Herzuma

What is Herzuma?

• Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist used for the treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Trastuzumab-HER2 complex 1N8Z

What are the uses of this medicine?

Herzuma (trastuzumab-pkrb) is used for the treatment of:

• HER2-overexpressing breast cancer.
• HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

How does this medicine work?

• Trastuzumab (tras tooz’ ue mab) is humanized monoclonal antibody to HER2 which is a human growth factor receptor that is overexpressed in 20% to 25% of breast cancers.
• The interaction of epidermal growth factor (EGF) with HER2 results in rapid cell growth and proliferation via intracellular pathways that include MAP and PI3 kinase.
• Binding of trastuzumab to the HER2 receptor blocks this cell signaling pathway and causes growth arrest.
• Trastuzumab was shown to decrease recurrences and prolong survival in women with breast cancer that were HER2 positive.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiac dysfunction
• If anthracyclines are used, the patient's cardiac function should be monitored carefully.

Is this medicine FDA approved?

• Trastuzumab was approved for medical use in the United States in September 1998, and in the European Union in August 2000.

How should this medicine be used?

Recommended dosage:

Adjuvant Treatment of HER2-Overexpressing Breast Cancer:

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

                   or

• Initial dose of 8 mg/kg over 90 minute IV infusion, then 6 mg/kg over 30-90 minute IV infusion every three weeks for 52 weeks.

Metastatic HER2-Overexpressing Breast Cancer:

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

Metastatic HER2-Overexpressing Gastric Cancer:

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

Administration:

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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution.
• For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Herzuma

What side effects can this medication cause?

The most common side effects of this medicine include:

In Adjuvant Breast Cancer:

• headache, diarrhea, nausea, and chills

In Metastatic Breast Cancer:

• fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash

In Metastatic Gastric Cancer:

• neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

What special precautions should I follow?

• Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Discontinue Herzuma for cardiomyopathy.
• Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herzuma for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
• Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.
• Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Trastuzumab products can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of trastuzumab products in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TRASTUZUMAB

Inactive ingredients:

• TREHALOSE DIHYDRATE
• HISTIDINE MONOHYDROCHLORIDE
• HISTIDINE
• POLYSORBATE 20

Who manufactures and distributes this medicine?

Manufactured by:

• CELLTRION, Inc.
• 23, Academy-ro,
• Yeonsu-gu, Incheon
• 22014, Republic of Korea

• Herzuma® is a registered trademark of CELLTRION, Inc.

What should I know about storage and disposal of this medication?

• Store Herzuma vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.

• Dailymed label info on Herzuma
• FDA Herzuma

Herzuma Resources
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