Patient information: uses, side effects, how to take - Hernexeos

What is HERNEXEOS?

HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that:

cannot be removed by surgery or that has spread to other parts of your body (metastatic), and
has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene.

Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.

It is not known if HERNEXEOS is safe and effective in children.

Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have heart problems
have lung or breathing problems other than lung cancer
are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS.
- Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose.
- Talk to your healthcare provider about birth control methods that might be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS.
are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take HERNEXEOS?

Take HERNEXEOS exactly as your healthcare provider tells you to take it.
Your healthcare provider may change your dose if needed. Do not change your dose or stop taking HERNEXEOS unless your healthcare provider tells you to.
Take HERNEXEOS 1 time a day, with or without food.
Swallow HERNEXEOS tablets whole with water. Do not split, crush, or chew tablets.
If you miss a dose of HERNEXEOS, take it as soon as you remember within 12 hours. If you missed your dose by more than 12 hours, skip the missed dose and take your next dose at your next scheduled time.
If you vomit after taking a dose of HERNEXEOS, do not take an extra dose. Take your next dose at your regularly scheduled time.
If you take too much HERNEXEOS, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of HERNEXEOS?

HERNEXEOS may cause serious side effects, including:

liver problems. Liver problems are common with HERNEXEOS and can be severe and life-threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

yellowing of your skin or the white part of your eyes (jaundice)
dark or brown (tea colored) urine
pain on the upper right side of your stomach area (abdomen)

bleeding or bruising more easily than normal
feeling very tired
loss of appetite
nausea or vomiting

heart problems that may affect your heart's ability to pump blood. HERNEXEOS can cause severe heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including:

feeling like your heart is pounding or racing
dizziness
tiredness
feeling lightheaded

shortness of breath
loss of consciousness
coughing
swelling of your legs, ankles or feet

lung problems. HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.

Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.

The most common side effects of HERNEXEOS include:

diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have new or worsening diarrhea.
rash
liver problems
feeling tired
nausea
muscle and joint pain
upper respiratory tract infection

The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests and decreased potassium levels.

HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of HERNEXEOS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HERNEXEOS?

Store HERNEXEOS at room temperature between 68°F to 77°F (20°C to 25°C).
Store HERNEXEOS tablets in the original bottle.
Keep the HERNEXEOS bottle tightly closed.
The HERNEXEOS bottle contains two desiccants to help keep your tablets dry (protect from moisture). Do not remove the desiccants from the container after opening. Do not eat or swallow the desiccants.
HERNEXEOS comes in a child-resistant bottle.
HERNEXEOS must be used within 3 months of first opening the bottle. Throw away (discard) any unused tablets 3 months after opening the bottle.

Keep HERNEXEOS and all medicines out of the reach of children.

General information about the safe and effective use of HERNEXEOS.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use HERNEXEOS for any condition for which it was not prescribed. Do not give HERNEXEOS to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HERNEXEOS that is written for health professionals.

What are the ingredients in HERNEXEOS?

Active ingredient: zongertinib

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The film-coating contains ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

HERNEXEOS^®is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.

COL13134EB242026

For more information about HERNEXEOS, including the current prescribing information and Patient Information, go to www.hernexeos.com, scan the code, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Hernexeos (Zongertinib): Uses, Side Effects and Dosage