Palsonify (Paltusotine) is an oral, highly selective somatostatin receptor 2 (SSTR2) agonist that inhibits the excessive secretion of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) by mimicking the action of endogenous somatostatin.

1、 Drug name

1. Common name: Paltusotine

2. Product Name: PALSONIY ™

2、 Indications

Used to treat adult acromegaly with poor surgical response and/or unsuitability for surgery.

3、 Specifications and characteristics

1. 20mg tablets: Pink, biconvex oval shaped tablets with "PAL" engraved on one side and "20" engraved on the other side.

2. 30mg tablets: yellow, double convex oval shaped tablets with "PAL" engraved on one side and "30" engraved on the other side.

4、 Main components

Active ingredient: Paltusotine hydrochloride.

5、 Usage and dosage

1. Administration method: once a day, taken orally on an empty stomach with a glass of water.

2. Important intake time: It should be taken at least 6 hours after meals (e.g. after a night of fasting) and at least 1 hour before the next meal.

3. Recommended initial dose: 40mg, once daily.

4. Dose titration: After 2 to 4 weeks of treatment, the dose can be increased to 60mg once daily based on insulin-like growth factor-1 levels.

6、 Dose adjustment

1. Based on tolerance: During the initial treatment period, the dose can be temporarily reduced to 20mg once daily according to tolerance. Once the adverse reactions are relieved, they should be restored to 40mg once a day.

2. Based on drug interactions:

Combination with potent CYP3A4 inducers: may require an increase in PALSONIY dosage, but not exceeding three times the pre combination dose or 120mg per day (whichever is lower).

Co administration with intermediate CYP3A4 inducer: may require an increase in PALSONIY dosage, but not exceeding twice the pre administration dose or 120mg per day (whichever is lower).

Combination with proton pump inhibitors: may require an increase in PALSONIFY dosage. Patients who have already taken a dose of 60mg should avoid co administration of proton pump inhibitors.

7、 Medication precautions

1. Before and after meals: It must be taken on an empty stomach, at least 6 hours after meals and at least 1 hour before the next meal.

2. Missed dose: It is not explicitly stated in the instructions. It is usually recommended that if missed, it should be taken as soon as possible when remembered. However, if it is close to the next dose, the missed dose should be skipped and the next dose should be taken at the usual time, without doubling the dose. Specific advice should be sought from a doctor or pharmacist.

3. Vomiting: If vomiting occurs shortly after taking medication, it may affect drug absorption. It is recommended to consult a doctor.

8、 Medication for special populations

1. Pregnant women: The existing data is insufficient to determine the risk of major birth defects, miscarriage, or other adverse maternal and infant outcomes related to medication. No teratogenicity was observed in animal experiments.

2. Breastfeeding women: It is unclear whether paroxetine is secreted into human milk and its effects on infant or breast milk secretion. Animal experiments have shown that drugs are secreted into breast milk. The benefits of breastfeeding, the clinical needs of mothers for PALSONIFY, and the potential risks to infants should be balanced.

3. Children: Safety and efficacy have not yet been established.

4. Elderly patients (≥ 65 years old): No overall difference in safety or efficacy was observed compared to younger adult patients, and dose adjustment is not necessary.

5. Patients with liver dysfunction: No need to adjust dosage.

9、 Adverse reactions

1. The most common adverse reactions (incidence ≥ 5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.

2. Serious Adverse Reaction Warning:

Cholelithiasis and its complications (such as acute cholecystitis, pancreatitis).

High blood sugar and low blood sugar.

Cardiovascular abnormalities (bradycardia, conduction block, sinus arrest).

Abnormal thyroid function (which may lead to hypothyroidism).

Fat diarrhea and poor absorption of dietary fat.

Vitamin B12 levels decrease.

10、 Contraindications

None.

11、 Drug interactions

1. Drugs that affect PALSONIFY: Strong or moderate CYP3A4 inducers, proton pump inhibitors may reduce the blood concentration of Palustine and may require an increase in PALSONIFY dosage.

2. Medications affected by PALSONIFY: PALSONIFY may reduce the blood concentration of cyclosporine and may require adjustment of cyclosporine dosage.

12、 Storage method

1. Store at room temperature of 20 ° C to 25 ° C (68 ° F to 77 ° F), allowing for brief fluctuations between 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Store in the original container or a sealed container that meets USP standards.

3. Keep out of reach of children.

Paltusotineinformation