Posted on April 28th, 2009 by
Generic Name: Tretinoin (TRE-ti-noyn), All-trans retinoic acid, ATRA
Trade Name: Vesanoid®
How is this drug used? Tretinoin is FDA approved for the treatment of acute promyelocytic leukemia that has not responded to other standard treatments. However, physicians often prescribe a drug for treatment of medical conditions other than its specific FDA approval. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Tretinoin belongs to a class of agents referred to as retinoids. Retinoids are related to vitamin A and play a part in controlling growth, maturation and death of a cell. Tretinoin binds to specific retinoid receptors in a cancer cell and affects cellular growth and maturation.
How is tretinoin given (administered)? Tretinoin is given in capsule form orally and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. It may also be in lotion form that is placed on the skin for treatment of acne or certain rashes.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with tretinoin. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. In addition, blood levels of fat and cholesterol will also be evaluated prior to and during treatment for all patients treated with tretinoin.
Patients treated with tretinoin will be monitored closely for a serious side effect that may occur referred to as APL differentiation syndrome. The syndrome causes high fever, difficulty breathing, lung and heart problems, organ dysfunction and sudden weight gain. APL differentiation syndrome often occurs within the first month of treatment, and may occur following the first dose. It can be treated with high-dose steroids and treatment with tretinoin often continues. It is extremely important that patients contact their healthcare provider immediately if they experience fever, difficulty breathing, chest pain, a noticeable change in heart rate or rhythm, dizziness or sudden weight gain.
Women treated with tretinoin will also be tested for pregnancy prior to treatment and regularly during treatment as this drug is known to cause birth defects.
What are the common (occur in 30% or more of patients) side effects of treatment with tretinoin?
• Weakness or fatigue
• Dry skin
• Dry mouth, dry nose
• Bone pain
• Mouth sores
• Swelling of feet or ankles
• Abdominal pain
• Bone pain
• Joint pain
• Unexplained bleeding (i.e. nosebleeds or bruising)
• Nausea and vomiting
• Increased in cholesterol and triglyceride levels
• Increased in liver function test results
• Diffficulty breathing
What are the less common (occur in 10% to 29% of patients) side effects of treatment with tretinoin?
• Heart rate or rhythm changes, chest discomfort
• Loss of appetite
• Weight loss
• Weight gain
• High blood pressure
• Low blood pressure
• Difficulty sleeping
• Numbness or tingling of hands and feet
• Earache or ear discomfort
• Redness of the face or neck
• Sensitivity to sunlight
• Agitation, anxiety
• Changes in eyesight
• Itching or dry eyes
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug causes birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Tretinoin is known to cause birth defects. Therefore, patients must use extreme caution against conceiving a child. Women should use two forms of birth control or practice complete abstinence.
• Patients should not dissolve, crush or chew tretinoin capsules.
• Keep tretinoin capsules away from light
• If patients miss a dose of tretinoin, they should not double up on the next dose, but contact their healthcare provider.
• Since tretinoin is related to vitamin A, patients should be particularly careful of any supplement that contains extra doses of vitamin A. Patients should discuss this with their healthcare provider.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
• Patients should use caution when driving or completing tasks that require mental alertness until effects of the drug are known, as they may experience fatigue, vision changes, and confusion.
• Patients with dry, irritated eyes may want to avoid wearing contact lenses.
When should patients notify their physician?
• Sudden weight gain
• Difficulty breathing
• Chest pain
• Heart rate or rhythm changes
• Prolonged diarrhea or constipation
• Prolonged nausea and vomiting
• Vision changes
• Bleeding, including black, tarry stools, blood in the urine, nosebleeds, etc.
• Severe abdominal pain, particularly right after a meal
• Yellowing of the skin or eyes
• Mouth sores
• Skin rash, hives or itching
• Signs of infection (fever, chills, sore throat, cough)
• Dizziness, confusion, depression, agitation, hallucinations, seizures, slow speech
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. Click here to view the package insert
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