Nerlynx

Before taking neratinib,

• tell your doctor and pharmacist if you are allergic to neratinib, any other medications, or any of the ingredients in neratinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics including as ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., E-Mycin, Erythrocin), and troleandomycin (no longer available in U.S.); certain antifungals including clotrimazole (Mycelex), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); aprepitant (Emend); bosentan (Tracleer); certain calcium channel blockers including diltiazem (Cardizem, Tiazac, others) and verapamil (Calan, Verelan, others); cobicistat (Tybost); conivaptan (Vaprisol); crizotinib (Xalkori); cyclosporine (Gengraf, Neoral, Sandimmune); dabigatran (Pradaxa); digoxin (Lanoxin); dronedarone (Multaq); enzalutamide (Xtandi); fexofenadine (Allegra); fluvoxamine (Luvox); H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac); idelalisib (Zydelig); imatinib (Gleevec); certain medications for hepatitis C including boceprevir (no longer available in U.S., Victrelis), dasabuvir (in Viekira Pak), ombitasvir (in Technivie, in Viekira XR), and paritaprevir (in Technivie, in Viekira XR); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including efavirenz (Sustiva, in Atripla), elvitegravir (in Genvoya, in Stribild), etravirine (Intelence), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); mitotane (Lysodren); modafinil (Provigil); nefazodone; proton pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); rifampin (Rifadin, Rimactane, in Rifater); and certain medications for seizures including carbamazepine (Carbatrol, Epitol, Tegretol) and phenytoin (Dilantin, Phenytek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with neratinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• if you are taking an antacid, take it at least 3 hours before or 3 hours after taking neratinib.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant while you are taking neratinib. If you are female, you will need to take a pregnancy test before you start treatment and should use birth control to prevent pregnancy during your treatment with neratinib and for at least 1 month after taking the final dose. If you are a male, you and your female partner should use birth control during your treatment with neratinib and continue for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking neratinib, call your doctor immediately. Neratinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking neratinib and for up to 1 month after your final dose.
• you should know that neratinib often causes diarrhea, which can be severe. Your doctor will probably tell you to take anti-diarrhea medication to prevent dehydration (loss of too much water from your body). Your doctor may also tell you to drink plenty of liquids, make changes in your diet, or take other medications to control the diarrhea. Call your doctor immediately if you have severe diarrhea (more than 2 bowel movements in 1 day or diarrhea that does not stop) or diarrhea along with weakness, dizziness, or fever while taking neratinib. Call your doctor immediately if you experience any of the following symptoms of dehydration: extreme thirst, dry mouth and/or skin, decreased urination, or fast heartbeat.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• nausea
• vomiting
• stomach pain

Neratinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Neratinib is used to treat a certain type of early-stage breast cancer. Neratinib is used for this condition only if your tumor tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Neratinib is usually given after you have been treated with another medicine called trastuzumab (Herceptin).

Neratinib may also be used for purposes not listed in this medication guide.

Neratinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given anti-diarrhea medications for the first 2 months of treatment with neratinib.

Call your doctor if you are sick with severe diarrhea, or you also have weakness, dizziness, or a fever.

You should not use neratinib if you are allergic to it.

To make sure neratinib is safe for you, tell your doctor if you have ever had:

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Neratinib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Neratinib use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 1 month after your last dose of neratinib. If you are a man, keep using birth control for at least 3 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using neratinib.

It is not known whether neratinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 1 month after your last dose.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take the medicine with food, at the same time each day.

The usual dose is 6 tablets taken once daily for 1 year. Follow your doctor's dosing instructions very carefully.

Do not crush, chew, or break a neratinib tablet. Swallow it whole.

Neratinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. For the first 2 months of treatment with neratinib, you may need to take medication to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking neratinib. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

To best control diarrhea, you may need to follow a special diet. Get familiar with the list of foods you should eat or avoid to help control diarrhea.

Call your doctor if you are sick with severe diarrhea, or you also have weakness, dizziness, or a fever. You may need to stop taking neratinib for a short time.

While using neratinib, you may need frequent blood tests.

Drink plenty of liquids while you are taking neratinib.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe diarrhea or vomiting, stomach pain, increased thirst, decreased urination, dark urine, dizziness, or hot and dry skin.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe diarrhea or vomiting, stomach pain, increased thirst, decreased urination, dark urine, dizziness, or hot and dry skin.

Grapefruit and grapefruit juice may interact with neratinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking neratinib.

If you also take an antacid: Wait at least 3 hours after taking the antacid before you take neratinib.

Neratinib maleate has the following uses:

Neratinib maleate is a kinase inhibitor indicated for extended adjuvant treatment following adjuvant trastuzumab-based therapy for early stage HER2-overexpressed/amplified breast cancer.1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Mouth irritation or mouth sores.
• Not hungry.
• Muscle spasm.
• Change in nails.
• Dry skin.
• Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Nerlynx 40 mg film-coated tablets are red, oval shaped and debossed with ‘W104’ on one side and plain on the other side.

