藥品異動通知2023.12.26

藥理作用/作用機轉

Ozanimod has a high affinity to sphingosine 1-phosphate receptors 1 and 5. Ozanimod blocks the lymphocytes' ability to emerge from lymph nodes; therefore, the amount of lymphocytes available to the CNS and intestine is decreased.

適應症/

劑量

PO

【Adult】

　●Multiple sclerosis, relapsing: 0.23 mg QD on days 1-4; then 0.46 mg QD on days 5-7; maintenance dose: 0.92 mg QD starting on day 8.

　●Ulcerative colitis: 0.23 mg QD on days 1-4; then 0.46 mg QD on days 5-7; maintenance dose: 0.92 mg QD starting on day 8.

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustments provided

『Hepatic Impairment: Adult』

Severe impairment (Child-Pugh class C): Use not recommended (has not been studied).

使用禁忌

MI, unstable angina, stroke, transient ischemic attack, decompensated HF requiring hospitalization, or class III or IV HF in the last 6 months; Mobitz type II 2- or 3-degree atrioventricular block, sick sinus syndrome, or sinoatrial block, unless patient has functioning pacemaker; severe untreated sleep apnea; concomitant use of a MAOIs

警告/預防

Varicella zoster infections, Infections, Cardiovascular, Hepatic impairment

不良反應

Adverse Reactions (Significant): Cardiovascular effects, Hepatotoxicity, Lymphocytopenia/Infection, Macular edema, Respiratory effects, Progressive multifocal leukoencephalopathy and sequelae, Reversible posterior leukoencephalopathy syndrome

【>10%】Increased liver enzymes, infection, upper respiratory tract infection

【1% to 10%】 Hypertension, orthostatic hypotension, peripheral edema, nausea, upper abdominal pain, UTI, lymphocytopenia, increased serum alanine aminotransferase, herpes zoster infection, headache, arthralgia, back pain, fever

【<1%】Bradycardia, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, macular edem

【Frequency not defined】Cervical carcinoma, testicular neoplasm (seminoma), adenocarcinoma, basal cell carcinoma of skin, malignant melanoma, malignant neoplasm of breast, hypersensitivity reaction, herpes simplex infection, decrease in forced vital capacity, reduced forced expiratory volume

懷孕用藥分級(FDA)

X / 致畸胎性

健保規範

• 藥品說明：Ozanimod每日限用1粒，若治療無效，第二線治療藥物不得使用fingolimod。Interferon beta-la、teriflunomide 14mg、dimethyl fumarate、peginterferon beta-1a、ozanimod僅得擇一使用。

• 藥品理由：

20AD01 (初次使用需專審)(罕病)復發型多發性硬化症

20O073(續用) (罕病)復發型多發性硬化症

其他

育齡女性在治療期間與停用後3個月須行有效避孕。

避免在治療期間與停用後3個月施打減毒活性疫苗。

併用心律不整藥品建議諮詢心血管科醫師。

避免食用含大量酪胺的食物(起司…)。