Miplyffa Side Effects

Generic name: arimoclomol

Note: This document provides detailed information about Miplyffa Side Effects associated with arimoclomol. Some dosage forms listed on this page may not apply specifically to the brand name Miplyffa.

Applies to arimoclomol: oral capsule.

Important warnings This medicine can cause some serious health issues

Use only as directed.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Your treatment may be permanently discontinued if you have certain side effects.

Common side effects may include:

• decreased weight;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to arimoclomol: oral capsule.

General adverse events

The most common adverse reactions associated with this drug in combination with miglustat were upper respiratory tract infection, diarrhea, and decreased weight.^[Ref]

Dermatologic

• Very common (10% or more): Urticaria (12%)
• Common (1% to 10%): Angioedema, progressive urticaria

Urticaria included 1 patient (3%) who reported urticaria alone and 2 patients (6%) who reported both urticaria and angioedema. The reactions occurred within the first 2 months of therapy.

Gastrointestinal

• Very common (10% or more): Diarrhea (23%)

Hematologic

• Frequency not reported: Thrombocytopenia

Thrombocytopenia was present at baseline in 2 patients and persisted throughout the trial. In 1 patient, thrombocytopenia developed and resolved during the trial.

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Hypersensitivity reactions included urticaria and angioedema.

Metabolic

• Very common (10% or more): Decreased appetite (12%)

Nervous system

• Very common (10% or more): Tremor (12%), headache (12%), seizure (12%)

Other

• Very common (10% or more): Decreased weight (15%)

Decreased weight occurred in 4 patients and resolved in 3 patients. The mean duration of decreased weight was 33 days and ranged from 22 to 60 days. In 1 patient, 2 separate instances of weight loss occurred during the trial, lasting 22 and 24 days, respectively. The mean weight loss was about 6% from baseline in all patients; use of this drug was not interrupted in any patient.

Renal

• Frequency not reported: Increased serum creatinine

Across clinical trials in patients with Niemann-Pick disease type C, healthy subjects, and patients with other diseases, serum creatinine increased about 10% to 20% compared to baseline; these increases mainly occurred during the first month of therapy, were not associated with changes in glomerular function, and were reversible upon discontinuation of therapy.

Respiratory

• Very common (10% or more): Upper respiratory tract infection (31%), lower respiratory tract infection (12%)

Upper respiratory tract infection included upper respiratory tract infection and rhinitis.

Further information

Miplyffa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer