What is the most important information I should know about apalutamide?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What is apalutamide?
Apalutamide is used to treat prostate cancer that has spread to other parts of the body (metastatic) and is also being treated with another medicine or with surgery.
Apalutamide is also used to treat prostate cancer that has not spread to other parts of the body, after surgery or other cancer treatments did not work or have stopped working.
Apalutamide is used together with a gonadotropin-releasing hormone (GnRH) or with surgical castration (removal of the testicles).
Apalutamide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking apalutamide?
Apalutamide is not for use by women or children.
This medicine can harm an unborn baby or cause miscarriage. Apalutamide can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.
Use effective birth control if your sex partner is able to become pregnant. Use condoms if your sex partner is pregnant. Keep using effective birth control and condoms for at least 3 months after your last dose of apalutamide.
Apalutamide may affect fertility (your ability to have children). However, it is important to use birth control to prevent pregnancy because apalutamide may harm the baby if a pregnancy does occur.
Also do not to donate sperm while you are taking apalutamide, and during the 3 months after your last dose.
Tell your doctor if you have ever had:
- a head injury or brain tumor;
- a seizure;
- a stroke;
- heart disease, high blood pressure;
- diabetes; or
- abnormal levels of cholesterol or fats in your blood.
Hormonal cancer treatment can weaken your muscles and bones. You may be more likely to have a broken bone while using apalutamide. Talk with your doctor about ways to keep your bones healthy.
How should I take apalutamide?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take apalutamide with or without food, at the same time each day.
Swallow the tablet whole and do not crush, chew, or break it.
You will need frequent medical tests.
You should not stop using apalutamide unless your doctor tells you to.
Store at room temperature away from moisture and heat.
Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Call your doctor for instructions if you miss an appointment for your GnRH injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking apalutamide?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Apalutamide can cause seizures. Avoid activities that could be dangerous if you have an unexpected seizure.
What are the possible side effects of apalutamide?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- chest pain or discomfort (even while at rest), shortness of breath;
- a seizure; or
- a fall.
Accidental falls may be more common in elderly patients who use apalutamide. Use caution to avoid falling or accidental injury while you are being treated with this medicine.
Common side effects may include:
- hot flashes;
- swelling in your hands, ankles, or feet;
- diarrhea, loss of appetite;
- weight loss;
- tiredness;
- falls;
- rash;
- joint pain;
- increased blood pressure; or
- bone fractures.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect apalutamide?
Other drugs may affect apalutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about apalutamide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 2.01. Revision date: 11/18/2019.
