40 mg film-coated tablets
neratinib
What Nerlynx is and what it is used for
What Nerlynx is
Nerlynx contains the active substance neratinib. It belongs to a group of medicines called “tyrosine kinase inhibitors” that are used to block cancer cells and treat breast cancer.
What Nerlynx is used for
Nerlynx is given to patients with early-stage breast cancer
- are hormone receptor positive (HR-positive) and human epidermal growth factor receptor 2-positive ( HER2 – positive) and
- previously treated with another medicine called ‘trastuzumab’.
The “HER2 receptor” is a protein found on the surface of cells in the body. It helps control the growth of a healthy breast cell. In HER2 -positive breast cancer, the cancer cells have large amounts of HER2 receptors on their surface. This leads to the cancer cells growing and dividing faster.
“Hormone receptors” are also proteins that are expressed inside the cells of certain specific issues. Estrogen and progesterone bind to these proteins and regulate cell activity. In HR-positive breast cancer, the cell division and growth of the tumor can be enhanced by estrogen and/or progesterone.
Before using Nerlynx, your cancer must have been tested and found to be HR-positive and HER2 – positive. You must also have previously been treated with trastuzumab.
How Nerlynx works
Nerlynx works by blocking the HER2 receptors on the cancer cells. This helps prevent the cells from growing and dividing.
What you need to know before you take Nerlynx
Do not take Nerlynx
- if you are allergic to neratinib or 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 used to treat tuberculosis ),
- if you are taking carbamazepine or phenytoin (medicines for epileptic seizures),
- if you are taking St. John’s wort (an herbal remedy for depression, mild anxiety).
Warnings and cautions
Talk to your doctor or pharmacist before taking Nerlynx.
You will need medicine for diarrhea when you start taking Nerlynx
Nerlynx can cause diarrhea early in treatment. You should take medicine for diarrhea so that your diarrhea does not become severe and to prevent you from becoming dehydrated during treatment with Nerlynx.
Tests and checks of liver problems
Nerlynx can cause changes in liver function – these are shown in blood tests. Your doctor will take blood samples before and during your treatment with Nerlynx. Your doctor will stop your treatment with Nerlynx if your liver tests show serious problems.
Children and young people
Do not use it for children under 18 years. The safety and efficacy 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. The reason for this is that Nerlynx may affect the way some other medicines work. Some other medicines may also affect the way Nerlynx works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- rifampicin – a drug for tuberculosis
- carbamazepine, phenobarbital or phenytoin – medicines for epileptic seizures
- St. John’s wort – an herbal remedy for depression, mild anxiety
- ketoconazole , voriconazole, itraconazole or fluconazole – antifungal drugs
- erythromycin or clarithromycin – medicines for bacterial infections
- protease inhibitors – antiviral drugs
- nefazodone – a drug used to treat depression
- diltiazem or verapamil – medicines for high blood pressure and chest pain
- dabigatran or digoxin – medicines for heart problems
- rosuvastatin – a drug used to treat high cholesterol
- irinotecan – a drug used in colorectal cancer
- sulfasalazine – an anti-inflammatory drug
- medicines for stomach problems such as:
- lansoprazole, omeprazole or similar medicines called ‘proton pump inhibitors’ are not recommended.
- ranitidine, cimetidine or similar medicines called ‘H 2 -receptor antagonists’. Neratinib should be taken 10 hours after taking the H 2 -receptor antagonist and at least 2 hours before the next dose of the H 2 -receptor antagonist.
- antacids – dose one of these drugs and Nerlynx should be taken at least 3 hours apart.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Nerlynx.
Nerlynx with food and drink
Avoid grapefruit and pomegranate while taking Nerlynx. You should not eat the fruit, drink the juice or take a dietary supplement that may contain grapefruit/pomegranate. The reason for this is that these fruits can interact with Nerlynx and affect the effect of the drug.
Pregnancy, contraception and breastfeeding
Pregnancy
If you are pregnant, your doctor will assess the potential benefit to you and the risk to the fetus before you receive this medicine. If you become pregnant while taking this medicine, your doctor will assess the potential benefit to you and the risk to the fetus of continuing to take this medicine.
Contraceptive
Women who may become pregnant must use an effective contraceptive, including a barrier method (such as a condom)
- while taking Nerlynx and
- for one month after the end of treatment.
Men must use an effective barrier contraceptive such as a condom
- while taking Nerlynx and
- for three months after the end of treatment.
