Rx Item-Faslodex 250Mg/5Ml Syringe 2X5Ml By Astra Zeneca Pharma

FASLODEX- fulvestrant injection
AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE

Monotherapy

FASLODEX is indicated for the treatment of hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Combination Therapy with Palbociclib

? FASLODEX is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose


Monotherapy

The recommended dose is 500 mg to be administered intramuscularly into the buttocks ?(gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter [see Clinical Studies (14)].

Combination Therapy with Palbociclib

? When FASLODEX is used in combination with palbociclib, the recommended dose is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter. The recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Please refer to the full prescribing information of palbociclib.

? Pre/perimenopausal women treated with the combination FASLODEX plus palbociclib should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards [see Clinical Studies (14) ? ] ? .

2.2 Dose Modification
Monotherapy

Hepatic Impairment:

A dose of 250 mg is recommended for patients with moderate hepatic impairment (Child-Pugh class B) to be administered intramuscularly into the buttock ?(gluteal area) slowly (1 - 2 minutes) as one 5 mL injection on days 1, 15, 29 and once monthly thereafter.

FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].

Combination Therapy with Palbociclib

? When FASLODEX is used in combination with palbociclib, refer to monotherapy dose modification instructions for FASLODEX. Refer to the full prescribing information of palbociclib for its dose modification, management of toxicities, and for use with concomitant medication.

RX ITEM-Faslodex 250Mg/5Ml Syringe 2X5Ml
NDC 00310-0720-10 UPC/GTIN No.3-03100-72010-7 Mfg.Part No.72010

Faslodex 250Mg/5Ml Syringe 2X5Ml By Astr
BRAND: FASLODEX NDC: 00310-0720-10,310072010 UPC: 3-03100-72010-7,303100720107 Astra Zeneca Pharma

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