Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Dosering och dosjusteringar - NSCLC

Den rekommenderade dosen ramucirumab är 10 mg/kg dag 1 i en 21-dagarscykel, före docetaxelinfusion, eller 10 mg/kg varannan vecka i kombination med erlotinib för NSCLC med aktiverande EGFR-mutationer.

Approved Dosing Regimen - Lung Cancer

Cyramza in combination with erlotinib for the treatment of NSCLC with activating EGFR mutations

The recommended dose of ramucirumab in combination with erlotinib is 10 mg/kg every two weeks.1

EGFR mutation status should be determined prior to initiation of treatment with ramucirumab and erlotinib using a validated test method. See erlotinib prescribing information for the posology and method of administration of erlotinib.1

Cyramza in combination with docetaxel for the treatment of NSCLC after platinum-based chemotherapy

The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion. The recommended dose of docetaxel is 75 mg/m2 administered by intravenous infusion over approximately 60 minutes on day 1 of a 21 day cycle. For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered. See docetaxel prescribing information for specific dosing advice.1

Premedication

Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab. 1

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 Adjustments

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:

10 mg/kg

8 mg/kg

6 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

EGFR = epidermal growth factor receptor

IRR = infusion-related reaction

IV = intravenous

NCI = National Cancer Institute

NSCLC = non-small cell lung cancer

Datum fӧr senaste ӧversyn 2017 M11 01

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