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Terms & Conditions

See below for BioMarin’s Terms of Use. For other region/country versions, please select from the dropdown menu.

Terms Of Use

Effective Date: October 1, 2018

These Terms of Use (“Terms”) govern your access to and use of the websites and online services that we operate and that link to these Terms, as well as our offline services that reference these Terms (collectively, the “Services”).

Please review these Terms carefully before using the Services because they are a legal contract between you and BioMarin Pharmaceutical Inc. (“BioMarin,” “we,” “us,” or “our”). By using the Services, you agree to be bound by and comply with these Terms. We may change these Terms or modify any features of the Services at any time. The most current version of the Terms can be viewed by clicking on the “Terms of Use” link posted through the Services. You accept the Terms by using the Services, and you accept any changes to the Terms by continuing to use the Services after we post the changes.

Privacy Notice

For more information on how BioMarin processes your personal information, and your rights regarding your personal information, please see our Privacy Notice.

Prohibited Conduct

You may not access or use, or attempt to access or use, the Services to take any action that could harm us or any third party, interfere with the operation of the Services, or in a manner that violates any law(s). For example, and without limitation, you may not:

  • Impersonate any person or entity or falsely state or otherwise misrepresent your affiliation with any person or entity or the origin of any information you provide;
  • Engage in unauthorized spidering, scraping, or harvesting of content or personal information, or use any other unauthorized automated means to compile information;
  • Obtain or attempt to gain unauthorized access to other computer systems, materials, information, or any services available on or through the Services;
  • Use any device, software, or routine to interfere or attempt to interfere with the proper working of the Services or any activity conducted on the Services or attempt to probe, scan, test the vulnerability of, or breach the security of any system or network;
  • Circumvent, reverse engineer, decipher, decompile, disassemble, decrypt, or otherwise alter or interfere with (or attempt, encourage, or support anyone else’s attempt to engage in such activities) any of the software comprising or in any way making up a part of the Services. The use or distribution of tools designed for compromising security (e.g., password guessing programs, cracking tools or network probing tools) is strictly prohibited;
  • Take any action that imposes an unreasonable or disproportionately large load on our network or infrastructure;
  • Upload or otherwise transmit any communication, software, or material that contains a virus or is otherwise harmful to BioMarin’s or its users’ computers or systems;
  • Send or cause to be sent any communication (including e-mail) to other users without their consent (e.g., “mailbombs” or “spamming”);
  • Cause damage, embarrassment, or adverse publicity to BioMarin; or
  • Engage in any other conduct that restricts or inhibits any person from using or enjoying the Services, or that, in our sole judgment, exposes us or any of our users, affiliates, or any other third party to any liability, damages, or detriment of any type.

Violations of system or network security may result in civil or criminal liability. We may investigate and work with law enforcement authorities to prosecute users who violate the Terms. We may suspend or terminate your access to the Services for any or no reason at any time without notice.

Medical Disclaimers

The Services and any information or content provided therein are for informational and educational purposes only and are not a substitute for the professional judgment of a health care professional in diagnosing and treating patients. BioMarin does not give medical advice, nor does it provide medical or diagnostic services. Your reliance upon any content or information provided through the Services is solely at your own risk.

User Content and Communications

You remain fully responsible for the materials that you provide to us, including, without limitation, information, stories, requests, creative works, pictures, photographs, letters, documents, demos, ideas, suggestions, reviews, concepts, methods, systems, designs, plans, techniques, or other materials submitted, posted, uploaded, sent, or otherwise transmitted to us (“User Content”). You agree not to provide User Content that:

  • Infringes on the copyright, trademark, patent, or other intellectual property right of any third party;
  • Is false, misleading, libelous, defamatory, obscene, abusive, hateful, or sexually-explicit;
  • Violates a third party’s right to privacy or publicity;
  • Degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability, or other classification;
  • Contains epithets or other language or material intended to intimidate or to incite violence;
  • Contains a virus, worm, Trojan Horse, time bomb, or any other harmful program or component;
  • Contains any commercial material or solicits any funds (charitable or commercial), perpetuates chain letters or pyramid schemes, promotes commercial entities, or otherwise engages in commercial activity; or
  • Violates any applicable local, state, national, or international law, or advocates illegal activity.

