Nerlynx

Patient Information Leaflet

Nerlynx 40 mg film-coated tablets

neratinib
Please read all of this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Nerlynx is and what it is used for
2. What you need to know before taking Nerlynx
3. How to take Nerlynx
4. Possible side effects
5. How to store Nerlynx
6. Contents of the pack and other information

1. What is Nerlynx and what is it used for

What is Nerlynx
Nerlynx contains the active substance "neratinib". It belongs to a group of medicines called
"tyrosine kinase inhibitors" used to block cancer cells and treat breast cancer.
What Nerlynx is used for
Nerlynx is used in patients with early-stage breast cancer that:

• is hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-positive (HER2-positive), and
• has previously been treated with another medicine called "trastuzumab".

The "HER2 receptor" is a protein found on the surface of the body's cells.
It helps regulate how healthy breast cells grow. In HER2-positive breast cancer, cancer cells have a large amount of HER2 receptors on their surface and therefore divide and grow more rapidly.
"Hormone receptors" are also proteins, expressed within the cells of certain specific tissues.
Estrogen and progesterone bind to these proteins and regulate cellular activity. In HR-positive breast carcinoma, the division and growth of cancer cells may be enhanced by estrogen and/or progesterone.
Before using Nerlynx, the cancer must have been tested and shown to be positive for HR and HER2. It must also have been previously treated with trastuzumab.
How Nerlynx works
Nerlynx blocks HER2 receptors on cancer cells, helping to prevent the cells from dividing and growing.

2. What you need to know before taking Nerlynx

Do not take Nerlynx

• if you are allergic to neratinib or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver problems,
• if you are taking rifampicin (a medicine for tuberculosis (TB)),
• if you are taking carbamazepine or phenytoin (medicines for epileptic seizures),
• if you are taking St. John's wort (a herbal product used for depression).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nerlynx.
An anti-diarrhoeal medicine must be taken when starting Nerlynx
Nerlynx may cause diarrhoea in the early stages of treatment. It is necessary to take an anti-diarrhoeal medicine to prevent diarrhoea from becoming severe and to avoid dehydration during treatment with Nerlynx.
Tests and monitoring for liver problems
Nerlynx may cause changes in liver function, which can be detected by blood tests. Your doctor will perform blood tests before and during treatment with Nerlynx. Your doctor will stop treatment with Nerlynx if liver tests show serious problems.
Children and adolescents
Do not use in children under 18 years of age. The safety and effectiveness of Nerlynx have not been studied in this age group.
Other medicines and Nerlynx
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Nerlynx may affect how some medicines work. In addition, some medicines may affect how Nerlynx works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• rifampicin – a medicine for tuberculosis (TB)
• carbamazepine, phenobarbital, or phenytoin – medicines for epileptic seizures
• St. John's wort – a herbal product used for depression
• ketoconazole, voriconazole, itraconazole, or fluconazole – medicines for fungal infections
• erythromycin or clarithromycin – medicines for bacterial infections
• protease inhibitors – antiviral medicines
• nefazodone – a medicine used to treat depression
• diltiazem or verapamil – medicines for high blood pressure and chest pain
• dabigatran or digoxin – medicines for heart problems
• rosuvastatin – a medicine to treat high cholesterol
• irinotecan – a medicine for colorectal cancer
• sulfasalazine – an anti-inflammatory medicine for the intestine
• medicines for stomach problems such as:
• lansoprazole, omeprazole, or similar medicines known as "proton pump inhibitors" or PPIs are not recommended;
• ranitidine, cimetidine, or similar medicines called "H₂ receptor antagonists". Neratinib should be taken 10 hours after taking the H₂ receptor antagonist and at least 2 hours before the next dose of the H₂ receptor antagonist
• antacid medicines: administration of these medicines and Nerlynx should be separated by at least 3 hours.

If any of the above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking Nerlynx.
Nerlynx with food and drinks
Do not consume grapefruit or pomegranate while taking Nerlynx, avoiding eating the fruit, drinking its juice, or taking a supplement that may contain it, as these fruits may interact with Nerlynx and affect how the medicine works.
Pregnancy
If you are pregnant, your doctor will assess the potential benefit for you and the risk to the fetus before prescribing this medicine. If you become pregnant while taking this medicine, your doctor will evaluate the potential benefit for you and the risk to the fetus if treatment continues.
Contraception
Women of childbearing potential must use an effective contraceptive method, including a barrier method:

• during treatment with Nerlynx and
• for one month after the end of treatment.

