Nilandron (Nilutamide)
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Nilandron (Nilutamide)

NILANDRON®
(nilutamide) Tablets

DRUG DESCRIPTION

NILANDRON® tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione with the following structural formula:

NILANDRON® (nilutamide) Structural Formula Illustration

Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25.

Its molecular formula is C12H10F3N3O4.

It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [ < 0.1% W/V at 25°C (77°F)]. It melts between 153°C and 156°C (307.4°F and 312.8°F).

Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON (nilutamide) tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc.

What are the possible side effects of nilutamide (Nilandron)?

If you experience any of the following serious side effects, stop taking nilutamide, and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),
  • shortness of breath, cough, chest pain, or fever;
  • liver damage (yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, or unexplained flulike symptoms).

Other less serious side effects may be more likely to occur. Continue to take...

Read All Potential Side Effects and See Pictures of Nilandron »

What are the precautions when taking nilutamide (Nilandron)?

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, drowsy, or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages...

Read All Potential Precautions of Nilandron »

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Metastatic Prostate Cancer

NILANDRON (nilutamide) tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).

For maximum benefit, NILANDRON (nilutamide) treatment must begin on the same day as or on the day after surgical castration.

DOSAGE AND ADMINISTRATION

The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. NILANDRON (nilutamide) tablets can be taken with or without food.

HOW SUPPLIED

NILANDRON (nilutamide) 150 mg tablets are supplied in boxes of 30 tablets. Each box contains 3 child-resistant, PVC, aluminum foil-backed blisters of 10 tablets (NDC 0088-1111-14). Each white, biconvex, cylindrical (10 mm in diameter) tablet has a triangular logo on one side and an internal reference number (168D) on the other.

Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.

Revised June 2006. Sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Country of Origin: France. FDA Rev date: 7/26/2004

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + surgical castration versus placebo + surgical castration. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with surgical castration are listed below. For comparison, adverse experiences seen with surgical castration and placebo are also listed.

  NILANDRON + surgical castration
(N=225)
Placebo + surgical castration
(N=232)
Adverse Experience % All % All
Cardiovascular System
  Hypertension 5.3 2.6
Digestive System
  Nausea 9.8 6.0
  Constipation 7.1 3.9
Endocrine System
  Hot flushes 28.4 22.4
Metabolic and Nutritional System
  Increased AST 8.0 3.9
  Increased ALT 7.6 4.3
Nervous System
  Dizziness 7.1 3.4
Respiratory System
  Dyspnea 6.2 7.3
Special Senses
  Impaired adaptation to dark 12.9 1.3
  Abnormal vision 6.7 1.7
Urogenital System
  Urinary tract infection 8.0 9.1

The overall incidence of adverse experiences was 86% (194/225) for the NILANDRON (nilutamide) group and 81% (188/232) for the placebo group.

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + leuprolide versus placebo + leuprolide. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with leuprolide are listed below. For comparison, adverse experiences seen with leuprolide and placebo are also listed.

  NILANDRON + leuprolide
(N=209)
Placebo + leuprolide
(N=202)
Adverse Experience % All % All
Body as a Whole
  Pain 26.8 27.7
  Headache 13.9 10.4
  Asthenia 19.1 20.8
  Back pain 11.5 16.8
  Abdominal pain 10.0 5.4
  Chest pain 7.2 4.5
  Flu syndrome 7.2 3.0
  Fever 5.3 6.4
Cardiovascular System
  Hypertension 9.1 9.9
Digestive System
  Nausea 23.9 8.4
  Constipation 19.6 16.8
  Anorexia 11.0 6.4
  Dyspepsia 6.7 4.5
  Vomiting 5.7 4.0
Endocrine System
  Hot flushes 66.5 59.4
  Impotence 11.0 12.9
  Libido decreased 11.0 4.5
Hemic and Lymphatic System
  Anemia 7.2 6.4
Metabolic and Nutritional System
  Increased AST 12.9 13.9
  Peripheral edema 12.4 17.3
  Increased ALT 9.1 8.9
Musculoskeletal System
  Bone Pain 6.2 5.0
Nervous System
  Insomnia 16.3 15.8
  Dizziness 10.0 11.4
  Depression 8.6 7.4
  Hypesthesia 5.3 2.0
Respiratory System
  Dyspnea 10.5 7.4
  Upper respiratory infection 8.1 10.9
  Pneumonia 5.3 3.5
Skin and Appendages
  Sweating 6.2 3.0
  Body hair loss 5.7 0.5
  Dry skin 5.3 2.5
  Rash 5.3 4.0
Special Senses
  Impaired adaptation to dark 56.9 5.4
  Chromatopsia 8.6 0.0
  Impaired adaptation to light 7.7 1.0
  Abnormal vision 6.2 4.5
Urogenital System
  Testicular atrophy 16.3 12.4

The overall incidence of adverse experiences is 99.5% (208/209) for the NILANDRON (nilutamide) group and 98.5% (199/202) for the placebo group.

