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Juxtapid

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Juxtapid

Indications
Dosage
How Supplied

INDICATIONS

Homozygous Familial Hypercholesterolemia

JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDLC), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

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.

DOSAGE AND ADMINISTRATION

Initiation And Maintenance Of Therapy

Before beginning treatment with JUXTAPID:

  • Measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin [see WARNINGS AND PRECAUTIONS];
  • Obtain a negative pregnancy test in females of reproductive potential [see WARNINGS AND PRECAUTIONS]; and,
  • Initiate a low-fat diet supplying < 20% of energy from fat [see WARNINGS AND PRECAUTIONS].

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]. 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. Dose adjustments are also required for patients who develop transaminase values ≥ 3x the upper limit of normal (ULN) during treatment with JUXTAPID.

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].

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]. Patients should swallow JUXTAPID capsules whole. Capsules should not be opened, crushed, dissolved, or chewed.

Dosing With Cytochrome P450 3A4 Inhibitors

JUXTAPID is contraindicated with concomitant use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS].

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, tipranavir/ritonavir, ticagrelor, zileuton) [see DRUG INTERACTIONS].

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].

Table 2: Dose Adjustment and Monitoring for Patients with Elevated Transaminases

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.
*Recommendations based on an ULN of approximately 30-40 international units/L.

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].

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].

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].

HOW SUPPLIED

Dosage Forms And Strengths

5 mg: Orange/orange hard gelatin capsule printed with black ink “A733” and “5 mg”

10 mg: Orange/white hard gelatin capsule printed with black ink “A733” and “10 mg”

20 mg: White/white hard gelatin capsule printed with black ink “A733” and “20 mg”

Storage And Handling

5 mg capsules

Orange/orange hard gelatin capsule printed with black ink “A733” and “5 mg”

Bottles of 28 NDC 76431-105-01

10 mg capsules

Orange/white hard gelatin capsule printed with black ink “A733” and “10 mg”

Bottles of 28 NDC 76431-110-01

20 mg capsules

White/white hard gelatin capsule printed with black ink “A733” and “20 mg”

Bottles of 28 NDC 76431-120-01

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep container tightly closed and protect from moisture.

Manufactured for: Aegerion Pharmaceuticals, Inc. Cambridge, MA 02142. Revised: Feb 2014

Last reviewed on RxList: 2/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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