Prospect: information for the patient

Nerlynx 40mg film-coated tablets

neratinib

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

What is Nerlynx

Nerlynx contains the active ingredient «neratinib». It belongs to a group of medications called «tyrosine kinase inhibitors»,which are used to block cancer cells and treat breast cancer.

How is Nerlynx used

Nerlynx is used in patients with early-stage breast cancer who:

• have hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-positive (HER2-positive) cancer, and
• have been previously treated with another medication called «trastuzumab».

The «HER2 receptor» is a protein found on the surface of cells in the body that helps control the growth of normal breast cells. In HER2-positive breast cancer, cancer cells have a large number of HER2 receptors on their surface. This causes cancer cells to divide and grow more quickly.

«Hormonal receptors» are also proteins that are expressed within specific cell types. Estrogens and progesterone bind to these proteins and regulate cellular activity. In HR-positive breast cancer, estrogens and/or progesterone can promote the division and growth of tumor cells.

Before using Nerlynx, it is necessary to analyze your cancer to confirm that it is HR-positive and HER2-positive. Additionally, you should have received prior treatment with trastuzumab.

How Nerlynx works

Nerlynx works by blocking the HER2 receptors on cancer cells. This prevents cells from dividing and growing.

Do not take Nerlynx

• if you are allergic to neratinib or any of the other components of this medication (listed in section6),
• if you have a severe liver problem,
• if you are taking rifampicin (a medication for tuberculosis (TB)),
• if you are taking carbamazepine or phenytoin (medications for seizures),
• if you are taking St. John's Wort or hypericum (herbal medication for depression).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nerlynx.

When starting treatment with Nerlynx, you will need to take a medication for diarrhea

Nerlynx may cause diarrhea at the beginning of treatment. You should take a medication to prevent diarrhea from worsening and to avoid dehydration during treatment with Nerlynx.

Tests and monitoring to detect liver problems

Nerlynx may cause changes in liver function, which are detected in blood tests. Your doctor will perform blood tests before and during treatment with Nerlynx and will stop treatment with Nerlynx if liver tests show severe problems.

Children and adolescents

Nerlynx should not be used in children under 18years. The safety and efficacy of Nerlynx have not been studied in this age group.

Other medications and Nerlynx

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Nerlynx may affect how other medications work. Additionally, some medications may affect how Nerlynx works.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• rifampicin, a medication for tuberculosis (TB)
• carbamazepine, phenobarbital, or phenytoin, medications for seizures
• St. John's Wort, herbal medication for depression
• ketoconazole, voriconazole,itraconazole, or fluconazole, medications for fungal infections
• erythromycin or clarithromycin, medications for bacterial infections
• protease inhibitors, antiviral medications
• nefazodone, medication for depression
• diltiazem or verapamil, medications for high blood pressure and chest pain
• dabigatran or digoxin, medications for heart problems
• rosuvastatin, a medication for high cholesterol.
• irinotecan, a medication used for colorectal cancer
• sulfasalazine, a medication for inflammatory bowel disease
• medications for stomach problems such as:

• lansoprazole, omeprazole, or other medications called "proton pump inhibitors" (PPIs) or IBP, whose use is not recommended.
• ranitidine, cimetidine, or medications called "H2 receptor antagonists". Neratinib should be taken 10 hours after the dose of the H2 receptor antagonist and at least 2 hours before the next dose of the H2 receptor antagonist
• antacids:the taking of these medications and Nerlynx should be spaced at least 3hours.

If any of the above situations apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Nerlynx.

Taking Nerlynx with food and drinks

Do not take grapefruit or pomelo while taking Nerlynx; this includes eating it, drinking its juice, or taking supplements that may contain it. The reason is that these fruits may interact with Nerlynx and affect its functioning.

Pregnancy

If you are pregnant, your doctor will evaluate the potential benefits for you and the risks to the fetus before prescribing this medication. If you become pregnant while taking this medication, your doctor will evaluate the potential benefits for you and the risks to the fetus derived from continuing treatment with this medication.

Contraception

Women who may become pregnant should use an effective contraceptive method, including a barrier method:

• while taking Nerlynx and
• for one month after completing treatment.

Men should use an effective barrier contraceptive method, such as a condom:

• while taking Nerlynx and
• for three months after completing treatment.

Breastfeeding

Consult your doctor before taking Nerlynx if you are breastfeeding or plan to do so, as small amounts of this medication may pass into breast milk. Your doctor will explain the benefits and risks of taking Nerlynx during this period.

