Ado-trastuzumab emtansine

Ado-trastuzumab emtansine
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: Alberto Plate [2]

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Overview

Ado-trastuzumab emtansine is an antineoplastic agent that is FDA approved for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. Common adverse reactions include fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation and epistaxis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Recommended Doses and Schedules

• The recommended dose of KADCYLA is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer KADCYLA at doses greater than 3.6 mg/kg. Do not substitute KADCYLA for or with trastuzumab.
• Closely monitor the infusion site for possible subcutaneous infiltration during drug administration.
• Dosing regimen:
  • First infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions.
  • Subsequent infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.

Dose Modifications

• KADCYLA dose should not be re-escalated after a dose reduction is made.
• If a planned dose is delayed or missed, it should be administered as soon as possible; do not wait until the next planned cycle. The schedule of administration should be adjusted to maintain a 3-week interval between doses. The infusion may be administered at the dose and rate the patient tolerated in the most recent infusion.
• The infusion rate of KADCYLA should be slowed or interrupted if the patient develops an infusion-related reaction. Permanently discontinue KADCYLA for life-threatening infusion-related reactions.
• Management of increased serum transaminases, hyperbilirubinemia, left ventricular dysfunction, thrombocytopenia, pulmonary toxicity or peripheral neuropathy may require temporary interruption, dose reduction or treatment discontinuation of KADCYLA as per guidelines provided in Tables 1 to 5.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ado-trastuzumab emtansine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ado-trastuzumab emtansine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ado-trastuzumab emtansine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ado-trastuzumab emtansine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ado-trastuzumab emtansine in pediatric patients.

Contraindications

There is limited information regarding Ado-trastuzumab emtansine Contraindications in the drug label.

Warnings

There is limited information regarding Ado-trastuzumab emtansine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ado-trastuzumab emtansine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ado-trastuzumab emtansine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ado-trastuzumab emtansine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ado-trastuzumab emtansine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ado-trastuzumab emtansine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ado-trastuzumab emtansine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ado-trastuzumab emtansine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ado-trastuzumab emtansine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ado-trastuzumab emtansine in geriatric settings.

Gender

There is no FDA guidance on the use of Ado-trastuzumab emtansine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ado-trastuzumab emtansine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ado-trastuzumab emtansine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ado-trastuzumab emtansine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ado-trastuzumab emtansine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ado-trastuzumab emtansine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ado-trastuzumab emtansine Administration in the drug label.

Monitoring

There is limited information regarding Ado-trastuzumab emtansine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ado-trastuzumab emtansine and IV administrations.

Overdosage

There is limited information regarding Ado-trastuzumab emtansine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ado-trastuzumab emtansine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ado-trastuzumab emtansine Mechanism of Action in the drug label.

Structure

There is limited information regarding Ado-trastuzumab emtansine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ado-trastuzumab emtansine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ado-trastuzumab emtansine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ado-trastuzumab emtansine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ado-trastuzumab emtansine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ado-trastuzumab emtansine How Supplied in the drug label.

Storage

There is limited information regarding Ado-trastuzumab emtansine 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 Ado-trastuzumab emtansine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ado-trastuzumab emtansine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ado-trastuzumab emtansine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ado-trastuzumab emtansine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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