Why is this medication prescribed?

Apalutamide is primarily prescribed for the treatment of prostate cancer. It is used in two main contexts:

• Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC): Apalutamide is used to treat prostate cancer that is no longer responding to hormone therapy but has not yet spread to other parts of the body.
• Metastatic Castration-Sensitive Prostate Cancer (mCSPC): It can also be used in combination with androgen deprivation therapy (ADT) for prostate cancer that has spread to other parts of the body but is still sensitive to hormone therapy.

Apalutamide works by blocking the action of androgens (male hormones like testosterone) that can stimulate the growth of prostate cancer cells.

How should this medicine be used?

Apalutamide should be used as follows:

• Dosage Form: Apalutamide is available in tablet form and should be taken orally.
• Recommended Dose: The typical dose is 240 mg (four 60 mg tablets) taken once daily. However, your doctor may adjust the dose based on your medical condition, response to treatment, and any side effects you may experience.
• Administration: Take Apalutamide at the same time every day, with or without food. Swallow the tablets whole with water; do not crush, chew, or split them.
• Additional Medication: Apalutamide is often prescribed alongside gonadotropin-releasing hormone (GnRH) analog therapy (which reduces testosterone production) or after surgical castration.
• Missed Dose: If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose; do not double up to make up for the missed one.
• Avoid Certain Activities: Apalutamide can cause dizziness or seizures. Avoid driving or operating heavy machinery until you know how the medication affects you.
• Stay Hydrated: Ensure adequate fluid intake while taking Apalutamide, as dehydration may increase the risk of certain side effects.

Other uses for this medicine

Apalutamide is primarily used for the treatment of prostate cancer, specifically non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). While it is not commonly prescribed for other uses, it may be considered in certain experimental settings or clinical trials for other androgen-sensitive conditions. Any such use should be under strict medical supervision.

What special precautions should I follow?

Special Precautions to Follow When Using Apalutamide

• Allergies: Inform your doctor if you are allergic to Apalutamide or any other medications, or if you have any other allergies (e.g., to foods, dyes, preservatives).
• Medical History: Discuss your entire medical history with your doctor, particularly if you have a history of seizures, brain injury, brain tumors, stroke, or cardiovascular issues. Inform your doctor if you have osteoporosis or are at risk of bone fractures, as Apalutamide can weaken bones.
• Seizure Risk: Apalutamide may increase the risk of seizures. Avoid activities like driving or operating heavy machinery until you know how the medication affects you. Report any episodes of loss of consciousness or convulsions to your healthcare provider immediately.
• Bone Health: Apalutamide can cause bone thinning or fractures. Your doctor may suggest bone-strengthening medications or supplements (such as calcium and vitamin D) to mitigate this risk.
• Cardiovascular Monitoring: Apalutamide may increase the risk of cardiovascular problems, including heart attack and stroke. Regular monitoring of heart health, blood pressure, and cholesterol levels is recommended.
• Hormonal Therapy: Continue any additional hormonal therapies (e.g., GnRH analog therapy) as prescribed. Do not stop these therapies without consulting your doctor.
• Pregnancy and Breastfeeding: Apalutamide is not intended for use in women, particularly during pregnancy or breastfeeding, as it can cause harm to the fetus or infant.
• Contraception: Male patients with partners who could become pregnant should use effective contraception during treatment and for 3 months after the last dose to avoid harm to a potential fetus.
• Hydration: Ensure adequate fluid intake to help manage side effects and prevent dehydration.
• Drug Interactions: Inform your doctor of all other medications, supplements, or herbal products you are taking, as Apalutamide can interact with various drugs (such as anticoagulants, certain antidepressants, and anticonvulsants).

Always consult your healthcare provider for advice tailored to your specific health needs and conditions.

What special dietary instructions should I follow?

• There are no specific dietary restrictions required while taking Apalutamide. However, maintaining a balanced diet is important for overall health and to support your body during treatment.
• Your doctor may suggest a diet rich in calcium and vitamin D to help protect bone health.
• Avoid excessive alcohol consumption, as it may increase the risk of side effects like dizziness or seizures.

What should I do if I forget a dose?

• If you forget a dose, take it as soon as you remember on the same day.
• If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
• Do not double the dose to make up for the missed one.

What side effects can this medication cause?

