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Vesanoid

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Vesanoid

VESANOID®
(tretinoin) Capsules

WARNINGS

1. Experienced Physician and Institution

Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to VESANOID (tretinoin). VESANOID (tretinoin) should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and in a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise. Use of VESANOID (tretinoin) requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy.

2. Retinoic Acid-APL Syndrome

About 25% of patients with APL treated with VESANOID (tretinoin) have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of VESANOID (tretinoin) .

The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. At the first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of the leukocyte count. The majority of patients do not require termination of VESANOID (tretinoin) therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of VESANOID (tretinoin) therapy should be considered.

3. Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During VESANOID (tretinoin) Treatment

During VESANOID (tretinoin) treatment about 40% of patients will develop rapidly evolving leukocytosis. Patients who present with high WBC at diagnosis (>5x109/L) have an increased risk of a further rapid increase in WBC counts. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.

If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some investigators routinely add chemotherapy to VESANOID (tretinoin) treatment in the case of patients presenting with a WBC count of >5x109/L or in the case of a rapid increase in WBC count for patients leukopenic at start of treatment, and have reported a lower incidence of the RA-APL syndrome. Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the VESANOID (tretinoin) therapy on day 1 or 2 for patients presenting with a WBC count of >5x109/L, or immediately, for patients presenting with a WBC count of <5x109/L, if the WBC count reaches ≥ 6x109/L by day 5, or ≥ 10x109/L by day 10, or ≥ 15x109/L by day 28.

4. Teratogenic Effects. Pregnancy Category D - see WARNINGS

There is a high risk that a severely deformed infant will result if VESANOID (tretinoin) is administered during pregnancy. If, nonetheless, it is determined that VESANOID (tretinoin) represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence is the chosen method

Within 1 week prior to the institution of VESANOID (tretinoin) therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. When possible, VESANOID (tretinoin) therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of VESANOID (tretinoin) treatment.

DRUG DESCRIPTION

VESANOID (tretinoin) is a retinoid that induces maturation of acute promyelocytic leukemia (APL) cells in culture. It is available in a 10 mg soft gelatin capsule for oral administration. Each capsule also contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oils and soybean oil. The gelatin capsule shell contains glycerin, yellow iron oxide, red iron oxide, titanium dioxide, methylparaben and propylparaben.

Chemically, tretinoin is all-trans retinoic acid and is related to retinol (Vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44.

The structural formula is as follows:

VESANOID® (tretinoin) Structural Formula Illustration

What are the possible side effects of tretinoin (Vesanoid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, breathing problems, weight gain, swelling of your hands or feet;
  • sudden and severe pain behind your eyes, with nausea, vomiting, and vision problems;
  • black, bloody, or tarry stools; or
  • vomit that looks like blood or coffee grounds.

Less serious side effects may include:

  • feeling tired or...

Read All Potential Side Effects and See Pictures of Vesanoid »

What are the precautions when taking tretinoin (Vesanoid)?

Before taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A or related drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, paraben preservatives), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high cholesterol/triglycerides (blood fats).

This drug may cause dizziness, severe headaches, or vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely....

Read All Potential Precautions of Vesanoid »

Last reviewed on RxList: 9/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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