Raloxifene

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`DRUG-RALOXIFENE`
Тип	Препарат
Синоніми	EvistaРалоксифен
Статус	переглянуто 2026-05-18 \| очікує клінічного підпису
Хвороби	Не вказано
Джерела	`SRC-NCCN-BCELL-2025` `SRC-NCCN-BREAST-2025`

Дані про препарат

Клас	Selective estrogen receptor modulator (SERM)
Механізм дії	Benzothiophene SERM with mixed estrogen-receptor agonist/antagonist activity tissue-specific to tamoxifen: antagonist in breast and uterus (no endometrial agonism — lower endometrial-cancer risk than tamoxifen), agonist in bone (BMD preservation) and lipid metabolism. FDA-approved for postmenopausal osteoporosis and invasive-breast-cancer risk reduction. STAR P-2 trial established non-inferior breast-cancer-prevention efficacy vs. tamoxifen in postmenopausal women with lower endometrial-cancer and VTE risk.
Типове дозування	PO: 60 mg once daily with or without food, for 5 years for chemoprevention (per STAR P-2 and NSABP P-2 protocols). Postmenopausal only. Same dose for osteoporosis prevention/treatment. No specific dose adjustment for hepatic/renal impairment but caution in severe.
Зареєстровано в Україні	True
Відшкодовується НСЗУ	False
Остання перевірка для України	2026-05-18

Застереження

Increased risk of venous thromboembolism (DVT, PE) — similar magnitude to estrogen and tamoxifen
Increased risk of fatal stroke in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events (RUTH trial)

Нотатки

STUB — v0.2 prevention-workstream authoring; pending two-Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. POSTMENOPAUSAL ONLY for breast chemoprevention. Per STAR P-2 (NSABP-P2), raloxifene reduces invasive breast cancer ~38% (vs. ~50% for tamoxifen) with lower endometrial cancer (no agonism) and lower VTE rates. Preferred over tamoxifen in postmenopausal women with intact uterus or VTE-risk profile. Adds osteoporosis benefit. NOT for premenopausal use or DCIS prevention (insufficient data; tamoxifen retains the indication there).

Де використовується

Access Pathways

AP-RALOXIFENE-OOP - Raloxifene for postmenopausal breast chemoprevention — out-of-pocket
AP-TAMOXIFEN-NSZU-CHEMOPREVENTION - Tamoxifen for breast chemoprevention — off-label НСЗУ status, low-cost generic

Regimens

REG-RALOXIFENE-CHEMOPREVENTION - Raloxifene 60 mg daily × 5 years for postmenopausal breast-cancer chemoprevention