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Drug overview for NILUTAMIDE (nilutamide):
Generic name: NILUTAMIDE (nye-LOO-tuh-mide)
Drug class: Antiandrogen
Therapeutic class: Antineoplastics
Nilutamide is a nonsteroidal antiandrogen.
No enhanced Uses information available for this drug.
Generic name: NILUTAMIDE (nye-LOO-tuh-mide)
Drug class: Antiandrogen
Therapeutic class: Antineoplastics
Nilutamide is a nonsteroidal antiandrogen.
No enhanced Uses information available for this drug.
DRUG IMAGES
NILUTAMIDE 150 MG TABLET
The following indications for NILUTAMIDE (nilutamide) have been approved by the FDA:
Indications:
Metastatic prostate carcinoma
Professional Synonyms:
Metastatic malignancy of prostate
Metastatic malignant neoplasm of prostate
Metastatic malignant tumor of prostate
Metastatic prostate cancer
Indications:
Metastatic prostate carcinoma
Professional Synonyms:
Metastatic malignancy of prostate
Metastatic malignant neoplasm of prostate
Metastatic malignant tumor of prostate
Metastatic prostate cancer
The following dosing information is available for NILUTAMIDE (nilutamide):
No enhanced Dosing information available for this drug.
Nilutamide is administered orally without regard to meals. Store tablets between 20-25degreesC (excursions permitted between 15-30degreesC) and protect from light.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NILUTAMIDE 150 MG TABLET | Maintenance | Adults take 1 tablet (150 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NILUTAMIDE 150 MG TABLET | Maintenance | Adults take 1 tablet (150 mg) by oral route once daily |
The following drug interaction information is available for NILUTAMIDE (nilutamide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for NILUTAMIDE (nilutamide):
Drug contraindication overview.
*Severe hepatic impairment. *Severe respiratory insufficiency. *History of hypersensitivity to nilutamide or any ingredient in the formulation.
*Severe hepatic impairment. *Severe respiratory insufficiency. *History of hypersensitivity to nilutamide or any ingredient in the formulation.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Interstitial lung disease |
| Respiratory depression |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for NILUTAMIDE (nilutamide):
Adverse reaction overview.
Adverse effects reported in >=5% of patients in clinical trials receiving nilutamide with surgical castration include hypertension, nausea, constipation, hot flushes, increased ALT, increased AST, dizziness, dyspnea, impaired adaptation to the dark, abnormal vision, and urinary tract infection. Adverse effects reported in >=10% of patients in clinical trials receiving nilutamide with leuprolide include pain, headache, asthenia, back pain, abdominal pain, nausea, constipation, anorexia, hot flushes, impotence, decreased libido, increased AST, peripheral edema, insomnia, dizziness, dyspnea, impaired adaptation to the dark, testicular atrophy, and gynecomastia.
Adverse effects reported in >=5% of patients in clinical trials receiving nilutamide with surgical castration include hypertension, nausea, constipation, hot flushes, increased ALT, increased AST, dizziness, dyspnea, impaired adaptation to the dark, abnormal vision, and urinary tract infection. Adverse effects reported in >=10% of patients in clinical trials receiving nilutamide with leuprolide include pain, headache, asthenia, back pain, abdominal pain, nausea, constipation, anorexia, hot flushes, impotence, decreased libido, increased AST, peripheral edema, insomnia, dizziness, dyspnea, impaired adaptation to the dark, testicular atrophy, and gynecomastia.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Drug-induced hepatitis Dyspnea Hypertension Interstitial pneumonitis Leukopenia Urinary tract infection |
| Rare/Very Rare |
|---|
| None. |
There are 11 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Drug-induced hot flash Erectile dysfunction Libido changes Nausea Night blindness |
Acquired chromatopsia Anorexia Constipation Diarrhea Dizziness Photophobia |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for NILUTAMIDE (nilutamide):
The safety and efficacy of nilutamide in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data on the use of nilutamide in pregnant women to evaluate the drug-associated risk in pregnancy. It is unknown whether nilutamide can cause fetal harm when administered to a pregnant patient. Administer nilutamide to a pregnant patient only if clearly needed. Nilutamide is not intended for use in women.
There are no available data on use during lactation.
The safety and efficacy of nilutamide in geriatric patients have not been established.
The following prioritized warning is available for NILUTAMIDE (nilutamide):
WARNING: Rarely, nilutamide has caused severe (sometimes fatal) lung problems (interstitial pneumonitis). Get medical help right away if you develop symptoms of lung problems (such as cough, trouble breathing, chest pain, fever). Lung problems can happen at any time while you are taking nilutamide, but they occur most often during the first 3 months of treatment.
Your doctor will tell you whether to stop or continue nilutamide. Your doctor may have you get a chest X-ray and breathing tests before you start nilutamide.
WARNING: Rarely, nilutamide has caused severe (sometimes fatal) lung problems (interstitial pneumonitis). Get medical help right away if you develop symptoms of lung problems (such as cough, trouble breathing, chest pain, fever). Lung problems can happen at any time while you are taking nilutamide, but they occur most often during the first 3 months of treatment.
Your doctor will tell you whether to stop or continue nilutamide. Your doctor may have you get a chest X-ray and breathing tests before you start nilutamide.
The following icd codes are available for NILUTAMIDE (nilutamide)'s list of indications:
| Metastatic prostate carcinoma | |
| C61 | Malignant neoplasm of prostate |
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