2.4 Dose Modification Based on Elevated TransaminasesTable 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 ImpairmentPatients 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 ImpairmentPatients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily [see Use in Specific Populations (8.8)].

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3 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”

30 mg: Orange/yellow hard gelatin capsule printed with black ink “A733” and “30 mg”

40 mg: Yellow/white hard gelatin capsule printed with black ink “A733” and “40 mg”

60 mg: Yellow/yellow hard gelatin capsule printed with black ink “A733” and “60 mg”

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4 CONTRAINDICATIONS

JUXTAPID is contraindicated in the following conditions:

Pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations