Cuvrior Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy [see Warnings and Precautions (5.1) ] Copper Deficiency [see Warnings and Precautions (5.2) ] Iron Deficiency [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orphalan at 1-800-961-8320 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.

Common Adverse Reactions Table 3 presents common adverse reactions over a 24-week period from Trial 1, a prospective, randomized, multi-center study that was conducted in adult patients with Wilson's disease who were de-coppered and tolerant to penicillamine [see Clinical Studies (14) ] .

Patients were either switched to receive CUVRIOR (N=26) or continued to receive penicillamine (N=27).

Table 3: Common Adverse Reactions Adverse reactions that occurred in >5% of CUVRIOR-treated patients and greater than in patients who continued to receive penicillamine.

from a Clinical Study of CUVRIOR in Adult Patients with Wilson's Disease (Trial 1) Adverse Reaction CUVRIOR (N=26) n (%) Penicillamine (N=27) n (%) Abdominal pain Abdominal pain is composed of several similar terms 5 (19%) 1 (4%) Change of bowel habits Includes constipation, abnormal feces, soft feces 4 (15%) 0 Rash Rash is composed of several similar terms 3 (12%) 0 Alopecia 2 (8%) 1 (4%) Mood swings 2 (8%) 0 Other Adverse Reactions In Trial 1, anemia developed in 4% (1/26) of CUVRIOR-treated patients and in no patients who continued to receive penicillamine.

In addition, the following adverse reactions have been reported in clinical studies of patients with Wilson's disease who were on therapy with trientine hydrochloride: Metabolism and Nutrition Disorders : Iron deficiency Musculoskeletal and Connective Tissue Disorders : Systemic lupus erythematosus 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of trientine hydrochloride.

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: Gastrointestinal Disorders : Colitis Musculoskeletal and Connective Tissue Disorders : Muscle spasms, Rhabdomyolysis Nervous System Disorders: Dystonia, Myasthenia gravis