esophageal reflux disease
Chapped lips
General disorders and administration site conditions
Fatigue
Pyrexia
Asthenia
Mucosal inflammation
Oedema peripheral
Chest pain
Pain
Chills
Infusion-related reaction
Immune system disorders
Hypersensitivity
Anaphylactic reaction
Infections and infestations
Paronychia
Rash pustular
Cellulitis
Folliculitis
Localised infection
Eye infection
Eyelid infection
Investigations
Weight decreased
Blood magnesium decreased
Metabolism and nutrition disorders
Hypokalaemia
Anorexia
Hypomagnesaemia
Hypocalcaemia
Dehydration
Hyperglycaemia
Hypophosphataemia
Musculoskeletal and connective tissue disorders
Back pain
Pain in extremity
Nervous system disorders
Headache
Dizziness
Psychiatric disorders
Insomnia
Anxiety
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Cough
Pulmonary embolism
Epistaxis
Bronchospasm
Nasal dryness
Skin and subcutaneous tissue disorders
Dermatitis acneiform
Rash2
Erythema
Pruritus
Dry skin
Skin fissures
Acne
Alopecia
Palmar-plantar erythrodysaesthesia syndrome
Skin ulcer
Scab
Hypertrichosis
Onychoclasis
Nail disorder
Angioedema
Hirsutism
Ingrowing nail
Onycholysis
Vascular disorders
Deep vein thrombosis
Hypotension
Hypertension
Flushing
1 Reports of this adverse reaction arose in the post-marketing setting
2 Rash includes common terms of skin toxicity, skin exfoliation, exfoliative rash, rash papular, rash pruritic, rash erythematous, rash generalised, rash macular, rash maculo-papular, skin lesion
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. Skin reactions were the most frequently occurring adverse reactions in patients 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 (NCI-CTC grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 17% of patients treated with Vectibix in combination with chemotherapy.
There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Infusion related reactions
Across all clinical studies, infusion reactions (occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever or dyspnea, were reported in 3% of Vectibix-treated patients, of which < 1% were severe (NCI-CTC grade 3 and grade 4).
A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell car |
