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Cyramza is a brand name for Ramucirumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1). Cyramza monotherapy is indicated for the…
Verbatim from this product's EMA label. Tap a section to expand.
Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology. Posology Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma Cyramza in 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.
Criteria to be met prior to each paclitaxel infusion are provided in Table 1. 5 x upper limit of normal value (ULN) Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT) No liver metastases: ALT/AST ≤ 3 x ULN Liver metastases: ALT/AST ≤ 5 x ULN Cyramza as a single agent The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Colorectal cancer The recommended dose of ramucirumab is 8 mg/kg every 2 weeks administered by intravenous infusion, prior to FOLFIRI administration. Prior to chemotherapy, patients should have a complete blood count. Criteria to be met prior to FOLFIRI are provided in Table 2.
5 x 109/L Platelets ≥ 100 x 109/L Chemotherapy-related gastro- intestinal toxicity ≤ Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]) Non-small cell lung cancer (NSCLC) 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.
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.
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. Hepatocellular carcinoma (HCC) The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
8. Fistula Patients may be at increased risk for the development of fistula when treated with Cyramza. 2). Proteinuria An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo. 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.
A second dose reduction is recommended if a urine protein level ≥ 2 g/24 hours reoccurs. 2). Stomatitis An increased incidence of stomatitis was reported in patients receiving ramucirumab in combination with chemotherapy as compared to patients treated with placebo plus chemotherapy.
Symptomatic treatment should be instituted promptly if stomatitis occurs. 2). 1). 1). For ramucirumab used in combination with erlotinib for the first line treatment of NSCLC with activating EGFR mutations, patients aged 70 years and older compared to patients under 70 years of age, experienced a higher incidence of grade ≥ 3 adverse events and all grade serious adverse events.
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) in each 10 ml vial, that is to say essentially ‘sodium free’. This medicinal product contains approximately 85 mg sodium in each 50 ml vial. This is equivalent to approximately 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Polysorbate This medicinal product contains approximately 1 mg of polysorbate 80 in each 10 ml, and 5 mg of polysorbate 80 in each 50 ml vial. 5 Interaction with other medicinal products and other forms of interaction No drug-drug interactions were observed between ramucirumab and paclitaxel.
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Arterial thromboembolic events Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
2). Gastrointestinal perforations Ramucirumab is an antiangiogenic therapy and may increase the risk of gastrointestinal perforations. Cases of gastrointestinal perforation have been reported in patients treated with ramucirumab. 2). Severe bleeding Ramucirumab is an antiangiogenic therapy and may increase the risk of severe bleeding.
2). Blood counts and coagulation parameters should be monitored in patients with conditions predisposing to bleeding, and in those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding.
For HCC patients with evidence of portal hypertension or prior history of oesophageal variceal bleeding, screening for and treatment of oesophageal varices should be performed as per standard of care before starting ramucirumab treatment.
Severe gastrointestinal haemorrhage, including fatal events, were reported in patients with gastric cancer treated with ramucirumab in combination with paclitaxel, and in patients with mCRC treated with ramucirumab in combination with FOLFIRI.
9 Pulmonary haemorrhage in NSCLC Patients with squamous histology are at higher risk of developing serious pulmonary bleeding, however, no excess of Grade 5 pulmonary haemorrhage was observed in ramucirumab treated patients with squamous histology in REVEL.
3). Patients receiving any kind of therapeutic anticoagulation were excluded from the REVEL NSCLC clinical trial and patients receiving chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL and RELAY NSCLC clinical trials.
1. 4).
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1). Duration of treatment It is recommended that treatment be continued until disease progression or until unacceptable toxicity has occurred. 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.
See prescribing information for paclitaxel, for components of FOLFIRI and for docetaxel, as applicable, for premedication requirements and additional information. 5 Posology adjustments for ramucirumab 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.
4). 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.
4). 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 3). A second dose reduction (see Table 3) is recommended if a urine protein level ≥2 g/24 hours reoccurs. Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.
