Fulvestrant (Faslodex)

Ce este 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, femei cu receptori de estrogen pozitiviFulvestrant este un tip de chimioterapie.

Ce este chimioterapia?

Chimioterapia este un tratament pentru cancer în care anumite medicamente sunt utilizate pentru a ucide celulele canceroase. Aceste medicamente sunt de obicei citotoxic substanțe chimice toxice pentru celule, care le restricționează creșterea, împiedică diviziunea și, în cele din urmă, distrug celulele. 

Protection From Chemotherapy

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.

Cum se utilizează Fulvestrant?

Fulvestrant a fost aprobat de Administrația pentru Alimente și Medicamente (FDA) pentru tratarea diferitelor tipuri de cancer de sân. Fulvestrant poate fi prescris în combinație cu alți agenți chimioterapici, cum ar fi palbociclib (Ibrance), abemaciclib (Verzenios) sau ribociclib (Kisqali), în funcție de severitatea și tipul de cancer. 

Formulări disponibile

Fulvestrant este disponibil numai sub formă de injecție care se administrează intramuscular în zona fesieră (gluteală). Fiecare seringă preumplută este disponibilă într-o doză de 5 ml care conține 250 mg de fulvestrant. Prin urmare, fiecare ml conține 50 mg de fulvestrant. Alte ingrediente incluse în injecție sunt etanol (96%), alcool benzilic (100 mg/ml), benzoat de benzil și ulei de ricin rafinat. 

Instrucțiuni de utilizare

Fulvestrant poate fi administrat indiferent de alimente. Seringa preumplută cu fulvestrant trebuie utilizată doar pentru injecție intramusculară în zona fesieră (gluteală). Nu trebuie administrat niciodată intravenos, subcutanat sau intraarterial. Trebuie administrate două seringi preumplute (250 mg per 5 ml), câte una în fiecare fesă, lent, timp de 1 până la 2 minute per injecție. Nu administrați mai mult de 5 ml per fesă. 

Pentru a pregăti fiecare seringă pentru administrare, țineți seringa în poziție verticală, înclinați cu grijă capacul seringii înainte și înapoi (fără a răsuci) până când capacul se deconectează pentru a fi îndepărtat. Scoateți capacul trăgând în sus fără a atinge vârful seringii (pentru a menține sterilitatea), atașați acul de siguranță la vârful seringii și rotiți ferm pentru a-l bloca. Scoateți capacul acului trăgând drept pentru a evita deteriorarea vârfului acului, scoateți teaca acului și eliminați excesul de aer din seringă înainte de administrare. Consultați eticheta produsului pentru instrucțiuni mai detaliate.

Fulvestrant se administrează inițial în doză de 500 mg în zilele 1, 15 și 29, apoi se administrează câte 500 mg o dată la 4 săptămâni pentru întreținere. Doza depinde de tipul și severitatea cancerului. Verificați doza și frecvența corecte cu medicul dumneavoastră. Doza nu trebuie să fie mai mare sau mai mică decât cea prescrisă. 

Doză omisă

Dacă ați uitat o doză din acest medicament, contactați imediat medicul dumneavoastră, deoarece acest medicament trebuie administrat conform unui program regulat. Nu încercați să recuperați prin dublarea dozei.

Storage

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. 

Efecte secundare

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

• You may not have all the side effects listed below. Many people may experience little to no side effects.
• The severity of side effects may vary from person to person, so don’t compare your side effects with other people’s experiences.
• Most of the side effects will improve when therapy is discontinued.
• 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.
• Do not hide any symptoms; when you feel any discomfort, do not hesitate to tell your physician or pharmacist about it.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions. 

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.

Allergic Reaction/Hypersensitivity 

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. 

Alte reacții adverse frecvente pot include:

• Tuse
• Iritația gâtului
• Simptome asemănătoare gripei
• Infecţie
• Infecția tractului urinar (ITU)
• Slăbiciune la picioare
• Vânătăi sau sângerări
• Depresie
• Durere în piept
• Umflarea brațelor sau picioarelor

Precauții

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.

Întrebări frecvente

Is fulvestrant a chemo agent?

Chemo drugs 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.