INDICATIONS AND USAGE
QINLOCK is a kinase inhibitor 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.
IMPORTANT SAFETY INFORMATION
There are no contraindications for QINLOCK.
Palmar-plantar erythrodysesthesia syndrome (PPES): In
INVICTUS, Grade 1-2 PPES occurred in 21% of the 85 patients who received
QINLOCK. PPES led to dose discontinuation in 1.2% of patients, dose
interruption in 2.4% of patients, and dose reduction in 1.2% of patients.
Based on severity, withhold QINLOCK and then resume at same or reduced dose.
New Primary Cutaneous Malignancies: In INVICTUS, cutaneous
squamous cell carcinoma (cuSCC) occurred in 4.7% of the 85 patients who
received QINLOCK with a median time to event of 4.6 months (range 3.8 to 6
months). In the pooled safety population, cuSCC and keratoacanthoma occurred
in 7% and 1.9% of 351 patients, respectively. In INVICTUS, melanoma occurred
in 2.4% of the 85 patients who received QINLOCK. In the pooled safety
population, melanoma occurred in 0.9% of 351 patients. Perform dermatologic
evaluations when initiating QINLOCK and routinely during treatment. Manage
suspicious skin lesions with excision and dermatopathologic evaluation.
Continue QINLOCK at the same dose.
Hypertension: In INVICTUS, Grade 1-3 hypertension occurred
in 14% of the 85 patients who received QINLOCK, including Grade 3
hypertension in 7% of patients. Do not initiate QINLOCK in patients with
uncontrolled hypertension. Monitor blood pressure as clinically indicated.
Based on severity, withhold QINLOCK and then resume at same or reduced dose
or permanently discontinue.
Cardiac Dysfunction: In INVICTUS, cardiac failure occurred
in 1.2% of the 85 patients who received QINLOCK. In the pooled safety
population, cardiac dysfunction (including cardiac failure, acute left
ventricular failure, diastolic dysfunction, and ventricular hypertrophy)
occurred in 1.7% of 351 patients, including Grade 3 adverse reactions in
1.1% of patients.
In INVICTUS, Grade 3 decreased ejection fraction occurred in 2.6% of the 77
patients who received QINLOCK and who had a baseline and at least one
post-baseline echocardiogram. Grade 3 decreased ejection fraction occurred
in 3.4% of the 263 patients in the pooled safety population who received
QINLOCK and who had a baseline and at least one post-baseline
echocardiogram.
In INVICTUS, cardiac dysfunction led to dose discontinuation in 1.2% of the
85 patients who received QINLOCK. The safety of QINLOCK has not been
assessed in patients with a baseline ejection fraction below 50%. Assess
ejection fraction by echocardiogram or MUGA scan prior to initiating QINLOCK
and during treatment, as clinically indicated. Permanently discontinue
QINLOCK for Grade 3 or 4 left ventricular systolic dysfunction.
Risk of Impaired Wound Healing: QINLOCK has the potential
to adversely affect wound healing. Withhold QINLOCK for at least 1 week
prior to elective surgery. Do not administer for at least 2 weeks following
major surgery and until adequate wound healing. The safety of resumption of
QINLOCK after resolution of wound healing complications has not been
established.
Adverse Reactions: The most common adverse reactions (≥20%)
were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia,
diarrhea, decreased appetite, PPES, and vomiting. The most common Grade 3 or
4 laboratory abnormalities (≥4%) were increased lipase and decreased
phosphate.
The safety and effectiveness of QINLOCK in pediatric patients have not been
established.
dminister strong CYP3A inhibitors with caution. Monitor patients who are
administered strong CYP3A inhibitors more frequently for adverse reactions.
Avoid concomitant use with strong CYP3A inducers.Please see accompanying
full Prescribing Information, including Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals,
LLC, at 1-888-724-3274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.