Safety

Juxtapid (Lomitapide) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

May 2016

Summary View

BOX WARNING (addition to 4th paragraph)

  • Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

WARNINGS AND PRECAUTIONS

Risk of Hepatotoxicity

Monitoring of Transaminases

  • Before initiating JUXTAPID and during treatment, monitor transaminases as recommended in Table 3.

Table 3: Recommendations for Monitoring Transaminases

  • Before initiating treatment 
    • Measure ALT, AST, alkaline phosphatase, and total bilirubin.
    • If abnormal, consider initiating JUXTAPID only after an appropriate work-up and the baseline abnormalities have been explained or resolved.
    • JUXTAPID is contraindicated in patients with moderate or severe hepatic impairment, or active liver disease, including unexplained persistent elevations of serum transaminases.
  • During the first year 
    • Measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first.
    • After the first year 
    • Measure liver-related tests (ALT and AST, at a minimum) at least every 3 months and before any increase in dose
  • At any time during treatment 
    • If transaminases are abnormal, reduce or withhold dosing of JUXTAPID and monitor as recommended.
    • Discontinue JUXTAPID for persistent or clinically significant elevations.
    • If transaminase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin =2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause.

ADVERSE REACTIONS

Gastrointestinal Adverse Reactions (addition as 3rd paragaraph of section)
  • There have been postmarketing reports of severe diarrhea with the use of JUXTAPID, including patients being hospitalized because of diarrhea-related complications such as volume depletion. Monitor patients who are more susceptible to complications from diarrhea, such as older patients and patients taking drugs that can lead to volume depletion or hypotension. Instruct patients to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness. In such cases, consider reducing the dose or suspending use of JUXTAPID.

PATIENT COUNSELING INFORMATION

Gastrointestinal Adverse Reactions (bullet addition to this section)
  • Instruct the patient to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness.

MEDICATION GUIDE (now available; please see label)

 

August 2014

Summary View

DRUG INTERACTIONS

  • * re-categorize the combination of tipranavir/ritonavir from the list of weak CYP3A4 inhibitors to the list of strong CYP3A4 inhibitors.*

 

February 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • Pregnancy Exposure Registry…added

17 PATIENT COUNSELING INFORMATION

  • Phone number added for registry program

MEDICATION GUIDE

2. Harm to your unborn baby.

  • If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your doctor right away.
  • Pregnancy Exposure Registry…section added

 

April 2013

Summary View

WARNINGS AND PRECAUTIONS

Risk of Hepatotoxicity
Hepatic Steatosis
  • …Juxtapid has not been studied concomitantly with other LDL-lowering agents that can also increase hepatic fat. Therefore, the combined use of such agents is not recommended.

 

Page Last Updated: 06/10/2016
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