Nilandron

(Nilutamide)

The generic name of Nilandron is nilutamide. Nilutamide is a non-steroidal anti-androgen used mainly in prostate cancer. It works by blocking androgen (testosterone) receptors, preventing testosterone from stimulating the growth of prostate cancer cells.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Nilandron. However, the following is a synopsis of the general guidelines for the use of Nilandron:

• Nilandron is taken by mouth as a prescription drug.
• It is usually started after surgical castration for metastatic prostate cancer.
• The medicine is taken once daily at the same time each day.
• Tablets should be swallowed whole with a glass of water.
• Alcoholic beverages should be avoided due to the risk of alcohol intolerance.
• If you miss a dose, take it as soon as you remember. However, if it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time.
• Do not take two doses at the same time.
• Always follow medical advice from your healthcare provider regarding the duration of therapy and discontinuation.

Some mild or common side effects of Nilandron seen in clinical trials include:

• Hot flashes.
• Gynecomastia or breast tenderness.
• Decreased libido or sexual dysfunction.
• Changes in body hair.
• Testicular atrophy.
• Nausea or stomach discomfort.
• Alcohol intolerance.
• Visual disturbances, including difficulty adapting to darkness or color vision impairment.

Some individuals may experience serious side effects while using Nilandron. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of interstitial pneumonitis, pulmonary fibrosis, or interstitial lung disease, which include shortness of breath (dyspnea), persistent cough or fever, and chest pain.
• Liver toxicity, including hepatitis or elevated liver enzymes.
• Severe, life-threatening allergic reactions.

These are not all of the possible side effects of Nilandron. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Nilandron, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A history of lung disease or breathing problems.
• Liver disease or abnormal liver function tests.
• A history of hepatitis.
• Heart disease or chest pain.
• A history of alcohol intolerance.
• Visual problems or color vision changes.
• Any known drug allergies.

Boxed Warning

Nilandron carries a boxed warning for interstitial pneumonitis.

Nilandron may cause severe and sometimes life-threatening lung conditions, including interstitial pneumonitis and pulmonary fibrosis. Symptoms may include shortness of breath, cough, chest pain, or fever. If these symptoms occur, treatment must be stopped immediately, and a medical evaluation is required.

Nilandron should not be used in individuals who:

• Have a known hypersensitivity to nilutamide.
• Have severe liver disease.
• Have a history of serious interstitial lung disease related to antiandrogen therapy.

Nilandron does not provide immediate symptom relief. Effects on prostate cancer progression may take several weeks. Response varies based on cancer stage, androgen levels, and individual patient factors. Regular follow-up with your healthcare provider is required.

When Nilandron is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Phenytoin, due to changes in drug metabolism and toxicity risk.
• Theophylline may have increased blood levels and side effects.
• Alcoholic beverages may worsen alcohol intolerance.

Nilandron is available in oral tablet dosage forms. The specific dose is determined by the healthcare provider based on treatment guidelines and patient response.

It should be stored at room temperature, away from the reach of children or pets.

Nilandron is manufactured by the company listed in the FDA-approved product labeling.

Yes. Nilutamide is available as a generic medication.

Do not stop taking Nilandron without medical advice. Abrupt discontinuation may affect cancer management. Your healthcare provider will guide any changes or discontinuation if serious adverse effects occur.

Nilandron is not intended for use in women. 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.

Nilandron is not intended for use in women. Breastfeeding is not recommended during exposure to this medication.