What is Nerlynx?

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

Nerlynx is used alone or with other medicines to treat early-stage HER2-positive breast cancer. Nerlynx is also used to treat HER2-positive breast cancer that is advanced or has spread to other parts of the body (metastatic).

Nerlynx is used for breast cancer 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).

Warnings

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.

Before taking this medicine

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.

Neratinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Nerlynx if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. 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 Nerlynx.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

How should I take Nerlynx?

Take Nerlynx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

The usual dose of Nerlynx is 6 tablets taken once daily. Take the medicine with food, at the same time each day.

You may need to take this medicine daily for up to one year. Nerlynx is sometimes taken daily in 21-day treatment cycles until the medicine stops working or until you have serious side effects.

Your doctor will determine how long to treat you with this medicine. Follow your doctor’s dosing instructions very carefully.

Swallow the tablet whole and do not crush, chew, or break it.

Nerlynx can cause severe diarrhea, which can be life-threatening if it leads to dehydration. For the first 2 months of treatment with Nerlynx, 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 Nerlynx. Take the anti-diarrhea medicine exactly 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. You may also need to drink extra fluids to keep from getting dehydrated.

Tell your doctor if you have more than 2 bowel movements in 1 day.

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 this medicine for a short time.

You may need frequent blood tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Breast Cancer — Adjuvant:

240 mg orally once a day continuously for 1 year

NOTE: Antidiarrheal prophylaxis is recommended during the first 2 cycles (56 days) of therapy and should be initiated with the first dose. Titrate loperamide to 1 to 2 bowel movements per day.
MANUFACTURER SUGGESTED PROPHYLACTIC LOPERAMIDE DOSING:
-Weeks 1 and 2 (days 1 through 14): 4 mg orally 3 times a day
-Weeks 3 through 8 (days 15 through 56): 4 mg orally 2 times a day
-Weeks 9 through 52 (days 57 through 365): 4 mg as needed (not to exceed 16 mg per day)

Use: For the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer (to follow adjuvant trastuzumab-based therapy)

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

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

What to avoid

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

Ask your doctor before using an antacid or stomach acid reducing medicine. Use only the type your doctor recommends.

Nerlynx side effects

Get emergency medical help if you have signs of an allergic reaction to Nerlynx: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe or ongoing diarrhea;
• pain or burning when you urinate;
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems – right-sided upper stomach pain, vomiting, tiredness, fever, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Nerlynx side effects may include:

• kidney problems;
• abnormal liver function tests;
• diarrhea, constipation;
• painful urination;
• nausea, vomiting, stomach pain, bloating;
• upset stomach, loss of appetite;
• dizziness, feeling weak or tired;
• nosebleed;
• rash, dry skin, problems with your fingernails or toenails;
• dry mouth, mouth sores;
• back pain, joint pain, muscle spasms;
• weight loss; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

What is osimertinib?

Osimertinib is used to treat non-small cell lung cancer that is positive for an abnormal “EGFR” gene. You doctor will test you for this gene.

Osimertinib is sometimes given when the cancer has spread to other parts of the body (metastatic), or may come back after surgery.

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

Osimertinib side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Osimertinib may cause serious side effects. Call your doctor at once if you have:

• skin redness or purple spots that don’t turn pale when pressed, and that still look red or bruised after 24 hours (may appear on your arms, legs, buttocks, or midsection);
• redness, rash, or blisters on the palms of your hands or the soles of your feet;
• new or worsening cough or trouble breathing;
• fast or pounding heartbeats;
• swelling in your lower legs, weight gain, feeling short of breath;
• a light-headed feeling, like you might pass out;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet; or
• eye problems–vision changes, watery eyes, increased sensitivity to light, eye pain or redness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of osimertinib may include:

• low blood cell counts;
• muscle, bone, or joint pain;
• diarrhea;
• tiredness;
• cough, mouth sores;
• dry skin, rash; or
• redness, tenderness, pain, or other problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Osimertinib can cause serious side effects on your heart, lungs, skin, or eyes.

Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, fever, cough, trouble breathing, skin blistering or peeling, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed or short of breath.

Before taking this medicine

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

Tell your doctor if you have ever had:

• lung or breathing problems;
• an electrolyte imbalance (such as high or low blood levels of sodium, calcium, potassium, or magnesium);
• eye problems; or
• heart problems, including long QT syndrome (in you or a family member).

Osimertinib can harm an unborn baby if the mother or the father is using osimertinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 weeks after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take osimertinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Osimertinib is usually given once per day, with or without food.

To make swallowing easier, you may place the tablet in a glass with about 2 ounces of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Add 4 to 8 ounces more water to the glass, swirl gently and drink right away.

You may need medical tests to check your heart function.

Store at room temperature away from moisture and heat.

Osimertinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day
Duration of therapy:
-Adjuvant setting: Until disease progression, unacceptable toxicity, or for up to 3 years
Metastatic lung cancer: Until disease progression or unacceptable toxicity

Uses:
-As adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

What is osimertinib?

Osimertinib is used to treat non-small cell lung cancer that is positive for an abnormal “EGFR” gene. You doctor will test you for this gene.

Osimertinib is sometimes given when the cancer has spread to other parts of the body (metastatic), or may come back after surgery.

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

Osimertinib side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Osimertinib may cause serious side effects. Call your doctor at once if you have:

• skin redness or purple spots that don’t turn pale when pressed, and that still look red or bruised after 24 hours (may appear on your arms, legs, buttocks, or midsection);
• redness, rash, or blisters on the palms of your hands or the soles of your feet;
• new or worsening cough or trouble breathing;
• fast or pounding heartbeats;
• swelling in your lower legs, weight gain, feeling short of breath;
• a light-headed feeling, like you might pass out;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet; or
• eye problems–vision changes, watery eyes, increased sensitivity to light, eye pain or redness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of osimertinib may include:

• low blood cell counts;
• muscle, bone, or joint pain;
• diarrhea;
• tiredness;
• cough, mouth sores;
• dry skin, rash; or
• redness, tenderness, pain, or other problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Osimertinib can cause serious side effects on your heart, lungs, skin, or eyes.

Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, fever, cough, trouble breathing, skin blistering or peeling, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed or short of breath.

Before taking this medicine

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

Tell your doctor if you have ever had:

• lung or breathing problems;
• an electrolyte imbalance (such as high or low blood levels of sodium, calcium, potassium, or magnesium);
• eye problems; or
• heart problems, including long QT syndrome (in you or a family member).

Osimertinib can harm an unborn baby if the mother or the father is using osimertinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 weeks after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take osimertinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Osimertinib is usually given once per day, with or without food.

To make swallowing easier, you may place the tablet in a glass with about 2 ounces of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Add 4 to 8 ounces more water to the glass, swirl gently and drink right away.

You may need medical tests to check your heart function.

Store at room temperature away from moisture and heat.

Osimertinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day
Duration of therapy:
-Adjuvant setting: Until disease progression, unacceptable toxicity, or for up to 3 years
Metastatic lung cancer: Until disease progression or unacceptable toxicity

Uses:
-As adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy