GNH USA

Europe — EMA

Iclusig

GNH USA supplies Iclusig (Ponatinib), a tyrosine kinase inhibitor for chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia. Request quote for supply.

Ponatinib

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What is Ponatinib?

Ponatinib, the active ingredient in Iclusig, is a tyrosine kinase inhibitor presented as a 15 mg and 30 mg tablet for oral use. It treats chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia that are resistant or intolerant to prior therapy, targeting the BCR‑ABL kinase including the T315I mutation.

GNH USA supplies Iclusig as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, with a focus on quality assurance, regulatory compliance and reliable global logistics, and timely delivery.

What is Ponatinib used for?

Ponatinib is indicated for hematologic malignancies driven by BCR‑ABL tyrosine‑kinase activity.

- Chronic myeloid leukemia (CML) resistant or intolerant to prior therapy: provides disease control when other tyrosine‑kinase inhibitors have failed. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior therapy: offers a targeted treatment option for patients with limited alternatives.

What are the side effects of Ponatinib?

Ponatinib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Hypertension: elevated blood pressure that may require monitoring or medication. - Diarrhea: mild to moderate gastrointestinal upset. - Nausea: occasional feeling of sickness. - Rash: skin irritation or erythema.

Serious or Rare Side Effects: - Arterial occlusive events: risk of serious cardiovascular complications such as ischemia or thrombosis. - Pancreatitis: inflammation of the pancreas that can be severe. - Hepatotoxicity: significant liver enzyme elevations indicating possible liver injury.

What precautions apply to Ponatinib?

Before initiating Ponatinib therapy, clinicians should consider several precautionary measures to minimize risk. - Cardiovascular monitoring: assess blood pressure and vascular health regularly. - Liver function: check hepatic enzymes before and during treatment. - Pancreatic enzymes: monitor amylase and lipase levels periodically. - Pregnancy: contraindicated; avoid use in pregnancy (Category D) and advise effective contraception. - Drug interactions: review concomitant medications for CYP3A4 inhibitors or inducers. - Store at ambient temperature: keep tablets below 25 °C in the original packaging, protected from moisture.

What does Ponatinib interact with?

Ponatinib interacts with several medicines; understanding the interaction level guides clinical management.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase ponatinib exposure and toxicity. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce ponatinib effectiveness.

Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): may enhance bleeding risk. - Antiplatelet agents (e.g., aspirin): may exacerbate vascular events. - CYP3A4‑metabolized statins (e.g., simvastatin): may raise statin plasma levels.

Frequently asked questions

What conditions is Iclusig prescribed for?+
Iclusig (ponatinib) is prescribed for patients with chronic myeloid leukemia (CML) or Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL) when the disease is resistant to, or cannot be tolerated with, previously used therapies. It is used in the adult population under specialist supervision.
How does Ponatinib work to treat these conditions?+
Ponatinib blocks the ATP‑binding site of the BCR‑ABL fusion protein, preventing its kinase activity even when the T315I mutation is present. By also inhibiting other kinases such as FGFR, VEGFR, PDGFR and SRC family members, it disrupts multiple signaling pathways that drive malignant cell growth, survival and angiogenesis.
What is the usual dose of Iclusig?+
The exact dose of Iclusig is determined by the prescribing physician based on the individual patient's disease characteristics, prior therapies and tolerance. Ponatinib is supplied in 15 mg and 30 mg tablets, and the prescriber selects the appropriate strength and dosing schedule for each patient.
Is Iclusig safe to use during pregnancy or while breastfeeding?+
Iclusig is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should not be used during pregnancy, and effective contraception is required for women of child‑bearing potential. Safety during breastfeeding has not been established, so breastfeeding is generally discouraged while on therapy.
How do I order Iclusig from GNH USA?+
To place an order, submit an enquiry on the Iclusig product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.
How does Iclusig compare with other tyrosine kinase inhibitors?+
Compared with earlier TKIs, ponatinib has a broader kinase inhibition profile and retains activity against the T315I mutation, which confers resistance to many other agents. This makes Iclusig a valuable option for patients who have failed prior TKIs, though its safety profile requires careful monitoring for vascular and hepatic events.
How should Iclusig be stored and handled?+
Iclusig tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed when not in use.
How is Iclusig administered to patients?+
Iclusig is taken orally as a whole tablet with or without food. Patients should swallow the tablet with water and follow the dosing schedule prescribed by their oncologist, who will adjust the regimen based on response and tolerability.
What are the most serious risks associated with Iclusig therapy?+
The most serious risks include arterial occlusive events such as heart attack or stroke, severe hypertension, pancreatitis, and hepatotoxicity manifested by marked liver enzyme elevations. Prompt recognition and management of these conditions are essential, and regular monitoring is recommended throughout treatment.
Who should not use Iclusig?+
Iclusig should be avoided in patients with known hypersensitivity to ponatinib or any tablet excipients, in pregnant women, and in individuals with uncontrolled cardiovascular disease or active severe infections. Clinicians must also assess liver and pancreatic function before initiating therapy.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ponatinib
Route
Oral Use
Manufacturer
Incyte Biosciences Distribution B.V.
Origin
EU

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