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Drug overview for EULEXIN (flutamide):
Generic name: flutamide (FLEW-tuh-mide)
Drug class: Antiandrogen
Therapeutic class: Antineoplastics
Flutamide, a nonsteroidal antiandrogen, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: flutamide (FLEW-tuh-mide)
Drug class: Antiandrogen
Therapeutic class: Antineoplastics
Flutamide, a nonsteroidal antiandrogen, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
EULEXIN 125 MG CAPSULE
The following indications for EULEXIN (flutamide) have been approved by the FDA:
Indications:
Prostatic carcinoma
Professional Synonyms:
Malignancy of prostate
Malignant neoplasm of prostate
Malignant tumor of prostate
Prostate cancer
Indications:
Prostatic carcinoma
Professional Synonyms:
Malignancy of prostate
Malignant neoplasm of prostate
Malignant tumor of prostate
Prostate cancer
The following dosing information is available for EULEXIN (flutamide):
Patients should be advised of the possibility of facial flushing during flutamide therapy and that alcohol could exacerbate this effect. Patients who experience such intolerance during therapy with the drug should avoid alcohol consumption.
Because of the intended labeled use of flutamide, safety and efficacy of the drug have not been established in women or children. Flutamide is not intended for use in women and should not be used in women, particularly for nonserious or nonlife-threatening conditions.
Flutamide is extensively metabolized to at least 6 metabolites.
No information is available concerning use of flutamide in patients with hepatic impairment. The manufacturer states that flutamide should not be used in patients with severe hepatic impairment. Serum transaminase concentrations should be measured prior to initiation of flutamide therapy, at regular intervals during the first 4 months of treatment, and periodically thereafter in all patients receiving flutamide.
(See Discontinuance of Therapy for Hepatic Toxicity, in Dosage and Administration: Dosage.)
In individuals with chronic renal insufficiency receiving a single 250-mg dose of flutamide, there was no correlation between creatinine clearance and plasma concentrations of the drug. Renal impairment did not affect peak concentrations or AUCs of the drug and principal active metabolite. In individuals with a creatinine clearance of less than 29 mL/minute, the half-life of the active metabolite is slightly prolonged. Adjustment of flutamide dosage in patients with renal impairment generally is unnecessary.
Because of the intended labeled use of flutamide, safety and efficacy of the drug have not been established in women or children. Flutamide is not intended for use in women and should not be used in women, particularly for nonserious or nonlife-threatening conditions.
Flutamide is extensively metabolized to at least 6 metabolites.
No information is available concerning use of flutamide in patients with hepatic impairment. The manufacturer states that flutamide should not be used in patients with severe hepatic impairment. Serum transaminase concentrations should be measured prior to initiation of flutamide therapy, at regular intervals during the first 4 months of treatment, and periodically thereafter in all patients receiving flutamide.
(See Discontinuance of Therapy for Hepatic Toxicity, in Dosage and Administration: Dosage.)
In individuals with chronic renal insufficiency receiving a single 250-mg dose of flutamide, there was no correlation between creatinine clearance and plasma concentrations of the drug. Renal impairment did not affect peak concentrations or AUCs of the drug and principal active metabolite. In individuals with a creatinine clearance of less than 29 mL/minute, the half-life of the active metabolite is slightly prolonged. Adjustment of flutamide dosage in patients with renal impairment generally is unnecessary.
Flutamide is administered orally without regard to meals.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| EULEXIN 125 MG CAPSULE | Maintenance | Adults take 2 capsules (250 mg) by oral route every 8 hours |
No generic dosing information available.
The following drug interaction information is available for EULEXIN (flutamide):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for EULEXIN (flutamide):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 7 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemoglobin H disease |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Hepatic failure |
| Hyperbilirubinemia |
| Lactation |
| Severe hepatic disease |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Methemoglobinemia |
| NADH methemoglobin reductase deficiency |
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for EULEXIN (flutamide):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Anemia Hypertension Leukopenia Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Hemolytic anemia Hepatic failure Hepatitis Jaundice Methemoglobinemia |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Drug-induced hot flash Erectile dysfunction Gynecomastia Libido changes |
Anorexia Drowsy Edema Nausea Nervousness Symptoms of anxiety Vomiting |
| Rare/Very Rare |
|---|
|
Skin photosensitivity Urine discoloration |
The following precautions are available for EULEXIN (flutamide):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for EULEXIN (flutamide):
WARNING: Rarely, flutamide has caused severe (sometimes fatal) liver problems. Immediately tell your doctor if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain that doesn't go away, loss of appetite, severe tiredness, dark urine, yellowing eyes/skin, aching muscles, joint pain). Liver problems can happen at any time while taking flutamide, but they occur most often during the first 3 months of treatment.
Your doctor will tell you whether to stop or continue flutamide. Your doctor will monitor your liver function with blood tests while you take flutamide. Keep all medical and lab appointments. Avoid alcohol while taking flutamide.
WARNING: Rarely, flutamide has caused severe (sometimes fatal) liver problems. Immediately tell your doctor if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain that doesn't go away, loss of appetite, severe tiredness, dark urine, yellowing eyes/skin, aching muscles, joint pain). Liver problems can happen at any time while taking flutamide, but they occur most often during the first 3 months of treatment.
Your doctor will tell you whether to stop or continue flutamide. Your doctor will monitor your liver function with blood tests while you take flutamide. Keep all medical and lab appointments. Avoid alcohol while taking flutamide.
The following icd codes are available for EULEXIN (flutamide)'s list of indications:
| Prostatic carcinoma | |
| C61 | Malignant neoplasm of prostate |
Formulary Reference Tool