Vijayaganesh Kasinathan
Written & Compiled by Pharmacist Vijayaganesh Kasinathan, B.Pharm, M.Pharm
Suchitra Chari
Medically Reviewed by Suchitra Chari, M.S. M.Sc.
Last Updated on May 03, 2018
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General Information on Apalutamide

Generic Name : Apalutamide

Pronunciation : a-pa-LOO-ta-mide

Latest prescription information about Apalutamide. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, warnings and its storage instructions . Also listed are the Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Hormones

Trade Names/Brand Names of Apalutamide


Overview of Apalutamide

• Apalutamide was the first FDA-approved oral drug for treating men with high-risk prostate cancer in February 2018.

Why is Apalutamide Prescribed? (Indications)

Apalutamide is a nonsteroidal antiandrogen agent or an androgen receptor inhibitor which is prescribed to treat adult male patients suffering from non-metastatic, castration-resistant prostate cancer.

Apalutamide works by blocking the effects of a type of hormone called androgen on the tumor and thereby reduces the growth of the tumor. 

When should Apalutamide not to be taken? (Contraindications)

Apalutamide should not be used in-

• Patients allergic to the drug
• Female patients
• Men taking fertility treatments
• Patients having a history of seizures
• Patients with decreased bone density
• Children below 18 years of age

What is the dosage of Apalutamide?

• The recommended dose of apalutamide is 240 mg (four tablets of 60 mg) and should be taken once a day.
• Patients taking apalutamide tablets should have had a bilateral orchiectomy or should receive an analog of gonadotropin-releasing hormone concurrently.
• Treatment should be withdrawn, if toxicity levels of grade 3 or more occur.
• The drug can be given as a regular or a reduced dose depending on the level of toxicity or to decrease the symptoms to grade 1 or even less.

How should Apalutamide be taken?

• Apalutamide tablets are available in tablet form and should be taken by mouth with food to avoid an upset stomach.
• Do not break or chew the tablets.
• Swallow the tablets as a whole with sufficient quantity of water.

What are the warnings and precautions for Apalutamide?

• Male patients with female partners of childbearing age should use effective contraceptive measures during the apalutamide therapy and for at least three months after stopping the therapy.
• Monitor patients for routine bone density assessment as apalutamide is associated with episodes of frequent falls and fracture. Care should be taken in patients who are at risk for fracture.
• Patients should be continuously observed for the occurrence of seizures during the treatment with apalutamide. If seizures occur during treatment, apalutamide should be discontinued permanently.
• Evaluate thyroid function and assess the level of thyroid stimulating hormone (TSH) in patients taking apalutamide to detect the risk of developing hypothyroidism.
• Monitor blood cell counts regularly for detecting blood abnormalities such as decreased number of red blood cells, lymphocytes, and white blood cells.
• Patients under apalutamide therapy should be treated accordingly if they show signs of high blood pressure, increased blood sugar levels, and high potassium levels.

What are the side effects of Apalutamide?

• Diarrhea
• Loss of appetite
• Upset stomach
• Weight loss
• Tiredness or weakness
• Pain in the joints
• A feeling of intense warmth and sweating
• Low white blood cell counts
• Swelling of arms or feet
• Reduced bone mineral density
• Raised level of thyroid stimulating hormone
• High potassium levels

What are the other precautions for Apalutamide?

• Apalutamide can cause an increase in the levels of cholesterol and triglycerides, and therefore patients should be monitored closely, mainly those who are associated with cardiac illness.
• To gain maximum benefit of apalutamide therapy never miss a dose
• Take the missed dose as soon as you remember and do not take an extra dose to make up for the missed dose.

What are the Drug Interactions of Apalutamide?

Drugs taken together with apalutamide may either result in loss of effect or toxicity of apalutamide and other drugs and hence should be avoided.

• Gemfibrozil
• Clopidogrel
• Paracetamol
• Antibiotics (e.g., Erythromycin, chloramphenicol)
• Antidepressants(e.g., Fluvoxamine, moclobemide, fluoxetine)
• Anti-hypertensive drugs (e.g., Diltiazem, verapamil, acebutolol)
• Antifungal agents (e.g., Ketoconazole, fluconazole, itraconazole)
• Cyclosporine
• Zidovudine

Avoid taking herbal supplements containing St.John’s Wort while taking apalutamide as it may result in a decreased concentration of apalutamide resulting in reduced therapeutic activity.

What are the storage conditions for Apalutamide?

• Store apalutamide tablets in the original container at room temperature in a cool, dry place.
• Protect from light and excess moisture.
• Do not remove the anti-moisture pack or the desiccant from the container.

Last Updated : 5/3/2018

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