Juxtapid

Juxtapid Manufacturers

• Aegerion Pharmaceuticals, Inc.
  

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  Juxtapid | Aegerion Pharmaceuticals, Inc.

  

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  2.1 Initiation and Maintenance of Therapy

  Before 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 Administration

  JUXTAPID 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 Inhibitors

  JUXTAPID 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, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, oral contraceptives, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton) [see Drug Interactions (7.2)].

  2.4 Dose Modification Based on Elevated Transaminases

  Table 2 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated transaminases during therapy with JUXTAPID [see Warnings and Precautions (5.1)].

  Table 2: Dose Adjustment and Monitoring for Patients with Elevated Transaminases *Recommendations based on an ULN of approximately 30-40 international units/L. ALT OR AST TREATMENT AND MONITORING RECOMMENDATIONS* ≥3x and <5x ULN Confirm elevation with a repeat measurement within one week. If confirmed, reduce the dose and obtain additional liver-related tests if not
  already measured (such as alkaline phosphatase, total bilirubin, and INR). Repeat tests weekly and withhold dosing if there are signs of abnormal liver
  function (increase in bilirubin or INR), if transaminase levels rise above 5x ULN,
  or if transaminase levels do not fall below 3x ULN within approximately 4 weeks.
  In these cases of persistent or worsening abnormalities, also investigate to identify
  the probable cause. If resuming JUXTAPID after transaminases resolve to <3x ULN, consider
  reducing the dose and monitor liver-related tests more frequently. ≥5x ULN Withhold dosing, obtain additional liver-related tests if not already measured
  (such as alkaline phosphatase, total bilirubin, and INR), and investigate to identify
  the probable cause. If resuming JUXTAPID after transaminases resolve to <3x ULN, reduce the dose
  and monitor liver-related tests more frequently.

  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 investigate to identify the probable cause [see Warnings and Precautions (5.1)].

  2.5 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 [see Use in Specific Populations (8.7)].

  2.6 Dosing in Patients with Baseline Hepatic Impairment

  Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily [see Use in Specific Populations (8.8)].

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