40 mg capsules:
Yellow/white hard gelatin capsule printed with black ink “A733” and “40 mg”
Bottles of 28                                                        NDC 76431-140-01

60 mg capsules:
Yellow/yellow hard gelatin capsule printed with black ink “A733” and “60 mg”
Bottles of 28                                                        NDC 76431-160-01

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.

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17 PATIENT COUNSELING INFORMATION

See FDA-approved labeling (Medication Guide)

Patients should be informed that a registry for patients taking JUXTAPID has been established in order to monitor and eva luate the long-term effects of JUXTAPID. Patients are encouraged to participate in the registry and should be informed that their participation is voluntary. For information regarding the registry program visit www.JUXTAPID.com or call 1-877-902-4099.

Advise patients of the following:

Risk of Hepatotoxicity [see Warnings and Precautions (5.1)]

JUXTAPID can cause both elevations in transaminases and hepatic steatosis. Discuss with the patient the importance of monitoring of liver-related tests before taking JUXTAPID, prior to each dose escalation, and periodically thereafter.
Patients should be advised of the potential for increased risk of liver injury if alcohol is consumed while taking JUXTAPID. It is recommended that patients taking JUXTAPID limit consumption to not more than one alcoholic drink per day.
JUXTAPID is commonly associated with nausea, vomiting, and abdominal pain. Advise patients to promptly report these symptoms if they increase in severity, persist, or change in the character, as they might reflect liver injury. Patients should also report any other symptoms of possible liver injury, including fever, jaundice, lethargy, or flu-like symptoms.
JUXTAPID REMS Program [see Warnings and Precautions (5.2)]

JUXTAPID is only ava