Please click on right here to see the QINLOCK (ripretinib) prescribing info.
INDICATION
What’s QINLOCK?
QINLOCK is a prescription medication used to deal with adults with superior gastrointestinal stromal tumor (GIST) who’ve obtained prior remedy with 3 or extra kinase inhibitor medicines, together with imatinib, for his or her GIST.
Essential Security Data
QINLOCK might trigger severe unintended effects, together with:
A pores and skin downside known as palmar-plantar erythrodysesthesia syndrome. Pores and skin issues are widespread and generally may be extreme. Inform your healthcare supplier straight away in case you develop redness, ache, blisters, bleeding, or swelling on the palms of your palms or soles of your ft, or extreme rash throughout remedy with QINLOCK.
New pores and skin cancers. QINLOCK might trigger pores and skin cancers known as cutaneous squamous cell carcinoma, keratoacanthoma, or melanoma. Discuss to your healthcare supplier about your danger for these cancers. Your healthcare supplier ought to verify your pores and skin earlier than and through remedy with QINLOCK to search for any new pores and skin cancers. Test your pores and skin and inform your healthcare supplier straight away about any pores and skin modifications, together with a:
- new wart
- pores and skin sore or reddish bump that bleeds or doesn’t heal
- change in measurement or colour of a mole
Hypertension (Hypertension). Hypertension is widespread with QINLOCK and may be extreme. Your healthcare supplier ought to verify your blood strain usually throughout remedy with QINLOCK.
Coronary heart issues. Your healthcare supplier ought to verify you for indicators or signs of coronary heart failure earlier than beginning QINLOCK and usually throughout remedy with QINLOCK. Coronary heart failure may be severe and might generally result in dying. Inform your healthcare supplier straight away if in case you have any of the next indicators or signs throughout your remedy with QINLOCK:
Danger of wound therapeutic issues. Wounds might not heal nicely throughout remedy with QINLOCK. Inform your healthcare supplier in case you plan to have any surgical procedure earlier than or throughout remedy with QINLOCK. Your healthcare supplier ought to inform you when to cease taking QINLOCK earlier than a deliberate surgical procedure and when you could begin taking QINLOCK once more after surgical procedure.
Danger of sensitivity to daylight (photosensitivity). Your pores and skin could also be delicate to the solar or different types of mild throughout remedy with QINLOCK. Keep away from or restrict publicity to direct daylight, sunlamps, and different sources of ultraviolet radiation throughout remedy and for at the very least 1 week after stopping remedy with QINLOCK. Use sunscreen and put on garments that cowl your pores and skin if you’ll want to be out within the solar.
The most typical unintended effects of QINLOCK embody:
These usually are not all of the potential unintended effects of QINLOCK.
Name your physician for medical recommendation about unintended effects. Chances are you’ll report unintended effects to FDA at 1-800-FDA-1088.
It’s not identified if QINLOCK is secure and efficient in kids.
Earlier than taking QINLOCK, inform your healthcare supplier about your entire medical circumstances, together with in case you:
Inform your healthcare supplier in case you:
- are pregnant or plan to change into pregnant. QINLOCK can hurt your unborn child.
- or your accomplice turns into pregnant, otherwise you assume you could be pregnant throughout remedy with QINLOCK.
- are breastfeeding or plan to breastfeed. It’s not identified if QINLOCK passes into your breast milk. Don’t breastfeed throughout remedy with QINLOCK and for 1 week after your final dose.
Females who can change into pregnant:
- Your healthcare supplier will do a being pregnant check earlier than you begin remedy with QINLOCK.
- You need to use efficient contraception (contraception) throughout remedy with QINLOCK and for 1 week after the final dose. Discuss to your healthcare supplier about contraception strategies which may be best for you.
For males with feminine companions who can change into pregnant:
- You need to use efficient contraception throughout remedy with QINLOCK and for 1 week after your final dose.
QINLOCK might have an effect on fertility in males which can have an effect on the flexibility to have kids. Discuss to your healthcare supplier if it is a concern for you.
Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. QINLOCK and sure different medicines can have an effect on one another inflicting unintended effects or have an effect on how QINLOCK works.
Know the medicines you’re taking. Hold a listing of them to point out to your healthcare supplier and pharmacist while you get a brand new medication.
Normal details about the secure and efficient use of QINLOCK.
Medicines are generally prescribed for functions aside from these listed in a Affected person Data leaflet. Don’t use QINLOCK for a situation for which it was not prescribed. Don’t give QINLOCK to different individuals, even when they’ve the identical signs that you’ve. It might hurt them. You may ask your pharmacist or healthcare supplier for details about QINLOCK that’s written for well being professionals.
Click on right here to see the QINLOCK Prescribing Data, together with Affected person Data.
[06/24] DCPH-P01490