You may only post User Content that is original and that you have the right to post. By submitting User Content, you grant us a royalty-free, irrevocable, perpetual, non-exclusive, worldwide, fully sublicensable license to publish, reproduce, distribute, display, perform, edit, adapt, modify, translate, create derivative works from, make, sell, export, and otherwise use your User Content (or any portion thereof) in any way that we want and in any form, media, or technology now known or later developed. You hereby waive any moral rights you may have in your User Content. You represent that you have obtained all necessary permissions, including the right to use an individual’s likeness in our advertising and marketing activities, from any individuals identified in or implicated by your submission (including those shown in photographic content), and, in the case of minors, also from their parents or legal guardians, as appropriate.

We are not obligated to publish or use your User Content. BioMarin is not in any manner endorsing the User Content and cannot, and will not, vouch for its reliability. We do not guarantee any confidentiality with respect to any User Content. Please do not send us any confidential or proprietary information or material.

BioMarin is not responsible for any User Content and has no duty to monitor the User Content posted on the Services. You use any information contained in User Content at your own risk.

BioMarin and its designees have the right, in their sole discretion, to monitor, review, edit, remove, delete, disable, refuse, restrict, or terminate access to your User Content or the Services (in whole or in part) at any time, without prior notice and in our sole discretion, for any or no reason. The obligations that you have to us under these Terms shall survive termination of the Services, any use by you of the Services, any User Content on the Services, or these Terms. You will not continue to post any User Content that BioMarin has previously advised you not to post.

Eligibility and Registration

You may be asked to register for certain activities in connection with the Services by creating a user profile. This registration may allow you to participate in interactive features of the Services, such as forums or discussion boards or to enter sweepstakes and contests. When you register, you agree to provide accurate, current, and complete information about yourself as requested or directed on the Services and to promptly update this information to maintain its accuracy. BioMarin has the right to suspend or terminate any account or other registration and to refuse any and all current or future use of the Services if it suspects that such information is inaccurate or incomplete. You are responsible for maintaining the confidentiality of any password and username that you are given or select in connection with the Services, and you are responsible for all activities that occur under your password or account.

Intellectual Property

The Services are protected under the copyright, trademark, and other intellectual property laws of the United States and other countries. All intellectual property rights in the Services are owned by us or our third-party licensors to the full extent permitted under U.S. and international intellectual property laws. Except for content that you have posted on the Services, you may not publish, reproduce, distribute, display, perform, edit, adapt, modify, or otherwise exploit any part of the Services, including the BioMarin name and logo, without our written consent. You may provide a link to the top page of the Services unless and until BioMarin gives notice that you must discontinue linking to the Services.

We respect intellectual property rights. If you believe in good faith that your work has been reproduced or is accessible on the Services in a way that constitutes copyright infringement, please provide our designated agent with the following information in writing:

  • An electronic or physical signature of the person authorized to act on behalf of the owner of the exclusive right that is allegedly infringed;
  • Identification of the copyrighted work or a representative list of the works claimed to have been infringed;
  • Identification of the allegedly infringing material and information reasonably sufficient to permit us to locate the material;
  • Your name, address, telephone number, and email address, so that BioMarin may contact you if necessary;
  • A statement that you have a good faith belief that the disputed use is not authorized by the copyright owner, its agent, or the law; and
  • A statement by you, made under penalty of perjury, that the above information in your notice is accurate and that you are the copyright owner or authorized to act on the copyright owner's behalf.

BioMarin’s designated agent for notice of claims of alleged copyright infringement is:

Eric Davis
Copyright Agent
105 Digital Drive
Novato, CA 94949
Phone: (415) 506-6700
edavis@bmrn.com

If you believe that a user of the Services is a repeat infringer, please contact BioMarin’s designated agent, as described above, and provide enough information for us to verify that the individual is a repeat infringer. Please note that United States law provides significant penalties for falsely submitting a notice of copyright infringement.

Third-Party Content and Links to Third-Party Websites

The Services may contain links to third-party content. We do not control, endorse, sponsor, recommend, or otherwise accept responsibility for such content. Use of any linked third-party content is at the user's own risk.

