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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 ) ] Most common adverse reactions (incidence > 20%) are hypersensitivity reactions including anaphylaxis ( 5.1 ), nasopharyngitis, pyrexia, headache, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions F rom Trial 1 The safety of LAMZEDE was evaluated in Trial 1, which included a total of 15 LAMZEDE-treated patients (8 adult patients aged 18-35 years old and 7 pediatric patients aged 6-17 years old; 9 male, 6 female) with alpha-mannosidosis [see Clinical Studies ( 14 )]. All patients received LAMZEDE 1 mg/kg weekly via intravenous infusion for 52 weeks. A serious adverse reaction of acute renal failure was reported in 1 (7%) LAMZEDE-treated patient (see Description of Selected Adverse Reactions) . Table 1 lists adverse reactions that occurred in at least 2 LAMZEDE-treated patients in Trial 1. Table 1: Adverse Reactions (≥2 patients) in Adult and Pediatric Patients with Alpha-Mannosidosis Treated with LAMZEDE in Trial 1 Adverse Reaction LAMZEDE N=15 n (%) Placebo N=10 n (%) Nasopharyngitis 10 (66) 7 (70) Pyrexia 6 (40) 5 (50) Headache 5 (33) 3 (30) Arthralgia 3 (20) 1 (10) Acute tonsillitis 2 (13) 0 Urinary tract infection 1 2 (13) 1 (10) Eye pruritus 2 (13) 0 Gastroenteritis 2 (13) 0 Hypersensitivity 2 (13) 0 Influenza 2 (13) 0 Syncope 2 (13) 0 Toothache 2 (13) 0 Back pain 2 (13) 1 (10) Ear infection 2 (13) 1 (10) 1 “Urinary tract infection” is composed of similar terms. Adverse Reactions from Trials 2 and 3 In Trial 2, 5 pediatric patients aged 3 to 5 years old (3 male, 2 female) with alpha-mannosidosis received LAMZEDE weekly for a mean exposure of 121 weeks [see Clinical Studies ( 14 )] . One patient treated with LAMZEDE (20%) presented serious reactions (chills and hyperthermia on the same occasion). The adverse reactions that occurred in at least 2 of 5 patients (and are in addition to the adverse reactions already identified in Trial 1 above) included: cough, otitis media, rhinitis, conjunctivitis, fall, ligament sprain, oropharyngeal pain, swelling face, and upper respiratory tract infection. Trial 3 is an integrated analysis that pooled the cumulative databases from LAMZEDE phase 1, 2, and 3 trials in patients with alpha-mannosodosis. A total of 33 patients (20 male, 13 female) aged 6 to 35 years old (14 adults, 19 pediatric) received LAMZEDE weekly for a mean exposure of 89 weeks in adult patients and 155 weeks in pediatric patients. One patient was withdrawn from the trial due to repeated IARs and successfully reintroduced after 89 weeks of pause. The adverse reactions that occurred in at least 10% of patients (and are in addition to the adverse reactions already identified in Trial 1 and 2 above) included abdominal pain upper, contusion, excoriation, post-lumbar puncture syndrome, wound, weight increased, erythema, rash, and tooth extraction. Description of S elected A dverse R eactions Acute R enal F ailure One patient out of 38 (3%) experienced one episode of acute renal failure. This patient paused LAMZEDE treatment for 4 weeks and acute renal failure resolved within 12 weeks of diagnosis. This patient is noted to have received the concomitant medication of ibuprofen. Immunoglobulin A V asculitis One episode of immunoglobulin A vasculitis (IgAV), reported as Henoch Schonlein Purpura , occurred in one patient out of 38 (3%) who developed high anti-drug antibody (ADA) levels. Seizure One patient out of 38 (3%), with no prior history of seizures experienced more than one episode of seizures. A relationship between the occurrence of seizures in this patient and exposure to LAMZEDE cannot be excluded. Pediatric Patients Hypersensitivity reactions overall were reported in 36% of adult patients and 58% of pediatric patients. Immunogenicity: Anti - D rug Antibody-Associated Adverse Reactions Infusion-associated reactions (including anaphylaxis and severe hypersensitivity reactions) occurred in a higher incidence in LAMZEDE-treated patients who developed anti-velmanase alfa-tycv antibodies (anti-drug antibodies, ADA) compared to patients who were ADA-negative (80% versus 20%) [see Clinical Pharmacology ( 12.6 ) ] . In Trial 1 following treatment with LAMZEDE for up to 52 weeks, 1 out of 5 ADA-positive patients developed severe hypersensitivity and this patient developed the highest ADA level among all the ADA-positive patients in the trial. In Trial 2 following treatment with LAMZEDE for up to 174 weeks, 2 out of 4 ADA-positive pediatric patients experienced IARs. In Trial 3, 3 out of 33 patients (9.1%) reported IARs; two of these patients were ADA positive (one of these two patients is described in Trial 1); one patient was ADA negative. 6. 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of velmanase alfa outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: aortic valve incompetence, palpitations, tachycardia Ear and labyrinth disorders: deafness Eye disorders: lacrimation increased Gastrointestinal disorders: odynophagia General disorders and administration site conditions: asthenia, fatigue Infections and infestations: endocarditis, staphylococcal infection, bacterial disease carrier, furuncle Metabolism and nutrition disorders: decreased appetite Musculoskeletal and connective tissue disorders: joint swelling, joint warmth Nervous system disorders: ataxia, nervous system disorder, somnolence Psychiatric disorders : psychotic disorder, agitation, encopresis, nervousness Respiratory, thoracic and mediastinal disorders: pharyngeal edema, wheezing Skin, subcutaneous tissue disorders: angioedema Vascular disorders: vascular fragility, hypotension