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 below and elsewhere in the labeling: Hypersensitivity Reactions [see Warning and Precautions ( 5.1 )].
Increased Creatinine without Affecting Glomerular Function [see Warnings and Precautions ( 5.3 )].
Most common adverse reactions (≥15%) are: Upper respiratory tract infection, diarrhea, and decreased weight.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zevra Therapeutics, Inc.
at toll-free phone 1-844-600-2237 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 MIPLYFFA was evaluated in a randomized, double-blind, placebo-controlled, 12-month trial (Trial 1), which included 50 patients 2 to 19 years old with NPC [see Clinical Studies ( 14 )] .
Patients received weight-adjusted doses of MIPLYFFA (31 to 124 mg orally three times daily);
28 of the patients were exposed to MIPLYFFA for one year.
In Trial 1, 78% of patients received miglustat.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Urticaria and angioedema have been reported.
Discontinue MIPLYFFA in patients who develop these adverse reactions.
( 5.1 ) Embryofetal Toxicity : May cause fetal harm.
Advise pregnant females of the potential risk to the fetus and consider pregnancy planning and prevention.
( 5.2 ) Increased Creatinine without Affecting Glomerular Function: Mean increases in serum creatinine of 10-20% have been reported.
Like all medications, Miplyffa 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: