About ICLUSIG® (ponatinib)
What is ICLUSIG?
ICLUSIG is a prescription medicine used to treat adults who have:
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- in combination with chemotherapy in newly diagnosed Ph+ ALL*
- alone in adults with Ph+ ALL who cannot receive any other kinase inhibitor medicines or who have a specific type of abnormal gene (T315I-positive) Ph+ ALL
- Chronic Myeloid Leukemia (CML)
- chronic phase CML who did not tolerate or no longer benefit from treatment with at least 2 prior kinase inhibitor medicines
- accelerated phase or blast phase CML who cannot receive any other kinase inhibitor medicines
- a specific type of abnormal gene (T315I-positive) chronic phase, accelerated phase, or blast phase CML
ICLUSIG is not for use to treat people with newly diagnosed chronic phase CML.
It is not known if ICLUSIG is safe and effective in children.
*ICLUSIG in combination with chemotherapy in newly diagnosed adult patients with Ph+ ALL was approved based on patient responses at 3 months of therapy. There is an ongoing study to confirm results.
Once-daily dosing with ICLUSIG
ICLUSIG is taken once daily, at the same time
Starting dose in CML
The recommended starting dose of ICLUSIG is 45 mg once a day. For people with chronic phase or accelerated phase CML, your doctor may reduce the dose if ICLUSIG is working for you.
Starting dose in newly diagnosed Ph+ ALL in combination with chemotherapy
The recommended starting dose of ICLUSIG is 30 mg once a day.
- Treatment starts with ICLUSIG + chemotherapy
- If ICLUSIG + chemotherapy helps you achieve a deep remission, your doctor can reduce your ICLUSIG dose
Starting dose in Ph+ ALL when TKIs stop working
The recommended starting dose of ICLUSIG is 45 mg once a day.
How should I take ICLUSIG?
- Take ICLUSIG exactly as your healthcare provider tells you to take it
- Do not change your dose or stop taking ICLUSIG unless your healthcare provider tells you
- Swallow ICLUSIG tablets whole. Do not crush, break, cut, chew, or dissolve ICLUSIG tablets
- Take ICLUSIG with or without food
- Do not eat grapefruit or drink grapefruit juice during treatment with ICLUSIG
- If you miss a dose of ICLUSIG, take your next dose at your regularly scheduled time the next day. Do not take 2 doses at the same time to make up for a missed dose
- If you take too much ICLUSIG, call your healthcare provider or go to the nearest hospital emergency room right away
How does ICLUSIG work?
ICLUSIG may help to stop cancer causing BCR-ABL1 proteins from creating cancerous cells. ICLUSIG has been shown to work even if these proteins have developed a type of mutation called the T315I mutation.
Working closely with your healthcare team can help you remain confident as you continue your treatment journey.
Talking to your doctor about ICLUSIG
It’s normal to have questions about your treatment. That’s why it’s important to work closely with your healthcare team and understand your treatment plan.
Talk to your doctor about the information you’ve read here. And be sure to ask questions like:
- Is ICLUSIG the right step for me?
- How can ICLUSIG help?
- What is the recommended dose?
- When can I expect to see results?
- How does my mutation affect my treatment?
- What do I do if I experience any side effects with ICLUSIG?
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