Some frequently occurring adverse experiences, for example hot flushes, impotence, and decreased libido, are known to be associated with low serum androgen levels and known to occur with medical or surgical castration alone. Notable was the higher incidence of visual disturbances (variously described as impaired adaptation to darkness, abnormal vision, and colored vision), which led to treatment discontinuation in 1% to 2% of patients.

Interstitial pneumonitis occurred in one ( < 1%) patient receiving NILANDRON (nilutamide) in combination with surgical castration and in seven patients (3%) receiving NILANDRON (nilutamide) in combination with leuprolide and one patient receiving placebo in combination with leuprolide. Overall, it has been reported in 2% of patients receiving NILANDRON (nilutamide) . This included a report of interstitial pneumonitis in 8 of 47 patients (17%) in a small study performed in Japan.

In addition, the following adverse experiences were reported in 2 to 5% of patients treated with NILANDRON (nilutamide) in combination with leuprolide or orchiectomy.

Body as a Whole: Malaise (2%).

Cardiovascular System: Angina (2%), heart failure (3%), syncope (2%).

Digestive System: Diarrhea (2%), gastrointestinal disorder (2%), gastrointestinal hemorrhage (2%), melena (2%).

Metabolic and Nutritional System: Alcohol intolerance (5%), edema (2%), weight loss (2%).

Musculoskeletal System: Arthritis (2%).

Nervous System: Dry mouth (2%), nervousness (2%), paresthesia (3%).

Respiratory System: Cough increased (2%), interstitial lung disease (2%), lung disorder (4%), rhinitis (2%).

Skin and Appendages: Pruritus (2%).

Special Senses: Cataract (2%), photophobia (2%).

Laboratory Values: Haptoglobin increased (2%), leukopenia (3%), alkaline phosphatase increased (3%), BUN increased (2%), creatinine increased (2%), hyperglycemia (4%).

Read the Nilandron (nilutamide) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

In vitro, nilutamide has been shown to inhibit the activity of liver cytochrome P-450 isoenzymes and, therefore, may reduce the metabolism of compounds requiring these systems.

Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level. The dosage of these drugs or others with a similar metabolism may need to be modified if they are administered concomitantly with nilutamide. For example, when vitamin K antagonists are administered concomitantly with nilutamide, prothrombin time should be carefully monitored and, if necessary, the dosage of vitamin K antagonists should be reduced.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Interstitial Pneumonitis

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON (nilutamide) , and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON (nilutamide) . Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON (nilutamide) . If symptoms occur, NILANDRON (nilutamide) should be immediately discontinued until it can be determined if the symptoms are drug related.

Hepatitis

Rare cases of death or hospitalization due to severe liver injury have been reported post-marketing in association with the use of NILANDRON (nilutamide) . Hepatotoxicity in these reports generally occurred within the first 3 to 4 months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in 1% of NILANDRON (nilutamide) patients in controlled clinical trials. Serum transaminase levels should be measured prior to starting treatment with NILANDRON (nilutamide) , at regular intervals for the first 4 months of treatment, and periodically thereafter. Liver function tests should also be obtained at the first sign or symptom suggestive of liver dysfunction, e.g. nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, NILANDRON (nilutamide) should be immediately discontinued with close followup of liver function tests until resolution.

Use in Women

NILANDRON (nilutamide) has no indication for women, and should not be used in this population, particularly for non-serious or non-life threatening conditions.

Other

Foreign postmarketing surveillance has revealed isolated cases of aplastic anemia in which a causal relationship with NILANDRON (nilutamide) could not be ascertained.

PRECAUTIONS

General

Antiandrogen Withdrawal Syndrome

Patients whose disease progresses while being treated with an antiandrogen may experience clinical improvement with discontinuation of the antiandrogen.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Administration of nilutamide to rats for 18 months at doses of 0, 5, 15, or 45 mg/kg/day produced benign Leydig cell tumors in 35% of the high-dose male rats (AUC exposures in high-dose rats were approximately 1 - 2 times human AUC exposures with therapeutic doses). The increased incidence of Leydig cell tumors is secondary to elevated luteinizing hormone (LH) concentrations resulting from loss of feedback inhibition at the pituitary. Elevated LH and testosterone concentrations are not observed in castrated men receiving NILANDRON. Nilutamide had no effect on the incidence, size, or time of onset of any spontaneous tumor in rats.

