nilutamide (Rx)

Brand and Other Names:Nilandron
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and nilutamide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            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 (9)

              • 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.

              • 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.

              • warfarin

                nilutamide will increase the level or effect of warfarin by decreasing metabolism. Use Caution/Monitor.

              Minor (5)

              • 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.

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              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

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              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

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              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.

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              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%)

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              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.

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              Patient Handout

              Patient Education
              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). Seek immediate medical attention 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, usually once daily or as directed by your doctor. 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.Dosage is based on your medical condition and response to therapy. 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.Tell your doctor if your condition persists or worsens (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 persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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. Seek immediate medical attention if you develop symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting/stomach pain, severe tiredness, dark urine, yellowing eyes/skin). 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 laboratory appointments.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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).Nilutamide should not be used in women. Women who are pregnant should avoid touching or accidentally taking this medication. It may harm an unborn baby. Consult your doctor for more information.It is not known whether this drug passes into breast milk. Women who are breast-feeding should avoid touching or accidentally taking this medication. Consult your doctor for more information.

              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.Laboratory and/or medical tests (such as liver function tests, blood PSA test) should be performed before and periodically during treatment to monitor your progress or check for side effects. 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 February 2019. Copyright(c) 2021 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.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.