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Why is this medication prescribed?

Prostate cancer in males that starts in the prostate (a male reproductive gland) and has spread to other parts of the body or that has not migrated to other areas of the body but has not responded to other medical treatments is treated with apalutamide. A class of drugs known as androgen receptor inhibitors includes apalutamide. In order to prevent the growth and spread of cancer cells, it blocks the effects of androgen, a hormone produced by male reproductive organs.

How should this medicine be used?

A tablet to be swallowed with food contains apalutamide. It is typically taken once day, with or without food. Take apalutamide every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer apalutamide exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole. Do not crush the tablets; instead, place them whole in 120 mL (4 ounces) of applesauce if you are unable to swallow the tablets whole. Wait 15 minutes before stirring the mixture and pills to ensure complete mixing and the removal of any chunks. Use a spoon to quickly drink the concoction. After rinsing the jar with 60 mL (2 ounces) of water, take the concoction right away. To make sure the entire dose is consumed, rinse the container once more with 60 mL (2 ounces) of water. Within one hour of preparation, swallow the entire combination. Never keep the combination on hand for later usage.

In the event that you encounter severe adverse effects while receiving therapy, your doctor might advise you to temporarily stop taking apalutamide or reduce your dose. As you receive apalutamide medication, be sure to discuss your feelings with your doctor.

You will need to continue taking this medication throughout your treatment with apalutamide if your doctor has prescribed it to treat your prostate cancer, such as goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Eligard, Lupron, in Lupaneta Pack), or triptorelin (Trelstar, Triptodur).

Even if you are feeling fine, keep taking apalutamide. Without consulting your doctor, do not discontinue taking apalutamide.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking apalutamide,

  • If you have an allergy to apalutamide, any other drugs, or any of the ingredients in apalutamide tablets, let your doctor and pharmacist know right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: anticoagulants (also known as “blood thinners”) like rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), fexofenadine (Allegra), gemfibrozil (Lopid), itraconazole (Onmel, Sporanox, Tolsura), ketoconazole (Nizoral), omeprazole (Prilosec, in Yosprala, Zegerid), mida (Crestor, Ezallor). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Apalutamide may interact with a wide range of other drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list.
  • Inform your physician if you are currently experiencing or have ever experienced cardiac issues, such as a heart attack, angina (chest discomfort), heart failure, hypertension, or a stroke or ministroke. Additionally, let your doctor know if you’ve ever suffered from osteoporosis, high cholesterol, diabetes, a brain tumour, or seizures.
  • You should be aware that men should only use apalutamide. In particular, women who are breastfeeding or who may become pregnant shouldn’t take this drug. Apalutamide may be harmful to the foetus if taken by pregnant women. A pregnant woman who takes apalutamide needs to contact her doctor right away.
  • During your treatment with apalutamide and for three months following your last dose, you must use a condom whenever you have sex if your partner is expecting. You must use a condom and an alternative method of birth control whenever you have sex while receiving therapy and for three months after your last dose if your partner is not pregnant but could become pregnant. While taking apalutamide and for three months following your last dose, avoid donating sperm or semen.
  • It’s important to be aware that apalutamide can cause seizures. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that taking apalutamide may weaken your bones and muscles, increasing your chance of falling and fracturing a bone.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. On the other hand, skip the missed dose and carry on with your regular dosing plan if you don’t remember until the following day. Never take two doses in a single day, and never double the dose to make up for a missing one.

What side effects can this medication cause?

Side effects are possible with apalutamide. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Weakness
  • Tiredness
  • Aching joints
  • A weakened or tight muscle
  • Diarrhea
  • Nausea
  • Reduced appetite
  • Loss of weight
  • Hot flashes

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • Seizures
  • Consciousness loss
  • Swollen hands, feet, legs, arms, or other body parts
  • Falling
  • Chest pain
  • Breathing difficulty
  • Having trouble speaking or understanding; having trouble seeing out of one or both eyes; feeling lightheaded; losing your balance or coordination; or having trouble walking
  • Rash
  • Blistering, peeling, or redness of the skin, with or without fever

Other negative effects of apalutamide are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from light, excessive heat, and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to apalutamide, your doctor will request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Erleada®
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