Nilutamide displayed no mutagenic effects in a variety of in vitro and in vivo tests (Ames test, mouse micronucleus test, and two chromosomal aberration tests).

In reproduction studies in rats, nilutamide had no effect on the reproductive function of males and females, and no lethal, teratogenic, or growth-suppressive effects on fetuses were found. The maximal dose at which nilutamide did not affect reproductive function in either sex or have an effect on fetuses was estimated to be 45 mg/kg orally (AUC exposures in rats approximately 1-2 times human therapeutic AUC exposures).

Pregnancy

Pregnancy Category C; Animal reproduction studies have not been conducted with nilutamide. It is also not known whether nilutamide can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Nilutamide should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been determined.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

One case of massive overdosage has been published. A 79-year-old man attempted suicide by ingesting 13 g of nilutamide (i.e., 43 times the maximum recommended dose). Despite immediate gastric lavage and oral administration of activated charcoal, plasma nilutamide levels peaked at 6 times the normal range 2 hours after ingestion. There were no clinical signs or symptoms or changes in parameters such as transaminases or chest X-ray. Maintenance treatment (150 mg/day) was resumed 30 days later.

In repeated-dose tolerance studies, doses of 600 mg/day and 900 mg/day were administered to 9 and 4 patients, respectively. The ingestion of these doses was associated with gastrointestinal disorders, including nausea and vomiting, malaise, headache, and dizziness. In addition, a transient elevation in hepatic enzyme levels was noted in one patient.

Since nilutamide is protein bound, dialysis may not be useful as treatment for overdose. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

CONTRAINDICATIONS

NILANDRON (nilutamide) tablets are contraindicated:

  • in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment)
  • in patients with severe respiratory insufficiency
  • in patients with hypersensitivity to nilutamide or any component of this preparation.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Prostate cancer is known to be androgen sensitive and responds to androgen ablation. In animal studies, nilutamide has demonstrated antiandrogenic activity without other hormonal (estrogen, progesterone, mineralocorticoid, and glucocorticoid) effects. In vitro, nilutamide blocks the effects of testosterone at the androgen receptor level. In vivo, nilutamide interacts with the androgen receptor and prevents the normal androgenic response.

Pharmacokinetics

Absorption

Analysis of blood, urine, and feces samples following a single oral 150-mg dose of [14C]-nilutamide in patients with metastatic prostate cancer showed that the drug is rapidly and completely absorbed and that it yields high and persistent plasma concentrations.

Distribution

After absorption of the drug, there is a detectable distribution phase. There is moderate binding of the drug to plasma proteins and low binding to erythrocytes. The binding is nonsaturable except in the case of alpha-1-glycoprotein, which makes a minor contribution to the total concentration of proteins in the plasma. The results of binding studies do not indicate any effects that would cause nonlinear pharmacokinetics.

Metabolism

The results of a human metabolism study using 14C-radiolabelled tablets show that nilutamide is extensively metabolized and less than 2% of the drug is excreted unchanged in urine after 5 days. Five metabolites have been isolated from human urine. Two metabolites display an asymmetric center, due to oxidation of a methyl group, resulting in the formation of D- and L-isomers. One of the metabolites was shown, in vitro, to possess 25 to 50% of the pharmacological activity of the parent drug, and the D- isomer of the active metabolite showed equal or greater potency compared to the L-isomer. However, the pharmacokinetics and the pharmacodynamics of the metabolites have not been fully investigated.

Elimination

The majority (62%) of orally administered [14C]-nilutamide is eliminated in the urine during the first 120 hours after a single 150-mg dose. Fecal elimination is negligible, ranging from 1.4% to 7% of the dose after 4 to 5 days. Excretion of radioactivity in urine likely continues beyond 5 days. The mean elimination half-life of nilutamide determined in studies in which subjects received a single dose of 100-300 mg ranged from 38.0 to 59.1 hours with most values between 41 and 49 hours. The elimination of at least one metabolite is generally longer than that of unchanged nilutamide (59-126 hours). During multiple dosing of 150 mg nilutamide (given as 3 x 50 mg) twice a day, steady state was reached within 2 to 4 weeks for most patients, and mean steady state AUC0-12 was 110% higher than the AUC0- ∞ obtained from the first 150 mg dose. These data and in vitro metabolism data suggest that, upon multiple dosing, metabolic enzyme inhibition may occur for this drug.

