medicationsxtandiXtandi dosage

Xtandi Dosage, forms & strengths

Jamie Winn, PharmD
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Medically reviewed by  Jamie Winn, PharmD

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Xtandi (enzalutamide) is an anti-androgen medication that is manufactured by Astellas Pharma US, Inc. It is an expensive tablet or capsule taken by mouth once a day. Xtandi is FDA-approved to treat adults with non-metastatic castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is not approved to treat pediatric patients under the age of 18.

How does Xtandi work?

Certain types of prostate cancer are dependent on androgen hormones such as testosterone to survive. Xtandi is an androgen receptor inhibitor that blocks androgen from binding to their androgen receptors. This inhibits the effects of testosterone on prostate cancer cells. Without testosterone, these prostate cancer cells cannot grow, even if has spread to other parts of the body (metastasis).

Xtandi dosage forms and strengths

  • 40 mg capsules
  • 40 mg tablets
  • 80 mg tablets

Xtandi dosage

The recommended daily dose of Xtandi is 160mg. It is taken by mouth once a day, with or without food. You should take Xtandi along with a gonadotropin-releasing hormone (GnRH) analog if you have not had surgery to remove both testicles (bilateral orchiectomy).

The concomitant use of strong CYP2C8 inhibitors with Xtandi is not recommended. If the coadministration of these medications can’t be avoided, your doctor should reduce your Xtandi dose to 80mg once daily. If you stop taking the strong inhibitor, your Xtandi dose should be increased back to your original dose.

The concomitant use of strong CYP3A4 inducers with Xtandi is also not recommended. If you must take these medications together, your doctor should increase your Xtandi dose from 160mg to 240mg once daily. If you stop taking the strong inducer, your Xtandi dose should be decreased back to your original dose.

Xtandi dosage restrictions

There are no dose adjustments recommended for patients with mild to moderate renal or hepatic impairment. Xtandi use has not been evaluated in patients with severe renal impairment or end-stage renal disease.

How to take Xtandi

  • Read the Full Prescribing Information, Patient Information, and Medication Guide that comes with this medication.
  • Take this medication exactly as it is prescribed to you. Do not change your dose or discontinue this medication without talking with them first.
  • Xtandi is taken by mouth once a day, at the same time each day. You can take this medication 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 Xtandi, take the missed dose as soon as you remember that day. If you forget your dose for the whole day, take your scheduled dose the next day. Do not take extra doses of Xtandi to make up for any 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.

Xtandi dosage FAQs

What are the most common possible side effects of Xtandi?

Some common side effects of Xtandi in clinical trials when compared to placebo include:

  • Fatigue/asthenia
  • Hot flushes
  • Back pain
  • Constipation
  • High blood pressure (hypertension)
  • Musculoskeletal pain
  • Decreased appetite
  • Diarrhea
  • Peripheral edema
  • Itchy, dry skin

Xtandi can sometimes cause more serious side effects, including:

  • Severe hypersensitivity reactions (hives, angioedema, and shortness of breath)
  • Posterior reversible encephalopathy syndrome (PRES)
  • Increased risk of falls and fractures
  • Increased risk of seizures
  • Loss of consciousness
  • Ischemic heart disease

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.

What drug interactions occur with Xtandi?

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 enzyme inhibitors such as gemfibrozil
  • Strong CYP3A4 enzyme inducers such as St. John’s Wort
  • CYP2C19 substrates such as omeprazole
  • CYP2C9 substrates such as warfarin
  • Sorafenib
  • Erlotinib
  • Tacrolimus
  • Rifampin
  • Midazolam

Are there any contraindications or precautions with Xtandi?

Xtandi should not be taken if you have a known hypersensitivity to enzalutamide or any inactive ingredients in Xtandi. You should also let your doctor know if you have a history of seizures, stroke, heart disease, brain tumors, uncontrolled cholesterol levels, are pregnant, plan on becoming pregnant, or are breastfeeding.

Can you take Xtandi while you are pregnant or breastfeeding?

Based on animal reproductive studies and Xtandi’s mechanism of action, this medication may cause fetal toxicity and loss of pregnancy. Male patients taking Xtandi should use an effective form of contraception during treatment and for 3 months after their last dose. Male patients should also wear a condom if having sex with a pregnant woman.

It is not known if Xtandi is found in breast milk or the effects it may have on the infant during lactation. 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.

Does Xtandi lower your prostate-specific antigen (PSA)?

PSA is a protein made in the prostate gland. PSA levels are increased when you have prostate problems such as cancer. Treatment with Xtandi has been shown to decrease PSA levels in patients with advanced prostate cancer. It also improves the overall survival rate.

How long does Xtandi stay in your system?

Clinical studies determined that the half-life of Xtandi is almost 6 days in metastatic CRPC patients after a single 160mg dose. That means Xtandi can stay in your bloodstream for up to 30 days after you discontinue treatment.

What is the maximum dose of Xtandi?

The maximum recommended dose of Xtandi is 240mg once daily in patients taking strong CYP3A4 inducers such as Dilantin (phenytoin).

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The content on this website is intended for information purposes only. It does not constitute medical advice. The information on this website should not be relied upon and is not a substitute for professional medical advice. You should always speak to your doctor regarding the risks and benefits of any treatment.