Disclaimer of Warranties

YOUR USE OF THE SERVICES IS AT YOUR OWN RISK. WE MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE OPERATION OF THE SERVCES OR THE INFORMATION, MATERIALS, GOODS, OR SERVICES APPEARING OR OFFERED ON THE SERVICES, ALL OF WHICH ARE PROVIDED "AS IS."

WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY (1) WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE; (2) WARRANTIES AGAINST INFRINGEMENT OF ANY THIRD-PARTY INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS; (3) WARRANTIES RELATING TO THE TRANSMISSION OR DELIVERY OF THE SERVICES; (4) WARRANTIES RELATING TO THE ACCURACY, RELIABILITY, CORRECTNESS, OR COMPLETENESS OF DATA MADE AVAILABLE ON THE SERVICES OR OTHERWISE BY BIOMARIN; (5) WARRANTIES OTHERWISE RELATING TO PERFORMANCE, NONPERFORMANCE, OR OTHER ACTS OR OMISSIONS BY BIOMARIN OR ANY THIRD PARTY; AND (6) WARRANTY OF TITLE. FURTHER, THERE IS NO WARRANTY THAT THE SERVICES WILL MEET YOUR NEEDS OR REQUIREMENTS OR THE NEEDS OR REQUIREMENTS OF ANY OTHER PERSON.

WE MAKE NO WARRANTIES, EXPRESS OR IMPLIED, (1) THAT THE SERVICES OR ANY EMAIL WE SEND YOU IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS THAT MAY INFECT YOUR COMPUTER EQUIPMENT OR OTHER PROPERTY BECAUSE OF YOUR ACCESS TO, USE OF, OR BROWSING ON THE SERVICES OR YOUR DOWNLOADING OF ANY MATERIALS, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE SERVICES; OR (2) THAT THE SERVICE, WEBSITE CONTENT, FUNCTIONS, OR MATERIALS CONTAINED THEREIN WILL BE TIMELY, SECURE, ACCURATE, COMPLETE, UP-TO-DATE, OR UNINTERRUPTED. BIOMARIN DOES NOT NECESSARILY ENDORSE, SUPPORT, SANCTION, ENCOURAGE, OR AGREE WITH ANY WEBSITE CONTENT OR ANY SUBMITTED MATERIALS, AND WE EXPRESSLY DISCLAIM ANY AND ALL LIABILITY IN CONNECTION WITH USER CONTENT, INCLUDING LINKS TO OR CONTENT CONTAINED ON THIRD-PARTY WEB SITES.

IF APPLICABLE LAW DOES NOT ALLOW THE EXCLUSION OF SOME OR ALL OF THE ABOVE WARRANTIES TO APPLY TO YOU, THE ABOVE EXCLUSIONS WILL APPLY TO YOU TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.

Limitation of Liability

UNDER NO CIRCUMSTANCES, INCLUDING NEGLIGENCE, WILL BIOMARIN, ITS AFFILIATES, OR ANY PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SERVICES BE LIABLE FOR DAMAGES OR LOSSES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR PUNITIVE DAMAGES AND LOST PROFITS, ARISING OUT OF YOUR ACCESS, USE, MISUSE, OR INABILITY TO USE THE SERVICES, WEBSITE CONTENT, USER CONTENT, OR ANY LINKED SITES, HOWEVER CAUSED, WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, EVEN IF BIOMARIN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR IN CONNECTION WITH ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, DEFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, OR LINE OR SYSTEM FAILURE. BIOMARIN WILL NOT BE A PARTY TO, AND WILL HAVE NO RESPONSIBILITY OR LIABILITY FOR, ANY TRANSACTION NEGOTIATED OR ARRANGED BY A USER ARISING IN CONNECTION WITH THE SERVICES. IN THE EVENT THAT YOU HAVE A DISPUTE WITH ANOTHER USER RELATED TO, ARISING FROM, OR IN ANY WAY CONNECTED WITH USE OF THE SERVICES, YOU RELEASE BIOMARIN FROM ANY CLAIMS, DEMANDS, AND DAMAGES OF EVERY KIND AND NATURE ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH A DISPUTE. BIOMARIN HAS NO OBLIGATION TO BECOME INVOLVED IN ANY DISPUTE BETWEEN A USER AND ANY OTHER PERSON.

