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A - Regimen Name

 

FLTM Regimen
Flutamide

 

 

Disease Site
Genitourinary - Prostate

 

 

Intent
Palliative

 

 

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
  • Metastatic prostate cancer (Stage D2) in conjunction with LHRH agonist or orchiectomy
  • Stage B2 or C prostate cancer prior to or during external beam radiotherapy in combination with LHRH agonist

 

 

Supplementary Public Funding

flutamide
ODB - General Benefit (flutamide) (

ODB Formulary

)
 

 

 

 
B - Drug Regimen

 

flutamide
 
250 mgPOEvery 8 hours (TID)
(Outpatient prescription in 250 mg tablets)

Flutamide should be used in combination with orchiectomy or with an LHRH agonist.  Start simultaneously / 24 hours prior to LHRH agonist.  If patient is receiving external beam radiation, start flutamide 8 weeks prior to radiation and continue throughout radiation treatment.

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C - Cycle Frequency

 

CONTINUOUS TREATMENT

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

Dosage in myelosuppression:  No adjustment required

 

Hepatic Impairment

Discontinue flutamide if jaundice or liver transaminases ≥ 2-3 x ULN.
 

Renal Impairment

No adjustment required; slightly prolonged half-life in patients with CrCl < 29 mL/min. Not significantly removed by hemodialysis.

 

 
F - Adverse Effects
Refer to flutamide drug monograph(s) for additional details of adverse effects.  The following table contains adverse effects reported in combination use with a LHRH agonist.
 
Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Androgen deprivation symptoms
  • Diarrhea
  • Nausea/vomiting
  • Cardiotoxicity
  • Arterial thromboembolism
  • Prolonged QT
  • Venous thromboembolism
  • Osteopenia/Osteoporosis
  • Rash
  • Hemolysis
  • ↑ LFTs
  • Secondary malignancies
  • Pneumonitis
  • Autoimmune - lupus-like syndrome
 
G - Interactions
Refer to flutamide drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to flutamide drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Blood glucose, HgA1c; in diabetic patients or patients at risk of hyperglycemia; regular
  • ECG and electrolyte for patients at risk of QT prolongation
  • Liver function tests; baseline, monthly for the first 4 months, then periodically and as clinically indicated
  • Clinical evaluation for symptoms of hypogonadism, gynecomastia, osteoporosis, hyperglycemia, cardiovascular and GI effects; regular
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • INR, in patients on anticoagulants; regular
  • Methemoglobin concentrations in at risk patients (e.g. G6PD deficiency, hemoglobin M disease)

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J - Administrative Information
Outpatient prescription for home administration
 
 
 
K - References

Crawford ED, Eisenberger MA, McLeod DG, et al. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med 1989;321(7):419-24.

Denis LJ, Carneiro de Moura JL, Bono J, et al. Goserelin acetate and flutamide versus bilateral orchiectomy : A phase III EORTC trial (30853). Urology 1993;42(2):119-29.

Eisenberger MA, Blumenstein BA, Crawford ED,, et al. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer.  N Engl J Med 1998;339(15):1036-42.

October 2017 Replaced regimen category with evidence-informed

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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.