Iclusig ponatinib hydrochloride
Refer to the “Also Known As” section to reference different products that include the same medication as Iclusig.
Drug Basics
Brand Name: Iclusig
Generic Name: PONATINIB HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET, FILM COATED
Packager: Millennium Pharmaceuticals, Inc.
Data Current As Of: 2021-02-11
Boxed Warning | 12/2020 |
Indications and Usage (1) | 12/2020 |
Dosage and Administration (2) | 12/2020 |
Warnings and Precautions (5) | 12/2020 |
Impaired Wound Healing and Gastrointestinal Perforation (5.16) | 1/2020 |
Indications & Usage
Iclusig is indicated for the treatment of adult patients with:
- Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
- Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
- T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
Iclusig is a kinase inhibitor indicated for the treatment of adult patients with:
- Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. (1)
- Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated. (1)
- T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL. (1)
Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. (5.7)
Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7)].
Drug Interactions
effects of other drugs on iclusig
Strong CYP3A Inhibitors
Coadministration of Iclusig with a strong CYP3A inhibitor increases ponatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may increase the risk of Iclusig adverse reactions. Avoid coadministration of Iclusig with strong CYP3A inhibitors. If coadministration of Iclusig with strong CYP3A inhibitors cannot be avoided, reduce the Iclusig dosage [see Dosage and Administration (2.3)].
Strong CYP3A Inducers
Coadministration of Iclusig with a strong CYP3A inducer decreases ponatinib plasma concentrations [see Clinical Pharmacology (12.3)]. Avoid coadministration of Iclusig with strong CYP3A inducers unless the benefit outweighs the risk of decreased ponatinib exposure. Monitor patients for reduced efficacy. Selection of concomitant medication with no or minimal CYP3A induction potential is recommended.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Arterial Occlusive Events and Venous Thromboembolic Events
Inform patients that serious arterial thromboses (including arterial stenosis sometimes requiring revascularization) and VTEs have occurred. Advise patients to immediately contact their healthcare provider with any symptoms suggestive of a blood clot such as chest pain, shortness of breath, weakness on one side of the body, speech problems, leg pain, or leg swelling [see Warnings and Precautions (5.1, 5.2)].
Heart Failure and Cardiac Arrhythmias
Inform patients of the possibility of heart failure, and abnormally slow or fast heart rates. Advise patients to contact their healthcare provider if they experience symptoms such as shortness of breath, chest pain, palpitations, dizziness, or fainting [see Warnings and Precautions (5.3, 5.12)].
Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their healthcare provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising [see Warnings and Precautions (5.4)].
Hypertension
Inform patients of the possibility of new or worsening of existing hypertension. Advise patients to contact their healthcare provider for elevated blood pressure or if symptoms of hypertension occur including confusion, headache, dizziness, chest pain, or shortness of breath [see Warnings and Precautions (5.5)].
Pancreatitis
Inform patients of the possibility of developing pancreatitis that may be accompanied by nausea, vomiting, abdominal pain, or abdominal discomfort, and to promptly report these symptoms [see Warnings and Precautions (5.6)].
Neuropathy
Inform patients of the possibility of developing peripheral or cranial neuropathy while being treated with Iclusig. Advise patients to report symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness [see Warnings and Precautions (5.8)].
Ocular Toxicity
Inform patients of the possibility of ocular toxicity while being treated with Iclusig. Advise patients to report symptoms of ocular toxicity, such as blurred vision, dry eye, or eye pain [see Warnings and Precautions (5.9)].
Hemorrhage
Inform patients of the possibility of serious bleeding and to immediately contact their healthcare provider with any signs or symptoms suggestive of hemorrhage such as unusual bleeding or easy bruising [see Warnings and Precautions (5.10)].
Fluid Retention
Inform patients of the possibility of developing fluid retention and to contact their healthcare provider for symptoms such as leg swelling, abdominal swelling, weight gain, or shortness of breath [see Warnings and Precautions (5.11)].
Myelosuppression
Inform patients of the possibility of developing low blood cell counts; inform patients to report immediately should fever develop, particularly in association with any suggestion of infection [see Warnings and Precautions (5.13)].
Tumor Lysis Syndrome
Inform patients of the possibility of developing TLS and to immediately contact their healthcare provider for any signs or symptoms associated with TLS [see Warnings and Precautions (5.14)]. Advise patients to be adequately hydrated when taking Iclusig to reduce the risk of TLS.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome)
Inform patients of the possibility of developing Reversible Posterior Leukoencephalopathy Syndrome while being treated with Iclusig. Advise patients to report symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances [see Warnings and Precautions (5.15)].
