Medicine Information

fulvest

Name: fulvest
Brand: fulvest
Rating: 4.5 (117 reviews)

Solution for injection250 mg/5 mLAntineoplastic agents, Hormone antagonistsATC: L02BA03

Generic Name

Fulvestrant

Manufacturer

AstraZeneca

Country

United Kingdom

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
fulvest 250 mg injection	৳ 8,000.00	N/A

Description

Overview of the medicine

Fulvestrant is a hormonal therapy used for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in postmenopausal women.

Uses & Indications

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in postmenopausal women who have progressed on endocrine therapy.

In combination with palbociclib, abemaciclib, or ribociclib for the treatment of HR+, HER2- advanced or metastatic breast cancer.

Dosage

Adults

500 mg intramuscularly on Days 1, 15, 29, and once monthly thereafter. (Administered as two 250 mg/5 mL injections).

Elderly

No specific dosage adjustment is required for elderly patients.

Renal_impairment

Mild-to-moderate renal impairment: No dosage adjustment. Severe renal impairment: Use with caution.

How to Take

Administer as a deep intramuscular injection, typically into the buttock. Administer slowly (1-2 minutes per injection). Avoid intravascular injection.

Mechanism of Action

Fulvestrant is a selective estrogen receptor downregulator (SERD). It binds to the estrogen receptor (ER) with high affinity and competitively inhibits estrogen binding. It also leads to the degradation of the ER protein, thus decreasing ER levels in target tissues.

Pharmacokinetics

Onset

Gradual onset of action; clinical effects are observed over several weeks.

Excretion

Primarily excreted in feces (approximately 90%) after hepatic metabolism; less than 1% renal excretion.

Half life

Approximately 40 days (terminal half-life).

Absorption

Slowly absorbed after intramuscular (IM) injection, reaching peak plasma concentrations (Cmax) in 5 to 7 days.

Metabolism

Extensively metabolized by CYP3A4, oxidation, sulfonation, and glucuronidation pathways.

Side Effects

Contraindications

Known hypersensitivity to fulvestrant or any of its excipients
Pregnancy
Severe hepatic impairment

Drug Interactions

CYP3A4 Inhibitors/Inducers

Fulvestrant is primarily metabolized by non-CYP pathways; however, some CYP3A4 metabolism occurs. Clinically significant interactions with strong CYP3A4 inhibitors or inducers are not expected due to its primary metabolism and high protein binding.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Keep in the original carton until use.

Overdose

There is no specific antidote for fulvestrant overdose. Treatment should be symptomatic and supportive.

Pregnancy & Lactation

Contraindicated in pregnancy due to potential fetal harm. Not recommended during lactation as it is unknown whether fulvestrant is excreted in human milk.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 prefilled syringe (250 mg/5 mL)2 prefilled syringes (250 mg/5 mL each)

Shelf Life

Typically 3 years from the manufacturing date when stored correctly.

Availability

Pharmacies, hospitals

Approval Status

FDA Approved

Patent Status

Patent expired, generic versions available

Clinical Trials

Fulvestrant has been extensively studied in pivotal clinical trials such as FALCON, CONFIRM, and FULFIL, as well as in combination with CDK4/6 inhibitors (e.g., PALOMA-3, MONALEESA-3, MONARCH 2).

Lab Monitoring

Liver function tests (baseline and periodically)
Complete blood count (periodically)

Doctor Notes

Ensure proper intramuscular administration technique to avoid nerve injury or intravascular injection.
Rotate injection sites to minimize local reactions.
Assess patients for signs of hepatic impairment regularly.

Patient Guidelines

Report any severe pain or inflammation at the injection site.
Inform your doctor immediately if you experience signs of liver problems (e.g., persistent nausea, vomiting, yellowing of skin/eyes).
Seek medical attention for unusual bleeding or bruising.