Elaprase and infusion related reaction Patient Reports February 13, 2012

Elaprase Side Effects Report #5331723-8
Elaprase side effect was reported by a Pharmacist from UNITED STATES on Dec 01, 2006. Male patient, child 9 years of age, weighting 69.45 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: anaphylactic reaction, antibody test positive, cyanosis, infusion related reaction, respiratory distress, retching. Elaprase dosage: (16 MG, 1 IN 1 WK), INTRAVENOUS DRIP. During the same period patient was treated with SYNERA. Patient was hospitalized. Patient recovered.

Elaprase Side Effects Report #5467644-X
Elaprase side effect was reported by a Physician from UNITED STATES on Sept 10, 2007. Male patient, child 9 years of age, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: adenotonsillectomy, anaphylactic reaction, cyanosis, dyspnoea, erythema, infusion related reaction, injection site extravasation, lip swelling, pyrexia. Elaprase dosage: 16 MG, 1X/WEEK, IV DRIP. During the same period patient was treated with PREDNISONE, CLARITIN, ZANTAC. Patient was hospitalized. Patient recovered.

Elaprase Side Effects Report #5875702-0
Elaprase side effect was reported by a Health Professional from UNITED STATES on Aug 26, 2008. Male patient, child 9 years of age, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: convulsion, cyanosis, grand mal convulsion, incorrect dose administered, infusion related reaction, pyrexia, tremor. Elaprase dosage: 13 MG, 1X/WEEK, IV DRIP. During the same period patient was treated with GLUCOCORTICOIDS HYDROXYZINE, DIPHENHYDRAMINE, ACETAMINOPHEN. Patient recovered.

Elaprase Side Effects Report #6039494-7
Elaprase side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 06, 2009. Male patient, child 9 years of age, weighting 57.10 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: convulsion, infusion related reaction, somnolence. Elaprase dosage: 12 MG, 1X/ WEEK, IV DRIP. Patient recovered.


Elaprase Side Effects Report #5875750-0
Elaprase side effect was reported by a Health Professional from UNITED KINGDOM on Aug 22, 2008. Male patient, child 7 years of age, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: feeling hot, flushing, infusion related reaction, pallor, petit mal epilepsy, tachypnoea. Elaprase dosage: 0.5 MG/KG, IV DRIP. During the same period patient was treated with HYDROCORTISONE, ALIMEMAZINE, HYDROXYZINE, ACETAMINOPHEN, RISPERDAL, CHLORPHENIRAMINE MALEATE, SALBUTAMOL, AMOXICILLIN. Patient recovered.

Elaprase Side Effects Report #6068844-0
Elaprase side effect was reported by a Health Professional from UNITED KINGDOM on Jan 20, 2009. Male patient, child 7 years of age, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: feeling hot, flushing, infusion related reaction, pallor, petit mal epilepsy, tachypnoea. Elaprase dosage: 0.5 MG/KG, IV DRIP. During the same period patient was treated with HYDROCORTISONE, ALIMEMAZINE, HYDROXYZINE, PARACETAMOL, RISPERIDONE, CHLORPHENIRAMINE MALEATE, SALBUTAMOL, AMOXICILLIN. Patient recovered.

Elaprase Side Effects Report #6024736-4
Elaprase side effect was reported by a Health Professional from IRELAND on Dec 17, 2008. Male patient, child 6 years of age, weighting 52.69 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: chills, infusion related reaction, livedo reticularis, pallor, upper respiratory tract infection. Elaprase dosage: 12 MG, 1X/WEEK, INTRAVENOUS. During the same period patient was treated with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE. Patient recovered.

