What is Xtandi Uses, warnings & interactions
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Xtandi (enzalutamide) is an anti-androgen medication that is manufactured by Astellas Pharma US, Inc. It was approved in 2012 by the U.S. Food and Drug Administration (FDA) as a type of androgen deprivation therapy for men with prostate cancer that has spread to other parts of the body (metastasis). Xtandi should be used along with gonadotropin-releasing hormone (GnRH) therapy unless you’ve had both testicles surgically removed. It is a very expensive medication and is available as an oral tablet or capsule.
If your doctor has prescribed Xtandi to you, you may want to know more about what it is and how it works. Here we’ll explain what Xtandi is used for, how it works, its side effects, and more.
What is Xtandi used for?
Xtandi (enzalutamide) is an androgen receptor inhibitor used for the treatment of adults with:
- Non-metastatic castration-resistant prostate cancer (CRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
The safety and effectiveness of Xtandi have not been established for pediatric patients under 18 years of age.
How does Xtandi work?
Certain types of prostate cancer are dependent on androgens such as testosterone to grow and spread. Xtandi is an androgen receptor inhibitor that has been shown to competitively inhibit androgen binding to their androgen receptors. This inhibition blocks the effect of testosterone on prostate cancer cells. Without testosterone, these cancer cells cannot grow, even if has metastasized to other parts of the body.
What are the most commonly prescribed doses of Xtandi?
- 40 mg capsules
- 40 mg tablets
- 80 mg tablets
Before taking Xtandi
Before beginning Xtandi, tell your doctor about your medical conditions, including:
- History of seizures, stroke, brain tumors, or injury
- History of heart disease or high blood pressure
- High cholesterol levels
- Are pregnant, plan on becoming pregnant, or are breastfeeding
How to take Xtandi
- Read the Full Prescribing Information, Patient Information, and Medication Guide that comes with Xtandi.
- Take Xtandi exactly as your doctor prescribes it to you. Do not change your dose or stop taking this medication without discussing it with them.
- Xtandi should be taken once a day, at the same time every day. It can be taken with or without food. Xtandi tablets or capsules should be swallowed whole. Don’t cut, chew, crush, dissolve, or open them.
- If you miss a dose of this medication, take the missed dose immediately that day. If you forget the dose for the whole day, take your regular dose the next day. Do not take extra doses of Xtandi to make up for a missed dose.
- Store Xtandi capsules and tablets at room temperature between 68°F to 77°F (20°C to 25°C) in a tightly closed container.
You should not use Xtandi if you have an allergy to enzalutamide or any inactive ingredients in this product.
- Xtandi increases the risk of seizures. This medication should be stopped permanently if you develop seizures during treatment.
- Xtandi should be discontinued if you have symptoms of posterior reversible encephalopathy syndrome (PRES), which include seizures, headache, fatigue, loss of vision, and high blood pressure.
- Falls and fractures have occurred in over 10% of people taking Xtandi. Evaluate and manage your risk of falls accordingly.
- Ischemic heart disease has occurred with Xtandi use. Your doctor should manage your cardiovascular risk factors (high blood pressure, diabetes, high cholesterol) to help minimize your risk.
- Xtandi may cause harm to the fetus and loss of pregnancy. Males with female partners who can become pregnant should use an effective form of contraception during treatment and for 3 months after their last dose.
Xtandi drug interactions
When Xtandi is taken with other medications, it may change the way they work or increase the frequency and severity of side effects. You should discuss with your doctor whether any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, including:
- Strong CYP2C8 Inhibitors such as gemfibrozil
- Strong CYP3A4 Inducers such as phenytoin and St. John’s Wort
- Certain cancer treatments such as sorafenib and erlotinib
Xtandi side effects
Some common side effects of Xtandi in clinical trials when compared to placebo include:
- Hot flashes
- Back pain
- Hypertension (high blood pressure)
- Joint pain
- Loss of appetite
- Swelling of the arms, legs, or feet
Xtandi can sometimes cause more serious side effects, including:
- Allergic reactions (hives, swelling of the face or throat, and shortness of breath)
- Posterior reversible encephalopathy syndrome (swelling in your brain)
- Broken bones or fractures
- Increased risk of seizures
- Loss of consciousness
- Increased risk of ischemic heart disease (chest pain, irregular heartbeat, trouble breathing)
Contact your healthcare professional for medical advice about any possible adverse events you experience while taking Xtandi. You can report your adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Your healthcare professional can prescribe other medications for your condition if Xtandi is not right for you. These other treatment options will vary by factors such as the condition being treated, side effects, and costs. Some FDA-approved alternatives to Xtandi include:
- Casodex (bicalutamide)
- Erleada (apalutamide)
- Firmagon (degarelix)
- Nilandron (nilutamide)
- Yonsa (abiraterone)
- Zytiga (abiraterone)
- Taxotere (docetaxel)
Can you take Xtandi while you are pregnant or breastfeeding?
There is no data on the use of Xtandi in pregnant women. Based on animal studies and its mechanism of action, Xtandi may cause harm to your unborn baby and loss of pregnancy. Male patients with female partners who can become pregnant should use an effective form of birth control while taking Xtandi and for 3 months after the last dose. It is not known if Xtandi is found in breast milk or the effects it may have on the infant. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Do I need to take Xtandi with food?
Xtandi is typically taken once a day with or without food.
Is Xtandi a chemotherapy drug?
No, Xtandi is an androgen receptor inhibitor. It is not a chemotherapy drug. It is a type of hormone therapy that works by blocking androgens to slow or stop the growth of prostate cancer cells.
What is the cost of Xtandi?
The average cost for #120, 40mg tablets or capsules of Xtandi is over $13,000.
Is there a generic for Xtandi?
Currently, there is no generic Xtandi available on the market. However, you can still save on brand-name drugs like Xtandi through NiceRx if eligible for assistance.