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Vectibix is a brand name for Panitumumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): • in first-line in combination with FOLFOX or FOLFIRI. • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). •…
Verbatim from this product's EMA label. Tap a section to expand.
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type RAS (KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (neuroblastoma RAS viral oncogene homologue)) status is required before initiating treatment with Vectibix.
Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3 and 4) and NRAS (exons 2, 3 and 4) mutations. Posology The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks.
3 Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows: Occurrence of skin symptom(s): ≥ grade 31 Administration of Vectibix Outcome Dose regulation Initial occurrence Withhold 1 or 2 doses Improved (< grade 3) Continuing infusion at 100% of original dose Not recovered Discontinue At the second occurrence Withhold 1 or 2 doses Improved (< grade 3) Continuing infusion at 80% of original dose Not recovered Discontinue At the third occurrence Withhold 1 or 2 doses Improved (< grade 3) Continuing infusion at 60% of original dose Not recovered Discontinue At the fourth occurrence Discontinue - - 1 Greater than or equal to grade 3 is defined as severe or life-threatening Special populations The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
There is no clinical data to support dose adjustments in the elderly. Paediatric population There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer. Method of administration Vectibix must be administered as an intravenous infusion via an infusion pump.
6). 22 micrometre in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes.
6). The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions. 4). Vectibix must not be administered as an intravenous push or bolus.
6. 4
Summary of the safety profile Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2 224), the most commonly reported adverse reactions are skin reactions occurring in approximately 94% of patients.
These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3) and < 1% life-threatening (grade 4). 4. 8 Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders [decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin (21%)].
Tabulated list of adverse reactions The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2 224) and spontaneous reporting.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4 Pulmonary complications 4 Skin necrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis and ulcerative keratitis are panitumumab ADRs that were reported in the post-marketing setting.
For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting.
13%). The safety profile of Vectibix in combination with chemotherapy consisted of the reported adverse reactions of Vectibix (as a monotherapy) and the toxicities of the background chemotherapy regimen. No new toxicities or worsening of previously recognised toxicities beyond the expected additive effects were observed.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Dermatologic reactions and soft tissue toxicity Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix.
8). 2. In clinical studies, subsequent to the development of severe dermatologic reactions (including stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Patients who have severe dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae (including cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated.
Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix. Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients treated with Vectibix in the post-marketing setting.
Withhold or discontinue Vectibix in the event of dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. g. doxycycline). It is also recommended that patients experiencing rash/dermatological toxicities wear sunscreen and hats and limit sun exposure as sunlight can exacerbate any skin reactions that may occur.
Patients may be advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night during treatment.
4). 4). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Skin reactions were the most frequently occurring adverse reactions in patients 10 receiving panitumumab in combination with chemotherapy. Other toxicities that were observed with a greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis.
These toxicities infrequently led to discontinuation of Vectibix or of chemotherapy. Description of selected adverse reactions Gastrointestinal disorders Diarrhoea when reported was mainly mild or moderate in severity. Severe diarrhoea (grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of patients treated with Vectibix in combination with chemotherapy.
4). 3% were severe (grade 3 and 4). A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell carcinoma of the head and neck treated with Vectibix […]
Pulmonary complications Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies. Cases of interstitial lung disease (ILD), both fatal and non-fatal, have been reported, mainly from the Japanese population.
In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur. If ILD is diagnosed, Vectibix should be permanently discontinued and the patient should be treated appropriately.
In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the 5 benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully considered. Electrolyte disturbances Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
8). Magnesium repletion is recommended, as appropriate. Other electrolyte disturbances, including hypokalaemia, have also been observed. Monitoring as above and repletion as appropriate of these electrolytes is also recommended. Infusion-related reactions Across monotherapy and combination mCRC clinical studies (n = 2 224), infusion-related reactions (occurring within 24 hours of an infusion) were reported in Vectibix-treated patients, including severe infusion-related reactions (grade 3 and grade 4).
In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome. g. 8). In patients experiencing a mild or moderate (grade 1 and grade 2) infusion-related reaction the infusion rate should be reduced for the duration of that infusion.
It is recommended to maintain this lower infusion rate in all subsequent infusions. Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a fatal case of angioedema that occurred more than 24 hours after the infusion.
Patients should be informed of the possibility of a late onset reaction and instructed to contact their physician if symptoms of a hypersensitivity reaction occur. Acute renal failure Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Patients who experience severe diarrhoea should be instructed to consult a healthcare professional urgently. 8). 5). […]