Newer Prostate Cancer Treatments: Zytiga and Xtandi

Zytiga and Xtandi 

Zytiga or Xtandi are both are good options to treat pre-chemo castration resistant prostate cancer. It will depend on safety profiles and the need of using steroid with Zytiga but not for Xtandi. 

Discuss further with your oncologist to select which one is the best for you.


How Does XTANDI work?
https://www.xtandi.com/how-xtandi-works

Imagine the inside of a prostate cancer cell as a puzzle

Prostate cancer cell
When androgens connect with androgen receptors, they may cause the tumor cells to grow.

Prostate Cancer Cell

XTANDI in a prostate cancer cell
Decreasing how often androgens can connect with androgen receptors may reduce tumor growth.

Xtandi in a Prostate Cancer Cell

This is how XTANDI was shown to work in laboratory studies.
As a result, the cancer cells may die and the prostate tumor may stop growing.
To see how XTANDI works, watch the XTANDI video. Go  
Who is XTANDI for? XTANDI is a prescription medicine used to treat men with prostate cancer that no longer responds to a medical or surgical treatment that lowers testosterone and that has spread to other parts of the body. (This is a type of advanced prostate cancer.)
Important Safety Information
Who should not take XTANDI? XTANDI is not for use in women. Do not take XTANDI if you are pregnant or may become pregnant. XTANDI can harm your unborn baby. It is not known if XTANDI is safe and effective in children.
Before you take XTANDI, tell your healthcare provider if you:
  • Have a history of seizures, brain injury, stroke or brain tumors.
  • Have any other medical conditions.
  • Have a partner who is pregnant or may become pregnant. Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with XTANDI. If your sexual partner may become pregnant, a condom and another form of birth control must be used during and for 3 months after treatment. Talk with your healthcare provider if you have questions about birth control. See “Who should not take XTANDI?”
  • Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. You should not start or stop any medicine before you talk with the healthcare provider that prescribed XTANDI.
How should I take XTANDI?
  • Take XTANDI exactly as your healthcare provider tells you.
  • Take your prescribed dose of XTANDI one time a day, at the same time each day.
  • Your healthcare provider may change your dose if needed.
  • Do not change or stop taking your prescribed dose of XTANDI without talking with your healthcare provider first.
  • XTANDI can be taken with or without food.
  • Swallow XTANDI capsules whole. Do not chew, dissolve, or open the capsules.
  • If you miss a dose of XTANDI, take your prescribed dose as soon as you remember that day. If you miss your daily dose, take your prescribed dose at your regular time the next day. Do not take more than your prescribed dose of XTANDI in one day.
  • If you take too much XTANDI, call your healthcare provider or go to the nearest emergency room right away. You may have an increased risk of seizure if you take too much XTANDI.
What are the possible side effects of XTANDI?
XTANDI may cause serious side effects including:
  • Seizure. If you take XTANDI you may be at risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure. Your healthcare provider will stop XTANDI if you have a seizure during treatment.
  • Posterior Reversible Encephalopathy Syndrome (PRES). If you take XTANDI you may be at risk of developing a condition involving the brain called PRES. Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your healthcare provider will do a test to check for PRES. Your healthcare provider will stop XTANDI if you develop PRES.
The most common side effects of XTANDI include weakness or feeling more tired than usual, back pain, decreased appetite, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet, shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and a feeling that you or things around you are moving or spinning (vertigo).
XTANDI may cause infections, falls and injuries from falls. Tell your healthcare provider if you have signs or symptoms of an infection or if you fall.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XTANDI. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the Full Prescribing Information for complete prescribing information.

The effectiveness of XTANDI was proven in 2 global clinical studies
 

PREVAIL Earth Icon AFFIRM
The PREVAIL study included 1,717 patients who:

  • Had prostate cancer that had spread to other parts of the body
  • Were no longer responding to a medical or surgical treatment to lower their testosterone
  • Had not received chemotherapy
The AFFIRM study included 1,199 patients who:

  • Had prostate cancer that had spread to other parts of the body
  • Were no longer responding to a medical or surgical treatment to lower their testosterone
  • Had previously received treatment with docetaxel, a type of chemotherapy
Patients taking XTANDI who were already receiving hormone therapy injections continued to do so during these studies. Patients not taking XTANDI also received hormone therapy injections.
    Abiraterone acetate (Zytiga)
    Prescription drug
    Consult a doctor if you have a medical concern.
    Brand nameZytiga
    Molar mass349.509 g/mol
    Pregnancy riskCategory X (Should not be used during pregnancy)

Every day tells a story.

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ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate drug. In a CYP2C8 drug interaction trial in healthy subjects, the AUC of pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a single dose of ZYTIGA®. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA®
Important Safety Information
Contraindications – ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.
Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess – Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI) – AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.
Hepatotoxicity – Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.
Increased ZYTIGA® Exposures with Food – ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least 2 hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA®is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.
Adverse Reactions –The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.
The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.
Drug Interactions – Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA® treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA® dosing frequency only during the co-administration period [see Dosage and Administration (2.3)]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate drug. In a CYP2C8 drug interaction trial in healthy subjects, the AUC of pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a single dose of ZYTIGA®. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA®.
Use in Specific Populations – Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).
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