tential risk for loss of the pregnancy or potential hazard to the foetus.
Women who become pregnant during Vectibix treatment are encouraged to enrol in Amgen's Pregnancy Surveillance programme. Contact details are provided in section 6 of the Package Leaflet – Information for the user.
Breast-feeding
It is unknown whether panitumumab is excreted in human breast milk. Because human IgG is secreted into human milk, panitumumab might also be secreted. The potential for absorption and harm to the infant after ingestion is unknown. It is recommended that women do not breast feed during treatment with Vectibix and for 3 months after the last dose.
Fertility
Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3). Panitumumab may impact the ability of a woman to become pregnant.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and 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.
4.8 Undesirable effects
Summary of safety profile
Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2588), the most commonly reported adverse reactions are skin reactions occurring in 93% of patients. These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 25% severe (grade 3 NCI-CTC) and < 1% life threatening (grade 4 NCI-CTC). For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Commonly reported adverse reactions occurring in 20% of patients were gastrointestinal disorders [diarrhoea (50%), nausea (41%), vomiting (27%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (37%), pyrexia (20%)]; metabolism and nutrition disorders [anorexia (27%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (45%), dermatitis acneiform (39%), pruritus (35%), erythema (30%) and dry skin (22%)].
Tabulated summary 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 = 2588). 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)
Rare
(1/10,000 to <1/1000
Blood and lymphatic system disorders
Anaemia
Leukopenia
Cardiac disorders
Tachycardia
Cyanosis
Eye disorders
Conjunctivitis
Blepharitis
Growth of eyelashes
Lacrimation increased
Ocular hyperaemia
Dry eye
Eye pruritus
Eye irritation
Eyelid irritation
Keratitis
Ulcerative
Keratitis1
Gastrointestinal disorders
Diarrhoea
Nausea
Vomiting
Abdominal pain
Stomatitis
Constipation
Rectal haemorrhage
Dry mouth
Dyspepsia
Aphthous stomatitis
Cheilitis
Gastroo |
