Nilandron

Unless your doctor tells you otherwise, continue your normal diet.

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.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Treatment with nilutamide should be started on the day of or on the day after surgical castration.

Take each dose with a full glass of water.

Nilutamide can be taken with or without food or milk.

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 at room temperature away from moisture and heat.

Prostate Cancer

Adjunct to orchiectomy in the treatment of metastatic prostate cancer involving distant lymph nodes, bone, or visceral organs (stage D2).1 2 3 5 6 7 8 24 30 33

Slows progression of the disease, relieves bone pain associated with metastatic disease, and improves overall survival rate after long-term therapy (8.5 years).3 5 6 7 9 30

Absorption

Bioavailability

Rapidly and completely absorbed to yield high and persistent plasma concentrations.a

Distribution

Plasma Protein Binding

Moderately bound to plasma proteins; minimally bound to erythrocytes.a

Elimination

Metabolism

Extensively metabolized in the liver and lungs by CYP isoenzymes to mainly inactive metabolites.a

Elimination Route

Eliminated almost exclusively by hepatic metabolism.b Excreted principally in urine as metabolites; <2% is excreted unchanged in urine.a

Half-life

Mean elimination half-life is approximately 30–59 hours following a single 100–300-mg dose.a

• Risk of interstitial pneumonitis.1 Importance of immediately notifying clinicians of dyspnea or worsening of preexisting dyspnea.1

• Risk of hepatic toxicity.1 Importance of notifying clinicians if symptoms of nausea, vomiting, abdominal pain, or jaundice occur.1

• Risk of delay in visually adapting to changes from light to dark.1 Importance of wearing tinted glasses during exposure to bright light and of exercising caution when driving at night or through tunnels.1

• Risk of alcohol intolerance (e.g., facial flushing, malaise, hypotension).1 32 Importance of avoiding alcohol consumption if such intolerance occurs.1 32

• Importance of taking only as prescribed; do not interrupt or discontinue therapy unless otherwise instructed by a clinician.a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In the U.S.

• Nilandron

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiandrogen

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You should begin taking this medicine on the day of or the day after your surgery. Do not stop taking this medicine without checking with your doctor first.

You may take this medicine with food or on an empty stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prostate cancer:
    • Adults—300 milligrams (mg) once a day for the first 30 days, then 150 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Do not stop taking Nilandron without calling the doctor who ordered it for you.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Nilandron, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nilandron. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Nilandron.

Review Date: October 4, 2017

Nilandron 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.

Nilandron 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 59212-111-14). 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. Keep out of reach of children.

Revised 05/2017

Manufactured for:
Concordia Pharmaceuticals Inc.
St. Michael, Barbados BB11005

© 2015 Concordia Pharmaceuticals Inc.
All rights reserved.

Common side effects of Nilandron include: nausea, nocturnal amblyopia, and decreased libido. Other side effects include: hemeralopia, visual disturbance, chromatopsia, and loss of body hair. See below for a comprehensive list of adverse effects.