What is it used for?
ICLUSIG® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at …ICLUSIG® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at …
Read the primary sourceThis source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Product details
- Active ingredient
- ponatinibponatinib
- Form and strength
- TABLET, FILM COATED · 15 mg; TABLET, FILM COATED · 45 mg; TABLET, FILM COATED · 30 mg; TABLET, FILM COATED · 10 mgTABLET, FILM COATED · 15 mg; TABLET, FILM COATED · 45 mg; TABLET, FILM COATED · 30 mg; TABLET, FILM COATED · 10 mg
- Manufacturer / applicant
- TAKEDA PHARMACEUTICALS AMERICA, INC.TAKEDA PHARMACEUTICALS AMERICA, INC.
Tablets, film-coated: 10 mg of ponatinib: Oval, white to off-white, biconvex, debossed "NZ" on one side and plain on the other side 15 mg of ponatinib: Round, white, biconvex, debossed "A5" on one side and plain on the …Tablets, film-coated: 10 mg of ponatinib: Oval, white to off-white, biconvex, debossed "NZ" on one side and plain on the other side 15 mg of ponatinib: Round, white, biconvex, debossed "A5" on one side and plain on the …
Safety and clinical review
Arterial Occlusive Events: Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and …Arterial Occlusive Events: Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and …
- Arterial Occlusive EventsArterial Occlusive Events
- Venous Thromboembolic EventsVenous Thromboembolic Events
- Heart FailureHeart Failure
- HepatotoxicityHepatotoxicity
- HypertensionHypertension
- PancreatitisPancreatitis
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
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Include the brand or generic name, strength, dosage form, requested quantity and country where care is needed. You can attach a prescription when you continue.
Questions patients ask
What is ICLUSIG used for?
ICLUSIG® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at …ICLUSIG® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at …
This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Which formulation of ICLUSIG should I ask about?
TABLET, FILM COATED · 15 mg; TABLET, FILM COATED · 45 mg; TABLET, FILM COATED · 30 mg; TABLET, FILM COATED · 10 mgTABLET, FILM COATED · 15 mg; TABLET, FILM COATED · 45 mg; TABLET, FILM COATED · 30 mg; TABLET, FILM COATED · 10 mg
Read the primary sourceWhat determines the price of ICLUSIG?
A current quote depends on the exact presentation, quantity, provider and access arrangements. A catalogue entry is not a stock or delivery promise. Medical charges are paid to the provider, separately from coordination fees.
What should I check before using ICLUSIG?
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
Sources and review scope
FDA prescribing informationThis source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.