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.
CRBP
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.
| CARBOplatin | AUC 5-6 | IV | Day 1 |
|
Adjust Carboplatin dose to AUC target (using Calvert formula) as outlined in the "Other Notes" section. |
|||
Moderate + NK1 antagonist (Carboplatin AUC ≥ 5)
Low
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Pre-medications (prophylaxis for infusion reactions):
- There is insufficient evidence that routine prophylaxis with pre-medications reduce infusion reaction (IR) rates.
- Corticosteroids and H1-receptor antagonists ± H2-receptor antagonists may reduce IR rates for some patients (e.g. gynecological patients with a PFI >12 months or a history of drug allergy who are receiving carboplatin starting from the 7th cycle) but no optimal pre-medication regimen has been established.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Below are suggested dose modifications.
|
Toxicity / Counts (x 109/L) |
Dose Modification |
|
ANC < 1.5 but ≥ 0.5 and/or Platelets < 100 but ≥ 25 |
Hold#; may consider dose ↓ at restart |
|
Febrile Neutropenia OR ANC < 0.5 for ≥ 5-7 days OR Platelets < 25 |
Hold# Restart by ↓ 25% |
|
Grade 3 related organ / non-hematologic |
Hold# Restart by ↓ 25% |
|
Grade 4 related organ / non- hematologic |
Discontinue |
Management of Infusion-related reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
There is insufficient evidence that routine prophylaxis with extended infusion reduces IR rates.
| Grade | Management | Re-challenge |
| 1 or 2 |
Restart:
|
|
| 3 or 4 |
|
|
* Up to 50% of patients can experience recurrent reactions during re-challenge despite using pre-medications (e.g. corticosteroid and H1/H2-receptor antagonist
Hepatic Impairment
No dose adjustment required.
Renal Impairment
|
Creatinine Clearance (ml/min) |
Carboplatin (% previous dose) |
|
20 - 50 |
Use Calvert formula*
|
|
< 20 |
Discontinue
|
Dosage in the Elderly
Caution should be exercised and dose reduction considered as elderly patients may have reduced renal function, more severe myelosuppression and neuropathy.
Refer to CARBOplatin 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 |
|
|
|
|
Refer to CARBOplatin drug monograph(s) for additional details
- Monitor closely with other nephrotoxic drugs, including aminoglycosides
Refer to CARBOplatin drug monograph(s) for additional details
Administration
- Mix in 100mL to 250mL bag (5% Dextrose or Normal Saline); infuse IV over 15 to 60 minutes.
- There is insufficient evidence that routine prophylaxis with extended infusion reduces IR rates.
- Incompatible with sets, needles or syringes containing aluminum – leads to precipitation and loss of potency.
- Protect from light.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Contraindications
- Patients who have a severe allergic reaction to this drug or other platinum-containing compounds
- Patients with pre-existing severe renal impairment
- Patients with severe myelosuppression or bleeding tumours
Other Warnings/ Precautions
- Patients with abnormal renal function or who are receiving concomitant nephrotoxic drugs.
- Patients who have received extensive prior treatment, have poor performance status and those over 65 years of age.
- Avoid live vaccines. Reduced immunogenicity may occur with the use of inactivated vaccines.
Pregnancy/ Lactation
- Carboplatin is not recommended 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.
- Fertility effects: Unknown
Recommended Clinical Monitoring
- CBC; baseline and before each cycle
- Renal function tests (including electrolytes); baseline and before each cycle
- Clinical toxicity assessment for neurotoxicity, ototoxicity, hypersensitivity, bleeding, infection, nausea and vomiting; at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Liver function tests; baseline and as clinically indicated
- INR for patients receiving warfarin; baseline and as clinically indicated
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Carboplatin drug monograph, Cancer Care Ontario.
Pavlidas N and Pentheroudakis G. Cancer of unkown primary site. Lancet 2012; 379(9824):1428-1435.
November 2019 Updated Adverse Effects, Interactions, Administration and Special Precautions sections. Updated infusion reaction information in Premedication, Dose Modifications and Drug Administration and Special Precautions sections.
Calvert Formula
DOSE (mg) = target AUC X (GFR + 25)
- AUC = product of serum concentration (mg/mL) and time (min)
- GFR (glomerular filtration rate) expressed as measured Creatinine Clearance or estimated from Serum Creatinine (by Cockcroft and Gault method or Jelliffe method)
To avoid toxicity, FDA recommends capping the carboplatin dose for a desired AUC. The maximum dose is based on a capped GFR estimate at 125 mL/min for patients with normal renal function:
Maximum Carboplatin Dose (mg) = target AUC (mg/mL per min) x (125 mL/min + 25)
For a target AUC = 6, the maximum dose is 6 x 150 = 900 mg
For a target AUC = 5, the maximum dose is 5 x 150 = 750 mg
For a target AUC = 4, the maximum dose is 4 x 150 = 600 mg
(U.S. Food and Drug Administration, Center for Drug Evaluation and research. Carboplatin dosing. 10 October 2010)
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.