Pralsetinib
Generic name: pralsetinib [ pral-SE-ti-nib ]
Brand name: Gavreto
Dosage form: oral capsule (100 mg)
Drug class:Multikinase inhibitors
What is pralsetinib?
Pralsetinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).
Pralsetinib is used only if your cancer has a specific genetic marker (an abnormal "RET" gene fusion). Your doctor will test you for this gene fusion.
Pralsetinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to pralsetinib, but further studies are needed.
Pralsetinib may also be used for purposes not listed in this medication guide.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
Tell your doctor if you have ever had:
lung or breathing problems other than lung cancer;
bleeding problems; or
Pralsetinib can harm an unborn baby if the mother or the father is using pralsetinib.
If you are a woman, do not use pralsetinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective non-hormonal birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using pralsetinib.
Pralsetinib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pralsetinib, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
Pralsetinib is not approved for use by anyone younger than 18 years old.
How should I take pralsetinib?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take pralsetinib on an empty stomach, at least 1 hour be...