Vesanoid - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Vesanoid

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 11 900 rub.

Buy

Vesanoid is an anticancer drug, a natural metabolite of retinol, belongs to the class of retinoids.

Release form and composition

Vesanoid dosage form - capsules: oval (length 8.8-11.2 mm; diameter 5.8-8.2 mm), soft gelatinous, opaque, one half of the capsule is yellow-orange, the other is reddish-brown; filling of capsules - yellow or greenish-yellow suspension (100 pcs. in amber glass vials, screwed with a polyethylene cap with first opening control, 1 vial in a cardboard box).

Composition of 1 capsule:

• active substance: tretinoin - 10 mg;
• auxiliary components: yellow beeswax, soybean oil, hydrogenated soybean oil, partially hydrogenated soybean oil;
• capsule shell: gelatin, glycerol 85%, Karion 83 (hydrolyzed potato starch, sorbitol, mannitol), titanium dioxide, iron oxide dyes yellow and red.

Indications for use

Vesanoid is used to induce remission in patients with acute promyelocytic leukemia - AML according to the FAB - AML-M3 classification, both in previously untreated patients and for the treatment of cases of relapse or patients refractory to standard chemotherapy (daunorubicin, cytarabine or their analogs).

Contraindications

Absolute:

• pregnancy and the period of breastfeeding (lactation);
• complex application with vitamin A;
• identified sensitization to tretinoin and / or other components of the drug.

With caution, Vesanoid is taken simultaneously with tetracyclines, antifibrinolytic drugs and tablet forms of gestagen-containing contraceptives (mini-pills).

Method of administration and dosage

The capsules are taken orally, dividing the daily dose into 2 doses.

The recommended daily dose is 45 mg / m2 ^of body surface, which for adult patients is ~ 8 capsules. The same dose of Vesanoid is recommended for children unless severe intoxication occurs. When a child develops severe headaches, the dose must be reduced.

The therapy continues from one to three months, depending on the achievement of complete remission, after which they immediately switch to the standard regimen of consolidation chemotherapy (for example, 3 courses of treatment with daunorubicin and cytarabine are carried out with an interval of 5-6 weeks).

If remission occurs during monotherapy with tretinoin, there is no need to change its dose when chemotherapy is started.

Patients with hepatic / renal insufficiency dose should be reduced to 25 mg / m ² (~ 4-5 capsules) per day.

Side effects

When the recommended dosage regimen was observed, the most common side effects characteristic of hypervitaminosis A, which also occur in the case of taking any other retinoids.

Retinoic acid syndrome (IBS) in AML can develop with tretinoin therapy in ≤ 25% of patients. The characteristic symptoms of the condition are: fever, shortness of breath, acute respiratory distress syndrome, the formation of pulmonary infiltrates, arterial hypotension, pleural and pericardial effusion, edema, weight gain, hepatic, renal and multiple organ failure. Quite often, IBS is accompanied by hyperleukocytosis, as a result of which the development of the syndrome can be fatal.

Other side effects observed on the part of organs and systems during Vesanoid therapy:

• skin and its appendages: erythema, dryness, rash, itching, hyperhidrosis, cheilitis, alopecia; dryness of the mucous membranes of the nasal and oral cavity, conjunctiva, other mucous membranes with or without signs of inflammation; in rare cases - ulceration of the genital mucosa, erythema nodosum, Sweet's syndrome;
• sense organs: hearing and vision impairments;
• central nervous system (CNS): intracranial hypertension, mainly observed in children, headache, dizziness, weakness, chills, fever, confusion, agitation, anxiety, paresthesia, insomnia, depression;
• musculoskeletal system: pain in the chest and bones; in rare cases, myositis;
• gastrointestinal tract (GIT): abdominal pain, nausea / vomiting, loss of appetite, diarrhea / constipation, pancreatitis;
• metabolism, liver and kidneys: an increase in the concentration of creatinine, cholesterol, triglycerides in the blood serum, an increase in the activity of liver enzymes; in some cases - hypercalcemia;
• respiratory organs: shortness of breath, bronchospasm, pleural effusion, respiratory failure;
• cardiovascular system (CVS): heart rhythm disturbances, edema, hot flashes; in some cases - thrombosis (venous / arterial);
• hematopoietic system: in rare cases - thrombocytosis, severe basophilia with clinically manifested hyperhistaminemia or without it (mainly in patients with a rare variant of APML with basophilic differentiation);
• the body as a whole: in rare cases - cutaneous vasculitis.

