Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Bleeding [see Warnings and Precautions ( 5.1 )] Increased Exposure in Patients with Hepatic Impairment [see Warnings and Precautions ( 5.2 )] Injection Site Reaction [see Warnings and Precautions ( 5.3 )] Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in ≥5% of patients receiving Fulvestrant Injection 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.
( 6.1 ) Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of Fulvestrant Injection patients and were not dose-dependent.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc.
at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
Monotherapy Comparison of Fulvestrant Injection 500 mg and Fulvestrant Injection 250 mg (CONFIRM) The following adverse reactions (ARs) were calculated based on the safety analysis of CONFIRM comparing the administration of Fulvestrant Injection 500 mg intramuscularly once a month with Fulvestrant Injection 250 mg intramuscularly once a month.
The most frequently reported adverse reactions in the Fulvestrant Injection 500 mg group 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 Injection 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.
5 WARNINGS AND PRECAUTIONS Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use.
( 5.1 ) Increased Exposure in Patients with Hepatic Impairment: Use a 250 mg dose for patients with moderate hepatic impairment.
( 2.2 , 5.2 , 8.6 ) Injection Site Reaction: Use caution while administering Fulvestrant Injection at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve.
( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm.
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Like all medications, Fulvestrant can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: