Neratinib (Nerlynx™)

About This Drug

Neratinib is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

  • Loose bowel movements (diarrhea)
  • Nausea and throwing up (vomiting)
  • Pain in your abdomen
  • Rash, dry skin
  • Soreness of the mouth and throat. You may have red areas, white patches, or sores that hurt
  • Decreased appetite (decreased hunger)
  • Bloating (distention)
  • Indigestion
  • Weight loss
  • Changes in your liver function. Your liver function will be checked as needed.
  • Tiredness
  • Muscle spasm
  • Changes in your nail color, nail loss and/or brittle nail
  • Urinary tract infection. Symptoms may include:
    • Pain or burning when you pass urine
    • Feeling like you have to pass urine often, but not much comes out when you do
    • Tender or heavy feeling in your lower abdomen
    • Cloudy urine and/or urine that smells bad
    • Pain on one side of your back under your ribs, this is where your kidneys are.
    • Fever, chills, nausea and/or throwing up

Note: Each of the side effects above was reported in 5% or greater of patients treated with niratinib. Not all possible side effects are included above.

Warnings and Precautions

  • Severe loose bowel movements (diarrhea) which can lead to dehydration, low blood pressure and changes in your kidney function.
  • Changes in liver function. Your liver function will be checked as needed.

Important Information

  • Your doctor will prescribe you medication to decrease your diarrhea. The goal is for you to have no more than 1-2 bowel movements a day. Please call your doctor or nurse if you have diarrhea, or more than 2 bowel movements a day.

How to Take Your Medication

  • Swallow the medicine whole with food. Do not chew, break, cut, or crush it.
  • Take this medicine at the same time each day.
  • Drugs that treat heartburn and stomach upset such Maalox®, Mylanta®, Milk of Magnesia®, Alka-Seltzer® may lower the effect of your cancer treatment if taken with neratinib. Take neratinib at least 3 hours after any of these drugs.
  • Missed dose: If you vomit or miss a dose, take your next dose at the regular time. Do not take 2 doses at the same time.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage: Store this medicine in the original container at room temperature. Discuss with your nurse or your doctor how to dispose of unused medicine.

Treating Side Effects

  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • If you get diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • Mouth care is very important. Your mouth care should consist of routine, gentle cleaning of your teeth or dentures and rinsing your mouth with a mixture of 1/2 teaspoon of salt in 8 ounces of water or ½ teaspoon of baking soda in 8 ounces of water. This should be done at least after each meal and at bedtime.
  • If you have mouth sores, avoid mouthwash that has alcohol. Also avoid alcohol and smoking because they can bother your mouth and throat.
  • To help with bloating, avoid gas-producing foods, such as Brussels sprouts, cabbage, cauliflower, carrots, prunes and apricots
  • Manage tiredness by pacing your activities for the day. Be sure to include periods of rest between energy-draining activities.
  • To help with decreased appetite, eat small, frequent meals.
  • Eat high caloric food such as pudding, ice cream, yogurt and milkshakes.
  • To help with weight loss, drink fluids that contribute calories (whole milk, juice, soft drinks, sweetened beverages, milkshakes, and nutritional supplements) instead of water.
  • Include a source of protein at every meal and snack, such as meat, poultry, fish, dry beans, tofu, eggs, nuts, milk, yogurt, cheese, ice cream, pudding, and nutritional supplements.
  • Keeping your nails moisturized may help with brittleness

Food and Drug Interactions

  • Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are a lot of known drug interactions with neratinib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.
  • Drugs that treat heartburn and stomach upset such Protonix®, Nexium®, Prilosec®, Pepcid®, Tagamet®, and Zantac® may lower the effect of your cancer treatment if taken with neratinib. Call your doctor to find out what drug you may take with neratinib to help with heartburn or stomach upset.
  • Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit and grapefruit juice may raise the levels of neratinib in your body. This could make side effects worse.
  • Avoid the use of St. John’s Wort while taking neratinib as this may lower the levels of the drug in your body, which can make it less effective.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
  • Pain in your mouth or throat that makes it hard to eat or drink
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Lasting loss of appetite or rapid weight loss of five pounds in a week
  • Pain or burning when you pass urine
  • Difficulty urinating
  • Feeling like you have to pass urine often, but not much comes out when you do
  • Tender or heavy feeling in your lower abdomen
  • Cloudy urine and/or urine that smells bad.
  • Pain in your abdomen that does not go away
  • Fatigue that interferes with your daily activities
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • If you think you may be pregnant or have impregnated your partner

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 1 month after treatment. Men with female partners of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 3 months after your cancer treatment. Let your doctor know right away if you think you may be pregnant or may have impregnated your partner.
  • Breastfeeding warning: Women should not breast feed during treatment and for 1 month after treatment because this drug could enter the breast milk and cause harm to a breast feeding baby.
  • Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

New July 2017