THESE LIMITATIONS APPLY WHETHER THE ALLEGED LIABILITY IS BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR ANY OTHER BASIS, EVEN IF BIOMARIN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, BIOMARIN’S LIABILITY IN SUCH JURISDICTIONS SHALL BE LIMITED TO THE EXTENT PERMITTED BY LAW. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BIOMARIN DISCLAIMS ALL LIABILITY OF ANY KIND ARISING FROM THE UNAUTHORIZED ACCESS TO OR USE OF YOUR INFORMATION.

IF YOU ARE DISSATISFIED WITH THE SERVICES, YOUR SOLE REMEDY IS TO STOP USING THE SERVICES.

Indemnification

You agree to defend, indemnify, and hold harmless BioMarin and its affiliates, subsidiaries, parent companies, successors, officers, directors, employees, contractors, services providers, and agents from and against any and all demands, claims, damages, liabilities, judgments, losses, costs, expenses, and harms, including, but not limited to, reasonable attorneys’ fees, arising in connection with your use of the Services (including, without limitation, your User Content), online conduct, any violation of these Terms, or dealings or transactions with other persons resulting from use of the Services.

Applicable Law; Jurisdiction

These Terms are governed by, and must be construed in accordance with, the laws of the United States and the State of California, as applicable, without giving effect to their principles of conflicts of law. By using the Services, you waive any claims that may arise under the laws of other countries or territories.

With respect to any and all disputes arising out of or in connection with the Services or these Terms (including, without limitation, the Privacy Notice), BioMarin and you agree to negotiate in good faith and undertake reasonable efforts to cooperate with one another in order to achieve a mutually satisfactory resolution. If you and BioMarin do not resolve any dispute by informal negotiation, any other effort to resolve the dispute will be conducted exclusively by binding arbitration as described in this section. You are giving up the right to litigate (or participate in as a party or class member) all disputes in court before a judge or jury. Instead, all disputes will be resolved before a neutral arbitrator, whose decision will be final except for a limited right of appeal under the Federal Arbitration Act. Any court with jurisdiction over the parties may enforce the arbitrator’s award.

Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor BioMarin will seek to have any dispute heard as a class action or in any other proceeding in which either party acts or proposes to act in a representative capacity. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings.

BioMarin and you agree that all disputes arising under these Terms that cannot be settled through informal negotiation will be settled exclusively through confidential binding arbitration in San Francisco, California, or another forum mutually agreed upon by the parties, pursuant to the Rules of Arbitration (“Rules”) of the International Chamber of Commerce (“ICC”) by a sole arbitrator nominated by agreement of the parties and confirmed in accordance with said Rules. The arbitrator's award shall be binding and may be entered as a judgment in a court of competent jurisdiction. You agree that BioMarin is entitled to obtain preliminary injunctive relief to the extent allowed by law to enforce any of the terms of these Terms pending a final arbitral decision.

To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute isn't filed within one year, it is permanently barred.

If any other provision of this section is found to be illegal or unenforceable, that provision will be severed, with the remainder of this section remaining in full force and effect.

Separate Terms and Conditions

In connection with your use of the Services, you may be asked to consent to policies or terms and conditions in addition to these Terms. Please read these supplemental policies and terms carefully before making any use of such portions of the Services. Any supplemental terms will not vary or replace these Terms regarding any use of the Services, unless otherwise expressly stated.

Access Outside the United States

BioMarin makes no claim that the Services are appropriate for access or use outside the U.S. Your access and use of the Services outside the U.S. are at your own risk, and you are responsible for compliance with the laws of your jurisdiction.

Miscellaneous

These Terms constitute the entire agreement between BioMarin and you, superseding any prior or contemporaneous communications and proposals (whether oral, written or electronic) between you and us. In the event any provision of these Terms is held unenforceable, it will not affect the validity or enforceability of the remaining provisions and will be replaced by an enforceable provision that comes closest to the intention underlying the unenforceable provision. You agree that no joint venture, partnership, employment, or agency relationship exists between you and BioMarin as a result of these Terms or your access to and use of the Services.

