Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.3 · PDF-Seite 3

HOS-109161 · Präparat HOS-093111

Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.

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Wechselwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 4

HOS-109162 · Präparat HOS-093111

No interaction studies and no in vitro metabolism studies have been performed. Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.

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Wechselwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 4

HOS-109163 · Präparat HOS-093111

Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamycin due to a theoretical risk of inhibition of intra-cellular -galactosidase A activity.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): amiodarone (HOS-085596) chloroquine (HOS-109138)

Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109164 · Präparat HOS-093111

Summary of the safety profile

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109165 · Präparat HOS-093111

Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity. Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs). Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section 4.4).

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109166 · Präparat HOS-093111

Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia. Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction. Anaphylactoid reactions have been reported in the postmarketing setting.

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109167 · Präparat HOS-093111

Tabulated list of adverse reactions

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109168 · Präparat HOS-093111

Adverse reactions reported from clinical trials with a total of 168 patients (154 males and 14 females) treated with Fabrazyme administered at a dose of 1 mg/kg every 2 weeks for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1,000 to < 1/100) in the table below. The occurrence of an adverse reaction in a single patient is defined as uncommon in light of the relatively small number of patients treated. Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data). Adverse reactions were mostly mild to moderate in severity:

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5–7

HOS-109169 · Präparat HOS-093111

5 Incidence of adverse reactions with Fabrazyme treatment System organ Very common Common Uncommon Not known class Infections and --- nasopharyngitis rhinitis infestations Immune system --- --- --- anaphylactoid disorders reaction Nervous system headache, dizziness, somnolence, hyperaesthesia, --- disorders paraesthesia hypoaesthesia, burning tremor sensation, lethargy, syncope Eye disorders --- lacrimation increased eye pruritus, ocular --- hyperaemia Ear and --- tinnitus, vertigo auricular swelling, --- labyrinth ear pain disorders Cardiac --- tachycardia, sinus bradycardia --- Disorders palpitations, bradycardia Vascular --- flushing, hypertension, peripheral coldness --- disorders pallor, hypotension, hot flush Respiratory, --- dyspnoea, nasal bronchospasm, hypoxia thoracic and congestion, throat pharyngolaryngeal mediastinal tightness, wheezing, pain, rhinorrhoea, disorders cough, dyspnoea tachypnoea, upper exacerbated respiratory tract congestion Gastrointestinal nausea, vomiting abdominal pain, dyspepsia, dysphagia --- Disorders abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea Skin and --- pruritus, urticaria, rash, livedo reticularis, leukocytoclastic subcutaneous erythema, pruritus rash erythematous, vasculitis tissue disorders generalised, rash pruritic, skin angioneurotic oedema, discolouration, skin swelling face, rash discomfort maculo-papular Musculoskeletal --- pain in extremity, musculoskeletal pain --- and connective myalgia, back pain, tissue disorders muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness General chills, pyrexia, fatigue, chest feeling hot and cold, --- disorders and feeling cold discomfort, feeling hot, influenza-like illness, administration oedema peripheral, pain, infusion site pain, site conditions asthenia, chest pain, face infusion site reaction, oedema, hyperthermia injection site thrombosis, malaise, oedema Investigations oxygen saturation decreased For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients. Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA) 6 Description of selected adverse reactions

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109170 · Präparat HOS-093111

Infusion associated reactions Infusion associated reactions consisted most often of fever and chills. Additional symptoms included mild or moderate dyspnoea, hypoxia (oxygen saturation decreased), throat tightness, chest discomfort, flushing, pruritus, urticaria, face oedema, angioneurotic oedema, rhinitis, bronchospasm, tachypnoea, wheezing, hypertension, hypotension, tachycardia, palpitations, abdominal pain, nausea, vomiting, infusion-related pain including pain at the extremities, myalgia, and headache.

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109171 · Präparat HOS-093111

The infusion-associated reactions were managed by a reduction in the infusion rate together with the administration of non-steroidal anti-inflammatory medicinal products, antihistamines and/or corticosteroids. Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction. The frequency of these reactions decreased over time. The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation. In a limited number of patients IgE antibodies were demonstrated (see section 4.4).

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109172 · Präparat HOS-093111

Paediatric population

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109173 · Präparat HOS-093111

Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109174 · Präparat HOS-093111

Reporting of suspected adverse reactions

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Nebenwirkungen · Fabrazyme

Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-109175 · Präparat HOS-093111

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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