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A - Regimen Name

LPRL Regimen
Leuprolide


Disease Site
Breast

Intent
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 the treatment of hormone receptor positive breast cancer in pre or peri-menopausal women.


Supplementary Public Funding

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

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

 
B - Drug Regimen

leuprolide
22.5 mg IM Day 1 of Q3M

 

OR

leuprolide
7.5 mg IM Day 1 of QM
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C - Cycle Frequency

22.5 MG - REPEAT EVERY 3 MONTHS

7.5 MG REPEAT EVERY MONTH 

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 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


Renal Impairment

No adjustment required


Dosage in the Elderly

No adjustment required

 


 
F - Adverse Effects

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


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Estrogen deprivation symptoms (i.e. hot flashes)
  • Musculoskeletal pain
  • Injection site reactions 
  • Edema
  • Fatigue
  • Rash
  • Headache
  • Tumour flare
  • Arrhythmia, QT prolongation
  • Cardiotoxicity
  • Arterial / venous thromboembolism
  • Osteoporosis
  • Pneumonitis
  • Pituitary apoplexy
  • Seizures
  • Hypersensitivity
  • GI hemorrhage, obstruction 
  • Mood changes, depression
  • Hepatotoxicity
  • Hyperglycemia
  • Increased creatinine
 
G - Interactions

Refer to leuprolide drug monograph(s) for additional details


  • Exercsise caution when used with drugs that prolong the QT interval
  • Leuprolide may interfere with diagnostic tests of pituitary-gonadal function; these tests should be conducted at more than 8 weeks after discontinuing treatment.
 
H - Drug Administration and Special Precautions

Refer to leuprolide drug monograph(s) for additional details


Administration - Lupron Depot®

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

Contraindications and Precautions:

  • 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, in patients at risk of disease flare or convulsions.
  • Adequate contraception (with non-hormonal methods) should be used by both sexes during treatment and up to 6 months after leuprolide cessation.  

Pregnancy & Lactation:

Leuprolide is contraindicated in pregnancy and breastfeeding. Adequate contraception (with non-hormonal methods) should be used by both sexes during treatment and up to 6 months after leuprolide cessation. 

 
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
  • 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

Francis, P et al. Adjuvant ovarian supression in premenopausal breast cancer. N Engl J Med. 2015;372:436-46. 

Kendzierski, DC et al. Efficacy of different leuprolide administration schedules in premenopausal breast cancer: a retrospective review. Clin breast cancer. 2018;5; 939-942. 

Leuprolide drug monograph, Cancer Care Ontario.

Schmid P, Untch M, Kossé V, Bondar G, Vassiljev L. Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: the TABLE study. J Clin Oncol. 2007 Jun 20;25(18):2509-15.


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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.