Tretinoin 10mg Capsules
WARNING: The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised and premature births have happened. Your doctor will talk about the risks before you start this drug. If you take this drug while you are pregnant, make sure that you know all the facts about the risks to the unborn baby.If you are able to get pregnant, you must use 2 kinds of birth control for 1 month before you start this drug, while you take it, and for 1 month after your last dose. A pregnancy test will be done to show that you are NOT pregnant before you start this drug and every month while you take it. If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away.If your sex partner may get pregnant, you may need to use birth control while you take this drug and for 1 week after your last dose. Talk with your doctor to see if you need to use birth control while you are taking this drug.This drug may cause a high white blood cell count. Sometimes, this can raise the chance of very bad and sometimes deadly health problems. You will be closely watched by your doctor.This drug may cause a severe and sometimes deadly health problem called differentiation syndrome (retinoic-acid-APL syndrome). Most of the time, this problem happens during the first month of taking this drug and sometimes after the first dose. Call your doctor right away if you have fever, shortness of breath or trouble breathing; swelling; weight gain; severe dizziness or passing out; signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes; or signs of kidney problems like not able to pass urine, change in how much urine is passed, or blood in the urine. @ COMMON USES: It is used to treat a type of leukemia.
Drug Class
Antineoplastic Agent
Pharmacologic Class
Retinoid; Vitamin A Derivative
Pregnancy Category
Category D
FDA Approved
Nov 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin 10mg capsules are a type of medicine related to Vitamin A. They are used to treat a specific type of blood cancer called Acute Promyelocytic Leukemia (APL). This medicine works by helping the abnormal cancer cells in your blood mature and function normally, rather than continuing to grow uncontrollably.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with a meal to help your body absorb it properly. Swallow the tablet whole - do not chew, break, open, or dissolve it. If you have difficulty swallowing the tablet whole, consult your doctor for guidance.
If you vomit after taking your medication, do not take an additional dose. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms and out of reach of children and pets. Properly dispose of any unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is less than 10 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with a meal to help your body absorb it properly. Swallow the tablet whole - do not chew, break, open, or dissolve it. If you have difficulty swallowing the tablet whole, consult your doctor for guidance.
If you vomit after taking your medication, do not take an additional dose. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms and out of reach of children and pets. Properly dispose of any unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is less than 10 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take this medicine exactly as prescribed by your doctor, usually with food to help absorption.
- Do NOT take extra Vitamin A supplements while on this medication, as it can lead to serious side effects.
- Avoid excessive sun exposure and use sunscreen, as tretinoin can increase sensitivity to sunlight.
- For females of childbearing potential: You MUST use two reliable forms of birth control (e.g., oral contraceptives and condoms) starting one month before, during, and for one month after stopping this medication, due to the very high risk of severe birth defects. You will also need regular pregnancy tests.
- For males: If your partner is pregnant or could become pregnant, you should use condoms during sexual activity while taking this medication and for one month after stopping it.
Available Forms & Alternatives
Available Strengths:
- Tretinoin 0.025% Cream 45gm
- Tretinoin Micro 0.1% Gel 20gm
- Tretinoin Micro 0.1% Gel 45gm
- Tretinoin Micro 0.1% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel 45gm
- Tretinoin Micro 0.04% Gel 20gm
- Tretinoin 10mg Capsules
- Tretinoin 0.01% Gel 45gm
- Tretinoin 0.1% Cream 45gm
- Tretinoin 0.05% Cream 45gm
- Tretinoin 0.05% Gel 45gm
- Tretinoin 0.025% Gel 45gm
- Tretinoin 0.01% Gel 15gm
- Tretinoin 0.025% Gel 15gm
- Tretinoin 0.05% Cream 20gm
- Tretinoin 0.025% Cream 20gm
- Tretinoin 0.1% Cream 20gm
- Tretinoin 0.08% Gel Pump 50gm
Dosing & Administration
Adult Dosing
Standard Dose:
45 mg/mΒ²/day orally, divided into two equal doses, until complete remission or for up to 90 days.
Condition-Specific Dosing:
Acute Promyelocytic Leukemia (APL):
45 mg/mΒ²/day orally, divided into two equal doses, until complete remission or for up to 90 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
45 mg/mΒ²/day orally, divided into two equal doses (similar to adults for APL).
Adolescent:
45 mg/mΒ²/day orally, divided into two equal doses (similar to adults for APL).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
Not specified, use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
Consider dose reduction or discontinuation if severe hepatic dysfunction develops.