Our failure to enforce any provisions of these Terms or respond to a violation by any party does not waive our right to subsequently enforce any terms or conditions of the Terms or respond to any violations. Nothing contained in these Terms is in derogation of our right to comply with governmental, court, and law enforcement requests or requirements relating to your use of the Services or information provided to or gathered by us with respect to such use.

Contact Information

If you believe that someone has violated these Terms, if you have questions regarding these terms, or if you have questions regarding the Services, please notify us by completing the form found here or by telephone at (415) 506-6700.

Important Safety Information
WARNING: RISK OF ANAPHYLAXIS
INFORMACIÓN IMPORTANTE DE SEGURIDAD
ADVERTENCIA: RIESGO DE ANAFILAXIS

Important Safety Information

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

PALYNZIQ can cause a severe allergic reaction (anaphylaxis) that may be life threatening and can happen any time during treatment with PALYNZIQ.

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) is a prescription medication used to lower blood levels of phenylalanine (Phe) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

Severe allergic reactions are a serious but common side effect of PALYNZIQ.

  • You will receive your first injection of PALYNZIQ in a healthcare setting where you will be closely watched for at least 1 hour after your injection for a severe allergic reaction
  • Your healthcare provider will prescribe auto-injectable epinephrine for you, and will teach you (or your caregiver) and your observer, if needed, when and how to use it if you have a severe allergic reaction
  • If you have a severe allergic reaction during treatment with PALYNZIQ, you will need to receive an injection of epinephrine immediately and get emergency medical help right away
  • Your healthcare provider will decide if you (or your caregiver) are able to give the PALYNZIQ injections, recognize the signs and symptoms of a severe allergic reaction, give an injection of epinephrine, and call for emergency help, if needed
  • Your healthcare provider may recommend that an adult observer (or your caregiver) be with you when you give your PALYNZIQ injection and for at least 1 hour after your injection to watch you for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of epinephrine and call for emergency medical help

Stop injecting PALYNZIQ and get emergency medical care right away if you have any of the following symptoms:

  • Fainting (passing out)
  • Dizziness or lightheadedness
  • Sudden confusion
  • Trouble breathing or wheezing
  • Chest discomfort or chest tightness
  • Fast heart rate
  • Swelling of your face, lips, eyes, or tongue
  • Throat tightness
  • Flushed skin
  • Skin rash, itching, or raised bumps on skin
  • Nausea, vomiting, or diarrhea
  • Losing control of urine or stools
 

Keep the auto-injectable epinephrine with you at all times during treatment with PALYNZIQ. Read the Patient Information that comes with the auto-injectable epinephrine that your healthcare provider prescribes for you for more information.

If you have a severe allergic reaction, do not continue to take PALYNZIQ until you talk with your healthcare provider. Your healthcare provider will tell you if you can continue treatment with PALYNZIQ.

People taking PALYNZIQ have also experienced allergic reactions other than anaphylaxis. Talk to your healthcare provider if you experience any allergic reactions when taking PALYNZIQ.

PALYNZIQ REMS: PALYNZIQ is available only through a restricted program called the PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Talk to your healthcare provider about the PALYNZIQ REMS and how to enroll.

What should I tell my healthcare provider BEFORE starting PALYNZIQ?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before injecting PALYNZIQ, talk to your healthcare provider right away if you cannot or will not use auto-injectable epinephrine to treat a severe allergic reaction. If you are pregnant or plan to become pregnant while taking PALYNZIQ, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ during pregnancy to you and your unborn baby. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the best way to feed your baby if you take PALYNZIQ.

Before injecting PALYNZIQ, read the Medication Guide and Instructions for Use that come with your PALYNZIQ injection.

What should I watch for AFTER starting PALYNZIQ?

