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regimen-monograph
OLAR(MNT)
Intent
Palliative
Regimen Category
Evidence-Informed
Drugs Used
QBP Type
Compassionate
This drug is not publicly funded. Universal compassionate access program is available.
A - Regimen Name
OLAR(MNT) Regimen
olaratumab
Disease Site
Gynecologic - Uterine Sarcoma
Sarcoma - Soft Tissue
Sarcoma - Uterine
Sarcoma - Soft Tissue
Sarcoma - Uterine
(leiomyosarcoma)
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
For maintenance treatment of patients with advanced soft tissue sarcoma following combination treatment with doxorubicin.
**Important - New Information as of January 2019**:
Results of a phase 3 RCT trial did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Based on the information available so far, no new safety concerns were identified during the study. Patients who currently are receiving olaratumab should discuss with their physician whether to continue their course of therapy. Olaratumab should not be initiated in new patients outside of an investigational setting.
B - Drug Regimen
| olaratumab | 15 mg /kg | IV | Days 1 and 8 |
| (This drug is not publicly funded. Universal compassionate access program is available. ) | |||
D - Premedication and Supportive Measures
Antiemetic Regimen:
Low
Other Supportive Care:
For cycle 1, premedicate all patients with an H1 antihistamine (e.g. diphenhydramine) and dexamethasone (or equivalent) intravenously 30-60 minutes prior to infusions. For subsequent cycles, premedicate all patients with an H1 antihistamine 30-60 minutes prior to infusions (unless prior infusion reaction - see dosage with toxicity table).
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 may be considered.
Dosage with toxicity
| Dose level | Olaratumab dose |
| 0 | 15 mg/kg |
| -1 | 12 mg/kg |
| -2 | 10 mg/kg |
| -3 | Discontinue |
The following are suggested dose modifications for olaratumab. In the phase II study, reduced doses were not re-escalated.
| Toxicity | Severity | Olaratumab dose |
| Infusion related reactions | Grade 1 or 2 | Hold and administer acetaminophen, H1 antihistamine and dexamethasone (or equivalent) as needed. Upon recovery, restart at 50% reduced infusion rate. For subsequent infusions, premedicate with acetaminophen, H1 antihistamine and dexamethasone (or equivalent) and maintain reduced infusion rate. |
| Grade 3 or 4 | Permanently discontinue. | |
| Neutropenia | Grade 4 for > 7 days or Febrile neutropenia | Hold until ANC ≥ 1 x 109/L, then reduce 1 dose level. |
| Other | 1st occurrence Grade 3 or 4 not manageable with supportive care | Hold until toxicity ≤ grade 1 or baseline. Reduce 1 dose level. |
| Recurrent grade 3 following 1 dose level reduction | Reduce 1 dose level. | |
| Recurrent grade 4 following 1 dose level reduction | Permanently discontinue. |
Hepatic Impairment
No formal studies have been done; patients with grade 2 or higher LFT abnormalities were excluded from the clinical trial.
| Hepatic impairment | Olaratumab dose |
| Mild (AST > ULN or total bilirubin > 1-1.5 x ULN) | no change |
| Moderate (total bilirubin > 1.5-3 x ULN) | no change |
| Severe (total bilirubin > 3 x ULN and any AST) | no data |
Renal Impairment
No formal studies have been done; patients with grade 2 or higher creatinine levels were excluded from the clinical trial.
| Renal function (CrCl) | Olaratumab dose |
| ≥ 60 ml/min | no change |
| 30-59 ml/min | no change |
| < 30 ml/min | no data |
Dosage in the Elderly
Clinical studies had insufficient numbers of patients aged 65 and older to determine whether they responded differently from younger patients.
F - Adverse Effects
Refer to olaratumab drug monograph(s) for additional details of adverse effects
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
|
|
|
G - Interactions
Refer to olaratumab drug monograph(s) for additional details
No drug interaction studies have been conducted.
H - Drug Administration and Special Precautions
Refer to olaratumab drug monograph(s) for additional details
Administration
- DO NOT administer as an IV push or bolus
- Dilute the drug with 0.9% saline solution to a final volume of 250 ml. Do not use dextrose as a diluent.
- Mix by gentle inversion.
- Infuse over 60 minutes through a separate infusion line. Flush the line with saline after administration.
- Vials should be stored at 2-8oC and protected from light.
- Diluted solutions demonstrate chemical and physical stability for up to 24 hours refrigerated and up to an additional 12 hours at room temperature.
- DO NOT freeze or shake vials or diluted solutions.
Contraindications
• Patients who have a hypersensitivity to this drug or any of its components
Precautions
- Severe and life-threatening infusion reactions have occurred during first administration; resuscitation equipment should be readily available.
- This treatment has been associated with fatigue; patients should exercise caution while driving or operating machinery.
- Olaratumab contains 57 mg of sodium per 50 ml vial. Consider this for patients on a controlled sodium diet.
Pregnancy & Lactation
- Olaratumab may cause fetal harm and is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 3 months after the last dose.
- Breastfeeding is not recommended during treatment and for at least 3 months following the last dose.
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
- CBC; Baseline and before each cycle
- Liver function tests; Baseline and before each cycle
- Clinical toxicity assessment for infusion related reactions, infection, bleeding, GI, skin and cardiac toxicity; At each visit
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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K - References
Olaratumab drug monograph, Cancer Care Ontario.
LARTRUVO (olaratumab) - New clinical trial information important to prescribing decisions. Health Canada, January 29, 2019.[Accessed February 1st, 2019]. Available from: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/68974a-eng.php
Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97.
February 2019 Updated with information from Health Canada alert
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.
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Last Updated: July 21, 2026
