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CYRAMZA is a brand name for Ramucirumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CYRAMZA® (ramucirumab) is indicated for: • Gastric Cancer – CYRAMZA (ramucirumab) as a single agent or in combination with paclitaxel is indicated for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior platinum…
Verbatim from this product's HC label. Tap a section to expand.
) • Increases risk of gastrointestinal perforations, including fatal events, (see 7 WARNINGS AND PRECAUTIONS and 4 DOSAGE AND ADMINISTRATION) • Impaired wound healing. 1 Dosing Considerations It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
2 Recommended Dose and Dosage Adjustment Gastric Cancer CYRAMZA single agent: CYRAMZA® ramucirumab Page 5 of 47 The recommended dose of CYRAMZA as a single agent is 8 mg/kg every 2 weeks administered as an intravenous infusion over approximately 60 minutes (maximum infusion rate 25 mg/min).
CYRAMZA in combination with paclitaxel:
The recommended dose of CYRAMZA is 8 mg/kg administered by intravenous infusion over approximately 60 minutes on days 1 and 15 of a 28-day cycle prior to paclitaxel infusion. Administer paclitaxel at 80 mg/m2 by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28-day cycle.
Criteria to be met prior to each paclitaxel administration are provided in Table 1. , diphenhydramine) intravenously prior to administration of CYRAMZA. If a patient experiences a Grade 1 or 2 infusion-related reaction (IRR), besides the histamine H1 antagonist, also administer dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion (see Dose Adjustments below).
See paclitaxel prescribing information for paclitaxel premedication requirements. Dose Adjustments Infusion-Related Reactions Reduce the CYRAMZA infusion rate by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a Grade 1 or 2 IRR [per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)] (see Premedication subsection above).
Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs (see 7 WARNINGS AND PRECAUTIONS). Hypertension Monitor blood pressure during treatment with CYRAMZA and treat as clinically indicated. Temporarily suspend CYRAMZA for severe hypertension until controlled with medical management and permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with antihypertensive therapy (see 7 WARNINGS AND PRECAUTIONS).
Posterior Reversible Encephalopathy Syndrome CYRAMZA® ramucirumab Page 6 of 47 Permanently discontinue CYRAMZA for patients who experience Posterior Reversible Encephalopathy Syndrome (PRES) (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
). Proteinuria Monitor for the development or worsening of proteinuria during CYRAMZA therapy. If the urine protein level is ≥ 2+, perform a 24-hour urine collection. Temporarily discontinue CYRAMZA administration if the urine protein level is ≥ 2 g/24 hours.
Resume treatment at a reduced dose level (to 6 mg/kg every 2 weeks) once the urine protein level returns to < 2 g/24 hours. A second dose reduction (to 5 mg/kg every 2 weeks) is recommended if a urine protein level ≥ 2 g/24 hours reoccurs.
Permanently discontinue CYRAMZA therapy if the urine protein level is > 3 g/24 hours or in the setting of nephrotic syndrome. Wound Healing Complications Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed (see 7 WARNINGS AND PRECAUTIONS).
Arterial Thromboembolic Events, Gastrointestinal Perforations, or Grade 3 or 4 Bleeding Permanently discontinue CYRAMZA in patients who experience a severe arterial thromboembolic event, gastrointestinal perforations, or Grade 3 or 4 bleeding (see 7 WARNINGS AND PRECAUTIONS).
Paclitaxel Paclitaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient. For NCI-CTCAE Grade 4 hematological toxicity or Grade 3 paclitaxel-related nonhematological toxicity, it is recommended to reduce the paclitaxel dose by 10 mg/m2 for all following cycles.
A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur. See paclitaxel prescribing information for additional dosage and administration recommendations. Health Canada has not authorized an indication in pediatric use (see 1 INDICATIONS).
9%) solution for injection as a diluent. Do not use dextrose as a diluent. 1. Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution. 2. Each vial is intended for single use only. Inspect the content of the vials for particulate matter and discolouration (material should be clear to slightly opalescent and colourless to slightly yellow) prior to dilution.
