Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Bleeding [see Warnings and Precautions ( 5.1 )] .
Hypophenylalaninemia [see Warnings and Precautions ( 5.2 )] .
Most common adverse reactions with SEPHIENCE (≥2% and greater than placebo) were diarrhea, headache, abdominal pain, hypophenylalaninemia, feces discoloration, and oropharyngeal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact PTC Therapeutics, Inc.
at 1-866-562-4620 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.
The safety of SEPHIENCE was evaluated in Trial 1 [Part 1 (open label);
Part 2, (placebo-controlled)];
and Trial 2 (open-label).
The two trials included a total of 215 SEPHIENCE-treated patients with PKU: 10 (5%) were <2 years old, 118 (55%) were ≥2 and <17 years old, and 87 (40%) were ≥17 years old.
5 WARNINGS AND PRECAUTIONS Increased Bleeding : SEPHIENCE may increase the risk of bleeding.
Consider treatment interruption in patients with active bleeding.
( 5.1 ) Hypophenylalaninemia : Some pediatric PKU patients experienced hypophenylalaninemia;
monitor patients blood Phe levels during treatment.
( 5.2 ) Interaction with Levodopa : Seizures, over-stimulation or irritability may occur;
Like all medications, Sephience can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: