🟩 Ponatinix 15 mg

Generic Name: Ponatinib Hydrochloride
Brand Name: Ponatinix
Manufacturer: Beacon Pharmaceuticals Ltd.
Dosage Form & Strength: Tablet, 15 mg
Therapeutic Class: Anticancer | Tyrosine Kinase Inhibitor (TKI)

📌 Indications:

Ponatinix (Ponatinib) is a third-generation tyrosine kinase inhibitor (TKI) specifically developed for resistant forms of leukemia. It is indicated for the treatment of:

• Chronic Myeloid Leukemia (CML): Chronic, accelerated, or blast phase.

• Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL): In patients resistant or intolerant to prior TKI therapy.

• T315I-positive mutation: Effective in patients with the T315I mutation, which is resistant to most other TKIs.

💊 Pharmacology:

Ponatinib is a potent, orally active TKI that works by:

• Inhibiting BCR-ABL kinase, including mutant forms resistant to first- and second-generation TKIs (like imatinib, dasatinib, nilotinib).

• Blocking other kinases such as VEGFR, FGFR, PDGFR, KIT, and FLT3, which may contribute to its anti-tumor activity.

• Its unique structure allows it to overcome resistance mutations, particularly the difficult-to-treat T315I mutation.

The result is suppression of leukemic cell proliferation and induction of apoptosis.

💉 Dosage & Administration:

• Standard Dose: 45 mg orally once daily.

• Dose reductions (30 mg or 15 mg daily) may be required based on response and tolerability.

• Can be taken with or without food.

• Tablets should be swallowed whole with water.

⚠️ Important: Therapy must be initiated and monitored by experienced hematologists/oncologists.

⚠️ Precautions & Warnings:

• Arterial occlusive events: Can cause fatal cardiovascular events (MI, stroke, arterial thrombosis). Careful cardiac monitoring required.

• Venous thromboembolism: Risk of DVT and PE.

• Hepatotoxicity: Regular liver function tests needed.

• Hypertension: Blood pressure should be monitored and controlled.

• Pancreatitis: Dose interruption may be required if severe.

• Myelosuppression: Monitor blood counts regularly.

• QT prolongation: ECG monitoring recommended.

❌ Contraindications:

• Hypersensitivity to Ponatinib or any excipients.

• Patients with uncontrolled cardiovascular conditions should avoid use.

🤰 Pregnancy & Lactation:

• Pregnancy: Can cause fetal harm. Contraception is required during treatment and at least 3 weeks after the last dose.

• Breastfeeding: Not recommended as the drug may harm infants.

⚕️ Side Effects:

Common:

• Hypertension

• Fatigue, headache

• Abdominal pain, constipation, diarrhea

• Rash, dry skin

• Arthralgia, myalgia

Serious:

• Cardiovascular events (stroke, heart attack, arterial thrombosis)

• Severe hepatotoxicity

• Venous thromboembolism

• Pancreatitis

• Severe myelosuppression

• Vascular occlusion (potentially fatal)

🧊 Storage Conditions:

• Store at below 30°C, in a dry place.

• Protect from light and moisture.

• Keep out of the reach of children.