Ponatinib hydrochloride

Ponatinib hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

WARNING: VASCULAR OCCLUSION, HEART FAILURE, AND HEPATOTOXICITY See full prescribing information for complete Boxed Warning. Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including 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 without cardiovascular risk factors, including patients age 50 years or younger, experienced these events . Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit-risk consideration should guide a decision to restart Iclusig therapy. Heart Failure: Heart failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure. Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Overview

Ponatinib hydrochloride is an antineoplastic agent that is FDA approved for the treatment of chronic myeloid leukemia,. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension,abdominal pain, constipation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Iclusig (ponatinib) is a kinase inhibitor indicated for the:

• Treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL).

• Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

• These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

Dosing

Recommended Dosing

• The optimal dose of Iclusig has not been identified. In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, 59% of the patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy.

• Start dosing with 45 mg once daily. Consider reducing the dose of Iclusig for chronic phase (CP) CML and accelerated phase (AP) CML patients who have achieved a major cytogenetic response.

• Consider discontinuing Iclusig if response has not occurred by 3 months (90 days).

• Iclusig may be taken with or without food. Tablets should be swallowed whole.

Dose Modifications for Myelosuppression

• Suggested dose modifications for neutropenia (ANC* less than 1.0 × 109/L) and thrombocytopenia (platelet less than 50 × 109/L) that are unrelated to leukemia are summarized in Table 1.

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This image is provided by the National Library of Medicine.

Dose Modifications for Non-Hematologic Adverse Reactions

• If a serious non-hematologic adverse reaction occurs, modify the dose or interrupt treatment. Do not restart Iclusig in patients with arterial or venous occlusive reactions unless the potential benefit outweighs the risk of recurrent arterial or venous occlusions and the patient has no other treatment options. For serious reactions other than arterial or venous occlusion, do not restart Iclusig until the serious event has resolved or the potential benefit of resuming therapy is judged to outweigh the risk.

Hepatic Toxicity

Recommended modifications for hepatic toxicity are summarized in Table 2.

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This image is provided by the National Library of Medicine.

Pancreatitis and Elevation of Lipase

Recommended modifications for pancreatic adverse reactions are summarized in Table 3.

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This image is provided by the National Library of Medicine.

Dose Modification for Use With Strong CYP3A Inhibitors

The recommended dose should be reduced to 30 mg once daily when administering Iclusig with strong CYP3A inhibitors.

Dose Modification for Use in Patients with Hepatic Impairment

The recommended starting dose is 30 mg once daily in patients with hepatic impairment (Child-Pugh A, B, or C)

DOSAGE FORMS AND STRENGTHS

• 15 mg and 45 mg round, white, film-coated tablets.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ponatinib hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ponatinib hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ponatinib hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ponatinib hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ponatinib hydrochloride in pediatric patients.

Contraindications

• None

Warnings

WARNING: VASCULAR OCCLUSION, HEART FAILURE, AND HEPATOTOXICITY See full prescribing information for complete Boxed Warning. Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including 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 without cardiovascular risk factors, including patients age 50 years or younger, experienced these events . Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit-risk consideration should guide a decision to restart Iclusig therapy. Heart Failure: Heart failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure. Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ponatinib hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ponatinib hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ponatinib hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ponatinib hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ponatinib hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ponatinib hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ponatinib hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ponatinib hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ponatinib hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ponatinib hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ponatinib hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ponatinib hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ponatinib hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Ponatinib hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Ponatinib hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ponatinib hydrochloride in the drug label.

Pharmacology

There is limited information regarding Ponatinib hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ponatinib hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ponatinib hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ponatinib hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ponatinib hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ponatinib hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Ponatinib hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ponatinib hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Ponatinib hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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