Naglazyme and infusion related reaction Patient Reports February 11, 2012

Naglazyme Side Effects Report #5615549-3
Naglazyme side effect was reported by a Physician from GERMANY on Jan 17, 2008. Female patient, child 9 years of age, weighting 44.09 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: anaphylactic reaction, anaphylactoid reaction, cough, hypersensitivity, hypertension, infusion related reaction. Naglazyme dosage: 5MG; IV, 15 MG; IV. During the same period patient was treated with DIMETINDENE MALEATE, PREDNISOLONE, RANITIDINE. Patient was hospitalized. Patient recovered.

Naglazyme Side Effects Report #6005877-4
Naglazyme side effect was reported by a Physician from TURKEY on Nov 28, 2008. Male patient, child 8 years of age, weighting 39.68 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: abdominal pain upper, infusion related reaction, upper respiratory tract infection. Naglazyme dosage: 20 MG;QW;IVDRP. Patient was hospitalized. Patient died on 11/14/2008.

Naglazyme Side Effects Report #5397131-9
Naglazyme side effect was reported by a Health Professional from UNITED STATES on July 06, 2007. Female patient, child 7 years of age, weighting 46.96 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: activated partial thromboplastin time prolonged, carpal tunnel syndrome , disease recurrence, gastrointestinal haemorrhage, hypertension, infusion related reaction, mastoiditis, rash erythematous, trigger finger. Naglazyme dosage: 1 MG/KG; QW; IV. During the same period patient was treated with METHYLPHENIDATE, PREDNISONE, LANSOPRAZOLE, CALCIUM CARBONATE, DIPHENHYDRAMINE, CLONIDINE, HYDROCORTISONE SUCCINATE. Patient was hospitalized. Patient recovered.

Naglazyme Side Effects Report #5926209-3
Naglazyme side effect was reported by a Physician from UNITED STATES on Oct 02, 2008. Female patient, child 7 years of age, weighting 46.96 lb, was diagnosed with mucopolysaccharidosis vi, attention deficit/hyperactivity disorder and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: activated partial thromboplastin time prolonged, bone marrow transplant , gastrointestinal haemorrhage, hypertension, infusion related reaction, international normalised ratio abnormal, mastoiditis, urticaria. Naglazyme dosage: 1 MG/KG; QW; IVDRP. During the same period patient was treated with METHYLPHENIDATE, PREDNISONE, LANSOPRAZOLE, CALCIUM CARBONATE, DIPHENHYDRAMINE, HYDROCORTISONE SUCCINATE. Patient was hospitalized. Patient recovered.


Naglazyme Side Effects Report #6017314-4
Naglazyme side effect was reported by a Consumer or non-health professional from BRAZIL on Dec 04, 2008. Male patient, child 4 years of age, weighting 35.27 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: chest pain , hypertension, infusion related reaction, lethargy. Naglazyme dosage: 15 MG;QW; IVDRP. During the same period patient was treated with FLEBOCORTID, ACETAMINOPHEN. Patient recovered.

Naglazyme Side Effects Report #6106778-3
Naglazyme side effect was reported by a Physician from BRAZIL on Feb 17, 2009. Male patient, child 3 years of age, weighting 35.27 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: chest pain , hypertension, infusion related reaction, lethargy. Naglazyme dosage: 15 MG QW IV DRP. During the same period patient was treated with FLEBOCORTID, ACETAMINOPHEN. Patient recovered.

Naglazyme Side Effects Report #6123832-0
Naglazyme side effect was reported by a Physician from BRAZIL on Mar 03, 2009. Male patient, child 3 years of age, weighting 35.49 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: abdominal pain , hyperthermia, infusion related reaction, nausea , pallor, tremor. Naglazyme dosage: 15 MG; QW; IVDRP. During the same period patient was treated with HYDROXIZINE, PRRDNTSOLON. Patient recovered.

Naglazyme Side Effects Report #6017353-3
Naglazyme side effect was reported by a Physician from BRAZIL on Dec 04, 2008. Female patient, 26 years of age, weighting 59.52 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: cholelithiasis, diarrhoea, infusion related reaction, oedema, vomiting. Naglazyme dosage: 25 MG;QW; IVDRP. During the same period patient was treated with FLEBOCORTID. Patient recovered.

