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KANJINTI is a brand name for Trastuzumab, supplied as a kit. 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 KANJINTI and the reference biologic drug HERCEPTIN. Early Breast Cancer (EBC) KANJINTI (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with ECOG 0 - 1 status, whose tumours overexpress HER2, following surgery and…
Verbatim from this product's HC label. Tap a section to expand.
4) XX/2021 WARNINGS AND PRECAUTIONS (8) 04/2021 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................... 4 1 INDICATIONS...................................................................................................
1 Pediatrics .......................................................................................... 2 Geriatrics........................................................................................... 5 2 CONTRAINDICATIONS ....................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................... 1 Dosing Considerations.......................................................................
2 Recommended Dose and Dosage Adjustment ................................... 3 Administration.................................................................................... 4 Reconstitution....................................................................................
5 Missed Dose.................................................................................... 10 5 OVERDOSAGE .............................................................................................. 11
1 Adverse Reaction Overview The adverse drug reaction profiles reported in clinical studies that compared KANJINTI to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Early Breast Cancer (EBC) HERA (adjuvant sequential: use of trastuzumab following surgery and after chemotherapy) Please see WARNINGS AND PRECAUTIONS, Cardiovascular, Cardiotoxicity, Early Breast Cancer (EBC) [8] - Table 5, Table 6, Table 7, Table 8 for a description of the absolute numbers and rates of cardiac endpoints in HERA as well as the median time to return to baseline LVEF/ stabilizations of LVEF in the HERA trial.
The HERA trial is a randomized, open label study in patients with HER2 positive EBC. Table 14 displays adverse events which were reported after 8 years of median f ollow up in ≥ 1% of patients, by study treatment. Table 14. 0 Classification System organ class Adverse Event Term Observation Only N = 1744 No.
(%) Trastuzumab 1 year N = 1682 No. (%) Blood and lymphatic system disorders Anemia 4 (<1) 15 (<1) Cardiac disorders Cardiac failure congestive 19 (1) 93 (6)* Palpitations 20 (1) 73 (4) Tachycardia 5 (<1) 25 (1) Ear and labyrinth disorders Vertigo 14 (<1) 33 (2) Tinnitus 6 (<1) 7 (<1) Eye disorders Conjunctivitis 7 (<1) 21 (1) Vision blurred 6 (<1) 16 (<1) KANJINTI® Product Monograph Page 28 of 129 Table 14.
(8) 04/2021 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................... 4 1 INDICATIONS...................................................................................................
1 Pediatrics .......................................................................................... 2 Geriatrics........................................................................................... 5 2 CONTRAINDICATIONS ....................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................... 1 Dosing Considerations.......................................................................
2 Recommended Dose and Dosage Adjustment ................................... 3 Administration.................................................................................... 4 Reconstitution....................................................................................
5 Missed Dose.................................................................................... 10 5 OVERDOSAGE .............................................................................................. 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...........
11 7 DESCRIPTION ............................................................................................... 12 8 WARNINGS AND PRECAUTIONS ................................................................. 1 Special Populations .........................................................................
1 Women and Men of Reproductive Potential:................................... 2 Pregnant Women .......................................................................... 3 Breast-feeding...............................................................................
(2) 04/20
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0 Classification System organ class Adverse Event Term Observation Only N = 1744 No. (%) Trastuzumab 1 year N = 1682 No. (%) Lacrimation increased 1 (<1) 12 (<1) Gastrointestinal disorders Diarrhea 23 (1) 156 (9) Nausea 37 (2) 134 (8) Vomiting 17 (<1) 76 (5) Constipation 27 (2) 55 (3) Abdominal pain 25 (1) 60 (4) Abdominal pain upper 30 (2) 45 (3) Dyspepsia 14 (<1) 42 (2) Stomatitis 1 (<1) 33 (2) Gastritis 17 (<1) 27 (2) Hemorrhoids 8 (<1) 18 (1) Mouth ulceration 2 (<1) 13 (<1) General disorders and administration site conditions Fatigue 83 (5) 198 (12) Edema peripheral 64 (4) 114 (7) Pyrexia 12 (<1) 119 (7) Asthenia 42 (2) 102 (6) Chills 1 (<1) 101 (6) Chest pain 36 (2) 65 (4) Influenza like illness 7 (<1) 51 (3) Pain 24 (1) 23 (1) Spinal pain 21 (1) 21 (1) Chest discomfort 6 (<1) 27 (2) Axillary pain 17 (<1) 18 (1) Edema 10 (<1) 23 (1) Mucosal inflammation 1 (<1) 18 (1) Malaise 1 (<1) 18 (1) Immune system disorders Seasonal allergy 6 (<1) 14 (<1) Infections and infestations# Nasopharyngitis 65 (4) 192 (11) Influenza 17 (<1) 95 (6) Upper respiratory tract inflection 31 (2) 53 (3) Urinary tract infection 19 (1) 54 (3) Rhinitis 11 (<1) 44 (3) KANJINTI® Product Monograph Page 29 of 129 Table 14.
