Links to prescribing information and adverse event reporting information can be found at the bottom of the page. For UK Healthcare professionals only.
Vectibix®
tolerability profile
VECTIBIX® TOLERABILITY PROFILE
The information provided on this page is a summary of adverse reactions that may be encountered with Vectibix®.
Please refer to the Summary of Product characteristics for comprehensive information of the tolerability profile (section 4.8) and all precautions and warnings (section 4.4).1
Summary of adverse reactions
The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received Vectibix® 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.
| Adverse reactions | |||
|---|---|---|---|
| MedDRA system organ class | Very common (≥ 1/10) |
Common (≥ 1/100 to < 1/10) |
Uncommon (≥ 1/1000 to < 1/100) |
| Infections and infestations | Conjunctivitis, Paronychia | Rash pustular, Cellulitis, Urinary tract infection, Folliculitis, Localised infection | Eye infection, Eyelid infection |
| Blood and lymphatic system disorders | Anaemia | Leucopenia | |
| Immune system disorders | Hypersensitivity | Anaphylactic reaction | |
| Metabolism and nutrition disorders | Hypokalaemia, Hypomagnesaemia, Decreased appetite | Hypocalcaemia, Dehydration, Hyperglycaemia, Hypophosphataemia | |
| Psychiatric disorders | Insomnia | Anxiety | |
| Nervous system disorders | Headache, Dizziness | ||
| Eye disorders | Blepharitis, Growth of eyelashes, Lacrimation increased, Ocular hyperaemia, Dry eye, Eye pruritus, Eye irritation | Ulcerative keratitis*, Keratitis, Eyelid irritation | |
| Cardiac disorders | Tachycardia | Cyanosis | |
| Vascular disorders | Deep vein thrombosis, Hypotension, Hypertension, Flushing | ||
| Respiratory, thoracic and mediastinal disorders | Dyspnoea, Cough | Pulmonary embolism, Epistaxis | Interstitial lung disease, Bronchospasm, Nasal dryness |
| Gastrointestinal disorders | Diarrhoea, Nausea, Vomiting, Abdominal pain, Stomatitis, Constipation | Rectal haemorrhage, Dry mouth, Dyspepsia, Aphthous ulcer, Cheilitis, Gastro-oesophageal reflux disease | Chapped lips, Dry lips |
| Skin and subcutaneous tissue disorders | Dermatitis acneiform, Rash, Erythema, Pruritus, Dry skin, Skin fissures, Acne, Alopecia | Skin ulcer, Skin exfoliation, Exfoliative rash, Dermatitis, Rash papular, Rash pruritic, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Skin lesion, Skin toxicity, Scab, Hypertrichosis, Onychoclasis, Nail disorder, Hyperhidrosis, Palmar-plantar erythrodysaesthesia syndrome | Toxic epidermal necrolysis*, Stevens-Johnson syndrome, Skin necrosis*, Angioedema, Hirsutism, Ingrowing nail, Onychoclasis |
| Musculoskeletal and connective tissue disorders | Back pain | Pain in extremity | |
| General disorders and administration site conditions | Fatigue, Pyrexia, Asthenia, Mucosal inflammation, Oedema peripheral | Chest pain, Pain, Chills | |
| Injury, poisoning and procedural complications | Infusion-related reaction | ||
| Investigations | Weight decreased | Blood magnesium decreased | |
| *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. The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2,224 (or 0.13%). | |||
References
- Vectibix® Summary of Product Characteristics.