Acretin 0.05% Cream

Tretinoin capsules are 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. …

• The recommended dosage of tretinoin capsules is 22.5 mg/m 2 orally twice daily until complete remission. • Discontinue 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first
• Important Safety Information Verify pregnancy status in females of reproductive potential prior to initiating tretinoin capsules
• Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules [see Use in Specific Populations ]
• Recommended Dosage The recommended dosage of tretinoin capsules is 22.5 mg/m 2 orally twice daily until complete remission is documented
• Discontinue tretinoin capsules 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first
• Discontinue tretinoin capsules if the t(15;17) translocation or PML/RARα fusion has not been identified [see Warnings and Precautions ]
• Take tretinoin capsules with a meal
• Swallow tretinoin capsules whole with water
• Do not chew, dissolve, or open capsule
• Do not take a missed dose of tretinoin capsules unless it is more than 10 hours until the next scheduled dose
• If vomiting occurs after tretinoin capsules administration, do not take an additional dose, but continue with the next scheduled dose
• Important Safety Information Verify pregnancy status in females of reproductive potential prior to initiating tretinoin capsules
• Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules [see Use in Specific Populations ] . …

Capsules: 10 mg, two-tone (lengthwise) with reddish-brown opaque and yellow gelatin shell, imprinted with “TR” with black ink on the yellow side. Capsules: 10 mg ( 3 )

• Safety and effectiveness of tretinoin capsules have been established
• In pediatric patients 1 year of age and older and the information on this use is discussed throughout the labeling
• The maximum tolerated dose is lower
• In pediatric patients compared to adults
• Some
• Pediatric patients experience severe headache and intracranial hypertension, which required management with an analgesic and a lumbar puncture
• Dose reduction may be considered for pediatric patients experiencing serious and/or intolerable adverse reactions. …

Across clinical studies of tretinoin capsules, 21% were 60 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

• Embryo-Fetal Toxicity Advise female patients of the potential risk to a fetus
• Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions and Use in Specific Populations ]
• Advise females of reproductive potential to use 2 methods of effective contraception during treatment with tretinoin capsules and for 1 month after the last dose [see Use in Specific Populations ]
• Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose [see Use in Specific Populations ] . …

• Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids
• Reactions have included rash, pruritus, face edema, and dyspnea [see Adverse Reactions ]
• Hypersensitivity to tretinoin capsules, any of its components, or other retinoids

• Strong CYP3A Inhibitors and Inducers: Avoid coadministration with strong CYP3A inhibitors and inducers. ( 7.1 ) • Concomitant Use of Products Known to Cause Intracranial Hypertension : Avoid concomitant use with other products that can cause intracranial hypertension. ( 7.2 ) • Vitamin A : Avoid concomitant use with vitamin A. ( 7.3 ) • Anti-fibrinolytic Agents : Avoid concomitant use with anti-fibrinolytic agents. ( 7.4 ) 7.1 Effects of Other Drugs on Tretinoin Capsules Strong or moderate CYP3A Inhibitors Avoid concomitant use of tretinoin capsules with strong CYP3A inhibitors if possible and monitor more frequently if concomitant use is unavoidable. …

• Patients Without t(15;17) Translocation or PML/RARα Fusion: Tretinoin capsules may be initiated based on morphological diagnosis of APL. Confirm diagnosis by detection of the t(15;17) translocation or PML/RARα fusion. ( 5.3 ) • Leukocytosis: Consider administering cytoreductive chemotherapy (including an anthracycline if not contraindicated or hydroxyurea) with tretinoin capsules in the setting of leukocytosis, as clinically indicated. ( 5.4 ) • Intracranial Hypertension: Tretinoin capsules have been associated with benign intracranial hypertension, especially in pediatric patients. Consider interruption, dose reduction, or discontinuation of tretinoin capsules as appropriate. …

The following clinically significant adverse reactions are described elsewhere in the labeling: • Differentiation Syndrome [see Warnings and Precautions ( 5.2 )] • Leukocytosis [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions (5.5)] • Lipid abnormalities [see Warnings and Precautions ( 5.6 )] • Hepatotoxicity [see Warnings and Precautions ( 5.7 )] • Thromboembolic events [see Warnings and Precautions (5 .8 )] The most common adverse reactions (≥30%) are headache, fever, skin/mucous membrane dryness, bone pain, malaise, shivering, upper respiratory tract disorders, dyspnea, hemorrhage, infections, nausea/vomiting, rash, peripheral edema, leukocy …

8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology ( 12.1 )], tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans. …

In case of overdose with tretinoin capsules, reversible signs of hypervitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects. There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit.

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.