Source: FDA, National Drug Code (US) Revision Year: 2020
QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
The recommended dosage of QINLOCK is 150 mg orally once daily with or without food until disease progression or unacceptable toxicity.
Instruct patients to swallow tablets whole.
Advise patients to take QINLOCK at the same time each day.
Advise patients to take a missed dose if less than 8 hours have passed since the missed scheduled dose.
Advise patients not to take an additional dose if vomiting occurs after taking QINLOCK and to continue with their next scheduled dose.
The recommended dose reduction for adverse reactions is:
Permanently discontinue QINLOCK in patients who are unable to tolerate 100 mg orally once daily.
The recommended dosage modifications of QINLOCK for adverse reactions are provided in Table 1.
Table 1. Recommended Dosage Modifications for QINLOCK for Adverse Reactions:
| Adverse Reaction | Severitya | QINLOCK Dosage Modifications |
|---|---|---|
| Palmar-Plantar Erythrodysesthesia Syndrome (PPES) [see Warnings and Precautions (5.1)] | Grade 2 | • Withhold QINLOCK until Grade ≤1 or baseline. If recovered within 7 days, resume QINLOCK at same dose; otherwise resume at reduced dose. • Consider re-escalating QINLOCK if maintained at Grade ≤1 or baseline for at least 28 days. • If PPES recurs, withhold QINLOCK until Grade ≤1 or baseline and then resume QINLOCK at a reduced dose regardless of time to improvement. |
| Grade 3 | • Withhold QINLOCK for at least 7 days or until Grade ≤1 or baseline (maximum 28 days). Resume QINLOCK at a reduced dose. • Consider re-escalating QINLOCK if maintained at Grade ≤1 or baseline for at least 28 days. | |
| Hypertension [see Warnings and Precautions (5.3)] | Grade 3 | • If symptomatic, withhold QINLOCK until symptoms have resolved and blood pressure is controlled. • If blood pressure is controlled to Grade ≤1 or baseline, resume QINLOCK at the same dose; otherwise, resume QINLOCK at reduced dose. • If Grade 3 hypertension recurs, withhold QINLOCK until symptoms have resolved and blood pressure is controlled. Resume QINLOCK at a reduced dose. |
| Grade 4 | Permanently discontinue QINLOCK. | |
| Left Ventricular Systolic Dysfunction [see Warnings and Precautions (5.4)] | Grade 3 or 4 | Permanently discontinue QINLOCK. |
| Arthralgia or Myalgia [see Adverse Reactions (6.1)] | Grade 2 | • Withhold QINLOCK until Grade ≤1 or baseline. If recovered within 7 days, resume QINLOCK at same dose; otherwise resume QINLOCK at reduced dose. • Consider re-escalating QINLOCK if maintained at Grade ≤1 or baseline for at least 28 days. • If arthralgia or myalgia recurs, withhold QINLOCK until Grade ≤1 or baseline and then resume QINLOCK at a reduced dose regardless of time to improvement. |
| Grade 3 | • Withhold QINLOCK for at least 7 days or until Grade ≤1 or baseline (maximum of 28 days). Resume QINLOCK at a reduced dose. • Consider re-escalating QINLOCK if maintained at Grade ≤1 or baseline for at least 28 days. | |
| Other Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 or 4 | • Withhold QINLOCK until Grade ≤1 or baseline (maximum 28 days), and then resume QINLOCK at a reduced dose; otherwise permanently discontinue. • Consider re-escalating QINLOCK if no recurrence of the adverse reaction for at least 28 days. • If Grade 3 or 4 recurs, permanently discontinue QINLOCK. |
a Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03).
Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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