Fulvestrant (Faslodex)

What Is Fulvestrant?

Fulvestrant (pronounced [fool VES trant]) is also known by the brand name, Faslodex. It is an antineoplastic (anti-cancer) drug that belongs to a class called estrogen receptor antagonists. It is an injectable solution that is used to treat locally advanced or metastatic breast cancer in postmenopausal, estrogen receptor-positive women. Fulvestrant is a type of 化疗.

什么是化疗？

Chemotherapy is a cancer treatment in which certain drugs are used to kill cancerous cells. These drugs are usually 细胞毒性 对细胞有毒的化学物质，限制细胞生长，阻止细胞分裂，最终杀死细胞。 

化疗保护

This drug is considered to be a hazardous agent; therefore, it is important to take appropriate precautions for receiving, handling, storing, administering, and disposing of this medication. It is highly recommended that you wear gloves while administering this medication and keep it stored in its original container.

How Is Fulvestrant Used?

Fulvestrant has been approved by the Food and Drug Administration (FDA) to treat different types of breast cancers. Fulvestrant can be prescribed in combination with other chemotherapy agents, like palbociclib (Ibrance), abemaciclib (Verzenios), or ribociclib (Kisqali), depending on the severity and type of cancer. 

可用配方

Fulvestrant is only available in the form of an injection to be administered intramuscularly in the buttocks (gluteal) area. Each pre-filled syringe is available as a 5 ml dose which contains 250 mg of fulvestrant. Therefore, each ml contains 50 mg of fulvestrant. Other ingredients included in the injection are ethanol (96%), benzyl alcohol (100 mg/ml), benzyl benzoate, and refined castor oil. 

使用方法

Fulvestrant may be taken without regard to food. The pre-filled syringe of fulvestrant is supposed to be used for intramuscular injection into the buttocks (gluteal) area only. It should never be administered intravenously, subcutaneously, or intra-arterially. Two pre-filled syringes (250 mg per 5 ml) should be administered, one in each buttock, slowly over 1 to 2 minutes per injection. Do not administer more than 5 ml per buttock. 

To prepare each syringe for administration, hold the syringe upright, carefully tilt the syringe cap back and forth (without twisting) until the cap disconnects for removal. Pull the cap off by pulling up without touching the syringe tip (to maintain sterility), attach safety needle to syringe tip, and twist firmly to lock. Remove needle cap by pulling straight off to avoid damaging needlepoint, remove needle sheath and expel excess air from the syringe before administration. Refer to the product labeling for more detailed instructions.

Fulvestrant is initially given as 500 mg on days 1, 15, and 29, and then dosed 500 mg once every 4 weeks for maintenance. The dose is dependent on the cancer type and severity. Verify the correct dose and frequency with your provider. The dose should not be more or less than what is prescribed. 

漏服剂量

If you have missed a dose of this medication, contact your physician immediately, as this drug should be taken on a regular schedule. Do not attempt to catch up by doubling the dose.

贮存

Keep medication stored in the original carton. Do not freeze and keep protected from light. Storage requirements may vary by product. Refer to the manufacturer’s labeling for further details. Fulvestrant should be stored in the refrigerator; however, some variations of fulvestrant can be stored at either room temperature or in the refrigerator. To minimize discomfort, you can take the medication out of the refrigerator up to 1 hour before the scheduled dose and allow it to reach room temperature. Do not reuse any single-use syringes and discard any unused portion. Dispose of the product as directed; do not flush down the drain. 

What To Avoid While Taking Fulvestrant?

While on fulvestrant therapy, you must follow some precautions. Always tell your physician about any medication you are already taking. Do not take any drug or medicine (even herbals, vitamins,  or over-the-counter medications) without prior consent from your physician or pharmacist, as they may have some significant interactions with fulvestrant. 

Pregnancy and Fulvestrant

Pregnancy status must be checked within 7 days prior to starting chemotherapy in women of child-bearing age. Effective contraception must be used during treatment and for 1 year after the last dose. Fulvestrant may cause fetal harm and is therefore not recommended for women who are breastfeeding during therapy. Breastfeeding should also be avoided for at least 1 year after the last dose. 