Nerlynx is available in:

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15-30°C (59–86°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Diarrhea

• Inform patients that Nerlynx has been associated with diarrhea which may be severe in some cases.
• Instruct patients to maintain 1-2 bowel movements per day and on how to use anti-diarrheal treatment regimens.
• Advise patients to inform their healthcare provider immediately if severe (≥Grade 3) diarrhea or diarrhea associated with weakness, dizziness, or fever occurs during treatment with Nerlynx [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

Hepatotoxicity

• Inform patients that Nerlynx has been associated with hepatotoxicity which may be severe in some cases.
• Inform patients that they should report signs and symptoms of liver dysfunction to their healthcare provider immediately [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

• Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].
• Advise females of reproductive potential to use effective contraception during treatment and for 1 month after receiving the last dose of Nerlynx [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.3)].
• Advise lactating women not to breastfeed during treatment with Nerlynx and for at least 1 month after the last dose [see Use in Specific Populations (8.2)].

Drug Interactions

• Nerlynx may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].
• Nerlynx may interact with gastric acid reducing agents. Advise patients to avoid concomitant use of proton pump inhibitors or H2-receptor antagonists. Advise patients to separate the dosing of Nerlynx by 3 hours after antacid medicine [see Dosage and Administration (2.3) and Drug Interactions (7.1)].
• Nerlynx may interact with grapefruit. Advise patients to avoid taking Nerlynx with grapefruit products [see Drug Interactions (7.1)].

Dosing and Administration

• Instruct patients to take Nerlynx with food at approximately the same time each day consecutively for one year.
• If a patient misses a dose, instruct the patient not to replace the missed dose, and to resume Nerlynx with the next scheduled daily dose [see Dosage and Administration (2.2)].

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Principal Display Panel - Nerlynx 180 Tablets Carton Label

NDC 70437-240-18

nerlyxn™
(neratinib) tablets

40 mg

Each film-coated tablet contains 40 mg neratinib
equivalent to 48.31 mg neratinib maleate.

180 tablets Rx only

Principal Display Panel - Nerlynx 180 Tablets Bottle Label

NDC 70437-240-18

Nerlynx™
(neratinib) tablets

40 mg

Rx only 180 tablets

Principal Display Panel - Nerlynx 126 Tablets Carton Label

NDC 70437-240-26

Nerlynx™
(neratinib) tablets

40 mg

Each film-coated tablet contains 40 mg neratinib
equivalent to 48.31 mg neratinib maleate.

126 tablets Rx only

Principal Display Panel - Nerlynx 126 Tablets Bottle Label

NDC 70437-240-26

Nerlynx™
(neratinib) tablets

40 mg

Rx only 126 tablets

Nerlynx (neratinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Nerlynx is used to treat a certain type of early-stage breast cancer. It is used for this condition only if your tumor tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Nerlynx is usually given after you have been treated with another medicine called trastuzumab (Herceptin).

Nerlynx can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given anti-diarrhea medications for the first 2 months of treatment with Nerlynx.

Call your doctor if you are sick with severe diarrhea, or you also have weakness, dizziness, or a fever.

You should not use Nerlynx if you are allergic to neratinib.

To make sure Nerlynx is safe for you, tell your doctor if you have ever had:

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Nerlynx can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Neratinib use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 1 month after your last dose of Nerlynx. If you are a man, keep using birth control for at least 3 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using neratinib.

It is not known whether neratinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 1 month after your last dose.

Grapefruit and grapefruit juice may interact with neratinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Nerlynx.

If you also take an antacid: Wait at least 3 hours after taking the antacid before you take Nerlynx.

Applies to neratinib: oral tablet

General

The most common adverse reactions (more than 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, increased AST or ALT, nail disorder, dry skin, abdominal distention, decreased weight, and urinary tract infection.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (95%), nausea (43%), abdominal pain (36%), vomiting (26%), stomatitis (14%), dyspepsia (10%)
Common (1% to 10%): Abdominal distention, dry mouth[Ref]

Other

Very common (10% or more): Fatigue (27%)[Ref]

Dermatologic

Very common (10% or more): Rash (18%)
Common (1% to 10%): Nail disorder, rash, skin fissures[Ref]

Metabolic

Very common (10% or more): Decreased appetite (12%)
Common (1% to 10%): Decreased weight, dehydration[Ref]

Musculoskeletal

Very common (10% or more): Muscle spasms (11%)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST[Ref]

Respiratory

Common (1% to 10%): Epistaxis[Ref]

Cardiovascular

Frequency not reported: Hypotension[Ref]

Renal

Frequency not reported: Renal failure[Ref]

Some side effects of Nerlynx may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.