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FULVESTRANT is a brand name for Fulvestrant, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................. 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Fulvestrant 500 mg was well tolerated with a similar tolerability profile to fulvestrant 250 mg. Adverse drug reactions for which there is evidence of an increased incidence for fulvestrant 500 mg include injection site reactions and hypersensitivity reactions (predominantly pruritus).
An increased incidence of injection site reactions and hypersensitivity reactions, such as pruritus, is consistent with the increased number of injections required for the fulvestrant 500 mg dose regimen compared to fulvestrant 250 mg.
Following review of clinical trial data, a number of adverse drug reactions (ADRs) were identified for fulvestrant 500 mg, where a causal link has been established between the ADR and fulvestrant treatment. These ADRs were assigned to frequency categories based on incidences of similar preferred terms (PTs) for adverse events (AEs) using medical dictionary for regulatory activities (MedDRA).
The frequencies are based on all reported AEs regardless of the investigator assessment of causality. The following ADRs were identified as being very common (incidence rate ≥10%): Injection site reactions (including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy), asthenia, joint and musculoskeletal pain (includes arthralgia, and less frequently musculoskeletal pain, back pain, myalgia and pain in extremity), nausea, hypersensitivity reactions, rash and hot flushes.
Common ADRs (incidence rate ≥1% but <10%) were: headache, reduced platelet count, vomiting, diarrhoea, anorexia, and urinary tract infections. Hepatotoxicity has been reported in patients treated with fulvestrant. 1% and <1%) in patients treated with fulvestrant.
In some cases, discontinuation of treatment resulted in improvement of transaminase and bilirubin levels. 2%) potential Hy’s law cases that were interpreted as possibly being predictive of more severe hepatic events in the post- marketing setting.
Serious adverse events (SAEs; irrespective of causality) were typically reported at single incidences in fulvestrant 500 mg clinical trials for any given MedDRA PT. 8%) in studies in which patients had prior anti-estrogen therapy. 8%).
AEs leading to permanent discontinuation of treatment (DAEs; irrespective of causality) were typically reported at single incidences in fulvestrant 500 mg clinical trials for any given MedDRA PT. 8% in the study in which patients had no prior endocrine therapy).
General Fulvestrant Injection (fulvestrant) is unlikely to impair the ability of patients to drive or operate machinery. However, during treatment with fulvestrant, asthenia has been reported, and caution should be observed by those patients who experience this symptom when driving or operating machinery.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection. Caution should be taken while administering Fulvestrant Injection at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve and large blood vessels (see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS).
Hematologic Due to the route of administration (intramuscular injection), caution should be used before treating patients on anticoagulants or patients with bleeding diatheses or thrombocytopenia Hepatic Fulvestrant is associated with elevated transaminase, bilirubin, and alkaline phosphatase levels.
In some cases, discontinuation of treatment resulted in improvement of transaminase and bilirubin levels. 2%) potential Hy’s law cases which may be predictive of more severe hepatic events in the post-marketing setting. Hepatic failure (in some cases fatal) has been reported in patients treated with fulvestrant.
There was no clear evidence of liver metastases in these case reports and the events had a clear temporal relationship with fulvestrant use; therefore a causal link between these events and fulvestrant could not be excluded (see ADVERSE REACTIONS).
Liver function tests should be performed on a regular basis or when clinically indicated. Immune Hypersensitivity reactions including angioedema and urticaria may occur. These reactions may occur shortly after injection, or in one reported case of angioedema, several days after injection.
g. g. widespread urticaria). Fulvestrant Injection therapy may need to be discontinued. Musculoskeletal There are no long-term data on the effect of fulvestrant on bone. Due to the mode of action of fulvestrant, there is a potential risk of osteoporosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Study in patients with no prior endocrine therapy The safety of fulvestrant 500 mg versus anastrozole 1 mg was evaluated in a Phase III, randomized, double-blind, double-dummy, multicentre study (Study D699BC00001, FALCON).
The data described below reflect exposure to fulvestrant in 228 out of 460 postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer not previously treated with endocrine therapy who received at least one dose of treatment in FALCON.
Adverse drug reactions reported in patients who received fulvestrant in the FALCON trial at an incidence of ≥5% (incidence is regardless of causality) in either treatment arm are listed in Table 1. 9) aGrade 3 or higher Table 2 summarizes the laboratory data from both treatment arms of the FALCON study for ‘elevated liver enzymes’ [aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood alkaline phosphatase (ALP)] and ‘elevated bilirubin’.
4) n = Number of patients with an increase in CTC grade N = Number of patients […]
These data were not collected in the long-term follow-up of the CONFIRM study. Renal Caution should be used before treating patients with creatinine clearance less than 30 mL/min. Fulvestrant Injection Page 5 of 36 Immunoassay Measurement of Serum Estradiol Fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels (see DRUG INTERACTIONS, Drug-Laboratory Interactions).
Special Populations Pregnant Women:
Fulvestrant Injection is contraindicated in pregnant women. Fulvestrant can cause fetal harm if administered to a pregnant woman. Women of childbearing potential should use effective contraception during treatment with Fulvestrant Injection and for 2 years after the last dose.
If a patient becomes pregnant while receiving Fulvestrant Injection she should be apprised of the potential hazard to the fetus, or the potential risk for loss of pregnancy.
Nursing Women:
Fulvestrant Injection is contraindicated in lactating women Fulvestrant is found in rats' milk at levels significantly higher than those in rat plasma. It is not known if fulvestrant is excreted in human milk. However, since many drugs are excreted in human milk, and because of the potential for serious adverse reactions from Fulvestrant Injection in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.
Pediatrics (< 18 years of age):
Fulvestrant Injection is not recommended for use in the pediatric population, as safety and efficacy have not been established in this age group.
Hepatic Impairment:
Fulvestrant is metabolized primarily in the liver; thus, clearance may be reduced in women with hepatic impairment. 2 fold in women with moderate hepatic impairment in comparison to healthy women. The average AUC of fulvestrant in these women (Child-Pugh Category B) increased by approximately 70% compared to patients with normal hepatic function (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
There are no efficacy and safety data available for Fulvestrant Injection in breast cancer patients with hepatic impairment. Caution should be used with Fulvestrant Injection in patients with mild to moderate hepatic impairment. The potential risk/benefit to patients with moderate hepatic impairment should be carefully considered before administration of Fulvestrant Injection.
Fulvestrant has not been investigated in women with severe (Child-Pugh Category C) hepatic impairment; therefore, it is not recommended for use in these patients. Monitoring and Laboratory Tests Liver function tests should be performed on a regular basis or when clinically indicated (see WARNINGS AND PRECAUTIONS, Hepatic).
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