Severe:
Consider dose reduction or discontinuation if severe hepatic dysfunction develops.
Pharmacology
Mechanism of Action
Tretinoin (all-trans retinoic acid, ATRA) induces differentiation and inhibits proliferation of human promyelocytic leukemia cells in vitro and in vivo. It binds to retinoic acid receptors (RARs), particularly RAR-alpha, which are involved in regulating gene expression and cellular differentiation. In APL, a specific chromosomal translocation (t(15;17)) results in a fusion protein (PML-RARΞ±) that blocks normal myeloid differentiation. Tretinoin overcomes this block, allowing the promyelocytes to mature into granulocytes.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, approximately 50-60%
Tmax:
1-2 hours
FoodEffect:
Absorption is increased when administered with food, especially fatty meals.
Distribution:
Vd:
Approximately 10-15 L/mΒ²
ProteinBinding:
>95% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier.
Elimination:
HalfLife:
0.5-2 hours (terminal half-life can be longer with repeated dosing due to autoinduction of metabolism)
Clearance:
High, approximately 1000-2000 mL/min/mΒ²
ExcretionRoute:
Primarily urine and feces (as metabolites)
Unchanged:
<1% (unchanged drug)
Pharmacodynamics
OnsetOfAction:
Clinical response (differentiation of promyelocytes) typically observed within weeks of initiation.
PeakEffect:
Not applicable in the same way as acute-acting drugs; effects are cumulative and sustained with continued dosing.
DurationOfAction:
Effects persist as long as adequate drug levels are maintained; clinical remission can be durable.
Safety & Warnings
BLACK BOX WARNING
Tretinoin is associated with a high risk of serious adverse events, including Differentiation Syndrome (formerly Retinoic Acid Syndrome), leukocytosis, and severe teratogenicity. Differentiation Syndrome is characterized by fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions, and can be fatal. Leukocytosis often occurs and may require treatment. Tretinoin is highly teratogenic and must not be used by pregnant women or women who may become pregnant during therapy. Effective contraception must be used by all females of childbearing potential during and for one month after treatment.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat or ear or sinus pain
+ Cough or increased sputum production (with a change in color)
+ Pain while urinating
+ Mouth sores or a wound that won't heal
Signs of lung or breathing problems, including:
+ Shortness of breath or difficulty breathing
+ Cough or fever
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance or coordination
Drooping on one side of the face or blurred vision
Changes in eyesight or hearing
Hearing loss
Abdominal swelling
Irregular heartbeat or palpitations
Burning, numbness, or tingling sensations
Depression or mood changes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion or hallucinations (seeing or hearing things that are not there)
Pale skin
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Hair loss
Flushing
Headache
Stomach pain
Bone, muscle, or side pain
Skin irritation
Dizziness, fatigue, or weakness
Dry mouth, eyes, skin, or lips
Excessive sweating
Mouth irritation or mouth sores
Anxiety
Sleep disturbances
Earache
Weight gain or loss
Decreased appetite
Shivering
* Symptoms of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat or ear or sinus pain
+ Cough or increased sputum production (with a change in color)
+ Pain while urinating
+ Mouth sores or a wound that won't heal
Signs of lung or breathing problems, including:
+ Shortness of breath or difficulty breathing
+ Cough or fever
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance or coordination
Drooping on one side of the face or blurred vision
Changes in eyesight or hearing
Hearing loss
Abdominal swelling
Irregular heartbeat or palpitations
Burning, numbness, or tingling sensations
Depression or mood changes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion or hallucinations (seeing or hearing things that are not there)
Pale skin
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Hair loss
Flushing
Headache
Stomach pain
Bone, muscle, or side pain
Skin irritation
Dizziness, fatigue, or weakness
Dry mouth, eyes, skin, or lips
Excessive sweating
Mouth irritation or mouth sores
Anxiety
Sleep disturbances
Earache
Weight gain or loss
Decreased appetite
Shivering
* Symptoms of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever, shortness of breath, unexplained weight gain, swelling (especially in legs or face), or chest pain (signs of Differentiation Syndrome - seek immediate medical attention).
- Severe headache, vision changes (blurry vision, double vision, loss of vision), nausea, or vomiting (signs of pseudotumor cerebri - seek immediate medical attention).
- Severe dry skin, cracked lips, hair loss, bone or joint pain, fatigue, or rash (signs of hypervitaminosis A).
- Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems).
- Unusual bleeding or bruising.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking any of the following medications:
+ Demeclocycline, doxycycline, minocycline, or tetracycline
+ Products containing vitamin A or similar substances
+ St. John's wort
+ Aminocaproic acid or tranexamic acid
* If you are breast-feeding, as you should not breast-feed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking any of the following medications:
+ Demeclocycline, doxycycline, minocycline, or tetracycline
+ Products containing vitamin A or similar substances
+ St. John's wort
+ Aminocaproic acid or tranexamic acid
* If you are breast-feeding, as you should not breast-feed while taking this medication and for 1 week after your last dose.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
This medication may cause increases in cholesterol and triglycerides levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor. Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition.
Common side effects of this medication include constipation, diarrhea, vomiting, and stomach upset. If you experience these side effects, consult your doctor about ways to minimize them. Immediately contact your doctor if these side effects are severe, persistent, or bothersome.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor. Be aware of the signs of a blood clot, which may include chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, as well as difficulty speaking or swallowing. If you experience any of these symptoms, contact your doctor right away.
This medication has also been linked to increased pressure in the brain, which can lead to permanent vision loss and, in severe cases, death. Seek immediate medical attention if you experience a severe headache, dizziness, stomach upset, vomiting, or seizures. Additionally, if you notice weakness on one side of your body, difficulty speaking or thinking, changes in balance, or vision changes, contact your doctor promptly.
When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.
It is not recommended to use progestin-only birth control pills (minipills) while taking this medication, as their effectiveness may be compromised. Consult your doctor for alternative birth control options.
If you miss a menstrual period, have unprotected sex, or suspect that your birth control has failed, contact your doctor immediately.
This medication may cause increases in cholesterol and triglycerides levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor. Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition.
Common side effects of this medication include constipation, diarrhea, vomiting, and stomach upset. If you experience these side effects, consult your doctor about ways to minimize them. Immediately contact your doctor if these side effects are severe, persistent, or bothersome.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor. Be aware of the signs of a blood clot, which may include chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, as well as difficulty speaking or swallowing. If you experience any of these symptoms, contact your doctor right away.
This medication has also been linked to increased pressure in the brain, which can lead to permanent vision loss and, in severe cases, death. Seek immediate medical attention if you experience a severe headache, dizziness, stomach upset, vomiting, or seizures. Additionally, if you notice weakness on one side of your body, difficulty speaking or thinking, changes in balance, or vision changes, contact your doctor promptly.
When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.
It is not recommended to use progestin-only birth control pills (minipills) while taking this medication, as their effectiveness may be compromised. Consult your doctor for alternative birth control options.
If you miss a menstrual period, have unprotected sex, or suspect that your birth control has failed, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe headache
- Nausea
- Vomiting
- Dizziness
- Visual disturbances
- Skin peeling
- Bone pain
- Dry mucous membranes
What to Do:
In case of suspected overdose, seek emergency medical attention immediately or call a poison control center (1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Vitamin A supplements (risk of hypervitaminosis A)
- Tetracyclines (risk of pseudotumor cerebri)
Major Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, grapefruit juice) - may increase tretinoin levels and toxicity.
- CYP3A4 inducers (e.g., phenobarbital, phenytoin, rifampin, carbamazepine) - may decrease tretinoin levels and efficacy.
- Gemtuzumab ozogamicin (increased risk of APL differentiation syndrome).
Moderate Interactions
- Other retinoids (additive toxicity)
- Drugs that prolong QT interval (use with caution, as tretinoin can rarely cause QT prolongation).
Minor Interactions
- Not many specific minor interactions listed; general caution with drugs affecting liver metabolism.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline leukocyte, platelet, and red blood cell counts, crucial for APL management and monitoring differentiation syndrome.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST, bilirubin, alkaline phosphatase)
Rationale: To assess baseline hepatic function due to hepatic metabolism and potential for hepatotoxicity.
Timing: Prior to initiation of therapy.
Renal Function Tests (BUN, creatinine)
Rationale: To assess baseline renal function.
Timing: Prior to initiation of therapy.
Lipid Profile (cholesterol, triglycerides)
Rationale: To assess baseline lipid levels, as tretinoin can cause hyperlipidemia.
Timing: Prior to initiation of therapy.
Pregnancy Test (for females of childbearing potential)
Rationale: To confirm non-pregnant status due to severe teratogenicity.
