Names and pronunciation
(ra-mue-sir′ue-mab) Cyramza
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Drug reference
(ra-mue-sir′ue-mab) Cyramza
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Func. class.: Antineoplastic
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Chem. class.: Vascular endothelial growth factor antagonist
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ACTION: Binds to vascular endothelial growth factor receptor 2 (VEGFR2; kinase insert domain-containing receptor; KDR), preventing the binding of ligands; as a result, ramucirumab inhibits ligand-induced proliferation and migration of human endothelial cells
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USES: As a single agent or in combination with PACLitaxel for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after fluoropyrimidine
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CONTRAINDICATIONS Hypersensitivity, pregnancy, breastfeeding Precautions: Anticoagulant therapy, bleeding, cirrhosis, MI, contraception requirements, GI perforation, hepatic disease, human antihuman antibody (HAHA), hypertension, hypothyroidism, infusion related reactions, renal disease, stroke, surgery
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SIDE EFFECTS CNS: Headache, fatigue, RPLS CV: Hypertension, arterial thromboem- bolic events, hemorrhage EENT: Epistaxis GI: Intestinal obstruction, diarrhea GU: Proteinuria HEMA: Neutropenia, anemia RESP: Lower respiratory tract infection, cough, pleuritic pain INTEG: Rash MISC: Hypothyroidism, hyponatremia, IRR, antibody formation, infusion site reactions, poor wound healing
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INTERACTIONS Drug/Lab Test Increased: urine protein Decreased: RBCs, serum sodium
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DOSAGE AND ROUTES Gastric cancer or gastroesophageal junction adenocarcinoma and Hepa- tocellular cancer (single agent) • Adults: IV infusion 8 mg/kg over 60 min q2wk until disease progression or unac- ceptable toxicity; if first infusion is tolerated, all subsequent infusions may be adminis- tered over 30 min Combination with PACLitaxel • Adults: IV infusion 8 mg/kg over 60 min q2wk with PACLitaxel 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle NSCLC • Adults: IV infusion 10 mg/kg over 60 min with docetaxel (75 mg/m2 IV) on day 1, give q21days until disease progression or unacceptable toxicity mCRC • Adults IV 8 mg/kg over 60 min on day 1 before FOLFIRI use, q2wk until disease progression or unacceptable toxicity; FOLFIRI consists of irinotecan 180 mg/m2 IV over 90 min and folinic acid (leucovorin) 400 mg/m2 given over 120 min on day 1, followed by fluoroura- cil 400 mg/m2 IV bolus over 2-4 min on day 1, followed by fluorouracil 2400 mg/ m2 by continuous IV infusion over 46-48 hr; if first infusion is tolerated, all subse- quent infusions may be given over 30 min Hepatic dose • Adults IV Mild to moderate hepatic impair- ment (Child-Pugh A; total bilirubin 1.1-3 times ULN and any AST, OR or total bilirubin within ULN and AST greater than ULN): no change; severe hepatic impairment (Child-Pugh B or C): Use only if the potential benefits outweigh the risks
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Available forms: Injection 10 mg/mL single-dose vial
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Administer: Intermittent IV infusion route Intermittent IV infusion route • Use cytotoxic handling precautions • Premedicate with an IV histamine-1 (H1) receptor antagonist (diphenhydra mine); for patients who have had a prior grade 1 or 2 infusion-related reaction, premedicate with an H1-re- ceptor antagonist, dexamethasone (or equivalent), and acetaminophen before each infusion • Dilute with normal saline to a final vol- ume of 250 mL; invert to mix; do not shake; stable for 4 hr at room temperature • Inspect for particles and discoloration before using • Use a protein-sparing 0.22-micron fil- ter; use separate line; flush with normal saline after use • Do not admix with other solutions or medications • Store vials in refrigerator; protect from light, do not freeze
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Evaluate: • Therapeutic response: decreased pro- gression of cancer
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CLINICAL CONSIDERATIONS Assess • Bleeding/hemorrhage: assess for GI bleeding; perforation (severe abdominal pain, nausea, vomiting, fever) may be fa- tal; discontinue and do not restart if this occurs • Poor wound healing: assess all wounds for changes, avoid use if present • Hypertension: monitor B/P frequently, at least q2wk; if hypertension occurs, with- hold until controlled • GI status: diarrhea, bowel sounds; obstruction/perforation has occurred • Infusion-related reactions: chills, fever, chest discomfort, tachycardia, wheezing • CNS: RPLS: assess for hypertension, blurred vision, impaired consciousness, seizures, headache; may be confirmed with MRI; discontinue and do not restart if confirmed R • Cardiac status: assess for serious cardiac events, including MI, stroke; dis- continue permanently if these occur • Pregnancy/breastfeeding: do not use in pregnancy; women should use ade- quate contraception during and for ≥3 months after last dose; if childbearing potential, do not breastfeed
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Patient and caregiver information: • Bleeding: teach patient that bleeding may occur, to contact provider for bleed- ing • Poor wound healing: teach patient to report wound changes, to discuss with all providers use of product • Hypertension: teach patient to monitor B/P frequently, at least q2wk; if high or if headache is present, notify provider • RPLS: assess for hypertension, blurred vision, impaired consciousness, seizures, headache; may be confirmed with MRI; discontinue and do not restart if con- firmed • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected; teach not to use in pregnancy, to use adequate contraception during and for ≥3 months after last dose; if childbearing potential, do not breastfeed; product may impair fertility
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PHARMACOKINETICS Onset 2 wk, half-life 15 days
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• Adults: IV infusion 8 mg/kg over 60 min q2wk until disease progression or unac- ceptable toxicity; if first infusion is tolerated, all subsequent infusions may be adminis- tered over 30 min Combination with PACLitaxel
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• Adults: IV infusion 8 mg/kg over 60 min q2wk with PACLitaxel 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle NSCLC
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• Adults: IV infusion 10 mg/kg over 60 min with docetaxel (75 mg/m2 IV) on day 1, give q21days until disease progression or unacceptable toxicity mCRC
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