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Enzalutamide (Xtandi)

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Enzalutamide

What Is Xtandi?

Enzalutamide (pronounced [en za LOO ta mide]) is also known by the brand name, Xtandi. It is currently only available as the brand, Xtandi, and there is no generic available. Xtandi is an antineoplastic (anti-cancer) drug that belongs to a class called antiandrogens and is used as hormonal therapy. It is a type of chemotherapy that is used to treat prostate cancer.

 

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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

This drug is considered to be a hazardous agent, and normally, the capsules are covered by a thin coating of material. If this coating is damaged, removed, melted, or if the capsule is damaged or opened, the chemical inside the pill can cause harm 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 capsule or tablet and put it directly into the mouth.

 

How Is Xtandi Used?

Xtandi has been approved by the Food and Drug Administration (FDA) to treat different types of prostate cancers. It can be prescribed in combination with other chemotherapy agents, depending on the severity and type of cancer. 

Available Formulations

Xtandi is only available in the form of capsules or tablets and must be administered orally. The tablets are available in two different strengths: 40 mg and 80 mg. The capsules are only available in 40 mg strength. The 40 mg round and 80 mg elliptical tablets are yellow and stamped with “E 40” and “E 80,” respectively. The 40 mg capsules are white and stamped with either “MDV” or “ENZ” on one side. The capsules contain an additional ingredient, sorbitol

Directions for Use

Xtandi may be taken without regard to food. It should be taken at the same time each day. While taking the capsule or tablet, swallow it whole; do not break, crush, chew, or allow it to be dissolved in your mouth. Xtandi is typically dosed once a day, and the dose is dependent on the cancer type and severity. Verify the correct dose and frequency with your provider. The dose should not be more or less than what is prescribed. 

Missed Dose

If you accidentally miss a dose, take your prescribed dose as soon as you remember that day. If you missed your dose for the day, take your prescribed dose at the regular time the next day. Do not take more than your prescribed dose of Xtandi each day.

Storage

Store mediation in a cool, dry place at room temperature and ensure the bottle is tightly closed.

 

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What To Avoid While Taking Xtandi?

While on the Xtandi therapy, you must follow some precautions. Always tell your physician about any medication 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, as they may have some significant interactions with Xtandi.

 

Pregnancy and Xtandi

Xtandi may cause fetal harm and/or loss of pregnancy (miscarriage). Male patients with female partners of childbearing age should use effective contraception during treatment and for 3 months after the last dose. 

 

Side Effects

xtandi

As with any other medication, you may encounter side effects while taking Xtandi. 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 fulvestrant or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
  • Do not hide any symptoms; when 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 most common side effects of Xtandi are:

Cardiac Complications

There is a risk that Xtandi may cause high blood pressure. It may typically present as a very bad headache, dizziness, passing out, or a change in eyesight. Less commonly, however, it can potentially lead to blood clots, heart attacks, stroke, venous thromboembolism (VTE), or pulmonary embolism (PE) if left uncontrolled. Typically, these side effects may be controlled with medications to treat high blood pressure. Xtandi may worsen preexisting hypertension. 

 

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Hormonal Side Effects

Because Xtandi affects androgen, a hormone, it may cause a hormonal imbalance in the body, resulting in side effects like hot flashes, fatigue/weakness, back or joint/muscle pain, lack of appetite, weight loss, and trouble sleeping.

Allergic Reactions

Allergic reactions can be another side effect of Xtandi. A mild allergic reaction can include a rash on the skin, skin becoming itchy, etc. Severe side effects may include swelling under the eyes, lips, or hands; and swelling of the throat or tongue with disturbed breathing. Immediately contact your physician if any signs of an allergic reaction are present. If a severe reaction occurs, discontinuation of Xtandi may be recommended. 

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.

Infertility

There is a risk that Xtandi may impair fertility in males of reproductive potential.

Other common side effects may include:

  • Constipation or diarrhea
  • Common cold symptoms
  • Change in taste
  • Anxiety

 

Precautions

Unless approved by your physician, Xtandi is generally not recommended in: 

  • Patients with risk of cardiovascular events. These events can include a history of heart disease, high blood pressure, abnormal amounts of fat or cholesterol in the blood (dyslipidemia), history of heart attack or stroke, etc. Xtandi is known for potentially increasing blood pressure, leading to an increased risk of cardiovascular events taking place. If any of these events occur, discontinuation or a decrease in dose may be warranted. 
  • Patients with posterior reversible encephalopathy syndrome (PRES). PRES is a neurological disorder and may present as headache, seizure, lethargy, confusion, blindness, and other visual/neurologic symptoms with possible hypertension. Diagnosis of PRES can be confirmed by MRI, and if confirmed, it is recommended to discontinue Xtandi immediately.
  • Patients with a history of seizures, brain injury, stroke, or brain tumors. If seizures develop during treatment, it is recommended to discontinue Xtandi immediately.

 

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FAQs

Is Xtandi a chemo agent?

Chemo drugs are those that are used in the management of various cancers. Xtandi kills cancer cells and is therefore a chemo agent. It is recommended as a treatment option for various cancer patients. 

How should Xtandi be taken?

Xtandi may be taken without regard to food and should be taken at the same time each day. When taking the pill, swallow it whole; do not break, crush, chew, or allow it to be dissolved in your mouth. Xtandi is typically dosed once a day, and the dose is dependent on the cancer type and severity. Verify the correct dose and frequency with your provider. The dose should not be more or less than what is prescribed. 

Can you touch Xtandi?

Chemo drugs contain chemicals that are hazardous to your health. Therefore, it is highly recommended to wear gloves when administering the drug. Store securely in its original container until time of use. 

 

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REFERENCES:

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  2. Enzalutamide Pricing Debate Goes to Washington [Internet]. OncLive. [cited 2021 Nov 2]. Available from: https://www.onclive.com/view/enzalutamide-pricing-debate-goes-to-washington
  3. Enzalutamide. In: Lexi-drugs online [database on the Internet]. Hudson (OH): Lexicomp, Inc.; 2016 [updated 16 Jan 2021; cited 20 Jan 2022]. Available from: http://online.lexi.com.
  4. Enzalutamide. In: In Depth Answers [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2017 [cited 2022 Jan 20]. Available from: www.micromedexsolutions.com. 
  5. Frequently Asked Questions – XTANDI® (enzalutamide) Safety Info [Internet]. [cited 2021 Nov 3]. Available from: https://www.xtandihcp.com/about-xtandi/faqs
  6. Hormone Therapy for Prostate Cancer [Internet]. [cited 2021 Oct 30]. Available from: https://www.cancer.org/cancer/prostate-cancer/treating/hormone-therapy.html
  7. Rajaram P, Rivera A, Muthima K, Olveda N, Muchalski H, Chen Q-H. Second-Generation Androgen Receptor Antagonists as Hormonal Therapeutics for Three Forms of Prostate Cancer. Molecules. 2020 May 24;25(10):2448.
  8. Xtandi: Uses, dosage, side effects, warnings. Drugs.com. (n.d.). Retrieved January 20, 2022, from https://www.drugs.com/Xtandi.html. 
  9. XTANDI (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer | Astellas Pharma US, Inc. [Internet]. [cited 2021 Oct 30]. Available from: https://www.astellas.com/us/news/4711
  10. XTANDI (enzalutamide) [Internet]. XTANDI. [cited 2021 Oct 30]. Available from: https://www.xtandi.com/

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