04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................ 2 TABLE OF CONTENTS..................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ...................................................................................................... 1 Pediatrics .............................................................................................
2 Geriatrics .............................................................................................. 4 2 CONTRAINDICATIONS ....................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................
4 4 DOSAGE AND ADMINISTRATION ..................................................................... 1 Dosing Considerations ......................................................................... 2 Recommended Dose and Dosage Adjustment ....................................
3 Reconstitution ...................................................................................... 4 Administration ...................................................................................... 5 Missed Dose ........................................................................................
7 5 OVERDOSAGE .................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7 7 WARNINGS AND PRECAUTIONS ......................................................................
1 Special Populations ............................................................................ 1 Pregnant Women .................................................................................. 2 Breast-feeding .......................................................................................
• CYRAMZA (ramucirumab) is contraindicated in patients with a known hypersensitivity to ramucirumab or to any other ingredient used in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Proteinuria Monitor for the development or worsening of proteinuria during CYRAMZA therapy. If the urine protein level is ≥ 2+, perform a 24-hour urine collection. Temporarily discontinue CYRAMZA administration if the urine protein level is ≥ 2 g/24 hours.
Resume treatment at a reduced dose level (to 6 mg/kg every 2 weeks) once the urine protein level returns to < 2 g/24 hours. A second dose reduction (to 5 mg/kg every 2 weeks) is recommended if a urine protein level ≥ 2 g/24 hours reoccurs.
Permanently discontinue CYRAMZA therapy if the urine protein level is > 3 g/24 hours or in the setting of nephrotic syndrome. Wound Healing Complications Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed (see 7 WARNINGS AND PRECAUTIONS).
Arterial Thromboembolic Events, Gastrointestinal Perforations, or Grade 3 or 4 Bleeding Permanently discontinue CYRAMZA in patients who experience a severe arterial thromboembolic event, gastrointestinal perforations, or Grade 3 or 4 bleeding (see 7 WARNINGS AND PRECAUTIONS).
Paclitaxel Paclitaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient. For NCI-CTCAE Grade 4 hematological toxicity or Grade 3 paclitaxel-related nonhematological toxicity, it is recommended to reduce the paclitaxel dose by 10 mg/m2 for all following cycles.
A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur. See paclitaxel prescribing information for additional dosage and administration recommendations. Health Canada has not authorized an indication in pediatric use (see 1 INDICATIONS).
9%) solution for injection as a diluent. Do not use dextrose as a diluent. 1. Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution. 2. Each vial is intended for single use only. Inspect the content of the vials for particulate matter and discolouration (material should be clear to slightly opalescent and colourless to slightly yellow) prior to dilution.
If particulate matter or discolourations are identified, discard the vial (see 11 STORAGE, STABILITY AND DISPOSAL). 3. Calculate the dose and volume of CYRAMZA needed to prepare the infusion solution. Vials contain either 100 mg or 500 mg as a 10 mg/mL solution of ramucirumab.
9%) solution for injection as a diluent. In case of prefilled intravenous infusion container usage: 4. 9%) solution for injection from the prefilled 250 mL intravenous container. Aseptically transfer the calculated volume of CYRAMZA to the intravenous CYRAMZA® ramucirumab Page 7 of 47 container.
The final total volume in the container should be 250 mL. The container should be gently inverted to ensure adequate mixing. DO NOT FREEZE OR SHAKE the infusion solution. DO […]
If particulate matter or discolourations are identified, discard the vial (see 11 STORAGE, STABILITY AND DISPOSAL). 3. Calculate the dose and volume of CYRAMZA needed to prepare the infusion solution. Vials contain either 100 mg or 500 mg as a 10 mg/mL solution of ramucirumab.
9%) solution for injection as a diluent. In case of prefilled intravenous infusion container usage: 4. 9%) solution for injection from the prefilled 250 mL intravenous container. Aseptically transfer the calculated volume of CYRAMZA to the intravenous CYRAMZA® ramucirumab Page 7 of 47 container.
