Fulviglen 250mg Injection

Monotherapy Fulvestrant injection 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. Combination Therapy Fulvestrant injection 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. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausalwomen not previouslytreatedwith endocrine therapy. HR-positive advanced breast cancer in postmenopausalwomen with disease progressionfollowingendocrinetherapy. HR-positive, HER2-negative advanced or metastatic breast cancer inpostmenopausal 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 incombination with palbociclib or abemaciclib in women with disease progression after endocrinetherapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Risk of Bleeding: Use with caution in patients with bleeding diatheses,thrombocytopenia, or anticoagulant use. IncreasedExposure in Patients with Hepatic Impairment: Use a 250 mg dose for patients with moderate hepatic impairment. Injection Site Reaction: Use caution while administering Fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Immunoassay Measurement of Serum Estradiol: Fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels. Risk of Bleeding Because Fulvestrant is administered intramuscularly, it should be used with caution in patientswith bleeding diatheses, thrombocytopenia, or anticoagulant use. Increased Exposure in Patients with Hepatic Impairment The safety and pharmacokinetics of Fulvestrant were evaluated in a study in seven subjects with moderate hepatic impairment (Child-Pugh class B) and seven subjects with normal hepatic function. Exposure was increased in patients with moderate hepatic impairment, therefore, a dose of 250 mg is recommended. Fulvestrant has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Injection Site Reaction Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheralneuropathy have been reported with Fulvestrant injection. Caution shouldbetaken while administering Fulvestrant at the dorsogluteal injection site due to theproximity of the underlying sciatic nerve. Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, Fulvestrant can cause fetal harm when administered to a pregnant woman. In animalreproductionstudies,administration of Fulvestrant to pregnant rats and rabbits duringorganogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Fulvestrant and for one year after the last dose. Immunoassay Measurement of Serum Estradiol Due to structural similarity of Fulvestrant and estradiol, Fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Bleeding Increased Exposure in Patients with Hepatic Impairment Injection Site Reaction Embryo-Fetal Toxicity Themostcommonadverse reactions occurring in ≥5% of patients receiving Fulvestrant 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash,vomiting,anorexia,asthenia,musculoskeletal pain, cough, dyspnea,and constipation. Increased hepatic enzymes (ALT, AST,ALP)occurred in >15% of Fulvestrant patients and were not dose-dependent. Clinical Trials Experience Because clinical trials are conducted under widely varyingconditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and maynot reflect the rates observed in clinicalpractice. Monotherapy Comparison of Fulvestrant 500 mg and Fulvestrant 250 mg (CONFIRM) The following adverse reactions (ARs) were calculated based on the safety analysis of CONFIRM comparingtheadministration of Fulvestrant 500 mgintramuscularly once a month with Fulvestrant 250 mgintramuscularlyonce a month. The mostfrequentlyreported adverse reactions in the Fulvestrant 500 mggroup were injection site pain (11.6% of patients),nausea (9.7% of patients), and bone pain (9.4% of patients); the most frequently reported adverse reactions in the Fulvestrant 250 mg group were nausea (13.6% of patients), back pain (10.7% of patients), and injection site pain (9.1% of patients). Table 1 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from CONFIRM. Table 1: Adverse Reactions in CONFIRM (≥5% in Either Treatment Group) 1 Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. Adverse Reactions Fulvestrant 500 mg N=361 % Fulvestrant 250 mg N=374 % Body as a Whole Injection Site Pain 1 12 9 Headache 8 7 Back Pain 8 11 Fatigue 8 6 Pain in Extremity 7 7 Asthenia 6 6 Vascular System Hot Flash 7 6 Digestive System Nausea 10 14 Vomiting 6 6 Anorexia 6 4 Constipation 5 4 Musculoskeletal System Bone Pain 9 8 Arthralgia 8 8 Musculoskeletal Pain 6 3 Respiratory System Cough 5 5 Dyspnea 4 5 In the pooled safety population(N=1127) from clinical trials comparing Fulvestrant 500 mg to Fulvestrant 250 mg,post-baseline increases of ≥1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in >15% of patients receiving Fulvestrant. Grade3-4increaseswere observed in 1-2% of patients. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.