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OGIVRI is a brand name for Trastuzumab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between OGIVRI and the reference biologic drug HERCEPTIN. OGIVRI (trastuzumab) is indicated for: Early Breast Cancer (EBC) OGIVRI (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours…
Verbatim from this product's HC label. Tap a section to expand.
, Dosing Considerations). Cardiotoxicity OGIVRI (trastuzumab) can result in the development of ventricular dysfunction and congestive heart failure. In the adjuvant treatment setting, the incidence of cardiac dysfunction was higher in patients who received trastuzumab plus chemotherapy versus chemotherapy alone.
An increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was OGIVRI® Product Monograph Page 7 of 132 administered after anthracycline-containing chemotherapy compared to administration with a non- anthracycline regimen of docetaxel and carboplatin.
The incidence was more marked when trastuzumab was administered concurrently with a taxane than when administered sequentially to a taxane. In the metastatic setting, the incidence and severity of cardiac dysfunction was particularly high in patients who received trastuzumab concurrently with anthracyclines and cyclophosphamide (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Evaluate left ventricular function in all patients prior to and during treatment with OGIVRI (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). Infusion Reactions; Pulmonary Toxicity OGIVRI administration can result in serious infusion reactions and pulmonary toxicity.
Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of trastuzumab. OGIVRI infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
Patients should be monitored until signs and symptoms completely resolve. Discontinue OGIVRI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome (see 7 WARNINGS AND PRECAUTIONS).
Embryo-Fetal Toxicity Exposure to OGIVRI during pregnancy can result in impairment of fetal renal growth and/or renal function impairment resulting in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, intrauterine growth retardation and neonatal death (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
4 DOSAGE AND ADMINISTRATION Trastuzumab intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only. If an alternate route of administration is required, other trastuzumab products offering such an option should be used.
). Interruption of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate. OGIVRI® Product Monograph Page 12 of 132 If prior infusion was well tolerated, subsequent weekly doses of 2 mg/kg OGIVRI may be administered over 30 minutes (see Recommended Dose and Dosage Adjustment).
Patients should still be observed for fever and chills or other infusion-associated symptoms (see 8 ADVERSE REACTIONS). 3-Weekly Schedule: Treatment may be administered in an outpatient setting by administration of a 8 mg/kg loading dose of OGIVRI by intravenous (IV) infusion over 90 minutes.
Do not administer as an IV push or bolus. Patients should be observed for fever and chills or other infusion associated symptoms (see 8 ADVERSE REACTIONS). Interruption of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate.
If prior infusion was well tolerated, subsequent 3-weekly doses of 6 mg/kg OGIVRI may be administered over 30 minutes (see Recommended Dose and Dosage Adjustment). Patients should still be observed for fever and chills or other infusion-associated symptoms (see 8 ADVERSE REACTIONS).
OGIVRI should not be mixed or diluted with other drugs. Infusions of OGIVRI should not be administered or mixed with dextrose solutions. 5 Missed Dose Weekly schedule: If the patient has missed a dose of OGIVRI by one week or less, then the usual maintenance dose (2 mg/kg) should be given as soon as possible (do not wait until the next planned cycle).
Subsequent maintenance OGIVRI doses of 2 mg/kg should be administered 7 days later according to the weekly schedule. If the patient has missed a dose of OGIVRI by more than one week, a re-loading dose of OGIVRI should be administered (4 mg/kg over approximately 90 minutes) as soon as possible.
Subsequent maintenance OGIVRI doses of 2 mg/kg should be administered 7 days later according to the weekly schedule. 3-Weekly Schedule: If the patient has missed a dose of OGIVRI by one week or less, then the usual maintenance dose (6 mg/kg) should be administered as soon as possible (do not wait until the next planned cycle).
Selection of Patients / Diagnostic Tests). OGIVRI can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
For information on the use of OGIVRI in combination with pertuzumab and docetaxel, consult the Product Monograph for pertuzumab. OGIVRI® Product Monograph Page 6 of 132 Metastatic Gastric Cancer (MGC) OGIVRI in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro- esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
OGIVRI should only be administered to patients with MGC whose tumours have HER2 overexpression as defined by IHC2+ confirmed by FISH+, or IHC 3+ as determined by an accurate and validated assay. 1 Pediatrics The safety and effectiveness of OGIVRI in pediatric patients (< 18 years of age) have not been established.
