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Submitted URL:
http://www.roctavian.com/
Effective URL:
https://www.roctavian.com/en-us/
Submission: On March 01 via manual (March 1st 2024, 1:16:26 pm UTC) from IE — Scanned from DE

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Text Content

This site is intended for use by US residents only.
 * Visit HCP Website
 * Patient Information
 * Important Safety Information
 * Prescribing Information

Connect with us
 * ROCTAVIAN stories
 * Why Roctavian?
   * How ROCTAVIAN works
   * ROCTAVIAN results
   * Safety information
 * Eligibility
   * Is ROCTAVIAN right for you?
   * TREATMENT DISCUSSION
   * CONNECT WITH YOUR REP
 * During & After Treatment
   * Committing to treatment
   * Infusion day
   * After your infusion
 * Support & Events
   * BIOMARIN PATIENT SUPPORT
   * DOWNLOADABLE RESOURCES
   * FAQs
   * CONNECT WITH US

 * Visit HCP Website
 * Patient Information
 * Important Safety Information
 * Prescribing Information

Connect with us
Search

Search this site


ROCTAVIAN: the only approved gene therapy for eligible adults with severe
hemophilia A

ARE YOU ELIGIBLE?

Andrew,
ROCTAVIAN clinical
study participant

MEET ANDREW

Learn about Andrew’s ROCTAVIAN experience and how it started.

hear his story

HOW ROCTAVIAN WORKS

A one-time infusion delivers a working Factor VIII gene into the body.

Watch now

RESULTS ARE IN

Find out how people responded to a one-time infusion of ROCTAVIAN.

see results


UPDATES ON ROCTAVIAN DELIVERED RIGHT TO YOUR INBOX

Sign up to receive the latest information on ROCTAVIAN, including how ROCTAVIAN
works, what to expect before and after treatment, and real patient stories.

All fields marked with an * are required.

*


WANT TO CONNECT WITH A BIOMARIN REPRESENTATIVE?


Yes! Connect me with a local BioMarin representative.




*


PLEASE CONFIRM YOU ARE A US RESIDENT.


I am a US resident.
this site is for US residents only



*
First Name



*
Last Name




*
Email Address



*
Phone Number




*
Zip Code



*
Which best describes you?

Select...I have hemophilia AI care for someone with hemophilia A I am an
advocacy team member None of the above



*
I agree to the terms of use

By checking the box to the left and clicking Submit below, I confirm I am at
least 18 years old; and confirm I agree to BioMarin’s Privacy Policy and CCPA
Notice and Terms of Use; consent to BioMarin, its successors, agents, and/or
assigns using the email address I have provided to keep me informed about news
and developments, market research or surveys, or other opportunities that may be
of interest to me; and confirm I understand these communications/materials may
contain information that markets or advertises BioMarin products, goods, or
services.


*
Use my phone number

By checking the box to the left and clicking Submit below, I consent to
BioMarin, its successors, agents, and/or assigns using the phone number I have
provided to phone and/or text me with communications/messages that contain
information marketing BioMarin’s products, goods, or services, including via use
of an automatic telephone dialing system; and confirm I understand I am not
required to provide my consent as a condition of purchasing or renting any
products, goods, or services.










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THANK YOU FOR REGISTERING. WE’LL BE IN TOUCH SOON.


INDICATION AND IMPORTANT SAFETY INFORMATION



Do not take ROCTAVIAN if you:

 * Have an active infection or if you have a long-term infection that is not
   controlled by the medicines you take
 * Have scarring of the liver (significant liver fibrosis or cirrhosis)
 * Are allergic to mannitol (an inactive ingredient in ROCTAVIAN)

What is the most important information I should know about ROCTAVIAN?

ROCTAVIAN may cause serious side effects during the infusion and afterward:

