TRAZIMERA Highlights

(trastuzumab-qyyp)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA.

TRAZIMERA™ (trastuzumab-qyyp) for injection, for intravenous use
Initial U.S. Approval: 2019

TRAZIMERA (trastuzumab-qyyp) is biosimilar* to HERCEPTIN (trastuzumab).

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

See full prescribing information for complete boxed warning

Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue TRAZIMERA for cardiomyopathy. (2.3, 5.1)

Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (5.2, 5.4)

Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. (5.3, 8.1, 8.3)

RECENT MAJOR CHANGES

Dosage and Administration, Preparation for Administration (2.4)11/2020

INDICATIONS AND USAGE

TRAZIMERA is a HER2/neu receptor antagonist indicated for:

  • The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
  • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3)

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1).

DOSAGE AND ADMINISTRATION

For intravenous (IV) infusion only. Do not administer as an intravenous push or bolus. (2.2)

Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine. (2.2)

Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (1, 2.1)

Adjuvant Treatment of HER2-Overexpressing Breast Cancer (2.2)

Administer at either:

  • Initial dose of 4 mg/kg over 90 minute intravenous infusion, then 2 mg/kg over 30 minute intravenous infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of TRAZIMERA, administer 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks to complete a total of 52 weeks of therapy, or
  • Initial dose of 8 mg/kg over 90 minutes intravenous infusion, then 6 mg/kg over 30 to 90 minutes intravenous infusion every three weeks for 52 weeks.

Metastatic HER2-Overexpressing Breast Cancer (2.2)

  • Initial dose of 4 mg/kg as a 90 minute intravenous infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute intravenous infusions.

Metastatic HER2-Overexpressing Gastric Cancer (2.2)

  • Initial dose of 8 mg/kg over 90 minutes intravenous infusion, followed by 6 mg/kg over 30 to 90 minutes intravenous infusion every 3 weeks.

DOSAGE FORMS AND STRENGTHS

  • For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution (3)
  • For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution (3)

CONTRAINDICATIONS

  • None. (4)

WARNINGS AND PRECAUTIONS

  • Exacerbation of Chemotherapy-Induced Neutropenia. (5.5, 6.1)

ADVERSE REACTIONS

Adjuvant Breast Cancer

  • Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. (6.1)

Metastatic Breast Cancer

  • Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1)

Metastatic Gastric Cancer

  • Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 and www.Pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of TRAZIMERA (8.3).

See 17 for PATIENT COUNSELING INFORMATION.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TRAZIMERA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 11/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA.

TRAZIMERA™ (trastuzumab-qyyp) for injection, for intravenous use
Initial U.S. Approval: 2019

TRAZIMERA (trastuzumab-qyyp) is biosimilar* to HERCEPTIN (trastuzumab).

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

See full prescribing information for complete boxed warning

Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue TRAZIMERA for cardiomyopathy. (2.3, 5.1)

Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (5.2, 5.4)

Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. (5.3, 8.1, 8.3)

RECENT MAJOR CHANGES

Dosage and Administration, Preparation for Administration (2.4)11/2020

INDICATIONS AND USAGE

TRAZIMERA is a HER2/neu receptor antagonist indicated for:

  • The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
  • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3)

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1).

DOSAGE AND ADMINISTRATION

For intravenous (IV) infusion only. Do not administer as an intravenous push or bolus. (2.2)

Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine. (2.2)

Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (1, 2.1)

Adjuvant Treatment of HER2-Overexpressing Breast Cancer (2.2)

Administer at either:

  • Initial dose of 4 mg/kg over 90 minute intravenous infusion, then 2 mg/kg over 30 minute intravenous infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of TRAZIMERA, administer 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks to complete a total of 52 weeks of therapy, or
  • Initial dose of 8 mg/kg over 90 minutes intravenous infusion, then 6 mg/kg over 30 to 90 minutes intravenous infusion every three weeks for 52 weeks.

Metastatic HER2-Overexpressing Breast Cancer (2.2)

  • Initial dose of 4 mg/kg as a 90 minute intravenous infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute intravenous infusions.

Metastatic HER2-Overexpressing Gastric Cancer (2.2)

  • Initial dose of 8 mg/kg over 90 minutes intravenous infusion, followed by 6 mg/kg over 30 to 90 minutes intravenous infusion every 3 weeks.

DOSAGE FORMS AND STRENGTHS

  • For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution (3)
  • For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution (3)

CONTRAINDICATIONS

  • None. (4)

WARNINGS AND PRECAUTIONS

  • Exacerbation of Chemotherapy-Induced Neutropenia. (5.5, 6.1)

ADVERSE REACTIONS

Adjuvant Breast Cancer

  • Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. (6.1)

Metastatic Breast Cancer

  • Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1)

Metastatic Gastric Cancer

  • Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 and www.Pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of TRAZIMERA (8.3).

See 17 for PATIENT COUNSELING INFORMATION.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TRAZIMERA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 11/2020
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