Nerlynx

Nerlynx is a prescription medication indicated for use in specific types of breast cancer following trastuzumab (Herceptin®) treatment. Nerlynx is a kinase inhibitor and works to slow or stop the multiplication of cancer cells. 

Nerlynx comes as a tablet and is taken once a day, every day, with food for a year. Do not chew, divide, or break Nerlynx tablets. Swallow tablets whole. 

Common side effects of Nerlynx include diarrhea, nausea, and stomach pain. 

Nerlynx can also cause tiredness. Do not drive or operate heavy machinery until you know how Nerlynx affects you.

Nerlynx is a prescription medication indicated for use in specific types of breast cancer following trastuzumab (Herceptin®) treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nerlynx. See the “Nerlynx Precautions” section.

Common side effects of Nerlynx include the following:

• diarrhea
• nausea
• stomach-area pain
• vomiting
• tiredness
• rash
• dry or inflamed mouth, or mouth sores
• decreased appetite
• muscle spasms
• upset stomach
• nail problems including color change 
• dry skin
• swelling of your stomach-area
• weight loss
• urinary tract infection 

Nerlynx can cause tiredness. Do not drive or operate heavy machinery until you know how Nerlynx affects you.

This is not a complete list of Nerlynx side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• stomach acid reducing agents such as omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), dexlansoprazole (Kapidex), cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid)
• CYP3A4 inhibitors such as macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone, grapefruit 
• CYP3A4 inducers such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that use P-glycoprotein transporter such as: digoxin (Lanoxin), loperamide (Imodium), quinidine (Cardioquine, Quinact, Duraquin), vinblastine (Velban), fexofenadine (Allegra), indinavir (Crixivan), colchicine (Colcrys), topotecan (Hycamtin), and paclitaxel (Abraxane, Onxol, Taxol) 

This is not a complete list of Nerlynx drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nerlynx including the following:

• Diarrhea. More severe effects such as dehydration, low blood pressure, or kidney failure related to diarrhea may also occur with Nerlynx. Pretreatment with an antidiarrheal (loperamide) helps prevent diarrhea symptoms during Nerlynx treatment. Tell your healthcare provider right away, as instructed, if you have some or all of the following symptoms of diarrhea:
  • severe diarrhea
  • diarrhea along with weakness, dizziness, or fever 
• Liver problems. Liver problems may occur during Nerlynx treatment. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems:
  • tiredness
  • nausea
  • vomiting
  • pain in the right upper stomach-area (abdomen)  
  • fever
  • rash
  • itching
  • yellowing of your skin or whites of your eyes 
• Harm to your unborn baby. Animal studies indicate an increased risk for unborn babies if Nerlynx is taken by pregnant women, including abortions, death, or abnormalities. It is recommended for women of reproductive age to use contraception while on Nerlynx treatment. 

Do not take Nerlynx if you are allergic to Nerlynx or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nerlynx, you should avoid eating products that contain grapefruit. Grapefruit and grapefruit juice may interact with Nerlynx and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Nerlynx, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Nerlynx or to any of its ingredients
• have or have had liver disease
• are taking or plan to take stomach acid reducing agents, called proton pump inhibitors or PPIs, and H-2 receptor antagonists. You should avoid taking these medicines during treatment with Nerlynx. 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Nerlynx can harm your unborn baby. If you are a female who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start taking Nerlynx.
• You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of Nerlynx.
• Talk with your healthcare provider about forms of birth control that you can use during this time.
• Tell your healthcare provider right away if you become pregnant during treatment with Nerlynx.

Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of Nerlynx. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Nerlynx crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, lactating women should not breastfeed while taking Nerlynx and for at least 1 month after the last dose. 

Take Nerlynx exactly as prescribed.

Nerlynx comes as a tablet and is taken once a day, every day, with food for a year. Do not chew, divide, or break Nerlynx tablets. Swallow tablets whole.

If you miss a dose, do not replace the missed dose, instead, take your next dose at the regular time. Do not take two doses of Nerlynx at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Nerlynx for the treatment of breast cancer is 240 mg (6 tablets) taken once a day. 

If you take too much Nerlynx, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Nerlynx at room temperature between 68° to 77°F (20° to 25°C). 
• Keep Nerlynx and all medications out of the reach of children.