Patient Medication Information: uses, side effects, how to take - Nerlynx
What is NERLYNX used for?
NERLYNX is used to treat breast cancer.
It is used alone to treat adult women whose disease is in an early-stage, when:
- their cancer cells produce a larger amount of HER2 proteins; and
- their cancer cells are sensitive to female hormones.
These patients will have had previous treatment with the medicine trastuzumab in the last 12 months.
It is used in combination with capecitabine to treat adult patients when:
- their disease has spread to other parts of the body. This is called metastatic disease; and
- their cancer cells that produce a larger amount of HER2 proteins.
These patients will have previously had their metastatic disease treated with two or more medicines that act on the HER2 protein.
Tests are used to find out if your cancer cells produce large amounts of HER2 proteins and are hormone-sensitive.
How does NERLYNX work?
NERLYNX is a tyrosine kinase inhibitor, which interferes with the growth of certain tumor cells.
What are the ingredients in NERLYNX?
Medicinal ingredients: neratinib (as neratinib maleate)
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, talc, titanium dioxide.
NERLYNX comes in the following dosage forms:
Tablets, 40 mg
Do not use NERLYNX if you:
- are allergic to neratinib or any of the other ingredients in this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NERLYNX. Talk about any health conditions or problems you may have, including if you:
- have a liver condition
- have a heart condition
- are younger than 18 years of age. The effects of NERLYNX in people younger than 18 years old are not known.
- are older than 60 years of age. This is because NERLYNX may not work as well in older adults whose disease is in an early stage. As well, those who are over 65 years of age are more likely to have side effects.
Other warnings you should know about:
Female patients:
Avoid becoming pregnant while taking NERLYNX. It may harm your unborn baby or make you lose the pregnancy.
- Use two forms of birth control while you are taking NERLYNX. Keep using these forms of birth control for 1 month after your last dose of NERLYNX.
- Talk to your healthcare professional about birth control methods that may be right for you.
- If you do become pregnant, or think you are pregnant during your treatment with NERLYNX, tell your healthcare professional right away.
- For women who can get pregnant: a pregnancy test should be done before you start to take NERLYNX.
- Do not breastfeed while you are taking NERLYNX and for one month after your last dose. It is not known if NERLYNX passes into your breast milk. You and your healthcare professional should decide if you will take NERLYNX or breastfeed.
Male patients:
- Avoid fathering a child while taking NERLYNX.
- Use effective birth control when having sexual intercourse with a female partner who is able to get pregnant. Use these birth control methods while you are taking NERLYNX and for 3 months after your last dose.
- If your partner gets pregnant, tell your healthcare professional right away.
Diarrhea:
Diarrhea (2 or more loose or liquid bowel movements in a day) is a common side effect of taking NERLYNX. It can be severe and cause you to be dehydrated, have low blood pressure or kidney problems.
To help prevent diarrhea, your healthcare professional may:
Start your treatment with NERLYNX using a lower dose for first two (2) weeks and prescribe another medicine to help prevent diarrhea as needed.
Or
Your healthcare professional may prescribe another medicine to take starting with your first dose of NERLYNX and for the first two months, to help prevent diarrhea.
Your healthcare professional will monitor you for severe diarrhea.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Some medicines can affect the level of NERLYNX in your body. NERLYNX can also affect the way some other medicines work. When medicines interact with NERLYNX, you may have more side effects. The medicines listed here may not be the only ones that could interact with NERLYNX.
The following may interact with NERLYNX:
Medicines to lower stomach acid or treat stomach ulcers, such as:
- medicines called proton pump inhibitors (like lansoprazole),
- antacids (magnesium-aluminum-hydroxide), or
- H2-receptor antagonists (like ranitidine and cimetidine).
- Ketoconazole, itraconazole, fluconazole, posaconazole, voriconazole - used to treat fungal infections.
- Clarithromycin, erythromycin, troleandomycin, ciprofloxacin, rifampin - used to treat bacterial infections.
- Medicines used to boost the effects of other medicines including, ritonavir, lopinavir, nelfinavir, indinavir, saquinavir, tipranavir, cobicistat, boceprevir - used to treat viral infections, including HIV.
- Phenytoin, carbamazepine - used to treat fits (seizures) and epilepsy.
- St John’s Wort (Hypericum perforatum) - an herbal medicine used mainly for depression.
- Digoxin - used for heart problems.
- Diltiazem, verapamil, dronedarone – used to treat heart conditions or high blood pressure.
- Cimetidine – used to treat stomach problems.
- Idelalisib, crizotinib, imatinib, enzalutamide, mitotane – used to treat other types of cancer.
- Conivaptan – used to treat low sodium levels in blood.
- Dabigatran – used to prevent blot clots.
- Fexofenadine – used to treat symptoms of allergy.
- Nefazodone, fluvoxamine – used to treat depression.
- Tofisopam – used to treat anxiety.
- Aprepitant – used to treat nausea.
