Do not take Gavreto
if you are hypersensitive (allergic) to pralsetinib or any of the other ingredients of Gavreto (listed in section 6).
Warnings and precautions
Tell your doctor or healthcare provider before taking Gavreto:
- if you have a history of lung or breathing problems other than lung cancer,
- if you have high blood pressure,
- if you have liver problems,
- if you have bleeding problems.
If you are female tell your healthcare provider:
- if you are pregnant or plan to become pregnant,
- if you are breastfeeding or plan to breastfeed.
Treatment with GAVRETO may harm your unborn baby. See “Pregnancy, Breastfeeding and fertility” for detailed advice.
What you should tell your doctor or pharmacist during your treatment with GAVRETO:
Tell your healthcare provider immediately if you get any of these symptoms during treatment with GAVRETO:
- lung inflammation (pneumonitis). GAVRETO may cause severe, life-threatening or fatal swelling (inflammation) of the lungs during treatment. The signs may be similar to those from your lung cancer. Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, cough with or without mucous, or fever.
- high blood pressure (hypertension). High blood pressure is common with GAVRETO and may sometimes be severe. Your doctor will monitor your blood pressure before you start treatment, then after 1 week of your treatment and then as needed. If you have high blood pressure, which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting GAVRETO treatment.
- liver problems (increased liver function blood test results). Liver problems (increased liver function blood test results) can happen during treatment with GAVRETO and may sometimes be serious. Your doctor will take blood tests before you start treatment, every 2 weeks for the first 3 months of your treatment and then as needed. This is to check that you do not have any liver problems while taking GAVRETO. Tell your doctor straight away if you get any of the following signs: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
- bleeding problems. Serious bleeding can occur during treatment with GAVRETO. Tell your doctor straight away if you are vomiting blood or vomit that looks like coffee - grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, unusual bleeding or bruising of your skin, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, nose bleeds that happen often, drowsiness or difficulty being awakened.
Older people (≥65 years)
You can use GAVRETO if you are aged 65 years or over at the same dose as for other adults.
Children and adolescents (<18 years)
NSCLC
Do not give GAVRETO to children or adolescents under 18 years because it is not known if GAVRETO is safe and effective.
RET - Mutant Medullary Thyroid Cancer (MTC) and RET - Fusion Positive Thyroid Cancer
Do not give GAVRETO to children or adolescents under 18 years because it is not known if GAVRETO is safe and effective.
Other medicines and Gavreto
Always tell your healthcare professional if you are taking, have recently taken or might take any other medicine. (This includes complementary or traditional medicines.) Certain other medicines may affect how GAVRETO works.
Gavreto with food and drink
You should avoid drinking grapefruit juice and eating grapefruit or Seville oranges while on treatment with GAVRETO.
Pregnancy, breastfeeding and fertility
Pregnancy
- Avoid becoming pregnant while being treated with this medicine as it may harm your unborn baby. If you are pregnant, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine. Your healthcare provider will consider the benefit of you taking GAVRETO against the risk to your baby.
- Your healthcare provider may check if you are pregnant before you start treatment with GAVRETO.
- If you do become pregnant during your treatment with GAVRETO, tell your healthcare provider straight away. You and your healthcare provider will decide what is best for you and your unborn baby.
Contraception
For women
If you are able to have children, you must use effective non-hormonal birth control (contraception) while on treatment and for at least 2 weeks after stopping treatment. 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 the birth control methods that may be right for you and your partner.
For men
If your female partner is able to have children, you need to prevent pregnancy. You should use effective birth control (contraception) during treatment and for 1 week after your final dose of GAVRETO. Talk to your healthcare provider about the birth control methods that may be right for you and your partner.
Breast feeding
Do not breast feed while taking this medicine and for at least 1 week after the last dose. This is because it is not known if GAVRETO passes into breast milk. If you are breastfeeding or planning to breastfeed, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.
Fertility
GAVRETO may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
Driving and using machines
GAVRETO may make you feel tired or dizzy. If this happens, do not drive or use machines.