The final total volume in the container should be 250 mL. The container should be gently inverted to ensure adequate mixing. DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medications (see 11 STORAGE, STABILITY AND DISPOSAL).
In case of empty intravenous infusion container usage: 5. Aseptically transfer the calculated volume of CYRAMZA into an empty intravenous container. 9%) solution for injection to the container to make the total volume 250 mL. The container should be gently inverted to ensure adequate mixing.
DO NOT FREEZE OR SHAKE the infusion solution. DO NOT dilute with other solutions or co-infuse with other electrolytes or medications (see 11 STORAGE, STABILITY AND DISPOSAL). Discard any unused portion of CYRAMZA left in a vial, as the product contains no preservatives.
4 Administration Administer CYRAMZA as an intravenous infusion only. Do not administer CYRAMZA as an intravenous push or bolus. Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is identified, discard the infusion solution.
Administer via infusion pump. 9%) solution for injection at the end of the infusion. 5 Missed Dose Missed or delayed doses should not be omitted but administered at a later time point, at the discretion of the treating physician, taking into account the planned interval between doses.
5 OVERDOSAGE There is no data on overdose in humans. In case of overdose, use supportive therapy. There is no known antidote to ramucirumab overdose. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 2 - Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Solution / 10 mg/mL L-histidine, L-histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, and water for injection.
CYRAMZA® ramucirumab Page 8 of 47 CYRAMZA (ramucirumab) is supplied as a sterile, preservative-free solution for intravenous infusion in 10 mL or 50 mL single-use vials. Each vial contains either 100 mg ramucirumab in 10 mL (10 mg/mL) or 500 mg ramucirumab in 50 mL (10 mg/mL).
Vials are individually packaged in a carton. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Cardiovascular Arterial Thromboembolic Events Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral […]
3 Pediatrics .............................................................................................. 4 Geriatrics ............................................................................................... 11 8 ADVERSE REACTIONS ....................................................................................
1 Adverse Reaction Overview ............................................................... 2 Clinical Trial Adverse Reactions ......................................................... 3 Less Common Clinical Trial Adverse Reactions .................................
5 Post-Market Adverse Reactions ......................................................... 25 CYRAMZA® ramucirumab Page 3 of 47 9 DRUG INTERACTIONS .....................................................................................
4 Drug-Drug Interactions ....................................................................... 5 Drug-Food Interactions....................................................................... 6 Drug-Herb Interactions .......................................................................
7 Drug-Laboratory Test Interactions ...................................................... 26 10 CLINICAL PHARMACOLOGY........................................................................... 1 Mechanism of Action ..........................................................................
2 Pharmacodynamics ............................................................................ 3 Pharmacokinetics ............................................................................... 26 11 STORAGE, STABILITY AND DISPOSAL .........................................................
27 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 27 PART II: SCIENTIFIC INFORMATION ......................................................................... 27 13 PHARMACEUTICAL INFORMATION ...............................................................
27 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ................................................................. 3 Immunogenicity ..................................................................................
37 15 MICROBIOLOGY ............................................................................................... 38 16 NON-CLINICAL TOXICOLOGY ......................................................................... 38 PATIENT MEDICATION INFORMATION .....................................................................
41 CYRAMZA® ramucirumab Page 4 of 47 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS CYRAMZA® (ramucirumab) is indicated for: • Gastric Cancer – CYRAMZA (ramucirumab) as a single agent or in combination with paclitaxel is indicated for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.
1 Pediatrics Pediatrics (< 18 years of age) The safety and effectiveness of CYRAMZA in children and adolescents have not been established. Therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age) No overall differences in safety or effectiveness have been observed between the elderly and younger patients, but greater safety sensitivity of some older individuals cannot be ruled out.
2 CONTRAINDICATIONS • CYRAMZA (ramucirumab) is contraindicated in patients with a known hypersensitivity to ramucirumab or to any other ingredient used in the formulation, including any […]