Brinsupri
Italy
Table of Contents
Patient Information Leaflet
Brinsupri 25 mg film-coated tablets
brensocatib
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Brinsupri is and what it is used for
- What you need to know before taking Brinsupri
- How to take Brinsupri
- Possible side effects
- How to store Brinsupri
- Contents of the pack and other information
1. What Brinsupri is and what it is used for
What Brinsupri is
Brinsupri contains the active substance brensocatib, which belongs to a class of medicines known as dipeptidyl peptidase 1 (DPP1) inhibitors.
What Brinsupri is used for
Brinsupri is used to treat patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more exacerbations or worsening of symptoms (also known as exacerbations) in the preceding 12 months. NCFB is a long-term (chronic) disease characterized by damage to the airways in the lungs, leading to cough with mucus production.
How Brinsupri works
Brinsupri targets a protein called DPP1, which is involved in the process causing inflammation in the lungs. By blocking the activity of this protein, the medicine prevents lung exacerbations and may improve certain symptoms of NCFB.
2. What you need to know before taking Brinsupri
Do not take Brinsupri if you are allergic to brensocatib or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Brinsupri if you have recently been vaccinated or are about
to be vaccinated.
Children and adolescents
Do not give this medicine to children under 12 years of age, as its safety and benefits in this age group are not known.
Other medicines and Brinsupri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
It is not known whether Brinsupri may harm the unborn child. If you are pregnant, you must not take
Brinsupri. If you could become pregnant, you must use adequate contraceptive measures during treatment with Brinsupri.
There are insufficient data available to determine whether the medicine is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue treatment with Brinsupri, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Your doctor will discuss this with you.
Driving and using machines
It is unlikely that Brinsupri will affect your ability to drive vehicles or operate machinery.
Brinsupri contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
3. How to take Brinsupri
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and adolescents aged 12 years and older is one 25 mg tablet taken orally once daily, with or without food.
If you take more Brinsupri than you should
If you take more Brinsupri than you should, seek urgent medical advice, taking the medicine pack with you.
If you forget to take Brinsupri
Take the next dose at your usual time the following day. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Brinsupri
Do not stop taking Brinsupri without discussing it with your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- infection of the nose and throat (upper respiratory tract infection)
- diarrhoea and vomiting (gastroenteritis)
- headache
- gum problems, including red, swollen and bleeding gums (gingival disorder)
- inflammation and infection of the gums and the bone surrounding the teeth (periodontal disease)
- thickening of small areas of skin (hyperkeratosis)
- rash
- dry skin
- skin inflammation (dermatitis)
- shedding of dead cells from the outer skin layer (skin exfoliation)
- hair loss (alopecia).
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Brinsupri
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the tablets are damaged or if there are signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Brinsupri contains
- The active substance is brensocatib. Each film-coated tablet contains 25 mg of brensocatib (as monohydrate).
- The other components are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate, colloidal hydrated silica and glycerol dibehenate. For further information, see section 2 'Brinsupri contains sodium'. Film coating: poly(vinyl alcohol), titanium dioxide (E 171), macrogol 4000 (MW 3350), talc and iron oxide black (E 172).
Description of the appearance of Brinsupri and contents of the pack
The 25 mg film-coated tablets (tablets) of Brinsupri are round, grey, with a diameter of approximately 9 mm, marked with "25" on one side and "BRE" on the other side.
The film-coated tablets are supplied in aluminium foil blisters containing 14 film-coated tablets. Each pack contains 28 film-coated tablets.
Marketing Authorisation Holder
Insmed Netherlands B.V.
Stadsplateau 7
3521 AZ Utrecht
The Netherlands
Manufacturer
Patheon France
40 Boulevard De Champaret
38300 Bourgoin Jallieu
France
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.