- Clotrimazole – used to treat yeast infections.
- Cyclosporine – used after organ transplantation.
- Efavirenz – used to treat HIV and AIDS.
Do not eat or drink any products or juices that contain grapefruit, grapefruit extract. These can affect the way NERLYNX works.
How to take NERLYNX:
NERLYNX will be given to you by a healthcare professional in a healthcare setting.
- Take exactly as your healthcare professional tells you.
Take once per day with food.
- Take at about the same time each day.
- Swallow tablets whole with a glass of water.
- Do NOT chew, crush or split tablets.
Usual adult dose: 240 mg (six tablets) once a day.
Your healthcare professional may start your dose at 120 mg (three tablets) once a day for the first week of treatment (days 1-7), followed by 160 mg (four tablets) once a day for the second week of treatment (days 8-14), then 240 mg (six tablets) once a day from week 3 (starting on day 15) and onwards.
If you are taking NERLYNX alone for early-stage breast cancer, you may take 240 mg of NERYLYX daily for up to one year.
If you are taking NERLYNX in combination with capecitabine for metastatic breast cancer, your healthcare professional will tell you:
- how long to take NERLYNX, and
- the dose of capecitabine, as well as when and how often to take your capecitabine.
Your healthcare professional may change your dose of NERLYNX, stop your treatment for a short time or stop NERLYNX completely. This will be based on how you are feeling.
Overdose:
| If you think you have taken too much NERLYNX, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose, take your next NERLYNX dose at the next scheduled time. Do not take extra tablets to make up the missed dose.
What are possible side effects from using NERLYNX?
These are not all the possible side effects you may feel when taking NERLYNX. If you experience any side effects not listed here, contact your healthcare professional.
Side effects of NERLYNX may include:
- fever
- chills
- flu-like symptoms
- nausea
- constipation
- abdominal pain
- swelling of your abdomen
- upset stomach
- heartburn
- dry or inflamed mouth, or mouth sores
- gas
- hemorrhoids
- loss of appetite
- weight loss
- feeling tired or weak
- muscle spasms
- back pain
- joint pain
- rash
- acne
- nail problems including color change or breakage
- dry skin, skin may crack
- nosebleeds
- runny nose
- nose dryness
- urinary tract infection
- pain or difficulty when urinating
- dizziness
NERLYNX may affect how your liver works. Blood tests will be done before you begin treatment, every month for the first 3 months, and then every 3 months as needed during your treatment with NERLYNX. The results of these tests will help your healthcare professional to check how well your liver is working. Your healthcare professional will stop your treatment with NERLYNX if your blood tests show severe liver problems.
If you experience any of the following signs or symptoms, call your healthcare professional right away. These may be signs that you are having liver problems.
- tiredness
- nausea
- vomiting
- pain in the right upper abdomen
- fever
- rash
- itching
- yellowing of your skin or whites of your eyes
NERLYNX can also cause other abnormal blood test results. Your doctor will decide when to perform other blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Diarrhea: increased number of stools, loose or watery stools. | X | ||
| Vomiting | X | ||
| COMMON | |||
| Dehydration (loss of too much fluid from the body often due to nausea, vomiting and/or diarrhea, or not taking enough liquids by mouth): thirst, headache, loss of appetite, lack of sweating, decreased urine, low blood pressure, problems with kidney function. | X | ||
| Pneumonia or Pleural Effusion (fluid on the lungs): cough, difficult or painful breathing, wheezing, pain in chest when breathing, fever. | X | ||
| Cellulitis or Erysipelas (serious skin reactions): pain; tenderness; swelling; redness of the skin; painful red, raised patches on the skin, which may be warm to the touch; fever; chills; feeling unwell. | X | ||
| Palmar-plantar erythrodysaesthesia syndrome (skin reaction also known as hand-foot syndrome): pain, tingling, swelling or redness, thick calluses and blisters on the palms of the hands or soles of the feet. | X | ||
| Liver injury: yellowing of the skin or the white of your eyes, dark or brown (tea colored) urine, nausea or vomiting, loss of appetite, feeling tired or weak. | X | ||
| UNCOMMON | |||
| Cholelithiasis (gallstones): intense pain in the upper abdomen, pain in right shoulder, nausea, vomiting. | X | ||
| Congestive heart failure or decreased left ventricular ejection fraction (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise. | X | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen. | X | ||
| RARE | |||
| Kidney problems: nausea, vomiting, fatigue, changes in how you urinate. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Keep out of reach and sight of children.
- Store: 15 – 25°C in the original package to protect from moisture. Keep bottle tightly closed.
- Do not take this medicine after the expiry date which is stated on the bottle after “EXP”. The expiry date refers to the last day of that month.
- Do not throw away any unused medicine in the garbage or down the drain or toilet. Ask your pharmacist how to best dispose of medicines that you no longer need. These measures will help to protect the environment.
If you want more information about NERLYNX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html), the manufacturer’s website (https://www.gud-knight.com/), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.