Driving and operating machinery

The influence of Nerlynx on the ability to drive and operate machinery is small. The adverse effects of Nerlynx (e.g., dehydration and dizziness due to diarrhea, fatigue, and fainting) may affect how tasks requiring judgment and motor or cognitive skills are performed.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How much Nerlynx to take

The recommended dose of Nerlynx is 6tablets once a day (a total of 240mg).

• Take the tablets with food. Do not crush or dissolve the tablets.
• Take all tablets with water, approximately at the same time each day, preferably in the morning.

The treatment duration is one year.

When starting treatment with Nerlynx, you will need to take a medication for diarrhea

Nerlynx may cause diarrhea at the beginning of treatment unless a diarrhea medication is used to prevent or reduce diarrhea. Diarrhea usually occurs at the beginning of treatment with Nerlynx and can be intense and cause dehydration.

• Start taking the diarrhea medication prescribed by your doctor with the first dose of Nerlynx.
• Your doctor will tell you how to take the diarrhea medication.
• Continue taking the antidiarrheal medication during the first month or the first two months of treatment with Nerlynx. Your doctor will tell you if you need to continue taking it after the first two months.
• Your doctor will also tell you if you need to change the dose of Nerlynx due to diarrhea.

If you take more Nerlynx than you should,contact a doctor or hospital immediately. Bring the medication packaging with you.

Some side effects that may occur if you take more Nerlynx than you should are: diarrhea, nausea, vomiting, and dehydration.

If you forget to take Nerlynx

• If you forget a dose, wait until the next day before taking the next dose.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Nerlynx

• You should not interrupt treatment with Nerlynx without first talking to your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects can occur with this medicine:

Diarrea

Nerlynx may cause diarrhea at the beginning of treatment unless antidiarrheal medications are used to prevent or reduce diarrhea. Diarrhea can be severe and cause dehydration. See section 3 for more information on the anti-diarrheal medication that should be taken at the same time as Nerlynx.

Consult your doctor if:

• diarrhea does not go away; your doctor may give you advice on how to control diarrhea.
• you feel weak or dizzy due to diarrhea; you may also go to the hospital immediately.

Liver problems

Nerlynx may cause changes in liver function, which are detected in blood tests. You may or may not have signs or symptoms of liver problems (e.g., yellowing of the skin or eyes, dark urine, or light-colored stools). Your doctor will perform blood tests before and during treatment with Nerlynx and will stop treatment with Nerlynx if liver tests show severe problems.

Other side effects

Inform your doctor or pharmacist if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

• diarrhea
• stomach pain, nausea, or vomiting, decreased appetite
• dry or inflamed mouth, blisters, or sores in the mouth
• skin rash
• muscle spasms or cramps
• intense fatigue

Common (may affect up to 1 in 10 people)

• burning sensation when urinating and frequent and urgent need to urinate (may be symptoms of urinary tract infection)
• dehydration
• lightheadedness
• nasal bleeding
• mild stomach discomfort
• dry mouth
• changes in blood test results that measure liver function
• nail problems, such as brittle or discolored nails
• dry, cracked skin
• changes in kidney function test results
• weight loss

Uncommon (may affect up to 1 in 100 people)

• kidney failure
• changes in blood test results that measure liver function (e.g., elevated bilirubin in the blood)

Inform your doctor or pharmacist if you have any of the side effects mentioned above.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD (EXP). The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Keep the bottle perfectly closed to protect it from moisture.

Do not use Nerlynx if you observe signs of damage to the packaging or if there are signs of handling (e.g., if the internal seal is broken).

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Nerlynx Composition

• The active ingredient is neratinib. Each film-coated tablet contains neratinib maleate, equivalent to 40mg of neratinib.
• The other components are:
• Tablet core: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, anhydrous colloidal silica, magnesium stearate
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172)

Product appearance and packaging contents

The film-coated tablets are red, oval-shaped with "W104" engraved on one face and smooth on the other face.

Nerlynx film-coated tablets are presented in a white high-density polyethylene (HDPE, by its English acronym) round bottle, with a child-resistant polypropylene closure, and with an internal aluminum seal sealed by induction. Each bottle contains 180film-coated tablets.

Inside each bottle, a HDPE desiccant bag with 1g of silica gel is included. Do not ingest the desiccant. Keep it inside the bottle.

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

Les Cauquillous

81500 Lavaur

France

Responsible for Manufacturing

Pierre Fabre Médicament Production – Cahors

Site de Cahors

Le Payrat

46000 Cahors

France

Last review date of this leaflet: MM/AAAA

Other sources of information

The detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.

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