Naglazyme Side Effects Report #5383875-1
Naglazyme side effect was reported by a Health Professional from UNITED STATES on Apr 27, 2007. Male patient, 25 years of age, weighting 47.84 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: agitation, blood pressure diastolic increased, heart rate increased, infusion related reaction, malaise, oxygen saturation decreased, pallor, refusal of treatment by relative. Naglazyme dosage: 1 MG/MKG; QW; IV. Patient recovered.


Naglazyme Side Effects Report #6137499-9
Naglazyme side effect was reported by a Consumer or non-health professional from BRAZIL on Mar 12, 2009. Female patient, 15 years of age, weighting 37.48 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: hypotension, infusion related reaction, pneumonia . Naglazyme dosage: 20 MG; QW; IVDRP. During the same period patient was treated with HYDROXYZINE, DIPYRONE, AMOXICILLIN. Patient was hospitalized. Patient recovered.

Naglazyme Side Effects Report #5445686-8
Naglazyme side effect was reported by a Physician from UNITED STATES on Aug 20, 2007. Male patient, 14 years of age, weighting 48.50 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: infusion related reaction, lip swelling, paraesthesia, pruritus, shock, throat tightness. Naglazyme dosage: 25 MG;QW;IV. During the same period patient was treated with FLUVOXAMINE MALEATE, ACETAZOLAMIDE, SUDAFED, ZANTAC, CLARITIN, BENADRYL. Patient recovered.

Naglazyme Side Effects Report #5614707-1
Naglazyme side effect was reported by a Physician from PORTUGAL on Jan 16, 2008. Male patient, 14 years of age, weighting 94.80 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: blood pressure increased, body temperature increased, cyanosis, dyspnoea, haemorrhage, infusion related reaction, oxygen saturation decreased, pharyngeal oedema, rash . Naglazyme dosage: QW IV ; 43 MG 1X IV. Patient recovered.

Naglazyme Side Effects Report #5724467-1
Naglazyme side effect was reported by a Consumer or non-health professional from AUSTRALIA on Apr 14, 2008. Female patient, 14 years of age, weighting 35.27 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: blood pressure decreased, chills, dizziness , dyspnoea, emotional distress, infusion related reaction, irritability, livedo reticularis. Naglazyme dosage: 20 MG;QW;IV. During the same period patient was treated with MONTELUKAST, FLUTICASONE, ALBUTEROL, BUDESONIDE, ROXITHROMYCIN, AUGMENTIN, PREDNISOLONE, CIPROFLOXACIN. Patient was hospitalized. Patient recovered.

Naglazyme Side Effects Report #5923624-9
Naglazyme side effect was reported by a Consumer or non-health professional from AUSTRALIA on Oct 01, 2008. Female patient, weighting 22.05 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: anaphylactic reaction, choking , diarrhoea, infusion related reaction, lower respiratory tract infection, upper respiratory tract infection, viral infection , vomiting. Naglazyme dosage: 10.5 MG;QW; IVDRP. During the same period patient was treated with CETIRIZINE, IBUPROFEN, HYDROCORTISONE, PREDNISOLONE. Patient was hospitalized. Patient recovered.


Naglazyme Side Effects Report #6088040-0
Naglazyme side effect was reported by a Consumer or non-health professional from BRAZIL on Feb 04, 2009. Female patient, weighting 37.48 lb, was diagnosed with mucopolysaccharidosis vi and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: hypotension, infusion related reaction, pneumonia . Naglazyme dosage: 20 MG; QW;IV DRP. During the same period patient was treated with HYDROXYZINE, DIPYRONE. Patient was hospitalized. Patient recovered.

Naglazyme Side Effects Report #6024083-0
Naglazyme side effect was reported by a Physician from BRAZIL on Dec 10, 2008. Male patient, child 3 years of age, weighting 35.49 lb, was diagnosed with mucopolysaccharidosis and was treated with Naglazyme. After drug was administered, patient experienced the following side effects: abdominal pain , chills, hyperthermia, infusion related reaction, nausea , pallor, tremor. Naglazyme dosage: 15 MG; QW; IV-DRIP. Patient recovered.