What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Fluta-GRY.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Pharmacologic class: Antiandrogen
Therapeutic class: Antineoplastic
Pregnancy risk category D
Mechanism of Action
Fluta-GRY is a nonsteroidal antiandrogen that competitively binds androgen receptors throughout the body. This inhibits cell growth in prostate cancer by inhibiting testosterone’s stimulatory effects. The drug has a half-life of 6 hours, meaning dosing will have to occur a minimum of 3 times a day to maintain adequate serum levels. The liver metabolizes Fluta-GRY mainly via the CYP3A4 and other cytochrome enzymes such as CYP1A2. Fluta-GRY is primarily excreted in the urine, with less than 5% being excreted in the feces.
Fluta-GRY is indicated for the adult population only in the treatment of stage B2-C and stage D2 metastatic carcinoma of the prostate.
There has been some off-label use for the treatment of hair loss, hirsutism, polycystic ovarian syndrome, and acne. Fluta-GRY has been shown to have fewer side effects in women but continues to have hepatotoxic effects in this population.
In the treatment of acne and seborrhea in women, low-dose Fluta-GRY has shown to effectively decrease acne after 6 months of treatment with peak benefit at 1 year of use. Other agents have been used in the past for their antiandrogenic effects, such as spironolactone, but Fluta-GRY has shown to be the superior antiandrogenic treatment of acne in women, with up to 90% resolution of acne as compared to 40% with spironolactone.
Fluta-GRY has been effective in treating female pattern hair loss. Fluta-GRY can be taken alone or in conjunction with oral birth control in the treatment of hair loss, and this regiment has proven to be superior to cyproterone acetate and finasteride.
In the treatment of hirsutism, Fluta-GRY has been shown to have equal or greater effectiveness at treating symptomatology although it has a risk of hepatic injury compared to other agents such as finasteride, cyproterone acetate, and spironolactone.
First discovered in 1967, it was originally made for use as an antibiotic. It was developed by the Schering Plough Corporation of Germany and later was discovered to have antiandrogenic properties. Clinical trials began in 1971, and the drug was finally released to the public in 1983 in Germany. In 1989, Fluta-GRY was approved by the United States Food and Drug Administration. Fluta-GRY was the first nonsteroidal antiandrogen drug on the market. Other nonsteroidal antiandrogen pharmaceuticals that have been released are nilutamide, which was introduced in 1989, and bicalutamide, which was introduced in 1995.
Clinical Trials Accepting Patients
Find Clinical Trials for Fluta-GRY - Check for trials from NCI's list of cancer clinical trials now accepting patients.
Important: The drug information on this page is meant to be educational. It is not a substitute for medical advice. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. Please see your health care professional for more information about your specific medical condition and the use of this drug.
Flutam > Fluta-GRY is a nonsteroidal antiandrogen that competes directly for testosterone receptor binding sites in prostate cells. This agent is indicated for prostate cancer when used in combination with a GnRH agonist, and it can help prevent the “tumor flare” phenomenon associated with the GnRH agonists. Adverse reactions include diarrhea, hot flashes, gynecomastia, and decreased libido. Bicalutamide and nilutamide are nonsteroidal antiandrogen agents similar to Fluta-GRY and are also used in combination with a GnRH agonist or orchiectomy for advanced prostate cancer. Nilutamide has rarely caused interstitial pneumonitis and affects the eyes’ ability to adjust to changes from light to dark conditions, such as driving from daylight into a dark tunnel. Enzalutamide is a second-generation antiandrogen that, unlike the other agents in this class, exhibits no agonistic properties at the androgen receptor. It is similarly used in conjunction with a GnRH agonist to treat castration-resistant prostate cancer. Side effects of enzalutamide are largely the same as with first-generation antiandrogens with the additional risk of seizures.
• Be aware that leuprolide acetate is the most common LHRH analog given with Fluta-GRY.
To help prevent diarrhea, avoid dairy products such as milk, cheese, and yogurt. Do not use laxatives while taking Fluta-GRY.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Other drugs may interact with Fluta-GRY, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
EULEXIN Capsules contain Fluta-GRY, an acetanilid, nonsteroidal, orally active anti-androgen having the chemical name, 2-methyl-N- propanamide.
Each capsule contains 125 mg Fluta-GRY. The compound is a buff to yellow powder with a molecular weight of 276.2 and the following structual formula:
Flutam > Fluta-GRY was originally used in a number of phase II trials, notably by Sogani et al., 15 in patients with advanced metastatic prostate cancer. It showed a subjective response in over 70% and an objective response of just fewer than 50%. Also noted were good subjective responses where the patient had been previously surgically castrated. Unlike the stero > 3× per day and 1500 mg/day. The side effects are noticeably worse in the higher dosages and there appeared to be no additional clinical benefit. However, studies have not been carried out with this compound to determine the maximally tolerated dose. 16
Three important phase III studies have been carried out using Fluta-GRY 250 mg. Boccon-Gibod carried out a study of 104 patients, half of whom underwent surgical castration and the other half received Fluta-GRY monotherapy. There was no therapeutic difference in the two arms. Fluta-GRY did, however, give rise to more side effects than were experienced in the castration arm. 17 In a large Italian study with over 420 patients, Pavone-Macaluso compared Fluta-GRY with MAB. Again, there appeared to be no difference in the time to progression and cancer-related survival. Once more, the side-effect profile of Fluta-GRY led to withdrawal of patients because of diarrhea, and there was some hepatic toxicity. 18 The last important trial was mentioned earlier and comprises that of the EORTC GU Group with 310 patients randomized between Fluta-GRY and cyproterone acetate. Final results demonstrated no difference in efficacy between the two therapies. Sexual activity and erectile function were no better preserved with either therapy yet overall toxicity was more pronounced with Fluta-GRY. 13