Select therapeutic use:

Colorectal and other GI cancers:

Indications for CYRAMZA:

As a single agent, or in combination with paclitaxel, for the treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. In combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), for the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. As a single agent for the treatment of hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥400ng/mL and have been treated with sorafenib.

Adult Dosage:

Give by IV infusion over 60mins. Premedicate with IV histamine H1-antagonist (eg, diphenhydramine) prior to each infusion; or with dexamethasone and acetaminophen in those who have experienced Grade 1 or 2 infusion reaction. 8mg/kg every 2 weeks until disease progression or unacceptable toxicity. Gastric cancer: administer prior to paclitaxel when given in combination. mCRC: administer prior to FOLFIRI. Dose modifications: see full labeling.

Children Dosage:

Not established.

CYRAMZA Warnings/Precautions:

Increased risk of hemorrhage; permanently discontinue if severe bleeding (Grade 3 or 4) occurs. Control hypertension prior to initiating. Monitor BP every 2 weeks or more frequently as indicated; withhold for severe hypertension until controlled. Monitor for infusion-related reactions during therapy. Have emergency resuscitative equipment available. Permanently discontinue if arterial thromboembolic events, severe uncontrolled hypertension (despite antihypertensives), hypertensive crisis or encephalopathy, Grade 3 or 4 infusion-related reactions, urine protein >3g/24hrs, nephrotic syndrome, or GI perforation occurs. Impaired wound healing: withhold for 28 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Clinical deterioration in patients with Child-Pugh B or C cirrhosis (eg, new or worsening encephalopathy, ascites, hepatorenal syndrome). Permanently discontinue if posterior reversible encephalopathy syndrome develops. Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio. Monitor thyroid function. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after last dose).

CYRAMZA Classification:

Vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor.

Adverse Reactions:

Hypertension, diarrhea, fatigue, asthenia, neutropenia, epistaxis, infections, alopecia, increased ALT/AST, anemia, stomatitis/mucosal inflammation, decreased appetite, peripheral edema, abdominal pain, proteinuria, nausea, ascites, thrombocytopenia, hypoalbuminemia, hyponatremia.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (10mL, 50mL)—1

Respiratory and thoracic cancers:

Indications for CYRAMZA:

In combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. In combination with docetaxel, for treatment of NSCLC with disease progression on or after platinum-based chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to initiation.

Adult Dosage:

Give by IV infusion over 60mins; if first infusion tolerated, give subsequent infusions over 30mins. Premedicate with IV histamine H1-antagonist (eg, diphenhydramine) prior to each infusion; or with dexamethasone and acetaminophen in those who have experienced Grade 1 or 2 infusion reaction. Continue until disease progression or unacceptable toxicity. Exon 19 deletions or exon 21 mutations: 10mg/kg every 2 weeks with erlotinib. Disease progression: 10mg/kg on Day 1 of a 21-day cycle prior to docetaxel. Dose modifications: see full labeling.

Children Dosage:

Not established.

CYRAMZA Warnings/Precautions:

Increased risk of hemorrhage; permanently discontinue if severe bleeding (Grade 3 or 4) occurs. Control hypertension prior to initiating. Monitor BP every 2 weeks or more frequently as indicated; withhold for severe hypertension until controlled. Monitor for infusion-related reactions during therapy. Have emergency resuscitative equipment available. Permanently discontinue if arterial thromboembolic events, severe uncontrolled hypertension (despite antihypertensives), hypertensive crisis or encephalopathy, Grade 3 or 4 infusion-related reactions, urine protein >3g/24hrs, nephrotic syndrome, or GI perforation occurs. Impaired wound healing: withhold for 28 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Clinical deterioration in patients with Child-Pugh B or C cirrhosis (eg, new or worsening encephalopathy, ascites, hepatorenal syndrome). Permanently discontinue if posterior reversible encephalopathy syndrome develops. Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio. Monitor thyroid function. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after last dose).

CYRAMZA Classification:

Vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor.

Adverse Reactions:

Hypertension, diarrhea, fatigue, asthenia, neutropenia, epistaxis, infections, alopecia, increased ALT/AST, anemia, stomatitis/mucosal inflammation, decreased appetite, peripheral edema, abdominal pain, proteinuria, nausea, ascites, thrombocytopenia, hypoalbuminemia, hyponatremia.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (10mL, 50mL)—1