💊 Medicine Name:
All-trans Retinoic Acid (ATRA)
Also known as: Tretinoin (oral formulation)
🧪 Formulation:
Capsule, Oral Use
💪 Strength:
10 mg
📜 Description:
All-trans retinoic acid is a vitamin A derivative used primarily in oncology, especially for Acute Promyelocytic Leukemia (APL). It promotes the differentiation of immature promyelocytes into mature blood cells, correcting the abnormal cell proliferation seen in APL.
🧾 Prescription:
Prescription-only (Rx)
Must be administered under the supervision of an oncologist or hematologist.
⚙️ Mechanism of Action:
- Binds to retinoic acid receptors (RARs) in the nucleus.
- Alters gene expression to induce differentiation of promyelocytic leukemia cells.
- Reduces leukemic cell burden and facilitates remission.
🎯 Indications / Uses:
- Acute Promyelocytic Leukemia (APL)
(characterized by t(15;17) translocation)
✅ Used alone or in combination with arsenic trioxide or chemotherapy depending on risk stratification.
💡 Advantages:
- Highly effective in achieving remission in APL.
- Helps avoid or reduce need for intensive chemotherapy in some protocols.
- Oral formulation makes outpatient management easier.
📦 Common Packaging:
- Blister strips or bottles containing 10 mg soft gelatin capsules
- Often supplied in 30-capsule packs
- Labeled: “Cytotoxic – Handle with care”
💉 Dosage & Administration:
- Typical adult dose: 45 mg/m²/day, divided into 2 doses
- Taken with food to enhance absorption.
- Duration: Often continued for 30–90 days or until hematologic remission is achieved.
- Dosage adjusted in pediatric patients or based on body surface area (BSA).
🧊 Storage:
- Store at 20–25°C (68–77°F)
- Protect from light and moisture
- Keep capsules in original container until use.
⚠️ Precautions:
- Teratogenic – Strict contraception required before, during, and after treatment.
- Monitor for:
- Differentiation syndrome (fever, edema, respiratory distress)
- Liver function (AST/ALT)
- WBC counts
- Triglyceride/cholesterol levels
🤒 Side Effects:
- Headache, dry skin, cheilitis
- Bone pain
- Fever, fatigue
- Hyperlipidemia
- Hepatotoxicity
- Differentiation syndrome (potentially life-threatening)
🚨 Black Box Warning:
- Pregnancy Category X: Can cause severe birth defects.
→ Mandatory use of two forms of contraception during and for at least 1 month after treatment.
→ Pregnancy test required before starting.
👨⚕️ Patient Advice:
- Do not get pregnant – use contraception reliably.
- Take with food to minimize nausea and improve absorption.
- Do not donate blood during or shortly after therapy.
- Report signs of:
- Sudden weight gain or swelling (→ possible differentiation syndrome)
- Persistent headaches or vision changes
- Unusual bleeding or infection