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Nilandron 150mg Tablet
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Indications & Clinical Uses
- Nilandron 150 mg (nilutamide) is an oral nonsteroidal antiandrogen used together with surgical castration (orchiectomy) to treat metastatic prostate cancer (Stage D2) in men.
- Nilandron blocks the effect of testosterone on prostate cancer cells and is started on the same day as, or the day after, surgical castration, as part of combined androgen-blockade treatment; it is not used as a treatment on its own without surgical castration.
- Generic nilutamide, made by other manufacturers, is also available and shares the same core label information as brand-name Nilandron.
- Nilandron/nilutamide is not approved for use in women or children, and it is not the same medicine as other prostate cancer hormone therapies such as bicalutamide or flutamide, which have different dosing and side-effect profiles.
Side Effects
- The most common Nilandron side effects, seen in about a quarter to two-thirds of men in combination with surgical castration, are hot flushes, delayed adaptation to seeing in the dark (which can affect night driving), nausea, and general weakness.
- There is no boxed warning on the current label, but two serious reactions must be recognised: interstitial pneumonitis, affecting around 2% of patients (higher in some populations), causes new or worsening shortness of breath, cough, chest pain or fever, usually within the first few months, and needs prompt medical review, a chest X-ray and often stopping Nilandron; and rare but serious hepatitis or liver injury, which can cause yellowing of the skin or eyes, dark urine, or unusual tiredness.
- About 5% of men experience alcohol intolerance - flushing, feeling unwell and low blood pressure after drinking.
- Report any breathing difficulty, jaundice, or severe reaction to alcohol to your healthcare provider promptly.
Precautions & Warnings
- Nilandron must not be used by anyone with severe liver impairment, severe breathing (respiratory) insufficiency, or a known allergy to nilutamide.
- A chest X-ray is taken before starting treatment to have a baseline in case interstitial pneumonitis develops later, and liver enzyme (transaminase) blood tests are checked before treatment and at regular intervals during the first 4 months.
- Nilandron often delays adaptation to darkness, so avoid night driving or using machinery in low light until you know how it affects you.
- Alcohol may trigger flushing, malaise and low blood pressure in some men (alcohol intolerance).
- Nilandron is for use in men only and is not indicated for women or children.
- Nilandron tablets are swallowed whole; there is no intravenous or injectable form of this medicine.
Avoid Interactions
- Nilandron can slow down liver enzymes (cytochrome P-450) that break down certain other medicines, so it may increase and prolong the effect of vitamin K antagonists such as warfarin (increasing bleeding risk), phenytoin, and theophylline; your healthcare provider will monitor your prothrombin time or blood levels more closely and may need to lower the dose of these medicines.
- Because Nilandron can cause alcohol intolerance, drinking alcohol while taking it may cause facial flushing, feeling unwell, or a drop in blood pressure.
- There is no requirement to avoid grapefruit or specific foods stated on the label, but you should tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter drug and supplement you take before starting Nilandron.
References
Frequently Asked Questions
Nilandron (nilutamide) is a hormone-blocking tablet used together with surgical castration to treat metastatic prostate cancer in men. It blocks testosterone's effect on prostate cancer cells. Treatment starts the same day as, or the day after, surgical castration and is not used on its own.
Nilandron tablets are swallowed whole with water, usually 300 mg (two 150 mg tablets) once daily for the first 30 days, then 150 mg once daily afterward. It can be taken with or without food, and dosing starts the same day as, or the day after, surgical castration.
Nilandron commonly causes hot flushes, nausea, weakness, and a delay in adjusting to dark (affecting night vision). Two serious reactions need urgent attention: interstitial pneumonitis (new cough, chest pain or breathlessness) in about 2% of men, and rare hepatitis causing jaundice or dark urine.
Avoid alcohol, since Nilandron can cause alcohol intolerance - flushing, feeling unwell and low blood pressure - in about 5% of men. Avoid night driving until you know how Nilandron affects your vision in the dark. Tell your healthcare provider about warfarin, phenytoin or theophylline use.
Before starting Nilandron, you have a baseline chest X-ray to check for future lung changes, and liver enzyme blood tests before treatment and regularly during the first 4 months. Report new cough, breathlessness, chest pain, or yellowing of the skin or eyes right away.
No, Nilandron does not carry an FDA boxed warning. It does carry strong warnings about interstitial pneumonitis (a lung reaction in about 2% of men) and rare hepatitis, both of which need prompt medical attention if symptoms of cough, breathlessness or jaundice appear.
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