LOMITAPIDE MESYLATE

Other

Brand names: Juxtapid

Oral

Mechanism of Action

12.1 Mechanism of Action JUXTAPID directly binds and inhibits microsomal triglyceride transfer protein (MTP), which resides in the lumen of the endoplasmic reticulum, thereby preventing the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. This inhibits the synthesis of chylomicrons and VLDL. The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C.

Indications

to reduce LDL-C in adult and pediatric patients aged 2 years and older with HoFH. ( 1 ).

Contraindications

• as this can increase JUXTAPID exposure [see Warnings and Precautions (5.6)
• Drug Interactions (7.1)
• and Clinical Pharmacology (12.3) ]. Patients with moderate or severe hepatic impairment (based on Child-Pugh category B or C) and patients with active liver disease

FDA Warnings

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: May cause fetal harm
Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception
1 Risk of Hepatotoxicity JUXTAPID can cause elevations in transaminases and hepatic steatosis in adults and pediatric patients, as described below [see Warnings and Precautions (5
JUXTAPID is contraindicated in patients with moderate or severe hepatic impairment, or active liver disease, including unexplained persistent elevations of serum transaminases [see Contraindications (4) ]

Known Side Effects

8 documented side effects by frequency

Diarrhea

>10%

Weight Loss

>10%

Nausea

1-10%

Gas/Bloating

0.1-1%

Vomiting

0.1-1%

Fatigue

0.1-1%

Constipation

0.1-1%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral