HERZUMA® 440MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

CELLTRION, INC., PLANT II (CLT2) (INCLUDING DILUENT) (KOREA, REPUBLIC OF)🇸🇬 Health Sciences Authority

Approval Date: Oct 29, 2019
Approval ID: 04b0440490870c43
Company: CELLTRION, INC., PLANT II (CLT2) (INCLUDING DILUENT) (KOREA, REPUBLIC OF)
Type: Therapeutic

Approval Details

Approval Id: 04b0440490870c43
Drug Name: HERZUMA® 440MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Product Name: HERZUMA® 440MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Approval Number: SIN15839P
Approval Date: 2019-10-29
Registrant: CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
Licence Holder: CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Dosage: 2.2 Dosage and Administration HER2 testing is mandatory prior to initiation of Herzuma® therapy. Herzuma is a biosimilar product. Substitution by any other biological medicinal product requires the consent of the prescribing physician. Physician to assess and monitor response upon switching of product. Herzuma® should be administered by a qualified health care professional. In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herzuma® (trastuzumab) and not Kadcyla (trastuzumab emtansine). Herzuma® (see section 4. Pharmaceutical Particulars – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information): Herzuma® is not to be used for subcutaneous administration and should be administered as intravenous infusion. Do not administer as an intravenous push or bolus. Metastatic breast cancer Weekly schedule: Loading dose: The recommended initial loading dose is 4 mg/kg body weight Herzuma® administered as a 90-minute intravenous infusion. Patients should be observed for fever and chills or other infusion-associated symptoms (see 2.6 Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Interruption of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate. Subsequent doses: The recommended weekly dose of Herzuma® is 2 mg/kg body weight. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion. Patients should be observed for fever and chills or other infusion-associated symptoms (see 2.6 Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Administration in combination with an aromatase inhibitor In the pivotal trial trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the Product Information for anastrozole or other aromatase inhibitors). 3-weekly schedule: Alternatively the following loading and subsequent doses are recommended for monotherapy and in combination with paclitaxel or an aromatase inhibitor. Initial Herzuma® loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion. Early breast cancer 3-weekly schedule: As a three-weekly regimen the recommended initial loading dose of Herzuma® is 8 mg/kg body weight. The recommended maintenance dose of Herzuma® at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. Alternative weekly schedule: As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide. Metastatic Gastric Cancer 3-weekly schedule: Herzuma® is administered at an initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the initial loading dose is well tolerated, the subsequent doses can be administered as a 30-minute infusion (See section 3.1 for chemotherapy combination dosing – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Duration of treatment In clinical studies, patients with metastatic breast cancer or metastatic gastric cancer were treated with trastuzumab until progression of disease. Patients with early breast cancer should be treated for 1 year or until disease recurrence, whichever occurs first. Extending treatment in EBC beyond one year is not recommended (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For instructions for use and handling refer to Section 4.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Dose reduction If the patient develops an infusion-related reaction (IRR), the infusion rate of Herzuma IV may be slowed or interrupted. No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue Herzuma® therapy during periods of reversible, chemotherapy-induced myelosuppression, but they should be monitored carefully for complications of neutropenia during this time. The specific instructions to reduce or hold the dose of chemotherapy should be followed. Missed doses If the patient has missed a dose of Herzuma® by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent Herzuma® maintenance doses be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively. If the patient has missed a dose of Herzuma® by more than one week, a re-loading dose of Herzuma® should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; 3- weekly regimen: 8 mg/kg) as soon as possible. Subsequent Herzuma® maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively. Duration of treatment In clinical studies, patients with metastatic breast cancer were treated with trastuzumab until progression of disease. Patients with early breast cancer should be treated for 1 year or until disease recurrence, whichever occurs first. Extending treatment in EBC beyond one year is not recommended (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For instructions for use and handling refer to Section 4.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Dose reduction If the patient develops an infusion-related reaction (IRR), the infusion rate of Herzuma IV may be slowed or interrupted. No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue Herzuma® therapy during periods of reversible, chemotherapy-induced myelosuppression, but they should be monitored carefully for complications of neutropenia during this time. The specific instructions to reduce or hold the dose of chemotherapy should be followed. 2.2.1 Special Dosage Instructions Elderly Data suggest that the disposition of trastuzumab is not altered based on age or serum creatinine (see Pharmacokinetics in special populations). In clinical trials, elderly patients did not receive reduced doses of trastuzumab. Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out. However in a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition. Children The safety and efficacy of trastuzumab in pediatric patients have not been established.
Route Of Administration: INTRAVENOUS
Indication Info: 2.1 Therapeutic Indications Metastatic Breast Cancer (MBC) Herzuma® is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2: <ol class="alphaparen"> <li>as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease</li> <li>in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease</li> <li>in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. This indication is based on data from one Phase III trial which studied the use of Herzuma® in combination with anastrozole (see 3.1.2 Clinical/ Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Experience with other aromatase inhibitors is limited.</li> </ol> Early Breast Cancer (EBC) Herzuma® is indicated for the treatment of patients with HER2 positive early breast cancer. <ul class="dash"> <li>following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.</li> <li>in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.</li> <li>in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma® therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 2.4 and 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul> Herzuma® should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic Gastric Cancer (MGC) Herzuma® in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro- esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herzuma® should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
Contraindications: 2.3 Contraindications Patients with known hypersensitivity to trastuzumab, murine proteins, hyaluronidase or to any other component of the product. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Atc Code: L01XC03
Atc Item Name: xl 01 xc 03
Pharma Manufacturer Name: CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Active Ingredients

Trastuzumab

440 mg/vial

TRASTUZUMAB

440 MG/VIAL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 29, 2019

Approval ID

04b0440490870c43

Type

Therapeutic

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