REMS
Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev:
- Treatment of the following conditions:
- First- or second-line treatment of metastatic colorectal cancer (in combination with IV 5–fluorouracil-based chemotherapy),
- Second-line treatment of metastatic colorectal cancer in patients who have progressed on a first-line regimen containing bevacizumab (in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy),
- First-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (in combination with carboplatin and paclitaxel),
- Recurrent glioblastoma (as monotherapy),
- Metastatic renal cell carcinoma (in combination with interferon alfa),
- Persistent, recurrent, or metastatic cervical cancer (in combination with paclitaxel and cisplatin or paclitaxel and topotecan),
- Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have received ≤2 previous chemotherapy regimens (in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan),
Avastin, Mvasi, Vegzelma, and Zirabev:
- Treatment of the following conditions:
- Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine),
- Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection (in combination with carboplatin and paclitaxel followed by bevacizumab as a single agent).
Avastin only:
- Unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not previously received systemic therapy (in combination with atezolizumab).
CV: HF, hypertension, hypotension.
Derm: NECROTIZING FASCIITIS.
GI: GI PERFORATION.
GU: ↑ serum creatinine, nephrotic syndrome, ovarian failure, proteinuria.
Hemat: BLEEDING, THROMBOEMBOLIC EVENTS.
Neuro: POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES).
Resp: HEMOPTYSIS, nasal septum perforation, non-gastrointestinal fistulas.
Misc: impaired wound healing, INFUSION REACTIONS, WOUND DEHISCENCE.
Colorectal Cancer
- IV (Adults): 5 mg/kg every 14 days when given with bolus-IFL chemotherapy regimen or 10 mg/kg every 14 days when given with FOLFOX4 chemotherapy regimen or 5 mg/kg every 14 days or 7.5 mg/kg every 21 days when given with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen.
Lung Cancer or Cervical Cancer
- IV (Adults): 15 mg/kg every 3 wk.
Glioblastoma or Renal Cell Carcinoma
- IV (Adults): 10 mg/kg every 2 wk.
Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- IV (Adults): 10 mg/kg every 2 wk when given with paclitaxel, pegylated liposomal doxorubicin, or topotecan (weekly) or 15 mg/kg every 3 wk when given with topotecan (every 3 wk).
Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- IV (Adults): 15 mg/kg every 3 wk when given with carboplatin and paclitaxel for 6–8 cycles, followed by 15 mg/kg every 3 wk as a single agent or 15 mg/kg every 3 wk when given with carboplatin and gemcitabine for 6–10 cycles, followed by 15 mg/kg every 3 wk as a single agent.
Stage III or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Surgical Resection
- IV (Adults): 15 mg/kg every 3 wk when given with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 wk as a single agent for a total up to 22 cycles or until disease progression, whichever occurs earlier.
Hepatocellular Carcinoma
- IV (Adults): 15 mg/kg every 3 wk (administer after atezolizumab on same day) until disease progression or unacceptable toxicity.
Alymsys, Avastin, Mvasi, Vegzelma, Zirabev
Therapeutic Classification: antineoplastics
Pharmacologic Classification: monoclonal antibodies
Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism/Excretion: Unknown.
Half-life: 20 days (range 11–50 days).
Abevmy, Aybintio, Bambevi
