Dosing and Administration

The recommended starting dose of Juxtapid is 5 mg once daily.

  • The dose should be escalated gradually based on acceptable safety and tolerability.
  • Transaminases should be measured prior to any increase in dose.
  • The maintenance dose should be individualized, taking into account patient characteristics such as goal of therapy and response to treatment to a maximum of 60 mg daily as per the table below.

Recommended Regimen for Titrating Dosage 
The table below shows the recommeded regimen for titrating dosage of Juxtapid.

Dosage Duration of Administration Before Considering Increase To Next Dosage
5mg daily At least 2 weeks
10mg daily At least 4 weeks
20mg daily At least 4 weeks
40mg daily At least 4 weeks
60mg daily

Maximum recomended dosage

Administration
Juxtapid should be taken in the evening, with a glass of water, without food, and at least 2 hours after dinner. Administration with food may increase the risk of gastrointestinal adverse reactions.  Patients should swallow Juxtapid capsules whole.

Administration of Juxtapid and bile acid sequestrants should be separated by at least 4 hours since bile acid sequestrants can interfere with the absorption of oral medications.

Because of Juxtapid’s mechanism of action in the small intestine, fat-soluble vitamins/fatty acids may not be properly absorbed. Patients on Juxtapid should take daily supplements containing 400 IU vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linoleic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Dosing Adjustments
Dosing modifications are recommended for patients taking concomitant CYP3A4 inhibitors, renal impairment, or baseline hepatic impairment.  Dosing adjustments are also required for patients who develop transaminases values ≥3x the upper limit of normal (ULN) during treatment with Juxtapid. Learn more here. Click the tabs below for recommended dosing modifications. 

Dosing with Cytochrome P450 3A4 Inhibitors
  • Juxtapid is contraindicated with concomitant use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors.
  • The recommended maximum dosage of Juxtapid is 30 mg daily with concomitant use of weak CYP3A4 inhibitors.
  • Combination with weak CYP3A4 inhibitors increases exposure to lomitapide approximately 2-fold.
  • Examples of weak CYP3A4 inhibitors include atorvastatin and oral contraceptives.
Dosing in Patients with Renal Impairment
  • Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily.
  • There are no data available to guide dosing in other patients with renal impairment.
Dosing in Patients with Baseline Hepatic Impairment

Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.

Juxtapid is contraindicated in patients with moderate or severe hepatic impairment or active liver disease, including unexplained persistent abnormal liver function tests.

Dose Modifications Based on Elevated Transaminases

Patient Monitoring of Transaminases
In the event that ALT/AST elevations occur during therapy with Juxtapid, the recommendations below should be followed:

If transaminase elevations are accompanied by clinical symptoms of liver injury, (such a nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin  2x ULN, or active liver disease, discontinue treatment with JUXTAPID and investigate to identify the probable cause.