FEMCORD SOLUTION FOR INJECTION 250 MG/5 ML

INTAS PHARMACEUTICALS LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Apr 21, 2021
Approval ID: c172ebe03abd8f52
Company: INTAS PHARMACEUTICALS LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: c172ebe03abd8f52
Drug Name: FEMCORD SOLUTION FOR INJECTION 250 MG/5 ML
Product Name: FEMCORD SOLUTION FOR INJECTION 250 MG/5 ML
Approval Number: SIN16163P
Approval Date: 2021-04-21
Registrant: ACCORD HEALTHCARE PRIVATE LIMITED
Licence Holder: ACCORD HEALTHCARE PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: • Posology and method of administration Posology Adult females (including the elderly) The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose. Combination therapy with palbociclib When Femcord is used in combination with palbociclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for palbociclib for Posology and method of administration. Prior to the start of treatment with the combination of Femcord plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. Combination therapy with abemaciclib When Femcord is used in combination with abemaciclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for abemaciclib for Posology and method of administration. Prior to the start of treatment with the combination of Femcord plus abemaciclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. Combination therapy with ribociclib When Femcord is used in combination with ribociclib, refer to monotherapy recommended dose instruction for Femcord. Refer to the prescribing information for ribociclib for Posology and method of administration. Special population Paediatric patient: Femcord is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group. Renal impairment: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min) and, therefore, caution is recommended in these patients (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, Femcord should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Special warnings and precautions for use and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAMUSCULAR
Indication Info: • Therapeutic indications Femcord is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. Combination therapy with palbociclib Femcord is indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression following endocrine therapy. Combination therapy with abemaciclib Femcord is indicated in combination with abemaciclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression after endocrine therapy. Combination therapy with ribociclib Femcord is indicated in combination with ribociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or following disease progression on endocrine therapy.
Contraindications: • Contraindications Hypersensitivity to the active substance, or to any of the other excipients. Pregnancy and lactation (see Pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Severe hepatic impairment (see Special warnings and precautions for use and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Combination therapy with palbociclib See palbociclib local Prescribing Information for Contraindications. Combination therapy with abemaciclib See abemaciclib local Prescribing Information for Contraindications. Combination therapy with ribociclib See ribociclib local Prescribing Information for Contraindications.
Atc Code: L02BA03
Atc Item Name: fulvestrant
Pharma Manufacturer Name: ACCORD HEALTHCARE PRIVATE LIMITED

Active Ingredients

Fulvestrant

250 mg/5 ml

FULVESTRANT

250 MG/5 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 21, 2021

Approval ID

c172ebe03abd8f52

Type

Therapeutic

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