Data on a limited number of exposed pregnancies indicate no adverse effects of C1 inhibitor on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. No maternal or embryofoetal effects of treatment were observed in reproductive studies in rats at dose levels up to 28-times the recommended human dose (1,000 IU) based on an average adult body weight of 70 kg. The potential risk for humans is unknown.
Therefore, C1 inhibitor should be given to pregnant women only if clearly indicated.
It is unknown whether C1 inhibitor is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from C1 inhibitor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No specific studies on fertility, early embryonic and postnatal development, or carcinogenicity studies were conducted.
Based upon the clinical data currently available, C1 inhibitor has minor influence on the ability to drive and use machines.
The very common adverse reactions observed following C1 inhibitor infusion in clinical studies were headache and nausea.
Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects. Only frequencies based on reporting rates from clinical trials are used to assign frequency category.
Adverse reactions to treatment with C1 inhibitor are classified by MedDRA System Organ Class and absolute frequency in Table 1. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Adverse reactions reported in clinical studies and in postmarketing reports:
Common: Hypersensitivity
Uncommon: Hyperglycaemia
Very common: headache
Common: Dizziness
Uncommon: Venous thrombosis, phlebitis, venous burning, hot flush
Uncommon: Cough
Very common: Nausea
Common: vomiting
Uncommon: Diarrhoea, abdominal pain
Common: Rash, erythema, pruritus
Uncommon: Contact dermatitis
Uncommon: Joint swelling, arthralgia, myalgia
Common: Injection site rash/erythema, infusion site pain, pyrexia
Uncommon: Chest discomfort
Among reports of venous thrombosis, the most common underlying risk factor was presence of an indwelling catheter.
Local reactions at the injection site were uncommon. In clinical studies local reactions (described as pain, bruising, or rash at the injection/catheter site, venous burning or phlebitis) occurred in association with approximately 0.2% of infusions.
Across clinical studies, there were 61 unique paediatric subjects enrolled and exposed to over 2,500 infusions of C1 inhibitor (2-5 years, n=3; 6-11 years, n=32; 12-17 years, n=26). Among these children, the only adverse reactions with C1 inhibitor included headache, nausea, pyrexia, and infusion site erythema. None of these adverse reactions were severe, and none led to discontinuation of medicinal product.
Overall, the safety and tolerability of C1 inhibitor are similar in children, adolescents and adults.
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