Elaprase Side Effects Report #5485661-0
Elaprase side effect was reported by a Consumer or non-health professional from JAPAN on Oct 03, 2007. Male patient, 42 years of age, weighting 103.6 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: blood immunoglobulin e increased, depressed level of consciousness, headache , hypotension, infusion related reaction, nausea , pulse pressure decreased, syncope vasovagal. Elaprase dosage: 0.5 MG/KG, 1X/WK, IV DRIP. During the same period patient was treated with VERAPAMIL, OMEPRAZOLE, ACETYLSALICYLIC ACID SRT, DIGOXIN, TORSEMIDE, PIMOBENDAN, LEVOTHYROXINE, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Elaprase Side Effects Report #6053626-6
Elaprase side effect was reported by a Physician from JAPAN on Jan 08, 2009. Male patient, 15 years of age, weighting 48.50 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: brain stem auditory evoked response abnormal, bronchitis , convulsion, epilepsy , infusion related reaction, pulmonary valve incompetence, tricuspid valve incompetence. Elaprase dosage: 11.2 MG, 1X/WEEK, IV DRIP. During the same period patient was treated with CHLORPHENIRAMINE MALEATE. Patient recovered.


Elaprase Side Effects Report #5926754-0
Elaprase side effect was reported by a Physician from CANADA on Oct 02, 2008. Male patient, child 11 years of age, weighting 66.14 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: agitation, cough, dermatitis allergic, discomfort, heart rate increased, infusion related reaction, wheezing. Elaprase dosage: 12 MG, 1X/WEEK, IV DRIP. During the same period patient was treated with VENTOLIN, PULMICORT, FLONASE, SINGULAIR, RANITIDINE, CARBAMAZEPINE, ZINC. Patient recovered.

Elaprase Side Effects Report #6127109-9
Elaprase side effect was reported by a Physician from CANADA on Mar 04, 2009. Male patient, child 11 years of age, weighting 66.14 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: agitation, cough, dermatitis allergic, discomfort, heart rate increased, infusion related reaction, wheezing. Elaprase dosage: 12 MG, 1 X/WEEK, IV DRIP. During the same period patient was treated with VENTOLIN, PULMICORT, FLONASE, SINGULAIR, RANITIDINE, CARBAMAZEPINE, ZINC, VITAMIN C. Patient recovered.

Elaprase Side Effects Report #5826979-9
Elaprase side effect was reported by a Physician from MEXICO on July 14, 2008. Male patient was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: dyspnoea, eyelid oedema, infusion related reaction, rash . Elaprase dosage: 0.5 MG/KG, 1X/2WKS, IV DRIP. During the same period patient was treated with HYDROCORTISONE, ACETAMINOPHEN, CLOROPROMIN. Patient recovered.

Elaprase Side Effects Report #6076754-8
Elaprase side effect was reported by a Health Professional from UNITED STATES on Jan 30, 2009. Male patient, weighting 29.76 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: abnormal behaviour, hypertension, infusion related reaction. Elaprase dosage: unknown. Patient recovered.

Elaprase Side Effects Report #6076773-1
Elaprase side effect was reported by a Physician from UNITED STATES on Jan 29, 2009. Male patient, weighting 27.56 lb, was diagnosed with mucopolysaccharidosis ii and was treated with Elaprase. After drug was administered, patient experienced the following side effects: catheter related complication, infusion related reaction. Elaprase dosage: unknown. Patient was hospitalized. Patient recovered.


Elaprase Side Effects Report #5218339-9
Elaprase side effect was reported by a Pharmacist from UNITED STATES on Jan 23, 2007. Male patient, child 5 years of age, was diagnosed with mucopolysaccharidosis and was treated with Elaprase. After drug was administered, patient experienced the following side effects: infusion related reaction, pruritus. Elaprase dosage: 12 MG, THEN 6 MG QWEEK IV. Patient recovered.

Elaprase Side Effects Report #5961658-9
Elaprase side effect was reported by a Physician from HONG KONG on Nov 07, 2008. Male patient, weighting 33.29 lb, was treated with Elaprase. After drug was administered, patient experienced the following side effects: chills, infusion related reaction, pyrexia. Elaprase dosage: 0.5 MG/KG, 1X/WEEK, IV DRIP. During the same period patient was treated with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE. Patient was hospitalized. Patient recovered.