Vesanoid Prescribing Information
- VESANOID can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating VESANOID. Advise females of reproductive potential to use two effective methods of contraception during treatment with VESANOID and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with VESANOID and for 1 week after the last dose[see Warnings and Precautions (5.1), Use in Specific Populations ].
- Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received VESANOID. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding VESANOID for moderate and severe Differentiation Syndrome until resolution[see Warnings and Precautions ].
VESANOID is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
Capsules: 10 mg, two-tone (lengthwise) with orange-yellow and reddish-brown, imprinted with “10 mg” in black ink
VESANOID is contraindicated in patients with a known hypersensitivity to VESANOID, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Differentiation Syndrome [see Warnings and Precautions ]
- Leukocytosis [see Warnings and Precautions ]
- Intracranial hypertension [see Warnings and Precautions ]
- Lipid abnormalities [see Warnings and Precautions ]
- Hepatotoxicity [see Warnings and Precautions ]
- Thromboembolic events [see Warnings and Precautions ]
Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C20H28O2 and the molecular weight is 300.44 g/mol. The structural formula is:
It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%).
VESANOID (tretinoin) is available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and refined soya-bean oil. The capsule shell contains gelatin, glycerol (85%), dry substance of Karion 83, titanium dioxide, yellow iron oxide, red iron oxide and traces of monogramming ink.