Fulvetraz injection contains the active substance fulvestrant. It is an antineoplastic drug that belongs to the class estrogen receptor antagonist. Estrogen, a type of female sex hormone, can sometimes be involved in the growth of breast cancer. This medicine is used alone to treat postmenopausal women with a certain type of breast cancer called estrogen receptor-positive breast cancer that is locally advanced or spread to other parts of the body. It is also indicated in combination with other anti-cancer medication to treat women with certain types of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, which is locally advanced or spread to other parts of the body. 

Do not take this injection if you are allergic to fulvestrant or any other ingredients of this medicine, pregnant or breastfeeding, or have severe liver problems. Before initiating the treatment, inform your physician if you have kidney or liver problems, bone diseases, bleeding disorders, and heart diseases. Fulvetraz injection is not indicated in children and adolescents under 18 years. Report to your physician if you have allergic reactions, including swelling of the face, lips, tongue, or throat, after administering this injection. 

Common side effects of Fulvetraz injection are pain or inflammation at the site of injection, abnormal levels of liver enzymes, nausea, headache, cough, weakness or tiredness, joint and muscle pain, hot flashes, hair loss, and skin rash. Your doctor may advise you to take certain blood tests while receiving this injection. This injection may increase your risk of bleeding and liver failure. Female patients of reproductive potential should use effective contraception during treatment with this injection and for two years after the last dose.

• Treat Hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER2)-negative breast cancer in postmenopausal women.

Many breast cancers have estrogen receptors (ER), and the growth of these tumors can be stimulated by estrogen. Fulvetraz injection is an estrogen receptor antagonist that binds to the estrogen receptors in cancer cells and works by blocking the action of estrogen on cancer cells. This can slow or stop the growth of tumor cells.   

Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter medications, recent vaccinations, nutritional and vitamin supplements, and herbal products. Certain medications may interact with Fulvetraz injection and reduce its effectiveness by causing undesirable side effects. 

• Store Fulvetraz injection in the refrigerator (2°C to 8°C)
• Do not freeze
• keep the injection away from the reach of children and pets.
• If you have missed any dosing appointments, inform your doctor and schedule immediately.

It should only be administered by a trained doctor or nurse as a slow intramuscular injection. Do not self-administer the injection. Your doctor will decide the dose and duration of the treatment based on your disease severity and other factors. 

Side effects are unwanted symptoms caused by medicines. Even though all drugs cause side effects, not everyone gets them. 

 Common

• Constipation, diarrhea
• Loss of appetite
• Nausea, vomiting
• Decreased RBC, WBC, and Platelets
• Infections
• Joint and muscle pain
• Backache, bone pain
• Weakness, tiredness
• Headache
• Cough, difficulty breathing
• Hot flushes
• Pain at the site of injection

Serious

• Changes in heart rhythm
• Severe neutropenia(decreased WBC)
• Liver failure, inflammation of liver
• Hypersensitivity reaction
• Swelling in the body

Inform your physician if you have vaginal bleeding, especially at starting of the therapy. This medicine is given as a shot into one of your muscles. Fulvetraz injection should be used with caution in patients with severe kidney disease. This medicine needs to be given on a fixed schedule; if you miss a dose inform your doctor immediately. Do not breastfeed during treatment and for one year after your last dose. This medicine may cause infertility. Talk to your doctor before using this medicine if you plan to have children. 

1. Faslodex 250 mg solution for injection - Summary of Product Characteristics (SmPC) - (emc). www.medicines.org.uk. [2020] [cited 2023 Mar 21]. Available from: https://www.medicines.org.uk/emc/product/68
2. HIGHLIGHTS OF PRESCRIBING INFORMATION. [2017] [cited 2023 Mar 21]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf
3. Goodman & Gilman’s, The Pharmacological Basics of Therapeutics, Estrogens and progestins, 12th edition, 2011, 1177.