Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Dosering och dosjusteringar - Magcancer

Den rekommenderade dosen ramucirumab är 8 mg/kg dag 1 och 15 i en 28 dagarscykel, före infusion av paklitaxel, eller 8 mg/kg varannan vecka som monoterapi.

Approved Dosing Regimens in Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma

Single Agent

The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks, administered as an IV infusion over approximately 60 minutes (maximum infusion rate 25 mg/min).1 

Combination with Paclitaxel

The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion. The recommended dose of paclitaxel is 80 mg/m2 administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle. Prior to each paclitaxel infusion, patients should have a complete blood count and blood chemistry performed to evaluate hepatic function. See labeling for hematological requirements prior to paclitaxel infusion.1

Premedication

Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab. If a patient experiences a Grade 1 or 2 infusion-related reaction  premedication must be given for all subsequent infusions. If a patient experiences a second Grade 1 or 2 infusion-related reaction (IRR) administer dexamethasone (or equivalent); then, for subsequent infusions, premedicate with the following or equivalent medicinal products: an intravenous histamine H1 antagonist (for example diphenhydramine hydrochloride), paracetamol and dexamethasone.1

Dose Modifications

Infusion-related reactions

The infusion rate of ramucirumab should be reduced by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a grade 1 or 2 IRR. Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR.1

Hypertension

The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated. Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management. If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued.1

Proteinuria

Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy. If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed. Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours. Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level (see Table 1). A second dose reduction (see Table 1) is recommended if a urine protein level ≥2 g/24 hours reoccurs.1

Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.1

Table 1. Ramucirumab dose reductions for proteinuria1

Initial ramucirumab dose:

First dose reduction to:

Second dose reduction to:

8 mg/kg

6 mg/kg

5 mg/kg

Elective surgery or impaired wound healing

Ramucirumab therapy should be temporarily discontinued for at least 4 weeks prior to elective surgery. Ramucirumab therapy should be temporarily discontinued if there are wound healing complications, until the wound is fully healed.1

Severe arterial thromboembolic events, gastrointestinal perforations, severe bleeding, spontaneous development of fistula, hepatic encephalopathy or hepatorenal syndrome

Ramucirumab therapy should be permanently discontinued in the event of:

  • Severe arterial thromboembolic events

  • Gastrointestinal perforations

  • Severe bleeding: NCI CTCAE Grade 3 or 4 bleeding 

  • Spontaneous development of fistula

  • Hepatic encephalopathy or hepatorenal syndrome1

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

CTCAE = Common Terminology Criteria for Adverse Events

IRR = infusion-related reaction

IV = intravenous

NCI = National Cancer Institute

Datum fӧr senaste ӧversyn 2017 M11 01

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