PALSONIFY 20 mg/1
PALTUSOTINE · TABLET, FILM COATED · Crinetics Pharmaceuticals, Inc.
PALSONIFY is a tablet, film coated containing paltusotine at 20 mg/1, taken oral. Manufactured by Crinetics Pharmaceuticals, Inc..
Key Facts
- Brand Name
- PALSONIFY
- Generic Name
- PALTUSOTINE
- NDC Code (Product)
84015-920- Manufacturer
- Crinetics Pharmaceuticals, Inc.
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA219070
- Marketing Start
- 09/25/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 )] . 2.2 Recommended Dosage, Titration, and Monitoring The recommended initial dosage of PALSONIFY is 40 mg once daily. During initiation period, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability [see Adverse Reactions ( 6.1 )] . Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily. After 2 to 4 weeks on PALSONIFY 40 mg once daily, based on IGF-1 levels, titrate to a PALSONIFY dosage of 60 mg once daily. 2.3 Do…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug 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. Clinical Impact Concomitant use of PALSONIFY with strong CYP3A4 inducers reduced paltusotine exposure and may affect therapeutic response [see Clinical Pharmacology ( 12.3 )]. Moderate CYP3A4 Inducers Intervention Concomitant use of PALSONIFY with moderate CYP3A4 inducers may require an increased dosage of PALSONIFY, not to exceed two-fold the dose prior to concomitant use or 120 mg daily, whichever …
Adverse Reactions
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 ). To report SUSPECTED ADVERSE REACTIONS, contact Crinetics Pharmaceuticals, Inc. at toll-free phone 1-833-CRN-INFO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Th…
Frequently Asked Questions
What is PALSONIFY used for?
PALSONIFY contains PALTUSOTINE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is PALSONIFY a controlled substance?
PALSONIFY is not classified as a controlled substance by the DEA.
What is the generic name for PALSONIFY?
The generic name for PALSONIFY is PALTUSOTINE. There are no other listed brand versions of PALTUSOTINE.
What is the NDC code for PALSONIFY 20 mg/1?
The NDC (National Drug Code) for PALSONIFY 20 mg/1 is 84015-920, listed by Crinetics Pharmaceuticals, Inc..
Other PALSONIFY Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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