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Qinlock is a brand name for Ripretinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
Verbatim from this product's EMA label. Tap a section to expand.
QINLOCK should be prescribed by physicians experienced in the administration of anticancer agents. Posology The recommended dose is 150 mg ripretinib (three 50 mg tablets) taken once daily at the same time each day with or without food.
If the patient misses a dose of QINLOCK within 8 hours of the time it is usually taken, the patient should be instructed to take it as soon as possible and then take the next dose at the regularly scheduled time. If a patient misses a dose by more than 8 hours of the time it is usually taken, the patient should be instructed not to take the missed dose and simply resume the usual dosing schedule on the following day.
In case of vomiting after QINLOCK administration, the patient should not take a replacement dose and should resume the dosing schedule the next day at the usual time. 4). 3 Posology adjustments Dose interruptions or dose reductions may be required based on individual safety and tolerability.
The recommended dose reduction for adverse reactions is 100 mg orally, once daily. QINLOCK should be permanently discontinued in patients who are unable to tolerate 100 mg orally once daily. The recommended dose modifications for QINLOCK for adverse reactions are provided in Table 1.
8) Grade 2 • Withhold until Grade ≤1 or baseline. If recovered within 7 days, resume at same dose; otherwise resume at reduced dose. • Consider re-escalating if maintained at Grade ≤1 or baseline for at least 28 days. • If PPES recurs, withhold until Grade ≤1 or baseline and then resume at a reduced dose regardless of time to improvement.
Grade 3 • Withhold for at least 7 days or until Grade ≤1 or baseline (maximum 28 days). Resume at a reduced dose. • Consider re-escalating if maintained at Grade ≤1 or baseline for at least 28 days. 8) Grade 3 • If symptomatic, withhold until symptoms have resolved and blood pressure is controlled.
• If blood pressure is controlled to Grade ≤1 or baseline, resume at the same dose; otherwise, resume at reduced dose. • If Grade 3 hypertension recurs, withhold until symptoms have resolved and blood pressure is controlled. Resume at a reduced dose.
Grade 4 Permanently discontinue. 8) Grade 3 or 4 Permanently discontinue. 8) Grade 2 • Withhold until Grade ≤1 or baseline. If recovered within 7 days, resume at same dose; otherwise resume at reduced dose. • Consider re-escalating if maintained at Grade ≤1 or baseline for at least 28 days.
1). In the Phase 1 Study DCC-2618-01-001, a total of 277 patients with advanced malignancies were enrolled, and 218 patients were treated at the recommended Phase 2 dose of 150 mg QINLOCK once daily. 49 months. 8%). 0%). 0%). 0%). Tabulated list of adverse reactions The overall safety profile of QINLOCK is based on pooled data from 392 patients (pooled safety population) who received at least 1 dose of QINLOCK.
1) and an open-label, first-in-human study in adult patients with advanced malignancies (Study DCC-2618-01-001). The double-blind period of the INVICTUS study formed the primary basis of the determination of adverse reactions. 5 times greater in the QINLOCK arm than those compared to placebo arm in INVICTUS were considered adverse drug reactions.
Treatment emergent adverse events identified within the INVICTUS study were also evaluated across the pooled safety population (n=392). These events were considered adverse drug reactions per the Sponsor assessment. They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
The severity of adverse drug reactions was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE), defining Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4=life threatening, and Grade 5=death. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) and are shown in Table 2.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4%) patients in the QINLOCK arm and no patients in the placebo arm. 4% of patients. All events were mild or moderate in severity (58% Grade […]
8). 2). 8). Ripretinib must not be initiated unless blood pressure is adequately controlled. Blood pressure is to be monitored as clinically indicated. 2). 8). Ejection fraction should be assessed by echocardiogram or multiple-gated acquisition (MUGA) scan prior to initiating ripretinib and during treatment, as clinically indicated.
2). The safety of ripretinib has not been assessed in patients with a baseline left ventricular ejection fraction below 50%. 8). Dermatological evaluations should be performed when initiating ripretinib and routinely during treatment.
Suspicious skin lesions should be managed with excision and dermatopathological evaluation. Ripretinib should be continued at the same dose. Wound healing complications No formal studies to evaluate the effect of ripretinib on wound healing have been conducted.
Impaired wound healing complications may occur in patients who receive medicinal products that inhibit the vascular endothelial growth factor (VEGF) signalling pathway. Therefore, ripretinib has the potential to adversely affect wound healing.
Treatment with ripretinib is to be withheld for at least 3 days prior to and after minor surgery and at least 5 days prior to and after major surgery. Ripretinib may then be resumed after surgery based on clinical judgement of adequate wound healing.
3). It is recommended to advise women to avoid pregnancy while taking ripretinib. The pregnancy status of females of reproductive potential must be verified prior to initiating ripretinib and during treatment. 3). Effects of ripretinib on contraceptive steroids have not been studied.
A barrier method contraception should be added if systemic contraceptive steroids are used. 3). It is recommended to advise patients to avoid or minimise exposure to direct sunlight, sunlamps, and other sources of ultraviolet radiation due to the risk of phototoxicity associated with ripretinib.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• If arthralgia or myalgia recurs, withhold until Grade ≤1 or baseline and then resume at a reduced dose regardless of time to improvement. Grade 3 • Withhold for at least 7 days or until Grade ≤1 or baseline (maximum of 28 days). Resume at a reduced dose.
• Consider re-escalating if maintained at Grade ≤1 or baseline for at least 28 days. 8) Grade 3 or 4 • Withhold until Grade ≤1 or baseline (maximum 28 days), and then resume at a reduced dose; otherwise permanently discontinue. • Consider re-escalating if no recurrence of the adverse reaction for at least 28 days.
• If Grade 3 or 4 recurs, permanently discontinue. 03). 5). If a strong or moderate CYP3A inducer must be co-administered, the QINLOCK dosing frequency may be increased during the co-administration period. For strong inducers, the dose may be increased from 150 mg once daily to 150 mg twice daily.
For patients taking QINLOCK twice daily, if the patient misses a dose within 4 hours of the time it is usually taken, the 4 patient should be instructed to take the missed dose as soon as possible and then take the next dose at the regularly scheduled time.
If a patient misses a dose by more than 4 hours of the time it is usually taken, the patient should be instructed not to take the missed dose and simply resume the usual dosing schedule. Close monitoring of overall efficacy and safety is recommended in these patients.
2). Only limited clinical data are available in patients with severe renal impairment [creatinine clearance (CLcr) <30 mL/min]. 2). Hepatic impairment No dose adjustment is recommended in patients with mild (Child-Pugh A), moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Data in patients with severe hepatic impairment is limited, thus close monitoring of overall safety is recommended in these patients. 1). 1). No data are available. Method of administration QINLOCK is for oral use. 2). Prescribers should instruct patients to swallow the tablets whole and not to chew, split, or crush them.
Patients should not ingest the tablets if they are broken, cracked, or otherwise not intact as the potential effects of these alterations have not been evaluated.
Patients should be instructed to use measures such as protective clothing (long sleeves and hat) and sunscreen with high sun protection factor (SPF). CYP3A inhibitors and inducers Ripretinib is a CYP3A substrate. 5). Caution is required when administering ripretinib with agents that are strong CYP3A and P-gp inhibitors.
Concurrent administration of ripretinib with the strong CYP3A inducer rifampicin resulted in a decrease in ripretinib plasma exposure. 5). Important information about some excipients QINLOCK contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.