Apalutamide can cause a range of side effects, some common and others more serious. It’s important to monitor for these effects and report any concerning symptoms to your healthcare provider.

Common Side Effects:

• Fatigue: Feeling tired or weak is a common side effect.
• Rash: Skin rash, which may be mild or severe, can occur. Notify your doctor if you develop a rash, as it can sometimes require treatment.
• Joint Pain: Pain in the joints or muscles is frequently reported.
• Hot Flashes: A sudden feeling of warmth or sweating.
• Diarrhea: Gastrointestinal upset, including diarrhea, is common.
• Nausea: Feeling nauseated or vomiting may occur.
• Weight Loss: Some patients experience unintended weight loss.
• Decreased Appetite: A reduced desire to eat.
• Falls and Fractures: There is an increased risk of falls and bone fractures.
• Hypertension: Increased blood pressure may develop or worsen.
• Swelling in Extremities: Edema, particularly in the hands, feet, or ankles.
• Dizziness: You might feel lightheaded or dizzy, especially when standing up quickly.

Serious Side Effects:

• Seizures: Apalutamide can increase the risk of seizures. Contact your doctor immediately if you experience a seizure.
• Heart Problems: Apalutamide may increase the risk of heart attack or stroke. Seek emergency help if you experience chest pain, shortness of breath, or sudden numbness or weakness.
• Severe Rash or Allergic Reaction: Look out for signs of a severe skin reaction (such as blisters or peeling), swelling, difficulty breathing, or other symptoms of a severe allergic reaction.
• Fractures and Osteoporosis: Apalutamide can weaken bones, increasing the risk of fractures.
• Thyroid Dysfunction: Apalutamide can cause changes in thyroid function. Symptoms may include fatigue, weight gain, or cold intolerance.
• Hepatotoxicity: Rarely, liver problems can occur. Watch for symptoms like jaundice (yellowing of the skin or eyes), dark urine, or pain in the upper right abdomen.

If you have symptoms of a seizure, severe rash, allergic reaction, chest pain, difficulty breathing, sudden numbness, or weakness. For any side effects that persist, worsen, or become bothersome, such as fatigue, diarrhea, dizziness, or any changes in your overall health.

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

Storage and Disposal of Apalutamide:

Storage:

• Store Apalutamide tablets at room temperature (68°F to 77°F or 20°C to 25°C).
• Keep the medication in its original container, tightly closed, and away from excess heat, moisture, and direct light.
• Do not store it in the bathroom.
• Keep the medication out of reach of children and pets.

Disposal:

• Do not flush Apalutamide down the toilet or pour it into a drain unless instructed to do so.
• Use a medication take-back program if available. If not, mix the medication with an undesirable substance (like dirt, coffee grounds, or cat litter), place it in a sealed plastic bag, and dispose of it in the household trash.
• Check with your pharmacist or local waste disposal company for more information about safe disposal methods.

In case of emergency/overdose

• Symptoms of Overdose: Symptoms may include severe dizziness, fainting, loss of consciousness, or seizures.
• Call Emergency Services: Immediately call your local emergency number (such as 911 in the U.S.) if you suspect an overdose or experience severe symptoms.
• Contact Poison Control: In the U.S., you can call the Poison Help line at 1-800-222-1222 for guidance. Have the medication container or label available to provide details.

What other information should I know?

• Regular Checkups: You should have regular medical and laboratory appointments to monitor your response to Apalutamide, including blood tests and heart monitoring.
• Medication Interactions: Always inform your healthcare provider of all the medications you are taking, including prescription and over-the-counter drugs, supplements, and herbal products. Some medications may interact with Apalutamide, affecting its effectiveness or increasing the risk of side effects.
• Missed Dose Instructions: If you miss a dose, take it as soon as you remember on the same day. If it is close to the next dose, skip the missed dose and resume your regular schedule. Do not take a double dose to make up for a missed one.
• Activity Precautions: Due to the risk of seizures, dizziness, or falls, avoid activities requiring alertness, such as driving or operating heavy machinery, until you know how Apalutamide affects you.
• Monitoring Bone Health: Discuss with your doctor about regular bone density monitoring and consider calcium and vitamin D supplements to help maintain bone health.

Always consult your healthcare provider if you have any questions or concerns about using Apalutamide, including questions about storage, disposal, or managing side effects.