Breast-feeding
Talk to your doctor before taking Nerlynx if you are breastfeeding or planning to breastfeed, as small amounts of this medicine may pass into breast milk. Your doctor will discuss the benefits and risks of taking Nerlynx during this time.
Driving and using machines
Nerlynx has a minor or moderate effect on the ability to drive and use machines. The side effects of Nerlynx (for example, dehydration and dizziness due to diarrhea, fatigue, and fainting) may affect the performance of tasks requiring judgment, motor skills, or cognitive ability.
How to take Nerlynx
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much Nerlynx to take
The recommended dose of Nerlynx is 6 tablets once daily (240 mg total).
- The tablets must be taken with food. They must not be crushed or dissolved. Do not swallow the desiccant.
- Take all tablets with water, at about the same time each day, preferably in the morning.
The treatment lasts for one year.
You will need medicine for diarrhea when you start taking Nerlynx
Nerlynx can cause diarrhea early in treatment if you are not taking medicines to prevent or reduce diarrhea. Diarrhea usually occurs early in treatment with Nerlynx. It can be difficult and cause you to become dehydrated.
- Start taking diarrhea medication with the first dose of Nerlynx.
- Your doctor will tell you how to take the medicine for diarrhea.
- Continue taking medicines for diarrhea during the first one to two months of treatment with Nerlynx. After this time, your doctor will tell you if you need to continue taking any medicines to control your diarrhea.
- Your doctor will 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. Take the medicine pack with you.
Some side effects associated with taking too much Nerlynx are the following: diarrhea, nausea, vomiting, and dehydration.
If you forget to take Nerlynx
- If you miss a dose , wait until the next day before taking your next dose .
- Do not take a double dose to make up for a forgotten dose .
If you stop taking Nerlynx
- Do not stop taking Nerlynx without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Diarrhea
Nerlynx can cause diarrhea early in treatment if you are not taking medicines to prevent or reduce diarrhea. Diarrhea can be severe, and you may become dehydrated. See section 3 for more information on the medicines for diarrhea you need to take with Nerlynx.
Talk to your doctor about
- your diarrhea does not go away – they can give you advice on how to control the diarrhea,
- you feel dizzy or weak from diarrhea – alternatively go to the hospital immediately.
Liver problem
Nerlynx can cause changes in liver function – these are shown in blood tests. You may, but need not, have signs or symptoms of liver problems (eg yellow skin and/or yellow eyes, dark urine, or light stools). Your doctor will take blood samples before and during your treatment with Nerlynx. Your doctor will stop your treatment with Nerlynx if your liver tests show serious problems.
Other side effects are
Tell your doctor or pharmacist immediately if any of the following side effects occur:
Very common: may affect more than 1 user in 10
- diarrhea
- stomach pain, nausea, vomiting, poor appetite
- dry or inflamed mouth, including blisters or cold sores
- rash
- muscle cramps
- severe fatigue
Common: may affect up to 1 in 10 users
- burning sensation during urination and frequent and sudden need to urinate (may be a symptom of a urinary tract infection)
- dehydration
- nosebleeds
- mild stomach upset
- dry mouth
- changes in blood tests for liver function
- nail problems such as cracked nails or nails that change color
- dry skin including cracked skin
- changes in kidney function tests
- weight loss
Uncommon : affects 1 in 1,000 people
- kidney failure
- changes in blood tests for liver function (ie increased bilirubin in the blood)
Tell your doctor or pharmacist if any of the above side effects occur.
How to store Nerlynx
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 can and carton after “EXP”. The expiration date is the last day of the specified month.
Close the jar tightly. Moisture sensitive.
No special temperature instructions.
Do not use Nerlynx if you notice that the packaging is damaged or if there are any signs of tampering (eg broken inner seal).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is neratinib. Each film-coated tablet contains neratinib maleate equivalent to 40 mg neratinib.
- Other ingredients:
- Tablet core: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate.
- Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).
What the medicine looks like and contents of the pack
The film-coated tablets are red, oval-shaped, and embossed with “W104” on one side and smooth on the other.
Nerlynx film-coated tablets are packaged in a white round jar of high-density polyethylene (HDPE) with a child-resistant polypropylene closure, as well as an internal security seal of foil. Each jar contains 180 film-coated tablets.
A container of HDPE desiccant with 1 g of silica gel is included in the tablets in each jar. Do not swallow the desiccant.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France
Manufacturer
AndersonBrecon (UK) Limited
Pharos House, Wye Valley Business Park
Brecon Road, Hay-on-Wye
Hereford HR3 5PG
UK