 * During and in the hours following the infusion, tell your doctor or nurse
   immediately about any symptoms you experience, including hives or other
   rashes, itching, sneezing, coughing, difficulty breathing, runny nose, watery
   eyes, tingling throat, nausea (feeling sick), diarrhea, low blood pressure,
   rapid heartbeat, light-headedness (near-fainting), fever, chills, or
   shivering. Talk to your doctor about what to do if you experience any side
   effects after you leave the infusion
 * Before and regularly following administration of ROCTAVIAN, your doctor will
   perform blood tests to check your liver health. Make sure you obtain these
   blood tests during the specified time your doctor instructs you to. Based on
   your liver test results, you may need to take corticosteroids or another
   medicine for a period of time (several months or longer) to help decrease
   liver enzyme levels, which may cause side effects while you receive them.
   Talk to your doctor about these side effects and what you need to do to
   improve and maintain your liver’s health
 * Patients with active Factor VIII inhibitors should not take ROCTAVIAN.
   Following administration your doctor will monitor you for inhibitors and you
   will have regular factor level testing. Talk to your doctor if you start
   bleeding following ROCTAVIAN, in order for your doctor to assess the need for
   additional tests or treatments
 * Depending on your risk factors, an improvement in Factor VIII levels may mean
   an increased possibility of unwanted blood clots (so called “thromboses,” in
   either veins or arteries). You and your doctor should discuss your risk
   factors before and after treatment and how to recognize symptoms of unwanted
   clots and what to do if you think you may have one
 * ROCTAVIAN can insert itself into the DNA of human body cells. The effect that
   insertion may have on those cells is unknown, but such events may contribute
   to a theoretical risk of cancer. There have been no reported cases of cancer
   caused by treatment with ROCTAVIAN. Your doctor may perform regular
   monitoring if you have pre-existing risk factors for developing liver cancer.
   In the event of cancer, your doctor may send a sample to BioMarin
   Pharmaceutical Inc. for further testing

What should I tell my doctor before I get ROCTAVIAN?

Talk to your doctor about the following:

 * Your medical conditions including
   * Any general risk factors for unwanted blood clots and for cardiovascular
     disease
   * If your immune system’s ability to fight infections is reduced
   * If you have inhibitors or a history of inhibitors to Factor VIII
 * All medicines you take or new medicines you plan to take, including
   prescription and nonprescription drugs, vitamins, herbal supplements, and
   vaccines
 * If you have a female partner that plans to become pregnant within 6 months of
   treatment

What should I avoid after taking ROCTAVIAN?

 * Avoid alcohol use for the first year. Talk to your doctor about how much
   alcohol may be acceptable after the first year
 * You and any female partner must prevent becoming pregnant for 6 months.
   Discuss with your doctor which methods of contraception are suitable
 * Do not donate semen for at least 6 months after treatment
 * Do not donate blood, organs, tissues, or cells

What are the possible side effects of ROCTAVIAN?

 * The most common side effects of ROCTAVIAN are:
   * Nausea, fatigue, headache, infusion-related reactions, vomiting, and
     abdominal pain
   * Changes to laboratory results from blood tests that measure your liver
     health and other ways your body is responding to ROCTAVIAN

What other information should I know before getting ROCTAVIAN?

 * Receiving gene therapy again in the future: ROCTAVIAN is a one-time
   treatment. Currently, treatment with ROCTAVIAN means you cannot receive
   another gene therapy for hemophilia
 * Hemophilia treatment registry: After treatment with ROCTAVIAN, you will be
   asked to enroll in a 15-year registry to help study the long-term safety of
   the treatment and how well it continues to work
 * Understanding the risks and benefits of ROCTAVIAN: While the majority of
   patients experience a benefit from ROCTAVIAN, the treatment response and
   duration may vary. Some patients do not experience a benefit from ROCTAVIAN.
   It is not possible to predict if and how much a patient may benefit. After
   administration, your doctor will monitor your lab tests and talk to you about
   whether you can stop prophylaxis, whether you should start prophylaxis again,
   and whether and how you should treat any surgeries, procedures, injuries, or
   bleeds

Talk to your doctor about the potential risks and benefits of ROCTAVIAN. Whether
a patient experiences a benefit or not, the risks discussed here and with your
doctor still apply.

 

These are not all the possible side effects of ROCTAVIAN. Talk to your doctor
for medical advice about side effects. You may report side effects to BioMarin
Pharmaceutical Inc. at 1-866-906-6100 or FDA at 1-800-FDA-1088.

 

Please see additional safety information in the Prescribing Information and
Patient Information.

What is ROCTAVIAN?

ROCTAVIAN is a one-time gene therapy used for the treatment of adults with
severe hemophilia A who do not have antibodies to the virus, AAV5 which is
determined by a blood test. ROCTAVIAN uses a modified virus, called a vector, to
deliver a working copy of the Factor VIII gene to liver cells to enable your
body to produce clotting factor on its own, which helps the blood to clot and
prevents or reduces the occurrence of bleeding. The modified virus does not
contain viral DNA and does not cause disease in humans.


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