Vepdegestrant

What it is used for

VEPPANU is a prescription medicine to treat people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least one line of endocrine-based therapy.

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

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

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

• have heart failure or heart rhythm problems, including QTc prolongation, and long QTc syndrome
• have low blood levels of potassium or magnesium
• are pregnant or plan to become pregnant. VEPPANU can harm your unborn baby.

Females who are able to become pregnant:

o Your healthcare provider may do a pregnancy test before you start treatment with VEPPANU. o Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose. o Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VEPPANU.

Males with female partners who are able to become pregnant:

o Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.

• are breastfeeding or plan to breastfeed. It is not known if VEPPANU passes into your breast milk. Do not breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VEPPANU and other medicines may affect the way each other works and may cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How to take it

• Take VEPPANU exactly as your healthcare provider tells you.
• Do not change your dose or stop taking VEPPANU unless your healthcare provider tells you.
• Take VEPPANU 1 time each day.
• Take VEPPANU with food.
• Swallow VEPPANU tablets whole. Do not chew, crush, dissolve, or split the tablets before swallowing.
• Do not take VEPPANU tablets that are broken, cracked, or look damaged.
• If you miss a dose or vomit after taking VEPPANU, do not take another dose of VEPPANU on that day. Take your next dose the following day at your regularly scheduled time. Do not take 2 doses on the next treatment day.

Side effects, and when to stop

VEPPANU can cause serious side effects, including:

• Heart rhythm problems (QTc interval prolongation). VEPPANU can cause changes in the electrical activity of your heart and may increase your risk of abnormal heart rhythm problems, and sudden death. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and check your blood potassium and magnesium levels before and as needed during treatment with VEPPANU. Get emergency medical help right away if you get any signs and symptoms of abnormal heart rhythm, including:

​o feeling lightheaded or faint

o dizziness

o feeling that your heart is pounding or beating fast (heart palpitations)

o shortness of breath

o chest pain

The most common side effects of VEPPANU include:

• decreased white blood cell counts
• increased liver function tests
• muscle and bone pain
• tiredness
• decreased red blood cell counts
• nausea
• decreased potassium levels in your blood
• decreased appetite
• abnormal electrocardiogram (QT prolonged)
• decreased platelet counts
• constipation

Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with VEPPANU, if you develop certain side effects.

VEPPANU may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

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

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

What to avoid

Avoid taking St. John's wort, eating grapefruit, or drinking grapefruit juice during treatment with VEPPANU.

Storing it

• Store VEPPANU at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
• VEPPANU comes in a bottle with a child-resistant closure. Keep VEPPANU and all medicines out of the reach of children.

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