2 Geriatrics The reported clinical experience is not adequate to determine whether older patients respond differently to OGIVRI treatment than younger patients (see 7 WARNINGS AND PRECAUTIONS, Geriatrics). 2 CONTRAINDICATIONS • OGIVRI (trastuzumab) is contraindicated in patients with known hypersensitivity to trastuzumab, Chinese Hamster Ovary (CHO) cell proteins, or to any ingredient in the formulation, including any non-medicinal ingredient, or any component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • When using in combination with pertuzumab and docetaxel, consult Product Monographs for pertuzumab and docetaxel for further information on these drugs.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions There is a risk of medication errors between OGIVRI (trastuzumab) and KADCYLA® (trastuzumab emtansine). In order to minimize this risk, check the vial labels to ensure that the drug being prepared and administered is OGIVRI (trastuzumab) and not KADCYLA® (trastuzumab emtansine).
• OGIVRI (trastuzumab) is contraindicated in patients with known hypersensitivity to trastuzumab, Chinese Hamster Ovary (CHO) cell proteins, or to any ingredient in the formulation, including any non-medicinal ingredient, or any component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • When using in combination with pertuzumab and docetaxel, consult Product Monographs for pertuzumab and docetaxel for further information on these drugs.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Dosing Considerations There is a risk of medication errors between OGIVRI (trastuzumab) and KADCYLA® (trastuzumab emtansine). In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is OGIVRI (trastuzumab) and not KADCYLA® (trastuzumab emtansine).
Ensure that the recommended OGIVRI (trastuzumab) dose is administered (see 4 Recommended Dose and Dosage Adjustment section). OGIVRI should be prescribed using both the trade name and non-proprietary name. Do not substitute OGIVRI for or with KADCYLA® (trastuzumab emtansine).
When using in combination with pertuzumab and docetaxel for treatment of patients with HER-2- positive metastatic breast cancer, consult Product Monographs for pertuzumab and docetaxel for further information, such as dose adjustment, sequence of administration of each medication and duration of treatment.
OGIVRI® Product Monograph Page 8 of 132 Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. 2 Recommended Dose and Dosage Adjustment Early Breast Cancer (EBC) 3-Weekly Schedule: The recommended initial loading dose is 8 mg/kg OGIVRI (trastuzumab) administered as a 90-minute infusion.
The recommended maintenance dose is 6 mg/kg OGIVRI 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion.
Do not administer as an IV push or bolus (see Preparation for Administration) Weekly schedule: As a weekly regimen, the recommended initial loading dose of OGIVRI is 4 mg/kg followed by 2 mg/kg every week. 4 Clinical Trials– Reference Biological Drug section for chemotherapy combination dosing.
Metastatic Breast Cancer (MBC) Weekly schedule:
The recommended initial loading dose is 4 mg/kg OGIVRI administered as a 90-minute infusion. The recommended weekly maintenance dose is 2 mg/kg OGIVRI and can be administered as a 30-minute infusion if the initial loading dose was well tolerated.
OGIVRI may be administered in an outpatient setting. Do not administer as an IV push or bolus (see Preparation for Administration).
Metastatic Gastric Cancer (MGC) 3-Weekly Schedule:
The recommended initial loading dose is 8 mg/kg OGIVRI administered as a 90- minute infusion. The recommended maintenance dose is 6 mg/kg OGIVRI 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes.
If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion. Do not administer as an IV push or bolus (see Preparation for Administration) Duration of Treatment Patients with MBC or MGC should be treated with OGIVRI until progression of disease or unmanageable toxicity.
Patients with EBC should be treated for 1 year or until disease recurrence or unmanageable toxicity, whichever occurs first (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). 4 Clinical Trials - Reference Biological Drug, Early Breast Cancer (EBC), HERA).
Dose Modification If the patient develops an infusion-related reaction (IRR), the infusion rate of OGIVRI IV may be slowed or interrupted. No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue therapy with trastuzumab during periods of reversible, chemotherapy-induced […]
Subsequent maintenance OGIVRI doses of 6 mg/kg should be administered 21 days later according to the 3-weekly schedule. If the patient has missed a dose of OGIVRI by more than one week, a re-loading dose of OGIVRI should be administered (8 mg/kg over approximately 90 minutes) as soon as possible.
Subsequent maintenance OGIVRI doses of 6 mg/kg should be administered 21 days later according to the 3-weekly schedule. 5 OVERDOSAGE There is no experience with overdosage in human clinical trials. Single doses higher than 500 mg (10 mg/kg) have not been tested.
Ensure that the recommended OGIVRI (trastuzumab) dose and NOT KADCYLA® (trastuzumab emtansine) dose is administered. For information on the risk of KADCYLA® overdose due to medication errors, see KADCYLA® Product Monograph. OGIVRI® Product Monograph Page 13 of 132 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 OGIVRI, 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 4 – Dosage Forms, Strengths, Composition and Packaging Composition:
OGIVRI (trastuzumab) is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous (IV) administration. 2 mg D - sorbitol. It also contains sodium hydroxide and hydrochloric acid to adjust the pH. 2 mL of Sterile Water for Injection (SWFI) (not supplied), yields a single-dose solution containing 21 mg/mL trastuzumab, at a pH of approximately 6.
9 mg D-sorbitol. It also contains sodium hydroxide and hydrochloric acid to adjust the pH. 1% benzyl alcohol as a preservative, yields a multi-dose solution containing 21 mg/mL trastuzumab, at a pH of approximately 6. Availability: 150 mg/vial Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients for Intravenous Infusion Lyophilized Powder 150 mg trastuzumab/vial 440 mg trastuzumab/vial L-histidine, L-histidine HCl monohydrate, PEG-3350/macrogol 3350, D-sorbitol.
It also contains hydrochloric acid and sodium hydroxide to adjust the pH.
Note:
The Sterile Water for Injection (SWFI) for dilution of the 150 mg/vial is not supplied. 1% benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS). OGIVRI® Product Monograph Page 14 of 132 OGIVRI is supplied as a lyophilized, sterile powder containing 150 mg trastuzumab per vial under vacuum.
Each carton contains one vial of 150 mg OGIVRI. 440 mg/vial OGIVRI is supplied as a lyophilized, sterile powder containing 440 mg trastuzumab per vial under vacuum. 1% benzyl alcohol as an antimicrobial preservative. 1% benzyl alcohol.
Description OGIVRI (trastuzumab) is a recombinant DNA-derived humanized monoclonal antibody directed against the extracellular domain of the human epidermal growth factor receptor 2 (HER2), a transmembrane glycoprotein with intrinsic tyrosine kinase activity.
OGIVRI binds to HER2 protein on the surface of cancer cells and inhibits their proliferation and survival. 7 […]
OGIVRI should be prescribed using both the trade name and non-proprietary name (see 4 DOSAGE AND ADMINISTRATION, Dosing Considerations). Cardiotoxicity OGIVRI (trastuzumab) can result in the development of ventricular dysfunction and congestive heart failure.
In the adjuvant treatment setting, the incidence of cardiac dysfunction was higher in patients who received trastuzumab plus chemotherapy versus chemotherapy alone. An increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was OGIVRI® Product Monograph Page 7 of 132 administered after anthracycline-containing chemotherapy compared to administration with a non- anthracycline regimen of docetaxel and carboplatin.
The incidence was more marked when trastuzumab was administered concurrently with a taxane than when administered sequentially to a taxane. In the metastatic setting, the incidence and severity of cardiac dysfunction was particularly high in patients who received trastuzumab concurrently with anthracyclines and cyclophosphamide (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Evaluate left ventricular function in all patients prior to and during treatment with OGIVRI (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). Infusion Reactions; Pulmonary Toxicity OGIVRI administration can result in serious infusion reactions and pulmonary toxicity.
Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of trastuzumab. OGIVRI infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
Patients should be monitored until signs and symptoms completely resolve. Discontinue OGIVRI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome (see 7 WARNINGS AND PRECAUTIONS).
Embryo-Fetal Toxicity Exposure to OGIVRI during pregnancy can result in impairment of fetal renal growth and/or renal function impairment resulting in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, intrauterine growth retardation and neonatal death (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
4 DOSAGE AND ADMINISTRATION Trastuzumab intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only. If an alternate route of administration is required, other trastuzumab products offering such an option should be used.
1 Dosing Considerations There is a risk of medication errors between OGIVRI (trastuzumab) and KADCYLA® (trastuzumab emtansine). In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is OGIVRI (trastuzumab) and not KADCYLA® (trastuzumab emtansine).
Ensure that the recommended OGIVRI (trastuzumab) dose is administered (see 4 Recommended Dose and Dosage Adjustment section). OGIVRI should be prescribed using both the trade name and non-proprietary name. Do not substitute OGIVRI for or with KADCYLA® (trastuzumab emtansine).
When using in combination with pertuzumab and docetaxel for treatment of patients with HER-2- positive metastatic breast cancer, consult Product Monographs for pertuzumab and docetaxel for further information, such as dose adjustment, sequence of administration of each medication and duration of treatment.
OGIVRI® Product Monograph Page 8 of 132 Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. 2 Recommended Dose and Dosage Adjustment Early Breast Cancer (EBC) 3-Weekly Schedule: The recommended initial loading dose is 8 mg/kg OGIVRI (trastuzumab) administered as a […]