Manufactor:Bigbear Pharmaceutical Laos
Introduction:PONADX (Ponatinib) 15mg / 45mg 30 Film-Coated Tablets Third-generation tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 (including T315I mutation), VEGFR, PDGFR, FGFR, SRC.
Indications:
● Treatment of chronic myeloid leukemia (CML) in adults (Ph+ ALL, T315I mutation-positive).
● Used for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) when other therapies fail.
Dosage & Administration
Standard Dose:
● Starting dose: 45 mg once daily (but 15 mg may be used for specific cases, e.g., dose reduction due to toxicity).
● Take with or without food.
● Swallow whole—do not crush, split, or chew.
Dose Adjustments:
● Based on response & side effects:
■ If well-tolerated & effective, may continue at 15–45 mg daily.
■ If severe side effects occur, may reduce to 10–15 mg daily or temporarily stop.
Missed Dose:
● If a dose is missed, skip it and take the next dose at the regular time.
● Do not double the dose.
Precautions
1. Cardiovascular Risks (Black Box Warning)
● Arterial thrombosis (heart attack, stroke, peripheral artery disease).
● Venous thrombosis (DVT, pulmonary embolism).
● Monitor blood pressure, cholesterol, and heart function regularly.
2. Liver Toxicity
● May cause elevated liver enzymes (ALT/AST) or hepatitis.
● Requires regular liver function tests (LFTs).
3. Pancreatitis & High Blood Sugar
● Monitor for abdominal pain (pancreatitis) and hyperglycemia (diabetes risk).
4. Hemorrhage (Bleeding Risk)
● Serious bleeding (GI, brain) possible—report unusual bruising, blood in stool, or severe headaches.
5. Avoid strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin)—increases toxicity.
● Avoid strong CYP3A inducers (e.g., rifampin, phenytoin)—reduces effectiveness.
Common Side Effects
● High blood pressure (hypertension)
● Rash, dry skin, joint pain
● Fatigue, headache, constipation
● Fluid retention (swelling in legs/arms)
● Low blood cell counts (anemia, neutropenia, thrombocytopenia)
Storage
Store at room temperature (20–25°C), away from moisture and light.
Note: Regular monitoring (ECG, blood tests, BP checks) is required during treatment.