Apalutamide Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Apalutamide Tablet, generic name apalutamide, is a prescription androgen receptor inhibitor (anti-androgen) used in men only, alongside ongoing testosterone-lowering treatment. It is used to treat certain types of prostate cancer by blocking androgens that stimulate cancer cell growth. The usual dose for adults is 240 mg once a day, and it is available as 60 mg and 240 mg tablets.

What is Apalutamide Tablet

Apalutamide is a prescription medicine that blocks the action of androgens (male hormones like testosterone) to slow the growth and spread of prostate cancer. It is used in men only, alongside ongoing testosterone-lowering treatment.

Apalutamide Tablet uses

• Non-metastatic castration-resistant prostate cancer.
• Metastatic castration-sensitive prostate cancer.
• Prostate cancer treatment alongside androgen-deprivation therapy when indicated.
• Prostate cancer in patients who meet approved treatment criteria.

Benefits of Apalutamide Tablet

• Helps slow prostate cancer growth.
• Helps delay cancer progression.
• May delay the spread of cancer in eligible patients.
• Can help control disease when used with the appropriate treatment plan.

How Apalutamide Tablet works

Apalutamide blocks the receptor that androgens (like testosterone) attach to on cancer cells. By blocking this receptor, it stops androgens from signaling the cancer to grow, which slows tumor growth and can shrink tumors over time.

Apalutamide Tablet dosage

Take exactly as your healthcare professional tells you, at about the same time each day. Swallow tablets whole; do not crush, split, or chew them. This medicine can be taken with or without food. If you cannot swallow tablets whole, ask your doctor or pharmacist about special instructions for dispersing the tablets in water with orange juice or applesauce, or giving them through a feeding tube. You should continue gonadotropin-releasing hormone (GnRH) analog therapy during treatment unless you have had surgery to remove the testicles. Do not stop taking this medicine without talking to your healthcare professional first.

Available forms and strengths

• Tablet, 60 mg
• Tablet, 240 mg

Side effects of Apalutamide Tablet

Common

• Feeling tired
• High blood pressure
• Skin rash
• Itching
• Diarrhea
• Nausea
• Decreased appetite
• Changes in the way things taste
• Underactive thyroid gland
• Weight loss
• Joint pain
• Muscle spasm
• Falls
• Hot flash
• Swelling in hands, ankles or feet

Serious

• Fracture (broken bone)
• Cardiac problems including heart attack, heart disease, and heart failure
• Stroke or mini-stroke
• Seizure (convulsion)
• QT prolongation (abnormal heart electrical signal)
• Interstitial lung disease (inflamed or scarred lung tissue)
• Severe skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis and DRESS

Warnings and precautions

• This medicine can increase the risk of serious heart and brain blood vessel problems, including heart attack and stroke, which can be fatal.
• This medicine can weaken bones and muscles, increasing the risk of falls and broken bones.
• This medicine can cause seizures. If a seizure occurs during treatment, the medicine must be stopped permanently.
• This medicine can cause severe skin reactions, including Stevens-Johnson syndrome and DRESS, which can be fatal or life-threatening.
• This medicine can cause serious lung inflammation that may be fatal or life-threatening.
• This medicine can harm an unborn baby. Men whose partners could become pregnant must use effective birth control during treatment and for 3 months after the last dose.
• This medicine may cause falsely high results on certain digoxin blood tests, so tell the laboratory if you are taking digoxin.
• This medicine is not for use in women. It must not be used by anyone who is or may become pregnant, as it can cause harm to an unborn baby. There is no information on whether this medicine passes into breast milk or affects a nursing infant, since it is not used in women.
• No dose change is needed for mild to moderate kidney problems. There isn't enough information on use in people with severe kidney disease. No dose change is needed for mild or moderate liver problems. People with severe liver impairment may need a lower dose, and should be monitored closely.
• Tell your doctor if you drink alcohol, as this may change how the medicine works in your body.
• This medicine can cause seizures, so avoid driving or operating machinery until you know how it affects you, and avoid activities where sudden loss of consciousness could cause harm.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C), with excursions permitted to 59°F to 86°F (15°C to 30°C)
• Store in the original package to protect from light and moisture
• If provided in a bottle, do not remove or throw away the silica gel desiccant packet that keeps the medicine dry
• Keep out of reach and sight of children
• Do not use after the expiry date on the label
• Do not flush medicines down the toilet; follow local rules for disposal or return unused medicine to a pharmacy

When to see a doctor

• Get medical help right away if you have chest pain or pressure, shortness of breath, numbness or weakness on one side of the body, trouble talking or seeing, dizziness, or loss of balance — these can be signs of a heart attack or stroke.
• Stop taking the medicine and get medical help right away if you develop a severe rash, fever, flu-like symptoms, swollen glands, or blistering/peeling skin — these can be signs of a severe skin reaction.
• Stop taking the medicine and get medical help right away if you have new or worsening shortness of breath, cough, or fever, as these could be signs of a serious lung problem.
• Tell your healthcare provider right away if you have a seizure or lose consciousness while taking this medicine.
• Tell your healthcare professional right away if your sexual partner becomes pregnant while you are taking this medicine.

Alternatives

• Abiraterone
• Darolutamide
• Enzalutamide