PALYNZIQ may cause serious side effects, including:

  • Severe allergic reactions (anaphylaxis)
  • Other allergic reactions to PALYNZIQ can happen during treatment with PALYNZIQ. Contact your healthcare provider right away if you have any of the following symptoms of an allergic reaction including: rash, itching, or swelling of the face, lips, eyes, or tongue. Your healthcare provider may change your dose of PALYNZIQ, stop your treatment with PALYNZIQ for a period of time, or prescribe medicine for you to take before your PALYNZIQ injection to help reduce the symptoms of an allergic reaction

The most common side effects of PALYNZIQ include injection site reactions (such as redness, itching, pain, bruising, rash, swelling, or tenderness), joint pain, headache, skin reactions that spread and last at least 14 days (such as itching, rash, or redness), nausea, stomach pain, vomiting, cough, mouth and throat pain, itching, diarrhea, stuffy nose, feeling very tired, dizziness, anxiety, and low levels of Phe in your blood.

These are not all of the possible side effects of PALYNZIQ. Speak with your healthcare provider right away about any side effects.

Important notes

Blood Phe testing and diet

  • Your healthcare provider will monitor your blood Phe levels during PALYNZIQ treatment
  • Monitor the amount of protein and Phe that you eat or drink. Your healthcare provider may change the amount of protein and Phe you should have in your diet during treatment with PALYNZIQ, depending on the levels of Phe in your blood. Follow your healthcare provider’s instructions about the amount of protein and Phe you should have in your diet

Missed dose

  • If a dose is missed, take your next dose as scheduled and do not take 2 doses of PALYNZIQ to make up for the missed dose

Pregnancy Surveillance Program

  • There is a pregnancy surveillance program for females who take PALYNZIQ during pregnancy, or who become pregnant while receiving PALYNZIQ or within 1 month after their last dose of PALYNZIQ. The purpose of this program is to collect information about the health of you and your baby while taking PALYNZIQ. Talk to your healthcare provider about how you can take part in this program or call BioMarin at 1-866-906-6100

You may report side effects to BioMarin at 1-866-906-6100.

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 full Prescribing Information, including an important warning for risk of anaphylaxis, and the Medication Guide.

US-PAL-00233 0422

US-PAL-000279 0422

US-PAL-00218 0322

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) is a prescription medication used to lower blood levels of phenylalanine (Phe) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

INFORMACIÓN IMPORTANTE DE SEGURIDAD

 

¿Cuál es la información más importante que debo conocer sobre PALYNZIQ?

PALYNZIQ puede causar una reacción alérgica grave (anafilaxia) que podría ser mortal y producirse en cualquier momento durante el tratamiento con PALYNZIQ.

¿Qué es PALYNZIQ?

PALYNZIQ® (pegvaliase-pqpz) es un medicamento de venta bajo receta médica indicado para reducir los niveles sanguíneos de fenilalanina (Phe) en adultos con PKU (fenilcetonuria) que tienen niveles sanguíneos de Phe no controlados mayores de 600 micromol/l (10 mg/dl) con su tratamiento actual. Se le recomienda hablar sobre los posibles beneficios y riesgos de PALYNZIQ con su profesional de atención médica.

Las reacciones alérgicas graves son un efecto secundario serio pero frecuente de PALYNZIQ.

  • Usted recibirá su primera inyección de PALYNZIQ en un entorno médico donde permanecerá bajo atenta vigilancia durante al menos 1 hora después de que se la administren, para poder detectar toda aparición de una reacción alérgica grave.
  • Su profesional de atención médica le recetará epinefrina autoinyectable y les enseñará a usted (o a su cuidador) y a su observador (de ser necesario) cuándo y cómo usarla en caso de que sufra una reacción alérgica grave.
  • Si usted sufre una reacción alérgica grave durante su tratamiento con PALYNZIQ, tendrá que recibir inmediatamente una inyección de epinefrina y conseguir ayuda médica de emergencia enseguida.
  • Su profesional de atención médica decidirá si usted (o su cuidador) es capaz de administrar las inyecciones de PALYNZIQ, reconocer los signos y síntomas de una reacción alérgica grave, administrar una inyección de epinefrina y llamar para solicitar ayuda de emergencia (si es necesario).
  • Su profesional de atención médica podría recomendarle que esté en presencia de un observador (o su cuidador) adulto cuando se administre su inyección de PALYNZIQ y durante al menos 1 hora después de aplicársela; dicha persona deberá estar pendiente de la aparición de signos y síntomas de una reacción alérgica grave y, de ser necesario, administrarle una inyección de epinefrina y llamar para solicitar ayuda médica de emergencia.

