FULVENAT 250 MG INJ. VIAL.

About

Fulvestrant is an estrogen receptor antagonist that works by binding to the estrogen receptor (ER) in a competitive manner, leading to its degradation. This mechanism of action distinguishes it from selective estrogen receptor modulators (SERMs) and aromatase inhibitors. By downregulating and degrading the ER, fulvestrant effectively blocks estrogen's proliferative effects on hormone receptor-positive breast cancer cells, thereby inhibiting tumor growth.

It is administered via intramuscular injection, providing a sustained therapeutic effect. Fulvestrant is primarily indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women, particularly after progression on endocrine therapy. Its unique mechanism of complete ER degradation offers a valuable option in managing endocrine-resistant disease.

Uses

• Treatment of hormone receptor-positive, HER2-negative advanced breast cancer.
• Used in postmenopausal women with disease progression after endocrine therapy.
• Can be used in combination with CDK4/6 inhibitors for advanced breast cancer.
• Management of metastatic breast cancer with estrogen receptor positivity.

Directions For Use

Administer as a deep intramuscular injection into the buttock, as prescribed by your healthcare provider. Do not administer intravenously.

Benefits

• Effectively blocks estrogen's growth-promoting effects on cancer cells.
• Causes degradation of the estrogen receptor, a unique mechanism.
• Offers a valuable option for endocrine-resistant breast cancer.
• Can be used as monotherapy or in combination with other agents.
• Improves progression-free survival in advanced breast cancer.
• Administered less frequently than daily oral therapies.

Side Effects

• Injection site pain
• Nausea
• Asthenia (weakness)
• Hot flashes
• Headache
• Back pain
• Bone pain
• Vomiting
• Anorexia
• Peripheral edema
• Constipation
• Diarrhea

Safety Measures

• Alcohol - No specific contraindication with alcohol, but excessive intake should be avoided as it may worsen general health or side effects.
• Pregnancy - Fulvestrant is contraindicated in pregnancy due to potential harm to the fetus. Women of childbearing potential should use effective contraception during treatment and for two years after the last dose.
• Breastfeeding - Breastfeeding is not recommended during treatment with fulvestrant due to the potential for serious adverse reactions in breastfed infants.
• Liver - Use with caution in patients with moderate to severe hepatic impairment. Dose adjustments may be necessary, and liver function should be monitored.
• Kidney - No specific dose adjustment is required for mild to moderate renal impairment. Use with caution in severe renal impairment, as data are limited.
• Lung - Monitor for signs of pulmonary embolism, though direct lung toxicity is not a primary concern.

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