Active ingredient
- pralsetinib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0929.
Gavreto 100 mg hard capsules
Package leaflet: Information for the patient
Gavreto 100 mg hard capsules
pralsetinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Gavreto is and what it is used for
2. What you need to know before you take Gavreto
3. How to take Gavreto
4. Possible side effects
5. How to store Gavreto
6. Contents of the pack and other information
1. What Gavreto is and what it is used for
What Gavreto is
Gavreto is a cancer medicine that contains the active substance pralsetinib.
What Gavreto is used for
Gavreto is used to treat adults with advanced stages of a form of lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’), that presents with a specific rearrangement in a gene called rearranged during transfection (RET) if you have not been previously treated with another RET inhibitor medicine.
How Gavreto works
In patients whose cancer is due to an altered RET gene, the change in the gene causes the body to make an abnormal protein called a RET fusion protein, which can lead to uncontrolled cell growth and cancer. Gavreto blocks the action of RET fusion proteins and may help to slow or stop your lung cancer from growing. It may also help to shrink your cancer.
If you have any questions about how Gavreto works or why this medicine has been prescribed for you, please ask your doctor.
2. What you need to know before you take Gavreto
Do not take Gavreto
Warnings and precautions
Talk to your doctor or pharmacist before taking Gavreto.
Gavreto can cause side effects that you need to tell your doctor about straight away. These include:
Look out for this while you are taking Gavreto. See ‘Side effects’ in section 4 for more information.
Children and adolescents
Gavreto has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years.
Other medicines and Gavreto
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Gavreto may affect the way other medicines work, and certain other medicines may affect how Gavreto works.
Tell your doctor or pharmacist before taking Gavreto if you are taking any of the following medicines:
The following medicines can increase the concentration of Gavreto in the blood:
The following medicines can reduce the effectiveness of Gavreto:
Gavreto may affect the way some other medicines work, including:
The medicines listed here may not be the only ones that could interact with Gavreto.
Ask your doctor or pharmacist for advice before taking any medicine.
Gavreto with food and drink
You should avoid drinking grapefruit juice and eating grapefruit or Seville oranges while on treatment with Gavreto.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Contraception in females:
You should avoid becoming pregnant while taking this medicine. If you are able to have children, you must use highly effective contraception (for example, double-barrier contraception such as condom and diaphragm) while on treatment and for at least 2 weeks after stopping treatment. Gavreto may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective. If hormonal contraception is unavoidable, it must be used in combination with a condom.
Contraception in males:
Males with female partners of childbearing potential should use effective contraception during treatment and for 1 week after completion of treatment.
Talk to your doctor about the right methods of contraception for you and your partner.
Pregnancy:
This medicine is not recommended for use during pregnancy unless absolutely necessary. Avoid becoming pregnant while being treated with this medicine as it may harm your unborn baby. Your doctor will discuss with you the potential risks of taking Gavreto during pregnancy.
Your doctor may check if you are pregnant before you start treatment with this medicine.
Breast-feeding:
Tell your doctor if you are breast-feeding or planning to breast-feed. It is not known if Gavreto passes into your breast milk. You should not breast-feed during treatment with this medicine and for at least 1 week after the last dose. Talk to your doctor about the best way to feed your baby during this time.
Fertility:
It is possible that this medicine could permanently affect your ability to have children. You are encouraged to talk to a doctor about saving your sperm or eggs before using Gavreto.
Driving and using machines
Gavreto may affect your ability to drive or use machines. Gavreto may cause you to feel fatigued. If this happens, you should not drive or operate heavy machinery until your symptoms resolve. Talk to your doctor about whether it is okay for you to drive or use machines.
Gavreto contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially “sodium-free”.
3. How to take Gavreto
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 400 mg (4 capsules) taken by mouth once daily.
If you get side-effects, your doctor may change your dose, temporarily stop, or permanently stop treatment. Do not change your dose or stop taking Gavreto unless your doctor tells you to.
Gavreto is for oral use. Swallow the capsules whole with a glass of water, on an empty stomach. Do not eat for at least two hours before and at least one hour after taking Gavreto.
If you vomit after taking a dose of Gavreto, do not take an extra dose. Take your regular dose of Gavreto the next day.
If you take more Gavreto than you should
If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention.
If you forget to take Gavreto
If you miss a dose of Gavreto, take it as soon as you remember on the same day. Take your regular dose of Gavreto the next day.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most serious side effects
Some side effects may be serious. Tell your doctor straight away if you get the following side effect (see also section 2):
Other side effects:
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Gavreto
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and outer carton after ”EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not use this medicine if you notice that the bottle is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Gavreto contains
What Gavreto looks like and contents of the pack
Gavreto 100 mg hard capsules are light blue, opaque hard capsules with “BLU-667” printed on the capsule shell body and “100 mg” on the capsule shell cap in white ink.
Gavreto is available in a plastic bottle with child-resistant cap containing 60, 90 or 120 hard capsules and a desiccant sachet. Each carton contains one bottle.
Keep the desiccant sachet in the bottle. The desiccant is a moisture absorbing material filled in a small sachet to protect the capsules from moisture. Do not swallow the desiccant.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in February 2022
gb-pl-gavreto-clean-221401-100mg-caps
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
+44 (0)1707 366 000
+44 (0)800 328 1629
+44 (0)800 731 5711
+44 (0)1707 338 297
+44 (0)1707 384555