Important Safety Information
WHAT IS GAVRETO (pralsetinib)?
GAVRETO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that:
- has spread to other parts of the body (metastatic) and
- is caused by abnormal rearranged during transfection (RET) genes. Your healthcare provider will perform a test to make sure that GAVRETO is right for you.
Important Safety Information
GAVRETO may cause serious side effects, including
Lung Problems: GAVRETO may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including shortness of breath, cough, or fever.
High blood pressure (hypertension): High blood pressure is common with GAVRETO and may sometimes be severe. You should check your blood pressure regularly during treatment with GAVRETO. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including confusion, dizziness, headaches, chest pain or shortness of breath.
Liver problems: Liver problems (increased liver function blood test results) can happen during treatment with GAVRETO and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment with GAVRETO to check you for liver problems. Tell your healthcare provider right away if you get any signs or symptoms of liver problem during treatment, including yellowing of your skin or the white part of your eyes (jaundice), loss of appetite, nausea or vomiting, dark “tea-colored” urine, pain on the upper right side of your stomach area, sleepiness, bleeding or bruising.
Bleeding problems: GAVRETO can cause bleeding which can be serious and cause death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment, including vomiting or if your vomit looks like coffee-grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or brown urine, drowsiness or difficulty being awakened, red or black (looks like tar) stools, confusion, coughing up blood or blood clots, headache, unusual bleeding or bruising of your skin, change in speech, or menstrual bleeding that is heavier than normal.
Risk of wound healing problems: Wounds may not heal properly during treatment with GAVRETO. Tell your healthcare provider if you plan to have any surgery before or during treatment with GAVRETO. You should not take GAVRETO for at least 5 days before surgery. Your healthcare provider should tell you when you may start taking GAVRETO again after surgery.
Before taking GAVRETO, tell your healthcare provider about all of your medical conditions, including if you:
- have lung or breathing problems other than lung cancer.
- have high blood pressure
- have bleeding problems
- plan to have surgery
- are pregnant or plan to become pregnant. GAVRETO can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start GAVRETO.
- Should use an effective form of non-hormonal birth control (contraception) during treatment with GAVRETO and for 2 weeks after the final dose of GAVRETO.
- Birth control methods that contain hormones (such as birth control pills, injections or transdermal system patches) may not work as well during treatment with GAVRETO.
- Talk to your healthcare provider about birth control methods that may be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with GAVRETO.
- are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of GAVRETO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GAVRETO may affect the way other medicines work, and other medicines may affect how GAVRETO works.
The most common side effects of GAVRETO include: tiredness, decreased levels of body salt (sodium) in the blood, constipation, muscle and joint pain, high blood pressure, decreased levels of calcium in the blood, decreased white blood cell and red blood cell counts, abnormal liver function blood tests, and decreased levels of phosphate in the blood.
GAVRETO may affect fertility in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of GAVRETO. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088.