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VECTIBIX is a brand name for Panitumumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VECTIBIX (panitumumab for injection) is indicated: for the treatment of previously untreated patients with non-mutated (wild-type) RAS metastatic colorectal carcinoma (mCRC) in combination with FOLFOX (infusional 5- fluorouracil, leucovorin, and oxaliplatin). as monotherapy for the treatment of patients with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations XX/2021 7 WARNINGS AND PRECAUTIONS, Ophthalmologic XX/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization may not be listed.
PART I:
HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS.............................................................................................................. 1 Pediatrics ...........................................................................................................
2 Geriatrics............................................................................................................ 4 2 CONTRAINDICATIONS ...............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations........................................................................................
2 Recommended Dose and Dosage Adjustment .................................................... 3 Reconstitution..................................................................................................... 4 Administration.....................................................................................................
5 Missed Dose....................................................................................................... 7 5 OVERDOSAGE ...........................................................................................................
8
). Hypersensitivity reactions should be treated immediately with appropriate medical therapy consistent with the treating physician’s medical judgement. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous (IV) Infusion Sterile Concentrate for Solution for Infusion / 100 mg, 400 mg (20 mg/mL) Sodium acetate, sodium chloride, water for injection (USP) Vectibix® (panitumumab) Page 9 of 66 It is recommended to warn patients of the possibility of a late onset hypersensitivity reaction and instruct them to contact their physician if symptoms occur.
VECTIBIX in Combination with Oxaliplatin-based Chemotherapy in Patients with Mutant RAS mCRC or for Whom RAS Status is Unknown VECTIBIX should not be administered to patients with mutant RAS (KRAS and NRAS) mCRC or for whom RAS (KRAS and NRAS) status is unknown.
A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC from the phase 3 study 20050203 identified additional RAS (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) mutations in 17% (n = 108) of patients.
A shortening of PFS and OS was observed in patients with mutant RAS mCRC who received VECTIBIX and FOLFOX (n = 51) versus FOLFOX alone (n = 57) (see Monitoring and Laboratory Tests, Tumour Genetic Marker Testing). Increased toxicity and decreased overall survival in combination with bevacizumab and chemotherapy A randomized, open-label, multicentre study of 1,053 patients evaluated the efficacy and safety of bevacizumab and oxaliplatin- or irinotecan-containing chemotherapeutic regimens with and without VECTIBIX in the first-line treatment of mCRC.
Across both chemotherapy treatment groups, more toxicity was seen in groups which also received VECTIBIX, manifesting as a greater incidence of grade 3 and higher adverse events, a greater incidence of serious adverse events, and more overall deaths relative to the control group.
, Ophthalmologic XX/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization may not be listed.
PART I:
HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS.............................................................................................................. 1 Pediatrics ...........................................................................................................
2 Geriatrics............................................................................................................ 4 2 CONTRAINDICATIONS ...............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations........................................................................................
2 Recommended Dose and Dosage Adjustment .................................................... 3 Reconstitution..................................................................................................... 4 Administration.....................................................................................................
5 Missed Dose....................................................................................................... 7 5 OVERDOSAGE ...........................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 8 7 WARNINGS AND PRECAUTIONS .............................................................................. 1 Special Populations ..........................................................................................
VECTIBIX (panitumumab) is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to panitumumab or to any ingredient 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. VECTIBIX is not indicated for the treatment of patients with RAS (KRAS and NRAS) mutant mCRC or for whom RAS (KRAS and NRAS) mutation status is unknown (see 7 WARNINGS AND PRECAUTIONS).
Vectibix® (panitumumab) Page 5 of 66
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Serious adverse events were experienced by 59% in the VECTIBIX group versus 37% in the control group, with higher incidences in the VECTIBIX group of dehydration, diarrhea, pulmonary embolism, nausea, and vomiting. Serious infections overall displayed a treatment difference (15% versus 9%); however, no one specific type of infection occurred at a high frequency.
Nineteen percent of patients receiving VECTIBIX experienced a serious event that was considered related to VECTIBIX, the most common of which were diarrhea, dehydration, and vomiting. VECTIBIX is not indicated for use in combination with bevacizumab with or without chemotherapy for the treatment of mCRC.
Combination treatment with Irinotecan, Bolus 5-fluorouracil, and Leucovorin (IFL) regimen In a single-arm study (N = 19), patients receiving VECTIBIX in combination with irinotecan, bolus 5-fluorouracil, and leucovorin administered as the IFL regimen experienced a high incidence of severe diarrhea (58%).
