Alitretinoin是一种能激活所有已知的细胞内维甲酸类受体亚型（RARα、RARβ、RARγ、RXRα、RXRβ和RXRγ）的内源性维甲酸。2009年11月加拿大批准Toctino（alitretinoin，阿利维A酸）软胶囊上市，每日一次，每次30mg，用于局部外用强效糖皮质激素无效的慢性手部湿疹患者。0．1%阿利维A酸凝胶剂（商品名：Panretin）已于1999年被批准用于治疗皮肤卡波济肉瘤
Generic Name for PANRETIN
Alitretinoin 0.1%; gel.
Legal Classification:
Rx
Pharmacological Class for PANRETIN
Retinoid.
Manufacturer of PANRETIN
Eisai Pharmaceuticals
Indications for PANRETIN
Cutaneous lesions of AIDS-related Kaposi's sarcoma (KS).
Adult dose for PANRETIN
Apply twice daily to lesions (avoid mucous membranes and normal skin); do not occlude; may increase to 3-4 times daily as tolerated. Reduce frequency or suspend treatment if local toxicity occurs.
Children's dosing for PANRETIN
Not recommended.
Warnings/Precautions for PANRETIN
Not for use when systemic KS therapy required. Avoid sun, UV light. Flammable. Pregnancy (Cat.D), nursing mothers: not recommended.
Interactions for PANRETIN
Increases DEET toxicity (avoid).
Adverse Reactions for PANRETIN
Photosensitivity, rash, pruritus, pain, exfoliative dermatitis, paresthesia, edema.
How is PANRETIN supplied?
Gel—60g
Related Disease:
Kaposi's sarcoma
Panretin® (alitretinoin) gel 0.1%
Panretin® (alitretinoin) gel is a prescription medicine that is applied to the skin for the treatment of skin lesions in patients with AIDS-related Kaposi's sarcoma (KS). Panretin gel should not be used when systemic (oral or injectable) anti-KS therapy is required (e.g. more than 10 new KS lesions in the prior month, symptomatic lymphedema [swelling in tissues], symptomatic pulmonary KS [affecting the lungs], or symptomatic visceral involvement [affecting internal organs]). There is no experience to date using Panretin gel with systemic anti-KS treatment.
Kaposi's sarcoma is a cancer that causes patches of abnormal tissue to grow under the skin, in the lining of the mouth, nose and throat or in other organs. In the United States, approximately 1.21 men per 100,000, in 2007, were diagnosed with Karposi's sarcoma.
Important Safety Information
Panretin gel is not indicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.
Pregnancy Category D - Panretin gel could cause fetal harm if significant absorption were to occur in a pregnant woman. If Panretin gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be made aware of the potential harm to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant. Because of the potential for adverse reactions from Panretin gel in nursing infants, mothers should discontinue nursing prior to using the drug.
Patients with cutaneous T-cell lymphoma were less tolerant of Panretin gel; 5 of 7 patients had 6 episodes of treatment limiting toxicities - grade 3 dermal irritation - with Panretin gel (0.01 or 0.05%).
Patients should minimize exposure of treated areas to sunlight and sunlamps during the use of Panretin gel. Patients should not use products that contain DEET (N,N-diethyl-m-toluamide), a common ingredient of insect repellant products, while using Panretin gel.
The safety of Panretin gel was assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin occurred almost exclusively at the gel application site. Dermal toxicity begins with erythema, with continued application of Panretin gel, erythema may increase and edema may develop. Dermal toxicity may become treatment limiting with intense erythema, edema, and vesiculation. Usually adverse events were mild to moderate to in severity and led to withdrawal from the study in 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients.
The most common adverse events with an incidence of at least 10% at the application site in Panretin gel-treated patients were; rash, pain, pruritus, and paraesthesia.
Please also see the Panretin Gel Full Prescribing Information.
Patients should consult their healthcare provider if they have any questions about, or are experiencing any side effects from, this product.
For more information about Panretin gel call Eisai Medical Services Oncology (877) 873-4724. To report suspected adverse reactions, call (877) 873-4724.
For more information on assistance with prescription drug costs that may be available to patients, call the Eisai Assistance Program at (866) 613-4724.
Panretin is a registered trademark of Eisai Inc.
CORP50
阿利维甲酸（alitretinoin）是一种能激活所有已知的细胞内维甲酸类受体亚型（RARα、RARβ、RARγ、RXRα、RXRβ和RXRγ）的内源性维甲酸。0．1％阿利维甲酸凝胶剂（商品名：Panretin）已于1999年被批准用于治疗皮肤卡波济肉瘤。尽管目前已对经口给予阿利维甲酸治疗卡波济肉瘤（和其他肿瘤）的效果进行了研究，且证明其有一定疗效，但阿利维甲酸的口服制剂尚未获得美国、日本以及欧盟的批准。在欧盟进行的一项Ⅲ期临床试验表明，口服阿利维甲酸对治疗慢性手部皮炎（湿疹）有效。如果得到批准，阿利维甲酸将成为第一个用于治疗慢性手部皮炎的口服药。Basilea制药公司已向欧洲和瑞士卫生署提出了将阿利维甲酸用于治疗重度顽固性慢性手部湿疹的上市申请