Dosing & Uses
Dosage Forms & Strengths
tablet
- 150mg
Prostate Cancer
300 mg PO qDay for 30 days, THEN
150 mg PO qDay
Begin treatment on same day as or day after surgical castration
Monitor
Chest X-ray, pulmonary function tests, LFTs before starting
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (5)
- dihydroergotamine intranasal
nilutamide will increase the level or effect of dihydroergotamine intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin base
nilutamide will increase the level or effect of erythromycin base by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin ethylsuccinate
nilutamide will increase the level or effect of erythromycin ethylsuccinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin lactobionate
nilutamide will increase the level or effect of erythromycin lactobionate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin stearate
nilutamide will increase the level or effect of erythromycin stearate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
Monitor Closely (11)
- artemether/lumefantrine
nilutamide will increase the level or effect of artemether/lumefantrine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- bazedoxifene/conjugated estrogens
nilutamide will increase the level or effect of bazedoxifene/conjugated estrogens by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clopidogrel
nilutamide will decrease the level or effect of clopidogrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Inhibition of CYP3A4 will reduce clopidogrel bioactivation
- conjugated estrogens, vaginal
nilutamide will increase the level or effect of conjugated estrogens, vaginal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- flotufolastat F 18
nilutamide, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.
- gallium Ga 68 PSMA-11
nilutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- mavacamten
nilutamide will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.
- pazopanib
nilutamide will increase the level or effect of pazopanib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid coadministration of pazopanib with strong CYP3A4 inhibitors if possible; if must coadminister, decrease pazopanib dose to 400 mg/day
- phenytoin
nilutamide will increase the level or effect of phenytoin by decreasing metabolism. Use Caution/Monitor.
- siponimod
siponimod and nilutamide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- theophylline
nilutamide will increase the level or effect of theophylline by decreasing metabolism. Use Caution/Monitor.
Minor (6)
- levoketoconazole
nilutamide will increase the level or effect of levoketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- maitake
maitake increases effects of nilutamide by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- paclitaxel
nilutamide will increase the level or effect of paclitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- paclitaxel protein bound
nilutamide will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- taurine
nilutamide decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
- vincristine liposomal
nilutamide will increase the level or effect of vincristine liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Hot flushes (28%)
Testicular atrophy (16%)
Altered adaptation to dark (13%)
Dyspnea (11%)
Heachache (undefined)
Insomnia (undefined)
1-10%
Abdominal pain (10%)
Nausea (10%)
Constipation
Diarrhea
Aplastic anemia
Leukopenia
Alcohol intolerance
Angina, heart failure
HTN
Syncope
Dizziness
Malaise
Elevated LFTs
Gynecomastia
Impaired vision
Interstitial pneumonitis
UTI
Warnings
Black Box Warnings
Interstitial pneumonitis has been reported in 2% of patients exposed to nilutamide. Reports of interstitial changes including pulmonary fibrosis leading to hospitalization and death rarely reported in post marketing surveillance. Most cases were reversible with discontinuation and occurred within first 3 months of therapy
Contraindications
Hypersensitivity; severe hepatic, and/or respiratory impairment
Cautions
Hepatic Impairment
Hepatitis reported
Delay in vision adaptation to dark
Pregnancy & Lactation
Pregnancy Category: C
Lactation: N/A
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Nonsteroidal antiandrogen, competitively binds androgen receptors and inhibits testosterone stimulation of cell growth in prostate cancer
Pharmacokinetics
Half-Life: 41-49 hr
Protein Bound: 84%
Metabolism: Liver
Excretion: urine (62%); feces (4%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| nilutamide oral - | 150 mg tablet |  | |
| nilutamide oral - | 150 mg tablet |  | |
| Nilandron oral - | 150 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
nilutamide oral
NILUTAMIDE - ORAL
(nye-LOO-tuh-mide)
COMMON BRAND NAME(S): Nilandron
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.
USES: This medication is used to treat prostate cancer. Nilutamide belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Nilutamide works by blocking the effects of testosterone, thereby slowing the growth and spread of prostate cancer.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily. If you are taking nilutamide after surgery, it is usually started on the day of surgery or the day after. After 30 days of treatment, your doctor will usually decrease your dose.The dosage is based on your medical condition and response to treatment. The length of treatment depends on how your body and the cancer respond to nilutamide and other treatments.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop any medications for your prostate cancer unless told to do so by your doctor. Stopping your medications could allow the cancer to spread more rapidly.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.Tell your doctor if your condition lasts or gets worse (such as urination becomes more difficult, bone pain increases).
SIDE EFFECTS: See also Warning section.Because nilutamide may be used with other medications, the side effects may be due to any one medicine or the combination of medications. Hot flashes, sweating, dizziness, loss of sexual interest/ability, vision changes (such as difficulty seeing when moving into the dark or light, changes in color vision), stomach pain, constipation, nausea, signs of alcohol intolerance (such as flushing, tiredness) dry skin, increased sensitivity to touch/pain, and loss of body hair may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, nilutamide has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). Liver problems can happen at any time while taking nilutamide, but they occur most often during the first 3-4 months of treatment. Your doctor will tell you whether to stop or continue nilutamide. Your doctor will monitor your liver function with blood tests before you start and while you are taking nilutamide. Keep all medical and lab appointments.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking nilutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease (such as asthma, chronic obstructive pulmonary disease-COPD, emphysema), liver problems.This drug may rarely make you dizzy or drowsy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Nilutamide should not be used by women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some of the products that may interact with this drug include: testosterone (patch, gel, injection), anabolic steroids (including over-the-counter androgens/anabolics/testosterone precursors), DHEA, phenytoin, warfarin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver function, blood PSA test) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. (See also Warning section.)
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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