Erleada

The recommended adult dose of apalutamide is **240 mg (4 × 60 mg tablets or 1 × 240 mg tablet), taken by mouth, once daily. **The tablets should be swallowed whole and may be taken with food or on an empty stomach.

If you have problems swallowing tablets whole, the 60 mg tablets may be mixed with applesauce. To do this, place the entire dose in 120 mL (4 oz) of applesauce and stir. Wait 15 minutes and stir the applesauce mixture again. Wait another 15 minutes and stir the applesauce mixture a third time until no solid pieces of medication remain. Use a spoon and eat the applesauce mixture right away. Rinse the applesauce container with 60 mL (2 oz) of water and drink the contents. Repeat this rinsing once more to ensure the entire dose has been taken.

This mixture should be eaten within 1 hour of preparing it. Do not keep the applesauce mixture to take later.

If you cannot swallow tablets whole, the 240 mg tablets may be dissolved in 2 teaspoons (10 mL) of non-carbonated water and mixed with 2 tablespoons (30 mL) of orange juice, green tea, apple sauce, or drinkable yogurt. Swallow the mixture immediately, then rinse the container with water and drink it immediately to make sure you take the whole dose.

Do not save any medicine/food or medicine/drink mixture to be used later.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

60 mg

Each slightly yellowish-to-greyish-green, oblong, film-coated tablet, debossed with "AR 60" on one side, contains 60 mg of apalutamide. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate (HPMC-AS), magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose; tablet coating: iron oxide black (E172), iron oxide yellow (E172), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

240 mg

Each bluish-grey-to-grey, oval, film-coated tablet, debossed with "E240" on one side, contains 240 mg of apalutamide. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose acetate succinate (HPMC-AS), magnesium stearate, microcrystalline cellulose (silicified); tablet coating: glyceryl monocaprylocaprate, iron oxide black (E172), macrogol poly (vinyl alcohol) grafted copolymer, polyvinyl alcohol, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to apalutamide or any ingredients of the medication

• are female and are or may become pregnant

This medication is not intended to be used by women or children.

**Many medications can cause side effects. **A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste

• decreased appetite

• diarrhea

• hot flushes

• itching

• joint pain

• muscle spasms

• nausea

• skin rash

• tiredness

• symptoms of  restless leg syndrome - uncontrollable need to move part of the body, usually the legs

• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• broken bones

• falls

• high blood pressure

• signs of heart problems (e.g., fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing; leg swelling)

• swelling of hands, ankles, or feet

• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)

• symptoms of scarring of the lungs (e.g., shortness of breath at rest, shortness of breath increased with activity, dry cough)

• symptoms of underactive thyroid gland (e.g., dry skin, constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, depression, memory problems)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures

• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; dizziness, sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Apalutamide can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, flecainide), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Bone health and fractures: **Long-term use of anti-androgen medications such as apalutamide has been shown to cause reduced bone strength and may increase the risk of bone fractures. Apalutamide may also increase the risk of falls. If you have osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: The risk of heart attack or heart failure is increased for people taking apalutamide. If you have a high blood pressure or a history of heart disease or risk factors for heart disease (obesity, high blood cholesterol, smoking), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Seizures: **There have been rare reports of seizures occurring with apalutamide in studies. The safety of using this medication if you have a seizure disorder has not been determined. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Stroke: Apalutamide may increase the risk of having a stroke or mini-stroke (transient ischemic attack [TIA]) caused by decreased blood flow to parts of the brain. If you have a history of either stroke or TIA, **discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of a stroke or TIA, such as confusion, difficulty speaking, loss of coordination, sudden headache, or vision changes, contact your doctor as soon as possible.

**Thyroid disease: **This medication may cause decreased thyroid gland function. If you have problems with your thyroid gland, apalutamide may make these problems worse. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication is not intended to be used by people who could become pregnant. Apalutamide may cause harm to the developing baby and cause loss of pregnancy if the fetus is exposed to the medication. If you have a partner who is or may become pregnant, it is important to use a condom, as well as a second effective method of birth control while receiving treatment and for 3 months after the last dose of apalutamide.

Breast-feeding: This medication is not intended to be used by people who could become pregnant.

Children: The safety and effectiveness of using this medication have not been established for children.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Erleada