Clinical Studies

Nilutamide through its antiandrogenic activity can complement surgical castration, which suppresses only testicular androgens. The effects of the combined therapy were studied in patients with previously untreated metastatic prostate cancer.

In a double-blind, randomized, multicenter study that enrolled 457 patients (225 treated with orchiectomy and NILANDRON (nilutamide) , 232 treated with orchiectomy and placebo), the NILANDRON (nilutamide) group showed a statistically significant benefit in time to progression and time to death. The results are summarized below.

  NILANDRON PLACEBO
Median Survival (months) 27.3 23.6
Progression-Free Survival (months) 21.1 14.9
Complete or Partial Regression 41% 24%
Improvement in Bone Pain 54% 37%

Animal Pharmacology and Toxicology

Administration of NILANDRON (nilutamide) to beagle dogs resulted in drug-related deaths at dose levels that produce AUC exposures in dogs much lower than the AUC exposures of men receiving the therapeutic doses of 150 and 300 mg/day. Nilutamide-induced toxicity in dogs was cumulative with progressively lower doses producing death when given for longer durations. Nilutamide given to dogs at 60 mg/kg/day (1-2 times human AUC exposure) for 1 month produced 100% mortality. Administration of 20 and 30 mg/kg/day nilutamide (1/2-1 times human AUC exposure) for 6 months resulted in 20% and 70% mortality in treated dogs. Administration to dogs of 3, 6, and 12 mg/kg/day nilutamide (1/10-1/2 human AUC exposure) for 1 year resulted in 8%, 33%, and 50% mortality, respectively. A "no-effect level" for nilutamide-induced mortality in dogs was not identified. Pathology data from the one-year oral toxicity study suggest that the deaths in dogs were secondary to liver toxicity. Marked-to-massive hepatocellular swelling and vacuolization were observed in affected dogs. Liver toxicity in dogs was not consistently associated with elevations of liver enzymes.

Administration of nilutamide to rats at a dose level of 45 mg/kg/day (AUC exposure in rats 1-2 times human therapeutic AUC exposures) for 18 months increased the incidence of lung pathology (granulomatous inflammation and chronic alveolitis).

The hepatic and pulmonary adverse effects observed in nilutamide-treated animals and men are similar to effects observed with another nitroaromatic compound, nitrofurantoin. Nilutamide and nitrofurantoin are both metabolized in vitro to nitroanion free-radicals by microsomal NADPH-cytochrome P450 reductase in the lungs and liver of rats and humans.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be informed that NILANDRON (nilutamide) tablets should be started on the day of, or on the day after, surgical castration. They should also be informed that they should not interrupt their dosing of NILANDRON (nilutamide) or stop taking this medication without consulting their physician.

Because of the possibility of interstitial pneumonitis, patients should also be told to report immediately any dyspnea or aggravation of pre-existing dyspnea.

Because of the possibility of hepatitis, patients should be told to consult with their physician should nausea, vomiting, abdominal pain, or jaundice occur.

Because of the possibility of an intolerance to alcohol (facial flushes, malaise, hypotension) following ingestion of NILANDRON (nilutamide) , it is recommended that intake of alcoholic beverages be avoided by patients who experience this reaction. This effect has been reported in about 5% of patients treated with NILANDRON (nilutamide) .

In clinical trials, 13% to 57% of patients receiving NILANDRON (nilutamide) reported a delay in adaptation to dark, ranging from seconds to a few minutes, when passing from a lighted area to a dark area. This effect sometimes does not abate as drug treatment is continued. Patients who experience this effect should be cautioned about driving at night or through tunnels. This effect can be alleviated by the wearing of tinted glasses.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be informed that NILANDRON (nilutamide) tablets should be started on the day of, or on the day after, surgical castration. They should also be informed that they should not interrupt their dosing of NILANDRON (nilutamide) or stop taking this medication without consulting their physician.

Because of the possibility of interstitial pneumonitis, patients should also be told to report immediately any dyspnea or aggravation of pre-existing dyspnea.

Because of the possibility of hepatitis, patients should be told to consult with their physician should nausea, vomiting, abdominal pain, or jaundice occur.

