Bezafibrate

Bezafibrate is investigational in the United States and has orphan designation for Barth syndrome.

Bezafibrate is available under the following different brand names: N/A.

Investigational in the United States. Consult your doctor.

Dosage Considerations – Should be Given as Follows:

Barth Syndrome (Orphan)

• Orphan designation for Barth syndrome
• Safety and efficacy not established in pediatric patients

Side effects of Bezafibrate include:

• Stomach upset
• Stomach pain
• Gas
• Nausea
• Itchy skin
• Redness
• Headache
• Dizziness

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of bezafibrate include:
  • isocarboxazid
  • linezolid
  • phenelzine
  • selegiline transdermal
  • tranylcypromine
• Serious interactions of bezafibrate include:
  • atorvastatin
  • colchicine
  • lovastatin
  • simvastatin
  • warfarin
• Moderate interactions of bezafibrate include:
  • chlorpropamide
  • cholestyramine
  • furosemide
  • glimepiride
  • glipizide
  • glyburide
  • insulin aspart
  • insulin degludec
  • insulin degludec/insulin aspart
  • insulin detemir
  • insulin glargine
  • insulin glulisine
  • insulin inhaled
  • insulin lispro
  • insulin NPH
  • insulin regular human
  • pravastatin
  • tolazamide
  • tolbutamide
• Mild interactions of bezafibrate include:
  • colestipol
  • octacosanol
  • orlistat

Warnings

This medication contains bezafibrate. Do not take bezafibrate if you are allergic to bezafibrate or any ingredients contained in this drug.

Contraindications

• Primary biliary cirrhosis
• Pre-existing gallbladder disease
• Concurrent use of monoamine oxidase inhibitors (MAO) inhibitors
• Pregnancy or breastfeeding

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Bezafibrate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Bezafibrate?"

Cautions

• History of jaundice or hepatic disorder
• Concurrent use of HMG-CoA reductase inhibitors ("statins")
• Hepatic/renal impairment
• Hypoalbuminemia or nephrotic syndrome

Pregnancy and Lactation

No information is available regarding use of bezafibrate during pregnancy. Bezafibrate is not recommended for use during pregnancy.

It is unknown if bezafibrate is excreted in milk. Breastfeeding is not recommended while using bezafibrate.