0 Classification System organ class Adverse Event Term Observation Only N = 1744 No. (%) Trastuzumab 1 year N = 1682 No. (%) Bronchitis 25 (1) 36 (2) Cystitis 15 (<1) 28 (2) Sinusitis 7 (<1) 36 (2) Pharyngitis 12 (<1) 33 (2) Herpes zoster 14 (<1) 31 (2) Lower respiratory tract infection 14 (<1) 17 (1) Gastroenteritis 10 (<1) 9 (<1) Oral herpes 5 (<1) 15 (<1) Cellulitis 6 (<1) 14 (<1) Vaginal infection 10 (<1) 13 (<1) Ear infection 6 (<1) 9 (<1) Localised infection - 18 (1) Injury, poisoning and procedural complications Confusion 12 (<1) 13 (<1) Investigations Ejection fraction decreased 11 (<1) 64 (4) Weight increased 23 (1) 42 (2) Weight decreased 10 (<1) 10 (<1) Metabolism and nutrition disorders Decreased appetite 17 (<1) 25 (1) Hypercholesterolemia 15 (<1) 16 (<1) Musculoskeletal and connective tissue disorders Arthralgia 148 (8) 223 (13) Back pain 105 (6) 145 (9) Pain in extremity 73 (4) 94 (6) Musculoskeletal pain 66 (4) 75 (4) Myalgia 28 (2) 86 (5) Muscle spasms 13 (<1) 68 (4) Bone pain 31 (2) 54 (3) Musculoskeletal chest pain 37 (2) 43 (3) Osteoporosis 29 (2) 30 (2) Neck pain 18 (1) 29 (2) Osteoarthritis 18 (1) 28 (2) Osteopenia 12 (<1) 19 (1) Musculoskeletal stiffness 8 (<1) 14 (<1) KANJINTI® Product Monograph Page 30 of 129 Table 14.
0 Classification System organ class Adverse Event Term Observation Only N = 1744 No. (%) Trastuzumab 1 year N = 1682 No. (%) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Contralateral breast cancer 10 (<1) 23 (1) Uterine letomyoma 7 (<1) 9 (<1) Nervous system disorders Headache 73 (4) 199 (12) Dizziness 39 (2) 80 (5) Paresthesia 21 (1) 42 (2) Hypoesthesia 15 (<1) 25 (1) Lethargy 8 (<1) 20 (1) Migraine 3 (<1) 15 (<1) Peripheral sensory neuropathy 6 (<1) 14 (<1) Pregnancy, puerperium and perinatal conditions Pregnancy 11 (<1) 22 (1) Psychiatric disorders Depression 59 (3) 87 (5) Insomnia 49 (3) 94 (6) Anxiety 32 (2) 56 (3) Sleep disorder 5 (<1) 13 (<1) Renal and urinary disorders Dysuria 3 (<1) 20 (1) Reproductive system and breast disorders Breast pain 26 (1) 36 (2) Vaginal hemorrhage 20 (1) 23 (1) Vulvovaginal dryness 16 (<1) 23 (1) Breast mass 22 (1) 17 (1) Vaginal discharge 9 (<1) 15 (<1) Endometrial hyperplasia 13 (<1) 17 (1) Respiratory, thoracic and mediastinal disorders Cough 61 (3) 116 (7) Dyspnea 46 (3) 81 (5) […]
4 Pediatrics ...................................................................................... 5 Geriatrics (> 65 years of age)......................................................... 26 9 ADVERSE REACTIONS .................................................................................
1 Adverse Reaction Overview............................................................. 2 Clinical Trial Adverse Reactions ....................................................... 3 Less Common Clinical Trial Adverse Reactions................................
4 Post-Market Adverse Reactions ....................................................... 75 10 DRUG INTERACTIONS .................................................................................. 1 Overview .........................................................................................
2 Drug-Drug Interactions..................................................................... 76 11 ACTION AND CLINICAL PHARMACOLOGY ................................................. 1 Mechanism of Action .......................................................................
2 Pharmacokinetics ............................................................................ 77 12 STORAGE, STABILITY AND DISPOSAL ....................................................... 79 13 SPECIAL HANDLING INSTRUCTIONS ..........................................................
80 PART II: SCIENTIFIC INFORMATION ....................................................................... 81 14 PHARMACEUTICAL INFORMATION ............................................................. 81 15 COMPARATIVE CLINICAL TRIALS ...............................................................
1 Comparative Trial Design and Study Demographics ......................... 2 Comparative Study Results.............................................................. 1 Comparative Bioavailability Studies ...............................................
1 Pharmacokinetics.......................................................................... 2 Comparative Safety and Efficacy ................................................... 1 Efficacy .........................................................................................
2 Safety ........................................................................................... 3 Immunogenicity ............................................................................. 86 16 COMPARATIVE NON-CLINICAL PHARMACOLOGY AND TOXICOLOGY ....
1 Comparative Non-Clinical Pharmacodynamics ................................. 2 Comparative Toxicology................................................................... 86 17 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG ...................................
87 18 NON-CLINICAL TOXICOLOGY – REFERENCE BIOLOGIC DRUG .............. 104 19 SUPPORTING PRODUCT MONOGRAPHS .................................................. 115 PATIENT MEDICATION INFORMATION .................................................................
116 KANJINTI® Product Monograph Page 4 of 129 PART I: HEALTH PROFESSIONAL INFORMATION KANJINTI® (trastuzumab for injection) is a biosimilar biologic drug (biosimilar) to Herceptin®. 1 INDICATIONS Indications have been granted on the basis of similarity between KANJINTI and the reference biologic drug HERCEPTIN.
Early Breast Cancer (EBC) KANJINTI (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with ECOG 0 - 1 status, whose tumours overexpress HER2, following surgery and after chemotherapy following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
For detailed information on the inclusion […]