mg/kg or 15/mg/kg of body weight once every 3 weeks. Dose reduction for adverse events is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended.
Non-small cell lung cancer (NSCLC): Administration is inn addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression. 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Advanced and/or metastatic renal cell cancer (mRCC): The recommended dose is 10 mg/kg of body weight given once every 2 weeks.
Metastatic breast cancer (mBC): 10 mg/kg body weight once every 2 weeks or 15 mg/kg body weight once every 3 weeks, I.V.
Treatment of glioblastoma in patients with progressive disease following prior therapy: 10 mg/kg body weight once every 2 weeks or 15 mg/kg body weight once ever three weeks as IV infusion.
Children and adolescents: The safety and efficacy in children and adolescents have not been studied, treatment is therefore not recommended.
Elderly: No dose adjustment is required in the elderly.
Renal/hepatic impairment: The safety and efficacy have not been studied.
Prescribing Restrictions:
Package(b):
VIAL (Concentrate for I.V. infusion): 1 x 400 mg/16 ml.
Dosage(b):
The initial dose should be delivered over 90 minutes as an I.V. 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.
Metastatic carcinoma of the colon or rectum (mCRC): Either 5 mg/kg or 10 mg/kg body weight once every two weeks or 7.5 mg/kg or 15/mg/kg of body weight once every 3 weeks. Dose reduction for adverse events is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended.
Non-small cell lung cancer (NSCLC): Administration is inn addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression. 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Advanced and/or metastatic renal cell cancer (mRCC): The recommended dose is 10 mg/kg of body weight given once every 2 weeks.
Metastatic breast cancer (mBC): 10 mg/kg body weight once every 2 weeks or 15 mg/kg body weight once every 3 weeks, I.V.
Treatment of glioblastoma in patients with progressive disease following prior therapy: 10 mg/kg body weight once every 2 weeks or 15 mg/kg body weight once ever three weeks as IV infusion.
Children and adolescents: The safety and efficacy in children and adolescents have not been studied, treatment is therefore not recommended.
Elderly: No dose adjustment is required in the elderly.
Renal/hepatic impairment: The safety and efficacy have not been studied.
Prescribing Restrictions:
Indications:
First-line treatment of patients with metastatic carcinoma of the colon or rectum, to be used in combination with I.V. 5-fluorouracil-based chemotherapy.
First-line treatment of patients with unresectable, advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
First-line treatment of patients with advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a.
First-line treatment of patients with metastatic breast cancer, in combination with paclitaxel.
As a single agent, for the treatment of glioblastoma in patients with progressive disease following prior therapy.
Contra-Indications:
In patients with known hypersensitivity to any component or Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
Pregnancy and lactation: Must not be used during pregnancy. Women must not breast-feed during treatment and for at least six months after the last dose.
See prescribing information for full details.
Special Precautions:
Gastrointestinal perforations: Patients with metastatic carcinoma of the colon or rectum may be at increased risk for the development of GI perforation when treated with Avastin and chemotherapy. Therapy should be permanently discontinued in patients who develop GI perforation.
Wound healing complications: May adversely affect the wound healing process: Therapy should not be initiated for at least 28 days following major surgery. In patients who experienced wound healing complications during treatment, therapy should be withheld until the wound is fully healed. Therapy should be withheld for elective surgery.
Hypertension: An increased incidence of hypertension was observed in treated patients. Monitoring of blood pressure is generally recommended during therapy.
Proteinuria: Patients with a history of hypertension may be at risk for the development of proteinuria when treated with Avastin.
Arterial thromboembolism: In clinical trials, the incidence of arterial thromboembolic events was higher in patients receiving therapy in combination with chemotherapy. Patients with a history of arterial thromboembolic events and age greater than 65 years, have a higher risk. Caution should be taken when treating these patients.
Hemorrhage: Patients with metastatic cancer of the colon or rectum might have an increased risk of developing tumor-associated hemorrhage. Therapy should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during therapy. Caution should be exercised before initiating therapy in patients receiving anticoagulants for the treatment of thromboembolism.
Congestive Heart Failure: Prior anthracycline exposure and/or prior radiation to the chest wall may be possible risk factors for the development of CHF. Caution should be exercised before initiating therapy in patients with these risk factors. See prescribing information for full details.
Side Effects:
The overall safety profile is based on 1132 patients with carcinoma, who received therapy either as a single agent or in combination with chemotherapy in clinical trials. The most serious adverse events were G.I. perforations, hemorrhage (3%), and arterial thromboembolism (3.3%). The most frequently observed adverse events across all clinical trials in patients receiving therapy with or without chemotherapy were asthenia, diarrhea, nausea and pain NOS (not otherwise specified). See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.
