Loading…
FULVESTRANT INJECTABLE 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.
General Fulvestrant Injectable (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 Injectable 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.
, widespread urticaria). Fulvestrant Injectable 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.
These data were not collected in the long- term follow-up of the CONFIRM study. Fulvestrant Injectable Product Monograph Page 5 of 41 Renal Caution should be used before treating patients with creatinine clearance less than 30 mL/min.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fulvestrant in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 Injectable 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 Injectable and for 2 years after the last dose.
If a patient becomes pregnant while receiving Fulvestrant Injectable she should be apprised of the potential hazard to the fetus, or the potential risk for loss of pregnancy.
Nursing Women:
Fulvestrant Injectable 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 Injectable in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.
Pediatrics:
Fulvestrant Injectable 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 Injectable in breast cancer patients with hepatic impairment. Caution should be used with Fulvestrant Injectable 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 Injectable.
Fulvestrant Injectable has not been investigated in women with severe (Child-Pugh Category C) hepatic impairment; therefore, it is not recommended for use in these patients. Fulvestrant Injectable Product Monograph Page 6 of 41 Monitoring and Laboratory Tests Liver function tests should be performed on a regular basis or when clinically indicated (see WARNINGS AND PRECAUTIONS, Hepatic).
ADVERSE REACTIONS 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 […]