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A - Regimen Name

 

LPRL Regimen
Leuprolide

 

 

Disease Site
Genitourinary - Prostate

 

 

Intent
Neoadjuvant
Adjuvant
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
  • for cytoreduction before brachytherapy
  • in combination with radiotherapy for the treatment of high-risk localized prostate cancer
  • for palliative treatment of recurrent, progressive or metastatic prostate cancer

 

 

Supplementary Public Funding

leuprolide
ODB - General Benefit (leuprolide - long-acting formulation)
 

 

 
B - Drug Regimen

 

leuprolide
 
   

Various dosage forms and dose schedules available.

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Leuprolide*

7.5 mg     EVERY MONTH

or

22.5mg     EVERY 3 MONTHS

or

30mg        EVERY 4 MONTHS

or

45mg        EVERY 6 MONTHS

(Outpatient prescription in fixed-dose injection kits of 7.5mg, 22.5mg, 30mg and 45mg depots)

*Route of administration depends on the product brand and formulation.  Refer to Leuprolide drug monograph.

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C - Cycle Frequency

 

EVERY 1, 3, 4 OR 6 MONTHS depending on formulation

  • Neoadjuvant - Generally up to 6 months in duration
  • Adjuvant - Generally up to 3 years
  • Palliative - for non-metastatic disease (for example: rising PSA after radiation), use an intermittent schedule.  Otherwise use continuously.

 

 
D - Premedication and Supportive Measures
 
Antiemetic Regimen:

Not applicable

 
E - Dose Modifications

Dosage with toxicity

 

Toxicity
Dose modification
Myelosuppression

No dose reduction needed

↑ LFTs

Hold until ≤ grade 1. If no recovery then discontinue

Arterial and venous thromboembolism

Discontinue
Pituitary apoplexy
Discontinue
Pneumonitis
Discontinue
 

Hepatic Impairment

No adjustment required. See table above for management of drug-related hepatotoxicity.
 

Renal Impairment

No adjustment required.
 
F - Adverse Effects
Refer to leuprolide drug monograph(s) for additional details of adverse effects
 

Most Common Side Effects

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

  • Androgen deprivation symptoms (impotence, decreased libido, hot flashes)
  • Fatigue, headache
  • Edema
  • Disease flare (may be severe)
  • Musculoskeletal pain
  • Rash
  • Injection site reactions 
  • Arrhythmia
  • Osteopenia/osteoporosis
  • Cardiotoxicity
  • Arterial thromboembolism
  • Venous thromboembolism
  • Pneumonitis
  • Pituitary apoplexy
  • Seizures
  • Hypersensitivity
  • QT prolongation
  • GI hemorrhage and obstruction
  • Depression (may be severe)
  • Hepatotoxicity
 
G - Interactions
Refer to leuprolide drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to leuprolide drug monograph(s) for additional details

 

 

Administration:

  • Outpatient prescription; administer in Cancer Centre or physician’s office
  • Vary injection site
  • For long-acting preparations, reconstitute with supplied diluent immediately before injection as directed (see product monograph). 
  • Do not give multiple monthly injections together to make up a q3 or q4 month dose, as the release characteristics are different

Lupron Depot® 7.5mg, 22.5mg and 30mg:

  • For Intramuscular use only. 
  • Usual sites of injection include the anterior thigh, gluteal area or deltoid.  Vary injection sites.
  • Store at room temperature.

Eligard® 7.5mg, 22.5mg, 30mg, and 45mg:

  • For Subcutaneous use only.  Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue. 
  • Keep refrigerated, or may be stored at room temperature in original packaging for a period of 8 weeks before administration.
  • Allow product to reach room temperature before using.

Warnings/precautions:

  • contraindicated in patients with hypersensitivity to the drug, its components or similar nonapeptides
  • Lupron® contains benzyl alcohol and may cause local reactions.
  • Use with caution in patients with osteoporosis (or risk factors for osteoporosis), diabetes, risk factors for QT prolongation, history of depression, cardiovascular disease, metastatic vertebral lesions and/or urinary tract obstruction due to the risk of disease flare, and in patients at risk of convulsions.
 
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

  • Blood glucose levels/HbA1c; baseline and periodic, especially in diabetic patients
  • EKG, Electrolytes, (including K, Ca, Mg); baseline, also regular for at risk patients
  • Liver function tests; periodic
  • PSA; baseline and periodic
  • Clinical assessment of disease flare, local reactions, thromboembolism, cardiovascular effects, osteoporosis, psychiatric effects, hot flashes and injection site reactions; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Renal function tests; periodic

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J - Administrative Information
Outpatient prescription; drug administration at Cancer Centre or physician's office
 
 
 
K - References

Chu F, Jayson M, Dineen M, Perez R, Harkaway R, Tyler R. A clinical study of 22.5 mg LA- 2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. Journal of Urology 2002;168:1199-1203.

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: 419-24.

Crook JM, O'Callaghan CJ, Duncan G, et al. Intermittent androgen suppression for rising PSA levels after radiotherapy. N Engl J Med 2012;367:895-903.

Denham JW, Steigler A, Lamb DS, et al.  Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial.  Lancet Oncol 2011;12(5):451-9.

Fornara P and Jocham D. Clinical study results of the new formulation leuprorelin acetate
three-month depot for the treatment of advanced prostate carcinoma. Urologia Internationalis
1996;56(1):18-22.

Heidenreich A, Bellmunt J, Bolla M, et al. EAU Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Treatment of Clinically Localised Disease. European Urology 2011;59:61-71.

Heyns CF, Simonin MP, Grosgurin P, et al. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU Int 2003;92(3):226-31.

Mottet N, Bellmunt J, Bolla M, et al.  EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration resistant prostate cancer. European Urology 2011:59;572-83.

Perez-Marreno R, Chu, F, Gleason D, Loizides E, Wachs B, Tyler R. A six-month, openlabel study assessing a new formulation of leuprolide 7.5 mg for suppression of testosterone in patients with prostate cancer. Clinical Therapeutics 2002;24(11):1902-1914.

Sartor O, Dineen M, Perez-Marreno R, Chu F, Carron G, Tyler R. An eight-month clinical study of LA-2575 30.0 mg: A new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer. Adult Urology 2003;62(2):319-323.

October 2017 Modified drug administration and special precautions section

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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.