Ramucirumab
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From MedlinePlus, U.S. National Library of Medicine
Vascular Endothelial Growth Factor Receptor 2 Antagonist
Dosing in kidney impairment
If the first infusion is tolerated, all subsequent CYRAMZA infusions may be administered over 30 minutes. Continue CYRAMZA until disease progression or unacceptable toxicity. When given in combination with paclitaxel, administer CYRAMZA prior to administration of paclitaxel. Refer to the prescribing information for paclitaxel for dosage information. 2.3 Recommended Dosage for Non-Small Cell Lung Cancer EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations – CYRAMZA in Combination with Erlotinib The recommended dosage of CYRAMZA is 10 mg/kg every 2 weeks administered by intravenous infusion over 60 minutes.
Dosing in liver impairment
Hepatic Impairment No dose adjustment is recommended for patients with mild (total bilirubin within ULN and aspartate aminotransferase [AST] >ULN or total bilirubin >1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment. Clinical deterioration was reported in patients with Child-Pugh B or C cirrhosis who received single agent CYRAMZA [see Warnings and Precautions, Clinical Pharmacology] .
Preparation and administration
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Premedication Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine-1 receptor antagonist (e.g., diphenhydramine hydrochloride) [see Warnings and Precautions] . For patients who have experienced a Grade 1 or 2 IRR, premedicate with a histamine-1 receptor antagonist, dexamethasone (or equivalent), and acetaminophen prior to each CYRAMZA infusion [see Dosage and Administration] .
Preparation and Administration Preparation Visually inspect vials for particulate matter and discoloration. Discard if particulate matter or discolorations are identified. Calculate the dose and the required volume of CYRAMZA needed for the calculated dose. Withdraw the required volume of CYRAMZA and further dilute with only 0.9% Sodium Chloride Injection in an intravenous infusion container to a final volume of 250 mL.
Do not use dextrose containing solutions . Do not shake. Gently invert the container to ensure adequate mixing. Do not dilute with other solutions or co-infuse with other electrolytes or medications. Do not freeze . Store diluted solution for no more than 24 hours at 2°C to 8°C (36°F to 46°F) or 4 hours at room temperature (below 25°C [77°F]).
Discard any unused portion of CYRAMZA. Administration Visually inspect the diluted solution for particulate matter and discoloration prior to administration. Discard if particulate matter or discolorations are identified. Do not administer CYRAMZA as an intravenous push or bolus. Administer diluted CYRAMZA solution via infusion pump through a separate infusion line.
Use of a protein sparing 0.22 micron filter is recommended. Flush the line with sterile 0.9% Sodium Chloride Injection at the end of the infusion.
| Adverse Reaction | Severitya | Dosage Modification |
|---|---|---|
| a National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 used to identify adverse reactions | ||
| Hemorrhage [see Warnings and Precautions (5.1)] | Grade 3 or 4 | Permanently discontinue CYRAMZA |
| Gastrointestinal Perforation [see Warnings and Precautions (5.2)] | All Grades | Permanently discontinue CYRAMZA |
| Wound Healing Complications [see Warnings and Precautions (5.3)] | All Grades | Withhold CYRAMZA for 28 days prior to elective surgery. Resume CYRAMZA no sooner than 2 weeks after surgery and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established. |
| Arterial Thromboembolic Events [see Warnings and Precautions (5.4)] | All Grades | Permanently discontinue CYRAMZA |
| Hypertension [see Warnings and Precautions (5.5)] | Severe hypertension | Withhold CYRAMZA until controlled with medical management |
| Severe hypertension that cannot be controlled with antihypertensive therapy | Permanently discontinue CYRAMZA | |
| Infusion-Related Reaction (IRR) [see Dosage and Administration (2.1), Warnings and Precautions (5.6)] | Grade 1 or 2 IRR | Reduce the infusion rate of CYRAMZA by 50% |
| Grade 3 or 4 IRR | Permanently discontinue CYRAMZA | |
| Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.8)] | All Grades | Permanently discontinue CYRAMZA |
| Proteinuria [see Warnings and Precautions (5.9)] | First occurrence of increased urine protein levels greater than or equal to 2 g per 24 hours | Withhold CYRAMZA until urine protein level is less than 2 g per 24 hours Resume CYRAMZA at a reduced dose:Reduce 8 mg/kg dose to 6 mg/kg Reduce 10 mg/kg dose to 8 mg/kg |
| Reoccurrence of urine protein level greater than 2 g per 24 hours following initial dose reduction | Withhold CYRAMZA until urine protein level is less than 2 g per 24 hours Resume CYRAMZA at a reduced dose:Reduce 6 mg/kg dose to 5 mg/kg Reduce 8 mg/kg dose to 6 mg/kg | |
| Urine protein level greater than 3 g per 24 hours or in the setting of nephrotic syndrome | Permanently discontinue CYRAMZA | |
Contraindications
None None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology ( 12.1 )] , CYRAMZA can cause fetal harm when administered to a pregnant woman. There are no available data on CYRAMZA use in pregnant women. Animal models link angiogenesis, VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise a pregnant woman of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data No animal studies have been specifically conducted to evaluate the effect of ramucirumab on reproduction and fetal development. In mice, loss of the VEGFR2 gene resulted in embryo-fetal death and these fetuses lacked organized blood vessels and blood islands in the yolk sac.
In other models, VEGFR2 signaling was associated with development and maintenance of endometrial and placental vascular function, successful blastocyst implantation, maternal and feto-placental vascular differentiation, and development during early pregnancy in rodents and non-human primates. Disruption of VEGF signaling has also been associated with developmental anomalies including poor development of the cranial region, forelimbs, forebrain, heart, and blood vessels.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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