Fukayna
Fulvestrant
Strength: 250mg
Pack Size: 1 PFS
Drug Class: Antiestrogens
Dosage and Administration:
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. The recommended dose of Fukayna is 250 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.
Cold Storage: yes
Fukayna (fulvestrant) injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene3,17-beta-diol. The molecular formula is C32H47F5O3S and its structural formula is:
Fulvestrant is a white powder with a molecular weight of 606.77.
Fukayna is indicated for the treatment of:
- Hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
- HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Fukayna is indicated for the treatment of:
- HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
- HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol and downregulates the ER protein in human breast cancer cells. Fulvestrant inhibited the growth of established MCF-7 xenografts and of tamoxifen-resistant breast tumor xenografts.
- Keep out of reach of children.
- Take as directed by physician.
Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, Fukayna can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose.
Lactation
Advise women not to breastfeed during treatment with Fukayna and for one year after the last dose