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

• during treatment with Nerlynx and
• for three months after the end of treatment.

Breast-feeding
Talk to your doctor before taking Nerlynx if you are breast-feeding or plan to breast-feed, as small amounts of this medicine may be present in your breast milk. Your doctor will discuss with you the benefits and risks of taking Nerlynx during this period.
Driving and using machines
Nerlynx has a minor influence on the ability to drive and use machines. The side effects of Nerlynx (e.g. dehydration and dizziness due to diarrhoea, fatigue and fainting) may affect performance of activities requiring judgment, motor, or cognitive skills.

3. How to take Nerlynx

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Amount of Nerlynx to take
The recommended dose of Nerlynx is 6 tablets once daily (a total of 240 mg).

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

The treatment cycle lasts one year.

An antidiarrheal medicine must be taken when starting Nerlynx
Nerlynx can cause diarrhoea in the early stages of treatment unless an antidiarrheal medicine is taken to prevent or reduce it. Diarrhoea usually occurs early in the course of treatment with Nerlynx and may become severe, leading to dehydration.

• Start taking the antidiarrheal medicine prescribed by your doctor together with the first dose of Nerlynx.
• Your doctor will instruct you on how to take the antidiarrheal medicine.
• Continue taking the antidiarrheal medicine during the first one or two months of treatment with Nerlynx. Your doctor will advise you whether you need to continue taking the antidiarrheal medicine beyond the first two months to control diarrhoea.
• Your doctor will also advise you whether the dose of Nerlynx needs to be adjusted due to diarrhoea.

If you take more Nerlynx than you should, contact a doctor or go to a hospital immediately.
Bring the medicine package with you.
Some side effects that may occur if you take too much Nerlynx include diarrhoea, nausea, vomiting, and dehydration.

If you forget to take Nerlynx

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

If you stop taking Nerlynx

• Do not stop treatment with Nerlynx without first consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine:
Diarrhoea
Nerlynx may cause diarrhoea in the early stages of treatment, unless anti-diarrhoeal medicines are taken to prevent or reduce diarrhoea. Diarrhoea may become severe and lead to dehydration. See section 3 for more information about the anti-diarrhoeal medicine to be taken in combination with Nerlynx.
Contact your doctor if:

• you experience persistent diarrhoea: your doctor can advise you on how to manage it;
• you feel dizzy or weak due to diarrhoea – alternatively, go to hospital immediately.

Liver problems
Nerlynx may cause changes in liver function, which will show up in blood tests. You may experience signs or symptoms of liver problems (e.g. yellowing of the skin and/or eyes, dark urine or pale stools). Your doctor will perform blood tests before and during treatment with Nerlynx. Your doctor will stop treatment with Nerlynx if liver tests show serious problems.
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)

• diarrhoea;
• stomach pain, feeling unwell/nausea, reduced appetite;
• dry or inflamed mouth, including mouth blisters or ulcers;
• rash;
• muscle spasms or cramps;
• feeling extremely tired.

Common (may affect up to 1 in 10 people)

• burning sensation when urinating, and frequent or urgent need to urinate (may be symptoms of a urinary tract infection);
• dehydration;
• fainting;
• nosebleeds;
• mild stomach discomfort;
• dry mouth;
• changes in blood test results relating to the liver;
• nail problems, including brittle nails or changes in nail colour;
• dry skin, including cracked skin;
• changes in kidney function tests;
• weight loss.

Uncommon (may affect 1 in 100 people)

• kidney failure;
• changes in blood test results relating to the liver (i.e., increased blood bilirubin).

Tell your doctor or pharmacist if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nerlynx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions regarding temperature.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not use Nerlynx if you notice any signs of damage to the packaging or tampering (e.g. breakage of the inner seal).
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 Nerlynx contains

• The active substance is neratinib. Each film-coated tablet contains neratinib maleate, equivalent to 40 mg 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).

Description of the appearance of Nerlynx and package contents
The film-coated tablets are red, oval-shaped, with "W104" engraved on one side and smooth on the other side.
The film-coated tablets of Nerlynx are packaged in a white, round, high-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap and an induction seal tamper-evident closure. Each bottle contains 180 film-coated tablets.
Inside each bottle, together with the tablets, there is an HDPE container containing 1 g of silica gel as a desiccant. Do not ingest the desiccant. Keep it inside the bottle.

Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France

Manufacturer
Pierre Fabre Médicament Production – Cahors
Site de Cahors
Le Payrat
46000 Cahors
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.