Timing: Within 1 week prior to initiation of therapy.
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac function, especially given the risk of differentiation syndrome and potential for QT prolongation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Daily during induction therapy, then weekly or bi-weekly during maintenance/consolidation.
Target: Normal ranges, monitoring for changes indicative of differentiation syndrome (e.g., leukocytosis).
Action Threshold: Significant leukocytosis (>5 x 10^9/L) may require initiation of chemotherapy or corticosteroids; rapid changes in counts require immediate evaluation.
Liver Function Tests (ALT, AST, bilirubin)
Frequency: Weekly during induction therapy, then monthly or as clinically indicated.
Target: Normal ranges.
Action Threshold: Elevations >2-3x ULN may require dose modification or interruption; severe elevations require discontinuation.
Lipid Profile (cholesterol, triglycerides)
Frequency: Weekly during induction therapy, then monthly or as clinically indicated.
Target: Normal ranges.
Action Threshold: Significant elevations may require dietary modification, lipid-lowering agents, or dose adjustment.
Symptoms of Differentiation Syndrome
Frequency: Daily clinical assessment.
Target: Absence of symptoms.
Action Threshold: Fever, dyspnea, weight gain, pulmonary infiltrates, hypotension, renal failure, or unexplained fever/pain require immediate evaluation and potential corticosteroid therapy.
Pregnancy Test (for females of childbearing potential)
Frequency: Monthly during therapy and for 1 month after discontinuation.
Target: Negative.
Action Threshold: Positive test requires immediate discontinuation of tretinoin and referral to a specialist.
Symptom Monitoring
- Signs and symptoms of Differentiation Syndrome (fever, dyspnea, weight gain, pulmonary infiltrates, pleural/pericardial effusions, hypotension, renal failure, hepatic dysfunction)
- Signs and symptoms of Pseudotumor Cerebri (severe headache, visual disturbances, papilledema, nausea, vomiting)
- Signs and symptoms of Hypervitaminosis A (dry skin, cheilitis, hair loss, headache, bone pain, fatigue, rash)
- Cardiac symptoms (chest pain, palpitations, shortness of breath)
- Neurological changes (dizziness, confusion, seizures)
Special Patient Groups
Pregnancy
Contraindicated. Tretinoin is a potent human teratogen and can cause severe and life-threatening birth defects. Females of childbearing potential must use two effective forms of contraception and have negative pregnancy tests before, during, and after treatment.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects, including craniofacial, central nervous system, cardiovascular, and thymic abnormalities.
Second Trimester:
Significant risk of birth defects.
Third Trimester:
Significant risk of birth defects.
Lactation
Contraindicated. It is not known if tretinoin is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for one month after the last dose.
Infant Risk:
High (potential for serious adverse effects).
Pediatric Use
Dosing for pediatric patients with APL is typically based on body surface area (45 mg/mΒ²/day), similar to adults. Close monitoring for adverse effects, particularly pseudotumor cerebri, is crucial.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, caution is advised due to the increased likelihood of comorbidities, polypharmacy, and potential for increased sensitivity to adverse effects in this population.
Clinical Information
Clinical Pearls
- Systemic tretinoin (ATRA) is a cornerstone of treatment for Acute Promyelocytic Leukemia (APL), often used in combination with chemotherapy or arsenic trioxide.
- The most critical adverse event is Differentiation Syndrome (formerly Retinoic Acid Syndrome), which can be life-threatening. Early recognition and prompt treatment with corticosteroids (e.g., dexamethasone) are essential.
- Strict adherence to pregnancy prevention measures is paramount for females of childbearing potential due to extreme teratogenicity.
- Monitor for signs of pseudotumor cerebri (idiopathic intracranial hypertension), especially in children, which presents with severe headache, visual disturbances, and papilledema.
- Administer tretinoin capsules with food to optimize absorption.
- Leukocytosis is common during induction therapy and may require concurrent chemotherapy.
- Tretinoin can cause hyperlipidemia; monitor lipid profiles regularly.
- This systemic formulation is distinct from topical tretinoin used for acne or wrinkles and oral isotretinoin (Accutane) used for severe acne, though all are retinoids.
Alternative Therapies
- Arsenic Trioxide (ATO) for APL (especially low-risk APL)
- Chemotherapy regimens (e.g., anthracyclines, cytarabine) for APL (often in combination with tretinoin)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 100 capsules (10mg)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (Tier 4 or 5) due to its specific oncology indication and cost.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.