Medication info

Ogivri 150mg (Trastuzumab)

Prescription medicationApproval withdrawn
Ingredient · strength
Trastuzumab›Strength being verified
Manufacturer / importer
(주)대웅제약
Appearance
A colorless injectable solution filled in a vial containing a white to pale yellow freeze-dried powder, which becomes a colorless to pale yellow clear or slightly cloudy liquid when diluent is added.
Packaging
1 vial/box [vial (150.0mg)]
Approval status
Approval withdrawn

MFDS item code 202006020 · Approved 2020.08.26

This product's status changed to Approval withdrawn on 2023.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effective for the treatment of HER2 positive metastatic and early-stage breast cancer, and metastatic gastric cancer.
Who uses it
Adults
Adult dosage
For metastatic and early-stage breast cancer and metastatic gastric cancer, there are 1-week and 3-week regimens. 1-week regimen: - Initial loading dose: 4mg/kg - Maintenance dose: 2mg/kg weekly, starting one week after the initial loading dose 3-week regimen: - Initial loading dose: 8mg/kg - Maintenance dose: 6mg/kg every 3 weeks, starting three weeks after the initial loading dose In combination with docetaxel or paclitaxel.

Ingredients

Importer
(주)대웅제약

Efficacy & effects

Effective for the treatment of HER2 positive metastatic and early-stage breast cancer, and metastatic gastric cancer.

  • Breast cancer
  • metastatic breast cancer
  • early-stage breast cancer
  • locally advanced disease
  • inflammatory disease
  • tumors
  • metastatic gastric cancer
  • metastatic gastric adenocarcinoma
  • gastroesophageal junction adenocarcinoma.
View approved original text

This medication is used for the treatment of patients with HER2 positive breast cancer and gastric cancer. It is administered alone to patients with metastatic breast cancer who have previously received chemotherapy, and in combination with other anticancer agents for treatment-naive patients. For early-stage breast cancer, it is used alone or in combination with chemotherapy before and after surgery, and may be used as adjuvant therapy depending on tumor size and progression. Additionally, for patients with metastatic gastric cancer who have no prior experience of chemotherapy, it is used in combination with platinum-based chemotherapy. This drug helps improve the effectiveness of cancer treatment and the patient's condition.

Dosage and Administration

Adult dosage

For metastatic and early-stage breast cancer and metastatic gastric cancer, there are 1-week and 3-week regimens. 1-week regimen: - Initial loading dose: 4mg/kg - Maintenance dose: 2mg/kg weekly, starting one week after the initial loading dose 3-week regimen: - Initial loading dose: 8mg/kg - Maintenance dose: 6mg/kg every 3 weeks, starting three weeks after the initial loading dose In combination with docetaxel or paclitaxel.

Precautions

This drug may affect heart function, so patients with heart disease or those who have had previous heart problems must undergo a thorough cardiac evaluation before administration. Special caution is required for patients with conditions that stress the heart, such as heart failure, angina, or hypertension. Allergic reactions or infusion-related side effects may occur during administration; therefore, the patient's condition must be closely monitored during the infusion. If symptoms such as shortness of breath, hypotension, or rash occur, administration should be stopped immediately, and appropriate treatment should be initiated. There is also a risk of lung issues, so patients with lung disease or symptoms of shortness of breath should avoid this medication. It should not be administered to patients with a history of hypersensitivity or severe shortness of breath. Various side effects such as decreased blood cell counts, infections, nausea, vomiting, diarrhea, hair loss, myalgia, etc. can occur, so any unusual symptoms should be reported to healthcare personnel immediately. Women who are pregnant or may become pregnant should use effective contraception during and for a period after treatment, and it is safest to avoid using this drug while breastfeeding. The safety and efficacy for children under 18 years of age have not been established, so it should not be used in this demographic. Additionally, while this drug does not significantly affect driving or machine operation ability, caution is needed if infusion-related symptoms occur. It is important to undergo precise testing before administration, regularly check heart and lung function during administration, and respond quickly to any side effects.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever, severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe dermatologic reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache.

Mild side effects

  • Nausea
  • myalgia
  • neuropathy
  • fever
  • sensory disturbances
  • chills
  • loss of appetite
  • peripheral neuropathy
  • vomiting
  • asthenia
Show 29 more
  • headache
  • arthralgia
  • alopecia
  • pruritus
  • leukopenia
  • dyspepsia
  • fatigue
  • constipation
  • pain
  • chest pain
  • rash
  • back pain
  • bone pain
  • peripheral edema
  • diarrhea
  • mucositis
  • systemic weakness
  • erythema
  • loose stools
  • facial flushing
  • insomnia
  • numbness
  • vaginal bleeding
  • abdominal distension
  • abdominal discomfort
  • back discomfort
  • limb pain
  • sleep disorders
  • infusion site reaction.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to prevent exposure to air or moisture. Additionally, it is important to store it at refrigerated temperatures between 2 to 8 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A colorless injectable solution filled in a vial containing a white to pale yellow freeze-dried powder, which becomes a colorless to pale yellow clear or slightly cloudy liquid when diluent is added.

Package unit

1 vial/box [vial (150.0mg)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.