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A - Regimen Name

PMDR Regimen
Pamidronate


Disease Site
Breast

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

Patients with metastatic breast cancer with bone metastases who cannot tolerate or are unlikely to tolerate oral bisphosphonates


Supplementary Public Funding

pamidronate
New Drug Funding Program (Pamidronate - Metastatic Breast Cancer)

 
B - Drug Regimen

pamidronate
90 mg IV Day 1
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C - Cycle Frequency

REPEAT EVERY 4 WEEKS *
OR
REPEAT EVERY 3 WEEKS WITH SCHEDULED CHEMOTHERAPY *
in the absence of unacceptable toxicity

*To reduce risk of osteonecrosis of the jaw after two years of treatment, consideration may be given to either:

Discontinue treatment in patients who have responded and who have stable bone metastases 
    OR
Decreasing frequency to every three months if the patient still needs active treatment

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Not applicable

Other Supportive Care:

All patients, especially those with hypercalcemia, should be adequately hydrated. Calcium and vitamin D supplements should be given to patients at risk of low serum calcium and who have no history of hypercalcemia.
 
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 dosage adjustment required.

Toxicity
Action
Osteonecrosis of jaw

Refer patient to dentist or dental surgeon; consider hold or discontinue.

Atypical fractures of the femur

Consider discontinuing
Severe musculoskeletal pain

Ocular symptoms other than uncomplicated conjunctivitis

Refer to ophthalmologist; consider discontinuing.

Nephrotoxicity

Hold until recovered to within 10% of baseline



Hepatic Impairment

AUC is increased in mild to moderate hepatic impairment but not considered clinically relevant; no dosage adjustment is required. No data available in patients with severe hepatic dysfunction and so should be used with caution.


Renal Impairment

Patients with severe renal impairment (< 30mL/min) have 3 times higher pamidronate exposure than those with normal renal function.
Baseline
During Treatment
Level
Action
Level/change
Action
Clcr > 90 mL/min
No adjustment needed
Creatinine ↑ of 44 µmol/L if normal baseline
Hold until returns to within 10% of baseline
Clcr 30-90 mL/min
Use 4 hour infusion
Creatinine ↑ of 88 µmol/L if abnormal baseline
Clcr < 30 mL/min
or
Creatinine
> 440 µmol/L (tumour induced hypercalcemia - TIH) or
> 180 µmol/L (myeloma)

Only use for life-threatening hypercalcemia where the benefit exceeds risk

Clcr < 30 mL/min
or
Creatinine
> 440 µmol/L (TIH) or
> 180 µmol/L (myeloma)
Only use for life-threatening hypercalcemia where the benefit exceeds risk

 
F - Adverse Effects

Refer to pamidronate 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

 

  • Nausea, vomiting
  • Flu-like symptoms

 

  • Headache
  • Musculoskeletal pain (may be severe)
  • Cough, dyspnea
  • Anorexia
  • Abdominal pain
  • Dyspepsia
  • Abnormal electrolytes

 

  • Arrhythmia, atrial fibrillation
  • Cardiotoxicity
  • Hypersensitivity
  • Anemia
  • Atypical fractures
  • Osteonecrosis of the jaw
  • Nephrotoxicity
  • Increased LFTs
  • Pneumonitis
  • Ocular (conjunctivitis, uveitis)
  • Viral reactivation
  • Seizure
 
G - Interactions
Refer to pamidronate drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to pamidronate drug monograph(s) for additional details


Administration
 

  • Pamidronate must not be mixed with calcium-containing solutions.
  • Mix in 250-500mL solution (D5W or NS) and infuse over 2-4 hours (Use the higher range of infusion volume and duration if renal impairment, tumour-induced hypercalcemia or myeloma). Never exceed 1 mg/minute.
  • May infuse using ambulatory infusion device over 2-4 hours.
  • Pamidronate must never be given as a bolus injection because of the risk of thrombophlebitis, severe local reactions and renal failure; it should always be diluted and administered as a slow IV infusion.
  • All patients, especially those who are dehydrated or hypercalcemic, must be adequately rehydrated prior to treatment with pamidronate.
  • Admixed solutions are chemically and physically stable for 24 h at 2-8oC, protected from light, followed by 24h at room temperature, exposed to light (total 48h stablity). 

 


Contraindications/Precautions

 

  • Patients with known or suspected hypersensitivity to pamidronate, or any of its components, or to other bisphosphonates.
  • Pamidronate should not be given together with other bisphosphonates to treat hypercalcemia, since the combined effects of these agents are unknown.

 

  • Patients must be adequately hydrated throughout treatment, but special care should be taken in the elderly and patients with cardiac disease, to prevent fluid overload and cardiac failure.
  • Avoid in patients with severe renal impairment, except in life-threatening cases of hypercalcemia.
  • Use with caution in patients with risk factors for ONJ (see adverse effects description section)
  • Pamidronate is contraindicated for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 6 months after the last dose (general recommendation).
  • Breastfeeding is not recommended.

 

 
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

  • Dental examination with appropriate preventative dentistry should be considered prior to treatment. Regular dental check- ups. Avoid invasive dental surgeries while on treatment.;
  • Electrolytes, including corrected serum calcium, phosphates, magnesium, and serum albumin; baseline and periodic
  • Serum creatinine; baseline and regular
  • Clinical toxicity assessment (including flu-like syndrome, hypersensitivity, hydration, pain, dental and ocular effects)
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • CBC, in patients with anemia, leukopenia, or thrombocytopenia; baseline and regular

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J - Administrative Information

Approximate Patient Visit
Intermate Infusor: 0.5 hour; IV infusion: 2.5-4 hours
Pharmacy Workload (average time per visit)
17.301 minutes
Nursing Workload (average time per visit)
45 minutes
 
K - References

Bloomfield D, Warr D, Whelan T, Pritchard K, Levine N, and the Breast Cancer Disease Site Group. Use of bisphosphonates in patients with bone metastases from breast cancer. Current Oncology 1999; 6(3): 144-154.

Hillner BE, Ingle JN, Chlebowski RT, Gralow J, Yee GC, Janjan N, et al. American Society of clinical oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol 2003;21:4042-57.

Pamidronate drug monograph, Cancer Care Ontario.


August 2018 Updated PEBC guideline link


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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.