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A - Regimen Name

NLTM Regimen

Disease Site
Genitourinary - Prostate


Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

Rationale and Uses

Treatment of metastatic prostatic carcinoma (Stage D2) in conjunction with surgical / medical castration

Supplementary Public Funding

ODB - General Benefit (niLUTAmide) (ODB Formulary)

B - Drug Regimen

300 mg PO Daily during the first month (days 1 to 30*)
150 mg PO Daily thereafter

(Outpatient prescription in 50 mg or 150 mg tablets)
*may start maintenance earlier should intolerance occur

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C - Cycle Frequency


Until disease progression or unacceptable toxicity.

D - Premedication and Supportive Measures

Antiemetic Regimen:

Not applicable

E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

Dosage with toxicity

Toxicity Dose Adjustment
Myelosuppression No adjustment required
Suspected pneumonitis Hold, investigate and treat appropriately; discontinue if confirmed
QT prolongation Discontinue

Hepatic Impairment

If transaminases >2-3x upper limit of normal, interrupt treatment and monitor liver function closely.  Discontinue if severe hepatic impairment.

Renal Impairment

No adjustment required.


Dosage in the elderly

No adjustment required.


Dosage with ethnicity

A higher rate of interstitial pneumonitis and elevated transaminases were reported in Japanese patients. Use with caution when treating Asian patients.

F - Adverse Effects

Refer to nilutamide drug monograph(s) for additional details of adverse effects

Less common side  effects (10-24%) Uncommon (< 10%), but may be severe or life-threatening
  • Androgen deprivation symptoms (e.g. hot flashes, mood changes, erectile dysfunction)
  • Eye disorders (e.g. reduced light to dark adaptation)
  • Cardiotoxicity
  • QT prolongation
  • Arterial thromboembolism
  • Pneumonitis
  • Hepatic failure
  • Bone loss, osteoporosis
  • Aplastic anemia



G - Interactions

Refer to nilutamide drug monograph(s) for additional details

  • Avoid alcohol as a potential disulfiram-like reaction may occur
  • Use with caution and monitor closely with drugs that increase the QT interval
  • Nilutamide is a weak inhibitor of CYP2C19. Use with caution and monitor with drugs that have a narrow therapeutic index (e.g. warfarin, phenytoin)
H - Drug Administration and Special Precautions

Refer to nilutamide drug monograph(s) for additional details


  • Take tablet(s) by mouth, before breakfast.
  • Avoid alcoholic beverages during treatment.
  • If a dose is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for missed doses.
  • Store between 15 to 30°C.


  • Patients with known hypersensitivity to the drug or to any constituents of the drug product
  • Patients with severe hepatic dysfunction or with severe respiratory insufficiency.
  • Nilutamide is also contraindicated in women and children.
  • Contains lactose and should not be used in patients with hereditary galactose/glucose/lactase disorders.

Other Warnings/Precautions:

  • Patients should be advised regarding impairment of light adaptation if they plan to operate a vehicle or machinery.
  • Nilutamide should not be administered to patients with congenital long QT syndrome, and should be discontinued in patients who develop QT prolongation.

Pregnancy and Lactation:

  • Nilutamide should not be used by women. In the laboratory, this drug may harm or affect the embryos of offspring of animals exposed to it. 
  • If there is a chance of pregnancy in a female partner, adequate contraception should be used by both sexes during treatment, and for at least 6 months after the last dose (general recommendation).



I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph

Recommended Clinical Monitoring

  • ECG and electrolytes at baseline; also regularly for patients at risk of QT prolongation
  • Chest X-ray +/- pulmonary function tests; baseline and as clinically indicated
  • Liver function tests; baseline and as clinically indicated
  • Blood glucose, HgA1c especially in diabetic patients; baseline and at each visit
  • Clinical evaluation for androgen deprivation symptoms, ocular and respiratory effects, cardiovascular effects; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • INR, in patients on warfarin; baseline and as clinically indicated

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J - Administrative Information

Outpatient prescription for home administration

K - References

Bertagna C, de Géry A, Hucher M, et al. Efficacy of the combination of nilutamide plus orchiectomy in patients with metastatic prostate cancer. A meta-analysis of seven randomized double-blind trials (1056 patients). British Journal of Urology 1994;73:396-402.

Janknegt RA, Abbou CC, Bartoletti R, et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol 1993;149(1):77-82.

Nilutamide drug monograph, Cancer Care Ontario.

September 2018 Updated adverse effects, administration and monitoring

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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.