Impaired Wound Healing and Gastrointestinal Perforation
Inform patients that impaired wound healing and gastrointestinal fistula or perforation have been reported. Advise patients to inform their healthcare provider of any planned surgical procedure [see Warnings and Precautions (5.16)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with Iclusig and for 3 weeks after the last dose [see Warnings and Precautions (5.17), Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with Iclusig and for 6 days after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential of the potential for reduced fertility from Iclusig [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Instructions for Taking Iclusig
Advise patients to take Iclusig exactly as prescribed and not to change their dose or to stop taking Iclusig unless they are told to do so by their healthcare provider. Iclusig may be taken with or without food. Iclusig tablets should be swallowed whole. Patients should not cut, crush or dissolve the tablets.
Patients should not take two doses at the same time to make up for a missed dose.
Advise patients not to drink grapefruit juice or eat grapefruit as it may increase the amount of Iclusig in their blood and therefore increase their risk of adverse reactions.
Lactose
Inform patients that Iclusig tablets contain lactose monohydrate.
Distributed by:
Millennium Pharmaceuticals, Inc.
40 Landsdowne Street
Cambridge, MA 02139-4234
ICLUSIG® is a registered trademark of ARIAD Pharmaceuticals, Inc. TAKEDA® is a registered trademark of Takeda Pharmaceutical Company Limited.
©2020 ARIAD Pharmaceuticals Inc. All rights reserved.
ICL348 R7
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: December 2020 | ||||
MEDICATION GUIDE ICLUSIG® (eye-CLUE-sig) (ponatinib) tablets |
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What is the most important information I should know about Iclusig? Iclusig can cause serious side effects, including: Blood clots or blockage in your blood vessels (arteries and veins). Blood clots or blockage in your blood vessels may lead to heart attack, stroke, or death. A blood clot or blockage in your blood vessels can prevent proper blood flow to your heart, brain, bowels (intestines), legs, eyes, and other parts of your body. You may need emergency surgery or treatment in a hospital. Get medical help right away if you get any of the following symptoms: |
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Blood clots or blockage in your blood vessels can happen in people with or without risk factors for heart and blood vessel disease, including people 50 years of age or younger. The most common risk factors for these problems are a history of high blood pressure (hypertension), high cholesterol, and heart disease. Blood clots or blockages in your blood vessels happen more often in people as they get older, and in people with a history of decreased blood flow, high blood pressure, diabetes, or high cholesterol. Heart problems. Iclusig can cause heart problems, including heart failure which can be serious and may lead to death. Heart failure means your heart does not pump blood well enough. Iclusig can also cause irregular, slow, or fast heartbeats and heart attack. Your healthcare provider will check you for heart problems during your treatment with Iclusig. Get medical help right away if you get any of the following symptoms: shortness of breath, chest pain, fast or irregular heartbeats, dizziness, or feel faint. Liver problems. Iclusig can cause liver problems, including liver failure, which can be severe and may lead to death. Your healthcare provider will do blood tests before and during your treatment with Iclusig to check for liver problems. Get medical help right away if you get any of these symptoms of liver problems during treatment:
See "What are the possible side effects of Iclusig?" for information about side effects. |
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What is Iclusig? Iclusig is a prescription medicine used to treat adults who have:
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. |
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Before you take Iclusig, tell your healthcare provider about all of your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Iclusig and other medicines may affect each other causing side effects. |
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How should I take Iclusig?
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What are the possible side effects of Iclusig? Iclusig may cause serious side effects, including:
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The most common side effects of Iclusig include: |
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Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Iclusig if you have certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Iclusig. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store Iclusig? Store Iclusig at room temperature between 68°F to 77°F (20°C to 25°C). Keep Iclusig and all medicines out of the reach of children. |
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General information about the safe and effective use of Iclusig Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Iclusig for a condition for which it was not prescribed. Do not give Iclusig to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Iclusig that is written for health professionals. |
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What are the ingredients in Iclusig? Active ingredient: ponatinib Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type B), colloidal silicon dioxide and magnesium stearate. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol and titanium dioxide. For more information, go to www.iclusig.com or call 1-844-817-6468. Distributed by: Millennium Pharmaceuticals, Inc. 40 Landsdowne Street, Cambridge, MA 02139-4234 ICLUSIG® is a registered trademark of ARIAD Pharmaceuticals, Inc. TAKEDA® is a registered trademark of Takeda Pharmaceutical Company Limited. ©2020 ARIAD Pharmaceuticals, Inc. All rights reserved. ICL348 R7 |
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