Hainan Deutenzalutamide Soft Capsules

1. Indications and Usage
Deutenzalutamide soft capsules are indicated for the treatment of adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC). It is used in combination with androgen deprivation therapy (ADT).
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 250 mg taken orally once daily.
Administration: The capsules should be swallowed whole with water. They should not be crushed, chewed, or broken. Food does not significantly affect the absorption of deutenzalutamide, so it can be taken with or without food.
Missed Dose: If a dose is missed, it should be taken as soon as possible on the same day. If it is discovered on the following day, the missed dose should be skipped, and the regular dosing schedule resumed. Two doses should not be taken at the same time.
3. Mechanism of Action
Deutenzalutamide is a novel, next-generation oral anti-androgen. It works by selectively and competitively inhibiting the binding of endogenous androgens (such as testosterone and dihydrotestosterone) to the androgen receptor (AR). This blockade of androgen receptor signaling inhibits the proliferation and survival of prostate cancer cells, leading to tumor regression.
4. Safety and Warnings
Cardiovascular Risk: Deutenzalutamide may increase the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and heart failure. Cardiovascular risk factors should be assessed and managed prior to treatment.
Hepatotoxicity: Elevations in liver enzymes (ALT/AST) and bilirubin have been reported. Liver function tests should be monitored regularly during treatment.
QT Prolongation: Deutenzalutamide can cause QT interval prolongation. Baseline and periodic ECG monitoring is recommended, especially in patients with a history of cardiac disease or those taking other QT-prolonging medications.
Fetal and Neonatal Toxicity: Deutenzalutamide can cause fetal harm. Women should be advised to avoid exposure to the drug or its fluids (e.g., semen, urine).
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequently reported adverse reactions include fatigue, musculoskeletal pain, hot flashes, nausea, diarrhea, and increased blood pressure.
Clinical Research: Clinical trials have demonstrated that the combination of deutenzalutamide and ADT significantly improves overall survival and radiographic progression-free survival compared to ADT alone in patients with mHSPC.
6. Drug Interactions
CYP3A4 Inhibitors/Inducers: Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase the plasma concentrations of deutenzalutamide, while strong CYP3A4 inducers (e.g., rifampin, phenytoin) may decrease them. Dose adjustments or avoidance of these concomitant medications may be necessary.
QT-Prolonging Agents: Concomitant use with other drugs that prolong the QT interval (e.g., amiodarone, sotalol) may increase the risk of arrhythmias and should be avoided.
7. Pharmaceutical Information
Composition: The active ingredient is deutenzalutamide.
Appearance: The soft capsules are typically yellow to orange-yellow and oval-shaped.
Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light and moisture.