Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
RIPR
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.
For previously treated advanced GIST, in patients who have disease progression on or intolerance to imatinib, sunitinib and regorafenib.
ripretinib
Exceptional Access Program
(ripretinib - For adult patients with advanced gastrointestinal stromal tumours (GIST) who have progression on or intolerance to imatinib, sunitinib and regorafenib)
(EAP Website)
CONTINUOUS TREATMENT
Until disease progression or unacceptable toxicity
May consider continuing ripretinib beyond progression if tolerated, as there are no other treatment options in these patients; discontinuation may exacerbate disease progression and contribute to symptom deterioration. Limited data from INVICTUS suggest that post-progression treatment may offer some degree of benefit. (CADTH). Refer to Blay et al for details.
Low – No routine prophylaxis; PRN recommended
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Other supportive care:
- Due to risk of photosensitivity, patients should avoid or minimize exposure to strong sunlight or other sources of UV radiation until at least 1 week after discontinuation of treatment. They should use a sunscreen and wear protective clothing to cover the skin when exposed to strong sunlight.
Doses should be modified according to the protocol by which the patient is being treated.
Blood pressure should be adequately controlled prior to initiation of ripretinib.
Hold ripretinib for at least 3 days prior to and after minor surgery and at least 5 days prior to and after major surgery. The decision to resume after surgery should be based on clinical judgment of adequate wound healing.
Dosage with toxicity
| Dose Levels | Ripretinib Dose (mg daily) |
| 0 | 150 |
| -1 | 100 |
| -2 | Discontinue permanently. |
| Toxicity | Severity | Action |
|---|---|---|
| Hand-foot syndrome | Grade 2 |
Hold* for at least 7 days. If resolves within 7 days, resume at same dose level. If resolves after 7 days, resume at 1 dose level ↓.
If recurs, hold*. Resume at 100 mg regardless of time to improvement. |
|
Grade 3 |
Hold* for at least 7 days (maximum 28 days). Resume at 1 dose level ↓. Consider re-escalation if maintained at Grade 1 or baseline for at least 28 days. |
|
|
|
Grade 3 |
Medically manage to achieve < Grade 1. If symptomatic, hold until symptoms resolve.
If recurs despite dose modification and medical management, discontinue. |
| Grade 4 Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) |
Discontinue. | |
| Arthralgia, myalgia | Grade 2 |
Hold* for at least 7 days. If resolves within 7 days, resume at same dose level. If resolves after 7 days, resume at 1 dose level ↓.
If recurs, hold*. Resume at reduced dose level (i.e. 100 mg) regardless of time to improvement. |
| Grade 3 |
Hold* for at least 7 days (maximum 28 days). Resume at 1 dose level ↓; otherwise, discontinue. Consider re-escalation if maintained at Grade 1 or baseline for at least 28 days. |
|
| Left ventricular systolic dysfunction | Grade 3 or 4 | Discontinue |
| Isolated Bilirubin Increased | Grade 2 |
Hold* (maximum 28 days). Restart with 1 dose level ↓. |
| Grade 3 or 4 | See "Other toxicities" below. | |
|
|
Any |
No dose modification required. Patients with suspicious skin lesions should be referred for evaluation immediately. |
| New primary cutaneous malignancies | ||
| Other toxicities | Grade 3 or 4 |
Hold* (maximum 28 days), then resume at 1 dose level ↓; otherwise, discontinue. Consider re-escalation if maintained at Grade 1 or baseline for at least 28 days. Discontinue at recurrence. |
*Do not resume until hand-foot syndrome, musculoskeletal pain, increased bilirubin, or other toxicities resolve to Grade 1 or baseline.
Hepatic Impairment
No dose adjustment is recommended in patients with hepatic impairment (Child-Pugh A, B or C).
Renal Impairment
| Creatinine Clearance (mL/min) | Ripretinib Dose |
| > 30 | No dose adjustment required |
| < 30 | Not studied |
Dosage in the Elderly
No dose adjustment required in patients of ≥ 65 years of age. Although data are limited, no differences in safety or efficacy were observed between patients ≥ 65 years of age and patients < 65 years
Refer to ripretinib 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 ripretinib drug monograph(s) for additional details.
-
Avoid concomitant use with strong or moderate CYP3A inducers. If must use a strong or moderate inducer, increase ripretinib dose to 150 mg twice daily. If inducer is discontinued, decrease ripretinib dose to previous dose 14 days after discontinuation of inducer.
-
Monitor closely for ripretinib toxicity with concomitant use of strong CYP3A inhibitors or grapefruit juice.
Refer to ripretinib drug monograph(s) for additional details.
Administration
-
Ripretinib may be taken with or without food at about the same time each day.
-
Tablets should be swallowed whole and not chewed, split, or crushed.
-
Grapefruit, starfruit, Seville oranges, their juices or products should be avoided during ripretinib treatment.
-
For patients taking 150 mg once daily (standard dose): if a dose is missed, patient may take within 8 hours of missed dose. If more than 8 hours, the dose should be skipped and taken at the next planned time. Extra doses should not be taken to make up for missed dose.
-
For patients taking 150 mg twice daily (with strong or moderate CYP3A4 inducers): if a dose is missed, patient may take within 4 hours of missed dose. If more than 4 hours, the dose should be skipped and taken at the next planned time. Extra doses should not be taken to make up for missed dose.
-
If patient vomits after taking a dose, an additional dose should not be taken. The next dose should be continued as scheduled.
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Store at room temperature (15°C to 25°C) in the original container.
Contraindications
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Patients who are hypersensitive to this drug or any of its components.
Other Warnings/Precautions
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Use caution and monitor more frequently in patients who have experienced hypersensitivity with prior use of other tyrosine kinase inhibitors.
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Patients with a baseline LVEF < 50%, CrCl < 50 mL/min, creatinine > 1.5 x ULN, or bilirubin > 1.5 x ULN and/or AST > 3 x ULN (> 5 x ULN with hepatic metastases) were excluded from clinical trials. Consider the benefits vs risks of using ripretinib in these patients.
Pregnancy/Lactation
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This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
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It is not known if ripretinib can affect hormonal contraception. If a hormonal contraception method must be used, a barrier method of contraception (e.g. condoms) must be used together with the hormonal contraception.
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Breastfeeding is not recommended during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
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Fertility Effects: Documented in studies with male animals. Discuss fertility preservation with patients prior to starting treatment.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Recommended Clinical Monitoring
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CBC; Baseline, monthly, and as clinically indicated
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Liver function tests; Baseline, monthly, and as clinically indicated
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Renal function tests; Baseline, monthly, and as clinically indicated
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Blood pressure; Baseline, monthly, and as clinically indicated
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LVEF (ECG or MUGA scan); Baseline and as clinically indicated
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Skin assessment (for new primary cutaneous malignancies); Baseline and as clinically indicated
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Clinical toxicity assessment for hypersensitivity, delayed wound healing (if applicable), musculoskeletal, gastrointestinal, cardiovascular, and skin effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Blay J-Y, Serrano C, Heinrich MC, et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2020 Jul;21(7):923-34.
CADTH reimbursement recommendation: ripretinib (advanced gastrointestinal stromal tumour). May 2022.
Ripretinib drug monograph. Ontario Health (Cancer Care Ontario).
December 2025 Expanded into full regimen monograph
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.