Table 3:
Ramucirumab dose reductions for proteinuria Initial ramucirumab dose First dose reduction to Second dose reduction to 8 mg/kg 6 mg/kg 5 mg/kg 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.
4). Permanent discontinuation Ramucirumab therapy should be permanently discontinued in the event of: Severe […]
The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel. The pharmacokinetics of irinotecan and its active metabolite, SN-38, were not affected when co-administered with ramucirumab.
The pharmacokinetics of docetaxel or erlotinib were not affected when co-administered with ramucirumab. 6 Fertility, pregnancy and lactation Women of childbearing potential/Contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on Cyramza and should be informed of the potential hazard to the pregnancy and foetus.
Women of childbearing potential should use effective contraception during and up to 3 months after the last dose of ramucirumab treatment. Pregnancy There are no data from the use of ramucirumab in pregnant women. 3). As angiogenesis is critical to maintenance of pregnancy and to foetal development, the inhibition of angiogenesis following ramucirumab administration may result in adverse events on pregnancy, including the foetus.
Cyramza should only be used if the potential benefit to the mother justifies the potential risk during pregnancy. If the patient becomes pregnant while being treated with ramucirumab, she should be informed of the potential risk 12 to the maintenance of pregnancy and the risk to the foetus.
Cyramza is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether ramucirumab is excreted in human milk. Excretion in milk and oral absorption is expected to be low.
As a risk to breast-fed newborns/infants cannot be excluded, breast-feeding should be discontinued during treatment with Cyramza and for at least 3 months after the last dose. Fertility There are no data on the effect of ramucirumab on human fertility.
3). 7 Effects on ability to drive and use machines Cyramza has no or negligible influence on the ability to drive and use machines. If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
4) The most common adverse reactions observed in patients treated with ramucirumab as monotherapy are: peripheral oedema, hypertension, diarrhoea, abdominal pain, headache, proteinuria and thrombocytopenia. The most common adverse reactions observed in patients treated with ramucirumab in combination with chemotherapy are: […]
1). Infusion-related reactions Infusion-related reactions were reported in clinical studies with ramucirumab. The majority of events occurred during or following a first or second ramucirumab infusion. Patients should be monitored during the infusion for signs of hypersensitivity.
Symptoms included rigors/tremors, back-pain/spasms, chest pain and/or tightness, chills, flushing, dyspnoea, wheezing, hypoxia, and paraesthesia. In severe cases symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
2). Hypertension An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo. In most cases hypertension was managed using standard antihypertensive treatment. Patients with uncontrolled hypertension were excluded from the trials: ramucirumab treatment should not be initiated in such patients until and unless their pre-existing hypertension is controlled.
Patients who are treated with ramucirumab should have their blood pressure monitored. Ramucirumab should be temporarily discontinued for severe hypertension until controlled with medical management. 2). Posterior Reversible Encephalopathy Syndrome Cases of posterior reversible encephalopathy syndrome (PRES), including fatal cases, have been rarely reported in patients receiving ramucirumab.
PRES symptoms may include seizure, headache, nausea/vomiting, blindness, or altered consciousness, with or without associated hypertension. , magnetic resonance imaging). Discontinue ramucirumab in patients who experience PRES. The safety of reinitiating ramucirumab in patients who develop PRES and recover is not known.
Aneurysms and artery dissections The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections. Before initiating Cyramza, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Impaired wound healing The impact of ramucirumab has not been evaluated in patients with serious or non-healing wounds. In a study conducted in animals, ramucirumab did not impair wound healing. However, since ramucirumab is an antiangiogenic therapy and may have the potential to adversely affect wound healing, ramucirumab treatment should be withheld for at least 4 weeks prior to scheduled surgery.
10 The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing. 2). Hepatic impairment Ramucirumab should be used with caution in patients with severe liver cirrhosis (Child-Pugh B or C), cirrhosis with hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome.
There are very limited efficacy and safety data available in these patients. […]