PONADX (Ponatinib) 15mg/45mg

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.

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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.


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