Microsoft word - replagal pi ireland april 2012 final.doc

Replagal (agalsidase alfa) Prescribing
0/7 male patients tested positive for IgG information: Please consult the Summary
of Product Characteristics (SmPC) before Presentation:
patient receiving Replagal. Extensive renal solution for IV infusion. 1ml of concentrate agalsidase alfa. Indication: Long-term
enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (- galactosidase A deficiency). Dosage and
intracellular α-galactosidase activity. Side
administration: Replagal 0.2mg/kg body
effects: Most reported adverse effects have
been mild to moderate. Very common other week. No dosage regimen in children (>1/10 patients): headache, flushes, nausea, (0-6 years) can presently be recommended rigors, pyrexia, pain/discomfort, fatigue; as safety and efficacy have not yet been common (>1/100, <1/10 patients): peripheral oedema, dizziness, dysgeusia, neuropathic unexpected safety issues were encountered pain, tremor, hypersomnia, hypoesthesia, paraesthesia, increased lacrimation, tinnitus, regimen is suggested for children between 7-18 years of age. Contraindications:
Hypersensitivity to the active substance or any of the excipients. Warnings and
throat secretion, rhinorrhoea, diarrhoea, precautions: 13.7% of adult patients
vomiting, abdominal pain/discomfort, acne, receiving Replagal in clinical trials had erythema, pruritus, rash, livedo reticularis, idiosyncratic infusion-related reactions musculoskeletal discomfort, myalgia, back (generally within 2–4 months of starting treatment although later onset [after 1 year] arthralgia, joint swelling, aggravated fatigue, feeling hot, feeling cold, asthenia, chest paediatric patients >7 years of age and 3 of pain, chest tightness, influenza-like illness, 8 paediatric patients <7 years experienced at least one infusion reaction over a period corneal reflex; uncommon (>1/1000, <1/100 patients): parosmia, angioneurotic oedema, effects have decreased with time. If mild or urticaria, sensation of heaviness, decreased moderate acute infusion reactions occur, oxygen saturation. Not known (since derived from post-marketing spontaneous reports): infusion can be temporarily interrupted (for cardiac arrhythmias (atrial fibrillation, 5–10 minutes) until symptoms subside. If ventricular extrasystoles, tachyarrhythmia), hypotension, hyperhidrosis. Infusion related reactions reported in the post marketing setting may also include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), triggering cardiac events in patients with myocardial ischemia, and heart failure in pre-existing cardiac manifestations of Fabry patients with Fabry disease involving the heart structures. Infusion-related symptoms antibodies to the protein. A low titre antibody may include dizziness, hyperhidrosis, and response was seen in approximately 24% of hypotension. The most frequent were mild male patients; the remaining 76% remained antibody negative throughout. In paediatric included rigors, pyrexia, flushing, headache, patients >7 yrs of age, 1/16 male patients nausea, and dyspnoea. Package quantity:
tested positive for IgG anti-agalsidase alfa Vials of 5ml (containing 3.5ml concentrate) antibodies. No increase in the incidence of in a pack size of 1 vial. Pharmaceutical
precautions: Store in a refrigerator (2°C–
patient. In paediatric patients <7 yrs of age, Marketing authorisation number and
holder: EU/1/01/189/001-006. Shire Human
(SmPC), or on request from the marketing Genetic Therapies AB, Svärdvägen 11D, SE authorisation holder. Date of preparation:
182 33 Danderyd, Sweden. Legal category:
Item code:
POM. Further information is available in the Adverse events should be reported to the Pharmacovigilance Unit at the Irish Medicines Board (IMB) (imbpharmacovigilance@imb.ie). Information about adverse event reporting can be found on the IMB website (www.imb.ie). Adverse events should also be reported to Shire Human Genetic Therapies on +44 (0)1256 894000 or faxed on +44 (0)1256 894715 or emailed to Globalpharmacovigilance@shire.com

Source: http://www.replagal.ie/resources/IE_PI.pdf