Important Safety Information

INFORMATION WARNINGS AND PRECAUTIONS:

• Cholelithiasis and Complications of Cholelithiasis: Gallbladder problems may occur.
Monitor patients periodically. If cholelithiasis is suspected, discontinue PALSONIFY and treat appropriately.
• Hyperglycemia and Hypoglycemia: Hypoglycemia, hyperglycemia, or diabetes mellitus may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dose is altered. Adjust antidiabetic treatment accordingly.
• Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block were reported in PALSONIFY clinical trials. Dosage adjustments of concomitant drugs that have bradycardia effects may be necessary.
• Thyroid Function: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.
• Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with

PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

• Changes in Vitamin B12 Levels: Vitamin B12 deficiency was reported in PALSONIFY clinical trials. Monitor vitamin B12 levels.

ADVERSE REACTIONS:
Most common adverse reactions (> 10%) are diarrhea, abdominal pain, nausea, and decreased appetite.

DRUG INTERACTIONS:

• Strong CYP3A4 inducers; moderate CYP3A4 inducers; and proton pump inhibitors may require increased dosages of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients
• Cyclosporine: adjustment of dose may be required when used with PALSONIFY.

Please report adverse events to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276- 4636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including Patient Information.