副作用

As with any other medication, you may encounter side effects while taking fulvestrant. A few things to remember are:

• 您可能不会出现以下列出的所有副作用。许多人可能几乎没有副作用。
• 副作用的严重程度可能因人而异，因此不要将您的副作用与其他人的经历进行比较。
• 停止治疗后，大多数副作用都会改善。
• These side effects are easily manageable most of the time either by readjusting the dose of fulvestrant or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
• 不要隐瞒任何症状；当您感到任何不适时，请毫不犹豫地告诉您的医生或药剂师。

笔记：此列表并未涵盖所有副作用。如有任何疑问，请咨询医生。 

Some of the most common side effects of fulvestrant are:

Gastrointestinal (GI) Effects

It is common to experience abdominal pain, constipation, decreased appetite, diarrhea, nausea, stomatitis, or vomiting while taking fulvestrant. 

Injection Site Pain

Pain at the injection site is very common with fulvestrant. The area where the medication is injected may feel sore for a few hours or days after injection. This may also be accompanied by mild bruising, swelling, or redness at the injection site. These pains can be controlled using over-the-counter painkillers like Tylenol or Motrin, but usually, they will resolve on their own within a few days. Consult your doctor or pharmacist before starting any new therapies.

过敏反应/超敏反应 

There have been cases reported of patients with allergic reactions to the fulvestrant injection or any of its components. Signs of an allergic reaction can include rash; hives; itching; swollen, red, blistered, or peeling skin with or without fever; wheezing; tightness in the throat or chest; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, lips, face, tongue, or throat. If you are experiencing any of these symptoms, seek emergency medical attention immediately. 

Hormonal Side Effects 

Because fulvestrant blocks the estrogen receptor, it affects the hormonal levels of estrogen. Due to the hormonal imbalance in the body, you may have side effects similar to menstruation or menopause like hot flashes, fatigue, headaches, dizziness, back or joint pain, muscle pain, nausea, vomiting, constipation/diarrhea, lack of appetite, trouble sleeping, pelvic pain, increased sweating, or fever. Due to the high risk of fatigue, avoid operating heavy machinery while taking fulvestrant. 

其他常见的副作用可能包括：

• 咳嗽
• 咽喉刺激
• Flu-like symptoms
• 感染
• Urinary tract infection (UTI)
• Leg weakness
• Bruising or bleeding
• 沮丧
• 胸痛
• Swelling of arms or legs

防范措施

Unless approved by your physician, fulvestrant is generally not recommended in: 

• Patients who have an allergy to fulvestrant, benzyl alcohol, or any other ingredients in the injection. These reactions can cause a rash over the whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using fulvestrant, and seek emergency medical attention immediately.
• Patients with a history of liver disorder or chronic alcohol use. Patients with liver impairment may require a lower dose. For those with a history of chronic alcohol use, it may be recommended to avoid fulvestrant entirely since it contains approximately 96% ethanol. Fulvestrant can also increase liver enzymes, including AST and ALT levels.
• Patients with bleeding or blood clotting problems. Bleeding or clotting problems may worsen with the use of fulvestrant. These problems may exhibit symptoms like bruising; black, tarry, or bloody stools; bleeding gums; blood in the urine; coughing up blood; cuts that take a long time to stop bleeding; nosebleeds; throwing up blood or vomit that looks like coffee grounds.

常见问题解答

Is fulvestrant a chemo agent?

化疗药物 are those that are used in the management of various cancers. Fulvestrant kills cancer cells and is therefore a chemo agent. It is recommended as a treatment option for various cancer patients. 

How should fulvestrant be taken?

The pre-filled syringe of fulvestrant is supposed to be used for intramuscular injection into the buttocks (gluteal) area only. Two pre-filled syringes (250 mg per 5 ml) should be administered, one in each buttock, slowly over 1 to 2 minutes per injection. The total dose should be 500 mg per month. Do not administer more than 5 ml (one syringe) per buttock. 

Can you touch fulvestrant?

Chemo drugs contain chemicals that are hazardous to your health. Therefore, it is highly recommended to wear gloves when administering the drug. Store securely in its original container until time of use.