Starting patients on Qinlock

Two simple options for prescribing Qinlock:

Option 1: Enroll your patient in Deciphera AccessPoint™
  • Submit a completed enrollment form with prescription and patient consent signature. The enrollment form is available for download below

Option 2: Contact a Qinlock specialty pharmacy or specialty distribution partner
  • Qinlock is available through the following specialty pharmacies:
  • Qinlock is available for in‑office dispensing through the following specialty distributors*:

*Direct purchase of Qinlock is available for eligible customers through contracted specialty distributors.

Qinlock Resources

A variety of resources are available to support you, your patients, and your practice.

For Healthcare Professionals/Office Staff

Qinlock Brochure for Healthcare Professionals

QINLOCK Brochure for Healthcare Professionals Download PDF

An overview of the efficacy and safety of Qinlock for prescribers

Starting & Managing Patients on Qinlock

QINLOCK Quick Start Guide Download PDF

A comprehensive guide to getting patients started on Qinlock and managing common treatment-related adverse events

INVICTUS Trial
Reprint Carrier

Invictus trial reprint Download PDF

Highlights of the methodology and key findings of the INVICTUS clinical trial

INVICTUS Trial Paper in Lancet Oncology

Invictus Lancet reprint Read the INVICTUS trial paper

The INVICTUS trial paper demonstrating the efficacy and safety of Qinlock in 4th‑line advanced GIST

Deciphera AccessPoint Enrollment Form

Deciphera AccessPoint Enrollment Form (for HCPs and Office Staff) Download PDF

A simple form that connects your patients to the many services and financial support options of Deciphera AccessPoint

Product Fact Sheet and Ordering Information

QINLOCK Product Fact Sheet and Ordering Information for HCPs and Office Staff Download PDF

A quick-reference resource with information about Qinlock and the specialty pharmacy and distribution network

For Patients

Qinlock Brochure for Patients

QINLOCK Brochure for Patients Download PDF

A guide for patients and care partners, with information about starting Qinlock

Patient Starter Kit

QINLOCK Patient Starter Kit Request a Patient Starter Kit

Help your patients start Qinlock on a positive note. Order a starter kit containing helpful tools and resources in a handy pouch

GIST Together logo

GISTTogether.com is an online hub that connects patients and care partners with information and resources to help them in their GIST journey

GISTTogether
Deciphera AccessPoint logo

Your single point-of-contact for Qinlock access and support

Deciphera AccessPoint

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 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 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 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 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.

Photosensitivity: Qinlock may cause photosensitivity reactions. In 621 patients treated with Qinlock in clinical trials, photosensitivity reactions occurred in 0.6% of patients. Advise patients to limit direct ultraviolet exposure during treatment with Qinlock and for at least 1 week after discontinuation of treatment.

Embryo‑Fetal Toxicity: Qinlock can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 1 week after the last dose. Qinlock may impair fertility in males of reproductive potential.

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.

Administer strong CYP3A inhibitors with caution. Monitor patients who are administered strong CYP3A inhibitors more frequently for adverse reactions. Avoid concomitant use with strong and moderate CYP3A inducers. If a moderate CYP3A inducer cannot be avoided, increase Qinlock dosing frequency from the recommended dose of 150 mg once daily to 150 mg twice daily during the co‑administration period. 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.

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.

Indication

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.

Please see full Prescribing Information, including Patient Information.

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 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 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 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 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.

Photosensitivity: Qinlock may cause photosensitivity reactions. In 621 patients treated with Qinlock in clinical trials, photosensitivity reactions occurred in 0.6% of patients. Advise patients to limit direct ultraviolet exposure during treatment with Qinlock and for at least 1 week after discontinuation of treatment.

Embryo‑Fetal Toxicity: Qinlock can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 1 week after the last dose. Qinlock may impair fertility in males of reproductive potential.

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.

Administer strong CYP3A inhibitors with caution. Monitor patients who are administered strong CYP3A inhibitors more frequently for adverse reactions. Avoid concomitant use with strong and moderate CYP3A inducers. If a moderate CYP3A inducer cannot be avoided, increase Qinlock dosing frequency from the recommended dose of 150 mg once daily to 150 mg twice daily during the co‑administration period. 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.

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.

Indication

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.

Please see full Prescribing Information, including Patient Information.