TM Owner Puma Biotechnology
Nerlynx 40mg Fc Tablet
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Nerlynx 40 mg (neratinib) is an oral kinase inhibitor used in two settings for HER2-positive breast cancer.
- First, it is used as extended adjuvant treatment in adults with early-stage HER2-positive breast cancer who have already completed roughly a year of trastuzumab-based therapy, to further reduce the chance of cancer returning; treatment is usually most beneficial when started within one year of finishing trastuzumab.
- Second, in combination with the chemotherapy drug capecitabine, Nerlynx treats adults with advanced or metastatic HER2-positive breast cancer who have already received two or more prior anti-HER2 treatment regimens for metastatic disease.
- Nerlynx is approved in the US, EU and Canada under the same brand name.
- It is prescribed by an oncologist experienced in treating breast cancer, and treatment decisions take into account prior therapy, disease stage and overall fitness.
Side Effects
- Diarrhoea is by far the most common side effect of Nerlynx, affecting the large majority of patients (around 95% taking Nerlynx alone and 83% when combined with capecitabine), and can be severe, causing dehydration, low blood pressure and kidney problems if not managed.
- For this reason, anti-diarrhoeal medicine is usually started with the first Nerlynx dose and continued for the first weeks of treatment as prescribed.
- Other common side effects include nausea, stomach pain, vomiting, tiredness, rash, mouth sores, reduced appetite and muscle cramps.
- Nerlynx can also cause liver damage, so liver blood tests are done monthly at first and then periodically during treatment.
- Contact your healthcare provider urgently for watery or bloody diarrhoea that doesn't improve, signs of dehydration such as dizziness or reduced urination, yellowing of the skin or eyes, or severe abdominal pain.
Precautions & Warnings
- Nerlynx's current US label does not carry an FDA boxed warning, but severe, sometimes life-threatening diarrhoea is its most important risk and must be actively prevented and managed from the first dose, using prescribed anti-diarrhoeal medicine, dose escalation over the first weeks, and, if needed, dose reduction or interruption.
- Liver function must be checked before starting and monitored monthly for the first three months, then every three months during treatment, because of the risk of liver injury.
- Nerlynx can cause harm to a developing baby, so effective contraception is required during treatment and for at least one month after the last dose in women, and for three months after the last dose in men with partners who could become pregnant; breastfeeding is not recommended during treatment.
- Nerlynx is taken with food to reduce nausea and improve absorption; never take it on an empty stomach.
Avoid Interactions
- Nerlynx must be avoided with proton pump inhibitors, which significantly reduce its absorption and effectiveness; if acid-reducing treatment is needed, an H2-blocker taken 2 hours before or 10 hours after Nerlynx, or an antacid taken 3 hours before or after, is used instead.
- Strong CYP3A4 inhibitors, such as certain antifungals (ketoconazole, itraconazole) and antibiotics (clarithromycin), sharply raise neratinib levels and increase toxicity, so they should be avoided; grapefruit and grapefruit juice have a similar effect.
- CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin and St. John's Wort, reduce Nerlynx's effectiveness and should also be avoided.
- Medicines that are sensitive P-glycoprotein substrates, such as digoxin, may reach higher levels when taken with Nerlynx.
- Always tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product, antacid and supplement you take, including anything for heartburn or indigestion.
References
Frequently Asked Questions
Nerlynx (neratinib) is used after early-stage HER2-positive breast cancer treatment to help stop the cancer from returning, usually starting within a year of finishing trastuzumab. It's also used with capecitabine chemotherapy for advanced HER2-positive breast cancer in patients who've already had two or more prior anti-HER2 treatments. It is approved in the US, EU and Canada.
Nerlynx is taken as tablets by mouth once daily, with food, at the same time each day. Swallow tablets whole; don't chew, crush or split them. Your doctor may start you on a lower dose and increase it over the first few weeks, alongside anti-diarrhoeal medicine, to help your body adjust.
Diarrhoea is very common with Nerlynx, affecting most patients, and can become severe if not managed early with anti-diarrhoeal medicine. Other common effects include nausea, tiredness, rash and stomach pain. Nerlynx can also affect the liver, so blood tests are done regularly. Seek urgent care for severe or bloody diarrhoea or signs of dehydration.
Avoid proton pump inhibitors (like omeprazole) — they reduce how well Nerlynx works. Avoid grapefruit, grapefruit juice, and strong CYP3A4-affecting medicines such as certain antifungals, antibiotics and St. John's Wort, which change neratinib levels. Tell your doctor about every medicine, including antacids and heartburn treatments, before starting Nerlynx.
Your doctor checks liver function tests before you start Nerlynx, then monthly for the first three months, and every three months after that, because of the risk of liver injury. You'll also be closely monitored for diarrhoea, especially in the first month, when dose adjustments are most often needed.
No. Nerlynx can harm an unborn baby, so effective contraception is needed during treatment — for at least one month after the last dose for women, and three months for men with partners who could become pregnant. Breastfeeding isn't recommended during treatment. Tell your doctor right away if you are or could be pregnant.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