The decision to continue or interrupt the Vesanoid course should be made by the attending physician based on an assessment of the ratio of the benefits of therapy to the severity of side effects.

There are limited data on the use of tretinoin in childhood; an increase in toxic reactions in children, in particular, intracranial hypertension, has been reported.

Overdose symptoms are reversible reactions characteristic of hypervitaminosis A, such as nausea and / or vomiting, headache, skin and mucous membrane lesions. Dose tretinoin adopted for the treatment of acute promyelocytic leukemia, is ¹ / ₄ of the maximum tolerated dose in patients with solid tumors, and at the maximum tolerated dose in children. There is no specific therapy for an overdose, but in such a situation, the patient should be placed in the hematology department.

special instructions

The drug is prescribed only for patients with acute promyelocytic leukemia, therapy is carried out under the close supervision of an oncologist or hematologist.

With hyperleukocytosis, manifested against the background of monotherapy with Vesanoid, it is required to carry out the prevention of IBS with the connection of full-dose chemotherapy with anthracyclines, carried out under the control of the level of leukocytes according to the following recommended scheme:

1. Immediately start treatment if, against the background of the combined use of tretinoin and chemotherapy, the white blood cell count is ≥ 5000 / μl.
2. Connect full-dose chemotherapy to the Vesanoid treatment course in patients with leukocyte count <5000 / μl at the time of diagnosis, if leukocytosis increases to ≥ 6000 / μl on days 1-6 of therapy, ≥ 10,000 / μl - on days 7-10 days of therapy, ≥ 15,000 / μl - on days 11–28 of therapy.
3. Start a course of dexamethasone therapy (10 mg once every 12 hours for a maximum of three days or until the syndrome stops) in case of the earliest signs of IBS.
4. Consider temporarily discontinuing therapy for moderate to severe IBS.

Due to the increased risk of thrombosis in the first month of tretinoin treatment, caution should be exercised when using Vesanoid in combination with antifibrinolytics such as tranexamic and aminocaproic acids or aprotinin.

When treating AML with tretinoin, it is important to carry out supportive measures, such as anti-infective therapy and prevention of bleeding. Frequent monitoring of the blood picture, blood clotting indicators, liver function, cholesterol and triglyceride concentrations is required.

The ability to increase concentration of attention and increase the speed of psychomotor reactions during treatment with Vesanoid can be impaired, especially with the appearance of such side reactions as severe headaches or dizziness. Therefore, patients should refrain from driving or engaging in other potentially hazardous activities.

Drug interactions

• inducers that stimulate the activity of hepatic enzymes of the cytochrome P _{450 system} (glucocorticosteroids, rifampicin, phenobarbital, pentobarbital): there is a possibility of changing the pharmacokinetic interaction;
• inhibitors that inhibit the activity of hepatic enzymes of the P ₄₅₀ system (ketoconazole, cimetidine, erythromycin, verapamil, diltiazem, and cyclosporin): there is no evidence of a clinically significant mutual change in the effectiveness or toxicity of these drugs;
• daunorubicin and cytarabine: there is no data on a possible pharmacokinetic interaction with tretinoin;
• antifibrinolytics (tranexamic and aminocaproic acids, aprotinin): in rare cases, fatal thrombotic complications are possible (caution must be exercised when used together with tretinoin);
• tetracyclines: together with retinoids for systemic use can lead to intracranial hypertension (simultaneous use with tretinoin is not recommended);
• vitamin A: it (and other retinoids) is contraindicated for combined use with Vesanoid due to increased symptoms of hypervitaminosis A;
• progestin-only contraceptives (mini-pills) for oral use: the reliability of the contraceptive action of mini-pills decreases.

Analogs

There is no information about Vesanoid's analogues.

Terms and conditions of storage

Store in a dark place at a temperature not exceeding 30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Vesanoid: prices in online pharmacies

Drug name Price Pharmacy

Vesanoid 10 mg capsule 100 pcs. RUB 11,900 Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!