Apalutamide

What is Apalutamide?

• Apalutamide (Erleada) is an androgen receptor inhibitor used for the treatment of prostate cancer.

What are the uses of this medicine?

This medicine is used used for the treatment of prostate cancer:

• that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR
• that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.

How does this medicine work?

• apalutamide (A-puh-LOO-tuh-mide) is a drug used to treat prostate cancer that has not spread to other parts of the body.
• It is used in patients whose cancer is castration resistant (has not responded to treatments that lower testosterone levels) .
• Apalutamide binds to proteins called androgen receptors, which are found in some prostate cancer cells.
• These proteins bind to androgens (male hormones) and may cause cancer cells to grow.
• Apalutamide blocks these proteins and may keep cancer cells from growing.
• It is a type of antiandrogen.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

• The recommended dose of Erleada is 240 mg (four 60 mg tablets) administered orally once daily.
• Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Administration

• Take Erleada exactly as your healthcare provider tells you.
• Your healthcare provider may change your dose if needed.
• Do not stop taking your prescribed dose of Erleada without talking with your healthcare provider first.
• Take your prescribed dose of Erleada 1 time a day, at the same time each day.
• Take Erleada with or without food.
• Swallow Erleada tablets whole.
• If you miss a dose of Erleada, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with Erleada unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
• If you take too much Erleada, call your healthcare provider or go to the nearest hospital emergency room.
• If you are unable to swallow Erleada tablets whole, you may:
• Place your dose of Erleada in a container that contains 4 ounces (120 mL) of applesauce and stir. Do not crush the tablets.
• Wait 15 minutes and stir the mixture.
• Wait another 15 minutes and stir the mixture until the tablets are well mixed with no chunks remaining.
• Swallow the mixture right away using a spoon.
• Rinse the container with 2 ounces (60 mL) of water and drink the water mixture right away.
• Repeat the rinse with 2 ounces (60 mL) of water one more time to make sure that you take your full dose of Erleada.
• Swallow all the applesauce and medicine mixture within 1 hour of preparation. Do not store Erleada that is mixed with applesauce.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 60 mg

This medicine is available in fallowing brand namesː

• Erleada

What side effects can this medication cause?

The most common side effects of this medicine include:

• feeling very tired
• joint pain
• rash. Tell your healthcare provider if you get a rash.
• decreased appetite
• fall
• weight loss
• hypertension
• hot flash
• diarrhea
• fracture

Erleada may cause serious side effects including:

• Heart disease, stroke, or mini-stroke
• Fractures and falls
• Seizure

What special precautions should I follow?

• Cerebrovascular and ischemic cardiovascular events occurred in patients receiving Erleada. Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease. Optimize management of cardiovascular risk factors.
• Fractures occurred in patients receiving Erleada. Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines.
• Falls occurred in patients receiving Erleada with increased incidence in the elderly. Evaluate patients for fall risk.
• Seizure occurred in 0.4% of patients receiving Erleada. Permanently discontinue Erleada in patients who develop a seizure during treatment.
• Erleada can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

What to do in case of emergency/overdose?

Management for overdosage:

• There is no known specific antidote for apalutamide overdose.
• In the event of an overdose, stop Erleada, undertake general supportive measures until clinical toxicity has been diminished or resolved.

Can this medicine be used in pregnancy?

• The safety and efficacy of Erleada have not been established in females.
• Based on findings from animals and its mechanism of action, Erleada can cause fetal harm and loss of pregnancy when administered to a pregnant female.

Can this medicine be used in children?

• Safety and effectiveness of Erleada in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: apalutamide
• Inactive ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Who manufactures and distributes this medicine?

• Manufactured by: Janssen Ortho LLC, Gurabo, PR 00778
• Manufactured for: Janssen Products, LP, Horsham, PA 19044

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

• Store Erleada at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Erleada in the original package.
• The bottle of Erleada contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.
• Protect Erleada from light and moisture.

• Dailymed label info on Apalutamide
• FDA Apalutamide

Apalutamide Resources
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