XTANDI® (enzalutamide) capsules | XTANDI access services

XTANDI Access Services^SM

Flexible and integrated resources for patient access and support*

Covers the needs of patients with private insurance and Medicare, as well as uninsured patients
Physician can send prescription direct to specialty pharmacy provider, HUB services, or self-dispense
Provides patient benefit verification and support with prior authorization and appeal assistance

XTANDI Patient Savings Program

Co-pay assistance for the privately insured: Covers patient's cost-sharing obligation beyond $20 per prescription. Maximum benefit of up to $12,000 per year^†
Enrollment is easy: Preferred XTANDI specialty pharmacy and XTANDI Access Services manage the enrollment process and answer questions
One-time enrollment per year

Referral to independent co-pay foundations

Insurance type doesn't affect eligibility: private insurance, Medicare, Medicaid, Tricare, or others
Funding can be used for deductibles, co-pays, Medicare Part D coverage gaps, etc

*Eligibility differs by program.

^†Income eligibility rules apply and void where prohibited by law. The program is not valid if patients have coverage under Medicare (including Medicare Part D), Medicaid or Medicare Advantage, Tricare, CHAMPUS, Puerto Rico government health insurance or any other federal– or state–funded pharmaceutical benefit program.

XTANDI Quick Start+^TM Program

One-time, 14-day free supply of XTANDI if a coverage determination has not been made by the health plan within 7 business days
XTANDI will be shipped directly to the patient's home

Astellas Access Program^SM enables eligible uninsured patients to gain access to XTANDI without cost.

Get more information at
XTANDI Access Services now.

CALL: 1-855-8XTANDI

(1-855-898-2634)

Fax: 1-855-982-6341

(9 am to 8 pm Eastern time
Monday through Friday) or visit

XtandiAccess.com

Indication

XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.

Important Safety Information

Contraindications XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure. Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

Adverse Reactions The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% grade 3-4) and in 6% of patients on placebo (no grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI

patients and 2% of patients on placebo. One percent of XTANDI patients compared to 0.3% of patients on placebo died from infections or sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI patients vs 1.3% of patients on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% of patients on placebo, with the majority on opioid-containing medications at the time of the event.

Drug Interactions: Effect of Other Drugs on XTANDI Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Coadministration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If coadministration of XTANDI cannot be avoided, reduce the dose of XTANDI. Coadministration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible. Effect of XTANDI on Other Drugs XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is coadministered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information for complete safety information.

XTANDI Access Services^SM

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Indication

Important Safety Information

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Indication

Important Safety Information

Reference

XTANDI Access ServicesSM

Interactive Overview ofXtandi

Links andDownloads

Registerfor Updates

Indication

Important Safety Information

Reference

Indication

Important Safety Information

Reference

XTANDI Access Services^SM

Interactive
Overview of
Xtandi

Links and
Downloads

Register
for Updates