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

Quick overview

Erleada Tablet (apalutamide) is a prescription androgen receptor inhibitor used to treat certain types of prostate cancer, including cancer that has spread and still responds to testosterone-lowering treatment, and cancer that has not spread but no longer responds to such treatment. It is taken once daily and is typically used long term alongside a GnRH analog medicine unless the testicles have been surgically removed. It is not known to be safe and effective in females or children.

What is Erleada Tablet

Erleada is a prescription tablet medicine used to treat certain types of prostate cancer. It contains the active ingredient apalutamide and belongs to a group of medicines called androgen receptor inhibitors.

Erleada Tablet uses

• Treatment of prostate cancer that has spread to other parts of the body and still responds to treatment that lowers testosterone (metastatic castration-sensitive prostate cancer)
• Treatment of prostate cancer that has not spread to other parts of the body and no longer responds to treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer)
• Not known to be safe and effective in females
• Not known to be safe and effective in children

Benefits of Erleada Tablet

• In a clinical study of men with prostate cancer that had spread, Erleada plus hormone therapy reduced the risk of death compared with hormone therapy alone
• In the same study, Erleada plus hormone therapy reduced the risk of the cancer getting worse compared with placebo plus hormone therapy
• In men whose cancer had not spread, Erleada plus hormone therapy helped delay the cancer from spreading to other parts of the body compared with placebo plus hormone therapy
• Erleada plus hormone therapy reduced the risk of needing to start chemotherapy compared with placebo plus hormone therapy

How Erleada Tablet works

Testosterone, a male hormone, can attach to receptors on prostate cancer cells and cause them to grow and spread. Erleada works by blocking testosterone from attaching to these receptors, which helps slow the growth of prostate cancer and can help kill cancer cells.

Erleada Tablet dosage

Take your prescribed dose one time a day, at the same time each day. You can take it with or without food. Swallow the tablets whole; do not crush, split, or chew them. If you cannot swallow tablets whole, ask your healthcare provider about alternate methods, such as mixing with water and then orange juice, applesauce, or more water, or giving through a feeding tube.

Unless you have had surgery to remove your testicles, you should also keep taking a gonadotropin-releasing hormone (GnRH) analog medicine during treatment. If you miss a dose, take your normal dose as soon as possible on the same day, then return to your normal schedule the next day; do not take extra tablets to make up for a missed dose. Do not stop taking your prescribed dose without talking with your healthcare provider first. This medicine is typically taken long term, for as long as your doctor recommends.

Available forms and strengths

• Tablets, 240 mg
• Tablets, 60 mg

Side effects of Erleada Tablet

Common

• Feeling very tired
• Joint pain
• Skin rash
• Decreased appetite
• Falls
• Weight loss
• High blood pressure
• Hot flashes
• Diarrhea
• Fractures (broken bones)

Serious

• Heart disease, stroke, or mini-stroke, including chest pain, shortness of breath, numbness or weakness on one side of the body, trouble talking or understanding, trouble seeing, dizziness or trouble walking
• Fractures and falls from weakened bones and muscles
• Seizures, including loss of consciousness
• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, with rash, blistering or peeling skin, fever, or swollen lymph nodes
• Serious allergic reaction, including a reaction called DRESS that can affect multiple organs
• Lung inflammation (interstitial lung disease or pneumonitis), with shortness of breath, cough, or fever
• Underactive thyroid

Warnings and precautions

• Erleada has been linked to serious heart and brain blood vessel problems, including heart attack and stroke, which can lead to death. Get medical help right away for chest pain, shortness of breath, one-sided weakness or numbness, trouble speaking, vision problems, or dizziness and trouble walking.
• Erleada can weaken bones and muscles, increasing the risk of falls and fractures.
• Erleada can increase the risk of seizures. Treatment will be stopped permanently if a seizure occurs during treatment.
• Erleada can cause severe, life-threatening skin reactions. Stop taking it and get medical help right away if you notice a worsening rash, fever, flu-like symptoms, swollen lymph nodes, mouth or genital sores, or blistering or peeling skin.
• Erleada can cause serious lung inflammation that can be fatal or life-threatening.
• Erleada can cause falsely high results on certain lab tests measuring digoxin levels; tell the lab if you take digoxin.
• Erleada may cause fertility problems in men and may affect the ability to father children. Men should not donate sperm during treatment and for 3 months after the last dose.
• Erleada is not approved for use in women and has not been studied in women. It can harm an unborn baby and cause loss of pregnancy if a pregnant woman is exposed to it. 
• Men taking Erleada whose partner could become pregnant should use effective birth control during treatment and for 3 months after the last dose, and use a condom if their partner is pregnant.
• It is not known if Erleada passes into breast milk, and it is not approved for use in women who are breastfeeding.
• People with severe liver impairment need a lower dose of Erleada. No dose change is needed for mild or moderate liver impairment.
• There are no known direct interactions between Erleada and alcohol, but both can cause similar side effects like tiredness, diarrhea, and nausea, so drinking alcohol while taking Erleada may increase the risk of these effects.
• Because Erleada can increase the risk of seizures, you should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C)
• Short trips outside this range, between 59°F and 86°F (15°C to 30°C), are permitted
• Store in the original container to protect it from light and moisture
• Keep the container tightly closed and do not throw away the desiccant packet included in the bottle, as it helps keep the medicine dry
• Keep out of the reach of children

When to see a doctor

• Get medical help right away if you have chest pain or discomfort, shortness of breath, numbness or weakness in the face, arm, or leg (especially on one side), trouble talking or understanding, trouble seeing, or dizziness, loss of balance, or trouble walking.
• Tell your healthcare provider right away if you lose consciousness or have a seizure.
• Stop taking Erleada and get medical help right away if you develop signs of a severe skin reaction, such as worsening rash, fever or flu-like symptoms, swollen lymph nodes, sores in the mouth, throat, nose, eyes, or genital area, or blistering or peeling skin.
• Stop taking Erleada and contact your healthcare provider or get medical help immediately if you develop new or worsening shortness of breath, cough, or fever, which could be signs of a lung problem.
• If you think you have taken too much Erleada, call your healthcare provider or go to the nearest hospital emergency room.

Alternatives

• Xtandi
• Nubeqa
• Zytiga