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Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

A - Regimen Name

 

TRIP Regimen
Triptorelin

 

 

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

triptorelin
ODB - General Benefit (triptorelin)
 

 

 
B - Drug Regimen

 

The dosage strengths are not additive, due to different release characteristics, and must be selected based on the desired dosing schedule.
 

 

triptorelin
 
3.75 mgIMMonthly
OR
triptorelin
 
11.25 mgIMEvery 3 months


Alternative Schedule:

triptorelin
 
22.5 mgIMEvery 6 months
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C - Cycle Frequency

 

Every 1, 3 or 6 months, depending on the 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

 

Doses should be modified according to the protocol by which the patient is being treated.

 

 

 

Dosage with toxicity

 

Worst grade of toxicity
Dose modification
Myelosuppression
No adjustment required
Grade 3 / 4 toxicity
Discontinue
 

Hepatic Impairment

Triptorelin exposure is increased in patients with hepatic impairment. Clinical consequences are unknown.

 

 

Renal Impairment

Triptorelin exposure is increased in patients with renal impairment. Clinical consequences are unknown.

 
F - Adverse Effects
Refer to triptorelin drug monograph(s) for additional details of adverse effects
 
Most Common Side Effects 

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

  • Hypogonadism and symptoms of ↓ testosterone
  • Disease flare - may be severe (may use short term antiandrogen therapy for blockade of  testosterone flare)
  • Musculoskeletal pain
  • Glucose intolerance (may be severe)
  • Anemia
  • Increased prothrombin time
  • QT prolongation
  • Arterial thromboembolism
  • Venous thromboembolism
  • Osteoporosis
  • Hypersensitivity
  • ↑ Cardiovascular risk
  • Pituitary apoplexy
  • Depression
  • Seizures
 
G - Interactions
Refer to triptorelin drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to triptorelin drug monograph(s) for additional details

 

Administration:

  • Intramuscular injection only; to be given in Cancer Centre or physician’s office, drug supplied by outpatient prescription.
  • The dosage strengths are not additive, due to different release characteristics, and must be selected based on the desired dosing schedule.
  • Vary injection sites. 
  • Reconstitute the drug vial with 2 mL sterile water for injection (forms a suspension) using a 21–gauge needle or using the single dose delivery system (MIXJECT®). Refer to the triptorelin (Trelstar®) product monograph for detailed instructions.
  • Store triptorelin (Trelstar®) at room temperature and protected from light; administer triptorelin suspension right after reconstitution. Any unused portion should be discarded immediately.

 

Warnings/precautions:

  • contraindicated in patients who have a hypersensitivity to gonadotropin releasing hormone or luteinizing hormone-releasing hormone (GnRH or LHRH), GnRH agonist analogs, to this drug or any of its components.
  • 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.
 
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 and/or HbA1c; baseline and periodic, more frequently in diabetic patients or patients at risk of hyperglycemia
  • ECG, electrolytes, including calcium and magnesium; baseline, also regularly in patients at risk of electrolyte abnormality or QT prolongation
  • PSA, bone and prostatic lesions; periodic
  • Clinical assessment of disease flare, osteoporosis, symptoms of hypogonadism, injection site reactions, thromboembolism, depression, cardiovascular effects; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Hemoglobin; baseline and periodic

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

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.

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.

Parmar H, Phillips RH, Lightman SL et al. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet 1985; 2:1201-5.

Triptorelin drug monograph, Cancer Care Ontario.

October 2017 modified drug regimen, drug administration and special precautions sections

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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.