QINLOCK

QINLOCK- ripretinib tablet
Deciphera Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

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.

2.2 Dosage Modifications for Adverse Reactions

The recommended dose reduction for adverse reactions is:

  • QINLOCK 100 mg orally once daily.

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 Severity a QINLOCK Dosage Modifications

a Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03).

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.

2.3 Dose Modifications for Moderate CYP3A Inducers

Avoid concomitant use of moderate CYP3A inducers during QINLOCK treatment.

If a moderate CYP3A inducer cannot be avoided, increase the QINLOCK dosing frequency from the recommended dose of 150 mg once daily to 150 mg twice daily during the co-administration period. Monitor for clinical response and tolerability. If the concomitant moderate CYP3A inducer is discontinued, resume QINLOCK dosage back to 150 mg once daily 14 days after the discontinuation of the moderate CYP3A inducer. [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg, white to off-white, oval shaped, debossed with “DC1” on one side.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Palmar-Plantar Erythrodysesthesia Syndrome

In INVICTUS, Grade 1-2 palmar-plantar erythrodysesthesia syndrome (PPES) occurred in 21% of the 85 patients who received QINLOCK [see Adverse Reactions (6.1)]. 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 [see Dosage and Administration (2.2)].

5.2 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 of 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.

5.3 Hypertension

In INVICTUS, Grade 1-3 hypertension occurred in 14% of the 85 patients who received QINLOCK, including Grade 3 hypertension in 7% [see Adverse Reactions (6.1)].

Do not initiate QINLOCK in patients with uncontrolled hypertension. Adequately control blood pressure prior to initiating QINLOCK. Monitor blood pressure as clinically indicated during treatment with QINLOCK, and initiate or adjust antihypertensive therapy as appropriate. Based on severity, withhold QINLOCK and then resume at same or reduced dose or permanently discontinue [see Dosage and Administration (2.2)].

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