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VESANOID is a brand name for Tretinoin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vesanoid (tretinoin, also known as all-trans retinoic acid [ATRA]) is indicated for: induction of remission in acute promyelocytic leukemia (APL; FAB classification AML-M3). Previously untreated patients, as well as patients who relapsed after, or were refractory to standard chemotherapy (daunomycin and cytosine…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Due to limited information on patients with hepatic and/or renal insufficiency, the dose should be decreased to 25 mg/m2 as a precautionary measure. Rule out pregnancy prior to administration. 1 Pregnant Women.
2 Recommended Dose and Dosage Adjustment Recommended Dose A total daily dose of 45 mg/m2 body surface divided in two equal doses is recommended for oral administration to APL patients, including pediatric and geriatric patients. This is approximately 8 capsules per adult dose.
Treatment should be continued for 30 to 90 days until complete remission has been achieved. After completion of remission, a course of consolidation chemotherapy including anthracycline and cytosine arabinoside should be initiated immediately; for example, three courses in 5 to 6 weeks intervals.
If there has been a remission with tretinoin alone, it is not necessary to modify the dose of tretinoin if tretinoin is used with chemotherapy. Dosage Adjustment In cases of moderate and severe differentiation syndrome, temporary interruption of tretinoin therapy should be considered (see 7 WARNINGS AND PRECAUTIONS, General).
The treatment with tretinoin may need to be withheld during the initial acute symptomatic period but may be resumed when symptoms resolve. If intracranial hypertension/pseudotumor cerebri occur, a dose reduction of tretinoin is recommended Vesanoid (tretinoin) Page 6 of 25 (see 7 WARNINGS AND PRECAUTIONS, Neurologic).
3 Pediatrics). The decision to interrupt or continue therapy should be based on an evaluation of the benefit of the treatment versus the severity of the side effects.
Pediatrics:
There is limited safety and efficacy information on the use of tretinoin in children. For children the same treatment regimen as for adults is applicable. The optimal pediatric dose of tretinoin has not yet been established. In an attempt to reduce tretinoin related toxicity, the daily dose administered in children can be reduced to 25 mg/m2.
3 Pharmacokinetics). The need for dosage adjustment in patients with renal or hepatic impairment is unknown; however, a reduction of dose to 25 mg/m2 is recommended as a precautionary measure. 4 Administration The capsules should be swallowed whole with water.
). 1 Serious Drug Interactions). Myocarditis Myocarditis was reported in APL patients treated with tretinoin and was commonly observed in patients experiencing DS. The most common symptoms of myocarditis included chest pain, dyspnea, fatigue, palpitations, and syncope.
Additionally, increased troponin and creatinine kinase values, changes in electrocardiogram with ST-segment elevation, decreased left ventricular ejection fraction, increased wall thickness and pericardial effusion were observed. In patients experiencing myocarditis, symptoms most often occurred within the first days of induction treatment, but in some patients, symptoms occurred only after 3 weeks of treatment.
In all cases, urgent treatment is required as myocarditis may be fatal. Possible treatment options are similar to the treatment of the DS and include glucocorticoid therapy and temporary interruption of tretinoin therapy. Driving and Operating Machinery The ability to drive or operate machinery might be impaired in patients treated with tretinoin, particularly if they are experiencing dizziness or severe headache.
Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Hematologic Hyperleukocytosis Patients experiencing hyperleukocytosis should be treated with full-dose anthracycline-based chemotherapy. Immediate treatment of patients with white blood cell (WBC) count of ≥ 5 x 109/L at diagnosis or during any time of therapy is recommended.
000/μL. Hepatic/Biliary/Pancreatic The pharmacokinetics of tretinoin in patients with compromised liver function have not been studied. As with other retinoids, the need for dosage adjustments in patients with hepatic impairment is unknown, however, a reduction of dose to 25 mg/m2 is recommended as a precautionary measure.
Monitoring and Laboratory Tests Because hypercalcaemia may occur during therapy, serum calcium levels should be monitored. The patient’s hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently.
, Cardiovascular 11/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 11/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ............................................................................................................
2 Geriatrics ............................................................................................................ 4 2 CONTRAINDICATIONS...................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration .................................................................................................... 5 Missed Dose ........................................................................................................
6 5 OVERDOSAGE ............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING................................... 7 7 WARNINGS AND PRECAUTIONS....................................................................................
Tretinoin is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Tretinoin is highly teratogenic; therefore, it is contraindicated during pregnancy and in nursing mothers. 1 Pregnant women). The use of tretinoin in combination with vitamin A, tetracyclines and other retinoids is contraindicated (See 9 DRUG INTERACTIONS).
Vesanoid (tretinoin) Page 5 of 25
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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They should not be chewed. It is recommended to take the capsules with a meal or shortly thereafter. 5 Missed Dose If a dose is missed, it should be taken within 6 hours of the initially missed dose. If 6 hours have passed since the initially missed dose, the dose should be omitted, and the regular dosing schedule should be continued.
Neurologic Tretinoin may cause intracranial hypertension/pseudotumor cerebri. The concomitant use of other agents known to cause intracranial hypertension/pseudotumor cerebri such as tetracyclines might increase the risk of this condition (See
1 Special Populations.............................................................................................. 2 Breast-feeding ............................................................................................. 3 Pediatrics.....................................................................................................
4 Geriatrics ..................................................................................................... 10 8 ADVERSE REACTIONS..................................................................................................
1 Adverse Reaction Overview ............................................................................... 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................
1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data........................................................................................................
5 Post-Market Adverse Reactions ......................................................................... 13 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions...................................................................................
2 Drug-Interactions Overview ............................................................................... 4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions......................................................................................
6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions...................................................................... 15 10 CLINICAL PHARMACOLOGY.........................................................................................
1 Mechanism of Action ................................................................................... 2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics.........................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL........................................................................... 17 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 17 PART II: SCIENTIFIC INFORMATION ........................................................................................
17 13 PHARMACEUTICAL INFORMATION ............................................................................. 17 14 CLINICAL TRIALS .........................................................................................................
18 15 MICROBIOLOGY.......................................................................................................... 18 16 NON-CLINICAL TOXICOLOGY .......................................................................................
19 PATIENT MEDICATION INFORMATION ................................................................................... 20 Vesanoid (tretinoin) Page 4 of 25 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Vesanoid (tretinoin, also known as all-trans retinoic acid [ATRA]) is indicated for: induction of remission in acute promyelocytic […]