Limitations of Use

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.
The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.
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2 DOSAGE AND ADMINISTRATION

2.1 Initiation and Maintenance of TherapyBefore beginning treatment with JUXTAPID:

Measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin [see Warnings and Precautions (5.1)];
Obtain a negative pregnancy test in females of reproductive potential [see Warnings and Precautions (5.3)]; and,
Initiate a low-fat diet supplying <20% of energy from fat [see Warnings and Precautions (5.5)].
The recommended starting dosage of JUXTAPID is 5 mg once daily, and the dose should be escalated gradually based on acceptable safety and tolerability. Transaminases should be measured prior to any increase in dose [see Warnings and Precautions (5.1)]. The maintenance dosage of JUXTAPID 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 described in Table 1. Modify dosing for patients taking concomitant CYP3A4 inhibitors, renal impairment, or baseline hepatic impairment [see Dosage and Administration (2.3), (2.5), and (2.6)]. Dose adjustments are also required for patients who develop transaminase values ≥3x the upper limit of normal (ULN) during treatment with JUXTAPID [see Dosage and Administration (2.4)].

Table 1: Recommended Regimen for Titrating Dosage  DOSAGE DURATION OF
ADMINISTRATION
BEFORE CONSIDERING
INCREASE TO NEXT
DOSAGE
5 mg daily At least 2 weeks
10 mg daily At least 4 weeks
20 mg daily At least 4 weeks
40 mg daily At least 4 weeks
60 mg daily Maximum recommended dosage
To reduce the risk of developing a fat-soluble nutrient deficiency due to JUXTAPID’s mechanism of action in the small intestine, patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA) [see Warnings and Precautions (5.4)].

2.2 AdministrationJUXTAPID should be taken once daily with a glass of water, without food, at least 2 hours after the evening meal because administration with food may increase the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.5)]. Patients should swallow JUXTAPID capsules whole. Capsules should not be opened, crushed, dissolved, or chewed.

2.3 Dosing with Cytochrome P450 3A4 InhibitorsJUXTAPID is contraindicated with concomitant use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Contraindications (4) and Drug Interactions (7.1)].

The recommended maximum dosage of JUXTAPID is 30 mg daily with concomitant use of weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxam