Apalutamide Oral Tablet (APALUTAMIDE - ORAL)

For treating cancer.

Brand Name(s): Erleada

Generic Name: Apalutamide

Instructions

Swallow the medicine without crushing or chewing it.

If needed, the medicine may be mixed in 4 ounces (120 mL) of applesauce. Stir the mixture but make sure not to crush the tablets. Wait 15 minutes, and then stir the mixture again. Wait another 15 minutes and stir the mixture for a third time. Make sure the tablets are well mixed with no solid chunks remaining. Swallow the mixture right away using a spoon. After taking the mixture, rinse the container with 2 ounces (60 mL) of water and drink the mixture right away. Repeat the rinse to make sure that the full dose of the medication is taken.

Keep the medicine in its original container.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If you don't remember until the next day, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This medicine is not approved for use by women.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Try to avoid contact with people with colds, flu or other infections.

This medicine may damage sperm. Men should use reliable birth control while taking this medicine.

Men with a pregnant partner must wear a condom during sexual activity while taking this medicine and for 3 months after stopping to prevent harm to the developing baby.

Men should continue using birth control for at least 3 months after finishing this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not donate sperm during treatment and for 3 months after last dose.

Do not share this medicine with anyone who has not been prescribed this medicine.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • decreased appetite
  • diarrhea
  • swelling of the legs, feet, and hands
  • lack of energy and tiredness
  • feeling of heat or flushing
  • high blood pressure
  • pain in the joints
  • nausea
  • weight loss

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bone pain
  • chest pain
  • swelling in the neck or throat
  • red, burning, or itchy skin
  • seizures
  • shortness of breath
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.