Because of the possibility of an intolerance to alcohol (facial flushes, malaise, hypotension) following ingestion of NILANDRON (nilutamide) , it is recommended that intake of alcoholic beverages be avoided by patients who experience this reaction. This effect has been reported in about 5% of patients treated with NILANDRON (nilutamide) .

In clinical trials, 13% to 57% of patients receiving NILANDRON (nilutamide) reported a delay in adaptation to dark, ranging from seconds to a few minutes, when passing from a lighted area to a dark area. This effect sometimes does not abate as drug treatment is continued. Patients who experience this effect should be cautioned about driving at night or through tunnels. This effect can be alleviated by the wearing of tinted glasses.

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Nilandron Consumer

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.

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 men with prostate cancer, and is used after surgery (removal of the testicles) or with other medications. 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).

Disclaimer

Nilandron Consumer (continued)

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Nilandron (nilutamide) Side Effects Center for a complete guide to possible side effects »

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, drowsy, or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. You may also develop intolerance to alcohol while taking this medication. Avoid alcoholic beverages while taking this medication.

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.

Disclaimer

Nilandron Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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, theophylline, warfarin.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Nilandron Patient Information Including Side Effects

Brand Names: Nilandron

Generic Name: nilutamide (Pronunciation: nih LUTE ah mide)

What is nilutamide (Nilandron)?

Nilutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones).

Nilutamide is used in the treatment of prostate cancer.

Nilutamide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of nilutamide (Nilandron)?

If you experience any of the following serious side effects, stop taking nilutamide, and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),
  • shortness of breath, cough, chest pain, or fever;
  • liver damage (yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, or unexplained flulike symptoms).

Other less serious side effects may be more likely to occur. Continue to take nilutamide and talk to your doctor if you experience

  • hot flashes,
  • dizziness,
  • constipation,
  • nausea or vomiting,
  • skin rash,
  • loss of appetite,
  • decreased libido,
  • impotence, or
  • poor visual adaptation to darkness or other changes in vision.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nilandron (nilutamide) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about nilutamide (Nilandron)?

Call your doctor immediately if you develop yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, unexplained "flu-like" symptoms, difficulty breathing, shortness of breath, cough, chest pain, or fever.

Alcohol may cause facial flushing, dizziness, and other symptoms in approximately 5% of patients when used during treatment with nilutamide. Do not drink alcohol if you experience any of these symptoms.

Nilutamide may cause a delay in your ability to see in the dark after being in a lighted area. Use caution when driving at night, when entering into a tunnel, and in other similar situations. Tinted glasses may alleviate this side effect.

Side Effects Centers

Nilandron Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking nilutamide (Nilandron)?

Before taking this medication, tell your doctor if you have

  • liver disease or
  • asthma or another lung disease.

You may not be able to take nilutamide, or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Nilutamide is in the FDA pregnancy category C. This means that it is not known whether nilutamide will harm an unborn baby. Nilutamide is not indicated for use by women. Do not take this medication if you are pregnant or are planning a pregnancy.

It is not known whether nilutamide passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take nilutamide (Nilandron)?

Take nilutamide exactly as directed by your doctor. However, if you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water.

Nilutamide can be taken with or without food or milk.

Treatment with nilutamide should be started on the day of or on the day after surgical castration to have maximum benefits.

Try to take your dose of nilutamide at the same time every day.

Do not stop taking this medication without first talking to your doctor.

Store nilutamide at room temperature away from moisture and heat.

Side Effects Centers

Nilandron Patient Information including If I Miss a Dose

What happens if I miss a dose (Nilandron)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Nilandron)?

Seek emergency medical attention.

Symptoms of a nilutamide overdose are not known but might include decreased activity, slow breathing, dizziness, watering eyes, decreased appetite, vomiting, and sedation.

What should I avoid while taking nilutamide (Nilandron)?

Alcohol may cause facial flushing, dizziness, and other symptoms in approximately 5% of patients when used during treatment with nilutamide. Do not drink alcohol if you experience any of these symptoms.

Nilutamide may cause a delay in your ability to see in the dark after you have been in a lighted area. Use caution when driving at night, when entering a tunnel, and in similar situations. Tinted glasses may alleviate this side effect.

What other drugs will affect nilutamide (Nilandron)?

Before taking this medication, tell your doctor if you are taking any of the following medicines

  • warfarin (Coumadin),
  • phenytoin (Dilantin), or
  • theophylline (Theo-Dur, Theochron, Theolair, others).

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with nilutamide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about nilutamide written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.08. Revision date: 12/15/2010.

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