Paltusotine
Generic Name: paltusotine
Brand Names:
Palsonify
11 DESCRIPTION PALSONIFY tablets contain paltusotine hydrochloride, a somatostatin receptor agonist. Paltusotine is known chemically as 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile hydrochloride. The molecular weight of paltusotine hydrochloride is 492.95 g/mol (C 27 H 22 F 2 N 4 O·HCl).
Overview
11 DESCRIPTION PALSONIFY tablets contain paltusotine hydrochloride, a somatostatin receptor agonist. Paltusotine is known chemically as 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile hydrochloride. The molecular weight of paltusotine hydrochloride is 492.95 g/mol (C 27 H 22 F 2 N 4 O·HCl).
Uses
1 INDICATIONS AND USAGE PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Take orally once daily with water on an empty stomach (at least 6 hours after a meal) and at least 1 hour before the next meal ( 2.1 ). Recommended initial dosage is 40 mg once daily. During initiation, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability. Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily ( 2.2 ). After 2 to 4 weeks, based on IGF-1 levels, titrate to 60 mg once daily ( 2.2 ). 2.1 Important Administration Instructions Take PALSONIFY orally once daily with water on an empty stomach, at least 6 hours after a meal (e.g., after overnight fasting) and at least 1 hour before the next meal [see Clinical Pharmacology ( 12.3 )] .
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.5 )] Changes in Vitamin B 12 Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ).
Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inducers: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ). Moderate CYP3A4 Inducers: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ). Proton Pump Inhibitors: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ) Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment ( 7.2 ). 7.1 Effect of Other Drugs on PALSONIFY Table 3. Clinically Significant Interactions Affecting PALSONIFY Strong CYP3A4 Inducers Intervention Concomitant use of PALSONIFY with strong CYP3A4 inducers may require an increased dosage of PALSONIFY, not to exceed three-fold the dose prior to concomitant use or 120 mg daily, whichever is less.
Warnings
5 WARNINGS AND PRECAUTIONS Cholelithiasis and its Complications: Monitor periodically. If complications of cholelithiasis occur, discontinue PALSONIFY and treat appropriately ( 5.1 ). Hyperglycemia and Hypoglycemia: Monitor glucose and adjust antidiabetic treatment as needed ( 5.2 ). Cardiovascular Abnormalities: Bradycardia or conduction abnormalities may occur. Dosage adjustments of concomitantly used drugs with bradycardia effects may be necessary ( 5.3 ). Thyroid Function Abnormalities: Hypothyroidism may occur. Assess thyroid function periodically ( 5.4 ). Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. 4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary The available data with PALSONIFY use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no malformations were observed with oral administration of paltusotine to pregnant rats and rabbits during organogenesis at exposures 11 and 3 times the human exposure at the maximum recommended human dose (MRHD) of 60 mg once daily, respectively (see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PALSONIFY is provided in two strengths: 20 mg and 30 mg. Table 8. PALSONIFY Configurations and NDC Numbers Strength Tablet Color/Shape Imprint NDC Package Size 20 mg Pink; biconvex oval shape “PAL” on one side; “20” on other side 84015-920-60 Bottle of 60 tablets 30 mg Yellow; biconvex oval shape “PAL” on one side; “30” on other side 84015-930-60 B...
Frequently Asked Questions
What is Paltusotine used for?▼
1 INDICATIONS AND USAGE PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ).
What are the side effects of Paltusotine?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.5 )] Changes in Vitamin B 12 Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ).
Can I take Paltusotine during pregnancy?▼
8.1 Pregnancy Risk Summary The available data with PALSONIFY use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no malformations were observed with oral administration of paltusotine to pregnant rats and rabbits during organogenesis at exposures 11 and 3 times the human exposure at the maximum recommended human dose (MRHD) of 60 mg once daily, respectively (see Data ) .
What are the important warnings for Paltusotine?▼
5 WARNINGS AND PRECAUTIONS Cholelithiasis and its Complications: Monitor periodically. If complications of cholelithiasis occur, discontinue PALSONIFY and treat appropriately ( 5.1 ). Hyperglycemia and Hypoglycemia: Monitor glucose and adjust antidiabetic treatment as needed ( 5.2 ). Cardiovascular Abnormalities: Bradycardia or conduction abnormalities may occur. Dosage adjustments of concomitantly used drugs with bradycardia effects may be necessary ( 5.3 ). Thyroid Function Abnormalities: Hypothyroidism may occur. Assess thyroid function periodically ( 5.4 ). Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. 4 CONTRAINDICATIONS None. None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.