VECTIBIX is not indicated for use in combination with IFL regimen. Patients With ECOG 2 Performance Status Treated With VECTIBIX in Combination With Chemotherapy In phase 3 study 20050203 (N = 1,183; 656 patients with wild-type KRAS and 440 patients with mutant KRAS mCRC) evaluating VECTIBIX in combination with FOLFOX compared to FOLFOX alone as first-line therapy, wild-type KRAS mCRC patients with ECOG 2 (Eastern Cooperative Oncology Group) performance status [N = 37; n = 19 (VECTIBIX plus FOLFOX), n=18 (FOLFOX alone)] were observed to have increased toxicity and significant shortening of Vectibix® (panitumumab) Page 10 of 66 progression-free survival (PFS) and overall survival (OS) relative to ECOG 0 or 1 performance status (n = 611).
In patients with wild-type KRAS mCRC , adverse events with > 20% difference between treatment arms within each ECOG group, and a > 5% difference between ECOG groups of the VECTIBIX plus FOLFOX arm were hypomagnesemia, hypokalemia, anemia, and weight decreased.
Similar safety findings were observed in patients with wild-type RAS mCRC. For patients with ECOG 2 performance status, assessment of risk-benefit is recommended prior to initiation of VECTIBIX in combination with chemotherapy for treatment of mCRC.
45 mg sodium) per ml of concentrate. This should be taken into consideration by patients on a controlled sodium diet. Carcinogenesis and Mutagenesis No carcinogenesis or mutagenesis studies were conducted with VECTIBIX. Driving and Operating Machinery No studies on the effects on the ability to drive and to use machines have been performed.
If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides. Hepatic/Biliary/Pancreatic The safety and effectiveness of VECTIBIX in patients with hepatic impairment have not been established.
Monitoring and Laboratory Tests Electrolyte Monitoring Progressively decreasing serum magnesium levels leading to severe hypomagnesemia have been observed in some patients across clinical trials. In Study 20020408, in the wild -type KRAS population, events of hypomagnesemia occurred in 3% (4/123) of VECTIBIX-treated patients.
Two patients (2%, 2/123) who received VECTIBIX had a grade 3 or higher event. In Study 20080763, events of hypomagnesemia occurred in 29% (143/496) of VECTIBIX-treated patients. Grade 3 or higher adverse events occurred in 7% (36/496) of VECTIBIX-treated patients.
In Study 20100007 (Safety Analysis Set), events of hypomagnesemia occurred in 29% (54/189) of VECTIBIX-treated patients. Twelve patients (6%, 12/189) who received VECTIBIX had a grade 3 or higher event. In the wild-type RAS Safety Analysis Set, events of hypomagnesemia occurred in 32% (45/142) of VECTIBIX-treated patients.
Eleven (8%, 11/142) who received VECTIBIX had a grade 3 or higher event. Patients should be monitored for hypomagnesemia and […]
1 Pregnant Women ........................................................................................ 2 Breast-feeding............................................................................................. 3 Pediatrics....................................................................................................
4 Geriatrics .................................................................................................... 12 8 ADVERSE REACTIONS ............................................................................................ 1 Adverse Reaction Overview..............................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .......................................................................................................
5 Post-Market Adverse Reactions ........................................................................ 40 9 DRUG INTERACTIONS ............................................................................................. 1 Serious Drug Interactions..................................................................................
2 Drug Interactions Overview............................................................................... 3 Drug-Behavioural Interactions........................................................................... 4 Drug-Drug Interactions......................................................................................
5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions...................................................................................... 7 Drug-Laboratory Test Interactions .....................................................................
40 10 CLINICAL PHARMACOLOGY ................................................................................... 1 Mechanism of Action ................................................................................... 2 Pharmacodynamics.....................................................................................
3 Pharmacokinetics........................................................................................ 41 11 STORAGE, STABILITY AND DISPOSAL .................................................................. 43 12 SPECIAL HANDLING INSTRUCTIONS .....................................................................
43 PART II: SCIENTIFIC INFORMATION .................................................................................. 44 13 PHARMACEUTICAL INFORMATION ........................................................................ 44 14 CLINICAL TRIALS ....................................................................................................
1 Trial Design and Study Demographics ......................................................... 2 Study Results.............................................................................................. 3 Comparative Bioavailability Studies .............................................................
4 Immunogenicity........................................................................................... 56 15 MICROBIOLOGY....................................................................................................... 57 16 NON-CLINICAL TOXICOLOGY .................................................................................
57 PATIENT MEDICATION INFORMATION .............................................................................. 61 Vectibix® (panitumumab) Page 4 of 66 PART I: HEALTH PROFESSIONAL INFORMATION 1 […]