Apalutamide (Erleada)

Apalutamide (pronounced [a pa LOO ta mide]) is also known by the brand name Erleada. It is an antineoplastic (anti-cancer) drug that belongs to a class called antiandrogen therapy. Erleada is a type of chemotherapy that prevents cancer cells from multiplying and restricts their growth.

What Is Chemotherapy?

Chemotherapy is a cancer treatment in which certain drugs are used to kill cancerous cells. These drugs are usually cytotoxic chemical substances that are toxic to the cells, restrict their growth, prevent their division, and ultimately kill the cells. 

Protection From Chemotherapy

Erleada is considered to be a hazardous agent, and normally, the pills are covered by a thin coating of material, but if this coating is damaged, removed, melted, or if the pill is broken into pieces, the chemical inside the pill can cause damage to your skin if you touch it. Therefore, it is important to take appropriate precautions for receiving, handling, storing, administering, and disposing of this medication. It is highly recommended to wear gloves if touching this medication or to avoid touching it entirely by using the cap of the bottle to scoop up the tablet and put it directly into the mouth.

How Is Erleada Used?

Erleada has been approved by the Food and Drug Administration (FDA) for males to treat many different types of prostate cancer. It can be prescribed alone or with other medications simultaneously. 

Available Formulations

At this time, Erleada is only available as a 60 mg oral tablet. 

Directions for Use

Erleada is typically dosed at 240 mg once a day. Most of the time, it is prescribed in combination with other continuous androgen deprivation therapy. Verify the correct dose and frequency with your provider. The dose should not be more or less than what is prescribed. Administer at the same time each day. Erleada may be taken with or without food. Swallow tablets whole with water; do not break, crush, chew, or allow the tablets to be dissolved in your mouth. If tablets are accidentally broken or damaged, avoid inhalation or contact with skin or mucous membranes. 

If unable to swallow tablets whole, mix tablets in 120 ml of applesauce without crushing them. Allow mixture to sit for 15 minutes, stir the mixture, let the mixture sit another 15 minutes, and then stir the mixture again until tablets are dispersed without any chunks remaining. Once dispersed, swallow the applesauce mixture immediately using a spoon. Rinse the container with 60 ml of water and immediately drink the contents. Repeat with a second 60 ml of water to ensure the entire dose is administered. Consume mixture within 1 hour of preparation; do not store for later use.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, administer it as soon as possible on the same day and return to the normal dosing schedule the following day. Do not administer extra tablets to make up for a missed dose. If you miss more than one dose, call your doctor immediately. 

Storage

Store tablets in their original containers in a cool, dry place at room temperature and ensure the bottle is tightly closed. Keep the bottle away from direct sunlight. Do not discard desiccant in the bottle, as the medication needs to be protected from moisture.

What To Avoid While Taking Erleada

While taking Erleada therapy, you must follow some precautions. Always tell your physician about any medications you are already taking. Do not take any drug or medicine (even herbals, vitamins, or over-the-counter medications) without prior consent from your physician or pharmacist. They may have some significant interactions with Erleada.

Pregnancy and Erleada

Erleada is not approved for use in females. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose. Pregnant women should wear gloves when handling tablets, especially if they are broken, crushed, or damaged, as this medication may cause fetal harm or fetal loss.

Erleada Side Effects

As with any other medication, you may encounter side effects while taking Erleada. A few things to remember are:

• You may not have all the side effects listed below. Many people may experience little to no side effects.
• The severity of side effects may vary from person to person, so don’t compare your side effects with other people’s experiences.
• Most of the side effects will improve when therapy is discontinued.
• These side effects are easily manageable most of the time either by readjusting the dose of Erleada or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
• Do not hide any symptoms; if you feel any discomfort, do not hesitate to tell your physician or pharmacist about it. 

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions. 

Some of the more serious side effects of Erleada are listed below:

Cardiac Complications

Although uncommon, there is a risk for Erleada to cause an increase in the interval between when the heart contracts and relaxes, potentially increasing the risk for even more cardiac complications. 

Skin Rash

On rare occasions, Erleada may cause a serious skin rash. These rashes may appear as red, swollen hives; itching, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes. Notify your physician or pharmacist immediately of any signs of a rash or allergic reaction, including wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. A rash can most typically appear within 3 months of Erleada use. Discontinuation of Erleada may be warranted if a rash is suspected. 

Fall or Fracture Risk

Patients who have a high fracture or fall risk may need to consider taking additional therapy that can help increase bone density to prevent any falls or bone fractures. This risk is potentially due to the high chance of fatigue and weakness/dizziness side effects. The risk is highest within the first 10 minutes after taking the medication. Monitoring of bone density may be warranted throughout therapy. 

Seizures

Although rare, it is possible that Erleada therapy may increase the risk for seizures. Patients receiving concomitant medications that may lower the seizure threshold (e.g., certain antidepressants) may be at a higher risk. If seizures occur, contact your physician immediately. 

Thyroid Impairment

Erleada may affect thyroid levels, and this can be managed with the use of thyroid replacement therapies as needed. It can typically cause a condition called hypothyroidism (lower thyroid-stimulating hormone lab value). Contact your physician immediately if you experience any abnormal changes in weight, anxiety, agitation, feeling very weak, hair thinning, depression, neck swelling, trouble focusing, inability to handle heat or cold, menstrual changes, tremors, or sweating. These may be signs of thyroid complications. 

Other common side effects may include:

• Feeling tired or weak
• Decreased appetite
• Weight loss
• Hot flashes
• Diarrhea
• Upset stomach
• Joint pain

Monitoring

Due to its many side effects, monitoring is an important part of managing Erleada therapy. The following includes what you can expect with Erleada use:

• Monitoring for fall risk, especially for patients aged 65 and older.
• Frequent blood tests to monitor thyroid function.
• Regular blood pressure checks for cardiac monitoring.
• For patients with a history of heart failure, recent myocardial infarction (MI), or ventricular arrhythmia, close monitoring for other cardiac complications.
• For patients with a history of seizures, continual monitoring throughout therapy.

Erleada FAQs

Is Erleada a chemo agent?

Chemo drugs are those that are used in the management of various cancers. Erleada works by blocking the production of the testosterone hormone, thereby slowing the growth and spread of prostate cancer. Thus, it is a chemo agent that is used as a treatment option for various cancer patients. 

How should Erleada be taken?

Erleada is only available as a 60 mg oral tablet. Most of the time, it is prescribed in combination with other medications. Verify the correct dose and frequency with your provider. Swallow tablets whole with water; do not break, crush, chew, or allow tablets to be dissolved in your mouth. Erleada can be taken with or without food. It is typically dosed at 240 mg once a day.

What can I do if I am unable to swallow tablets whole?

If unable to swallow tablets whole, mix tablets in 120 ml of applesauce without crushing them.

• Allow mixture to sit for 15 minutes, stir the mixture, then let the mixture sit another 15 minutes.
• Stir the mixture again until tablets are dispersed without any chunks remaining.
• Once dispersed, swallow the applesauce mixture immediately using a spoon.
• Rinse the container with 60 ml of water and immediately drink the contents.
• Repeat with a second 60 ml of water to ensure the entire dose is administered.
• Consume mixture within 1 hour of preparation; do not store for later use.