Moroctocog alfa interacts in the following cases:
In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Because of the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available. Therefore, factor VIII should be used during pregnancy only if clearly indicated.
Because of the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during breast-feeding is not available. Therefore, factor VIII should be used during breast-feeding only if clearly indicated.
Animal reproduction studies have not been conducted with factor VIII, therefore no data are available on fertility.
Moroctocog alfa has no influence on the ability to drive and use machines.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for moroctocog alfa, and may in some cases progress to severe anaphylaxis including shock.
Trace amounts of hamster protein may be present in moroctocog alfa. Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae. In a study of moroctocog alfa, twenty of 113 (18%) previously treated patients (PTPs) had an increase in anti-CHO antibody titre, without any apparent clinical effect.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.
The list presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). The lists adverse reactions reported in the clinical trials with moroctocog alfa. The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 765 subjects.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1,000 to <1/100
Very common: FVIII inhibition (PUPs)*
Uncommon: FVIII inhibition (PTPs)*
Uncommon: Anaphylactic reaction
Common: Decreased appetite
Very common: Headache
Common: Dizziness
Uncommon: Neuropathy peripheral; somnolence; dysgeusia
Uncommon: Angina pectoris; tachycardia; palpitations
Common: Haemorrhage; haematoma
Uncommon: Hypotension; thrombophlebitis; flushing
Very common: Cough
Uncommon: Dyspnoea
Common: Diarrhoea; vomiting; abdominal pain; nausea
Common: Urticaria; rash; pruritus
Uncommon: Hyperhidrosis
Very common: Arthralgia
Common: Myalgia
Very common: Pyrexia
Common: Chills; catheter site related reaction
Uncommon: Asthenia; injection site reaction; injection site pain; injection site inflammation
Common: Antibody test positive; Anti-factor VIII antibody test positive
Uncommon: Aspartate aminotransferase increased; alanine aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to moroctocog alfa treatment.
Safety of moroctocog alfa was evaluated in studies that included both previously treated adults and previously treated children and adolescents (n=18, aged 12-16 years in a study and n=49, aged 7-16 years in a supporting study), with a tendency for higher frequencies of adverse reactions in children aged 7-16 years as compared to adults. Additional safety experience in children has been accrued through studies that encompassed both previously treated (n=18 aged <6 years and n=19 aged 6 to <12 years) and previously untreated (n=23 aged <6 years) patients and which supports a safety profile similar with that observed in adult patients.
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