Deje de inyectarse PALYNZIQ y consiga inmediatamente ayuda médica de emergencia si presenta cualquiera de los siguientes síntomas:

  • Desmayo (pérdida del conocimiento)
  • Mareos o sensación de aturdimiento
  • Confusión repentina
  • Sibilancias o dificultad para respirar
  • Malestar u opresión en el pecho
  • Frecuencia cardíaca rápida
  • Hinchazón de la cara, los labios, los ojos o la lengua
  • Opresión en la garganta
  • Rubor de la piel
  • Erupción, picazón o ronchas en la piel
  • Náuseas, vómitos o diarrea
  • Pérdida del control de la orina o las heces
 

Tenga consigo la epinefrina autoinyectable en todo momento durante el tratamiento con PALYNZIQ. Para obtener más información, lea la Información del paciente que acompaña a la epinefrina autoinyectable recetada por su profesional de atención médica.

Si usted sufre una reacción alérgica grave, interrumpa el tratamiento con PALYNZIQ hasta que consulte con su profesional de atención médica. Su profesional de atención médica le dirá si puede continuar el tratamiento con PALYNZIQ.

Algunas personas tratadas con PALYNZIQ también han sufrido reacciones alérgicas que no son anafilácticas. Consulte con su profesional de atención médica si sufre alguna reacción alérgica mientras reciba PALYNZIQ.

Programa REMS de PALYNZIQ: PALYNZIQ está disponible únicamente de forma restringida a través del Programa REMS (Estrategia de evaluación y mitigación de riesgos) de PALYNZIQ. Consulte con su profesional de atención médica sobre el Programa REMS de PALYNZIQ y lo que debe hacer para inscribirse.

¿Qué debo decirle a mi profesional de atención médica ANTES de comenzar a recibir PALYNZIQ?

Informe a su profesional de atención médica acerca de todos los medicamentos que use, incluidos los de venta con y sin receta médica, las vitaminas y los suplementos a base de hierbas.

Antes de inyectarse PALYNZIQ, consulte de inmediato con su profesional de atención médica si no puede o no quiere usar epinefrina autoinyectable para tratar una reacción alérgica grave. Si está embarazada o piensa quedar embarazada mientras reciba PALYNZIQ, consulte con su profesional de atención médica para averiguar los riesgos y beneficios que el uso de PALYNZIQ durante el embarazo podría tener para usted y su bebé en gestación. Si usted recibe PALYNZIQ y está amamantando o piensa amamantar, consulte con su profesional de atención médica para saber cuál es la mejor manera de alimentar a su bebé.

Antes de inyectarse PALYNZIQ, lea la Guía del medicamento y las Instrucciones de uso que se adjuntan a la inyección de PALYNZIQ.

¿De qué debo estar pendiente DESPUÉS de comenzar a recibir PALYNZIQ?

PALYNZIQ puede causar efectos secundarios serios,, tales como:

  • Reacciones alérgicas graves (anafilaxia)
  • Durante el tratamiento con PALYNZIQ pueden surgir otras reacciones alérgicas a PALYNZIQ. Comuníquese de inmediato con su profesional de atención médica si tiene alguno de los síntomas siguientes de reacción alérgica: sarpullido, picazón o hinchazón de la cara, los labios, los ojos o la lengua. Su profesional de atención médica podría cambiarle la dosis de PALYNZIQ, interrumpirle el tratamiento con PALYNZIQ durante cierto tiempo o recetarle un medicamento para que lo use antes de su inyección de PALYNZIQ, a fin de ayudar a reducir los síntomas de una reacción alérgica.

Los efectos secundarios más frecuentes de PALYNZIQ comprenden: reacciones en el lugar de la inyección (como enrojecimiento, picazón, dolor, moretones, sarpullido, hinchazón o sensibilidad al tacto); dolor en las articulaciones; dolor de cabeza; reacciones de la piel que se diseminan y duran al menos 14 días (como picazón, sarpullido o enrojecimiento); náuseas; dolor en el estómago, la boca y la garganta; vómitos; tos; picazón; diarrea; congestión nasal; sensación de cansancio extremo; mareos; ansiedad, y bajos niveles sanguíneos de Phe.

Estos no son todos los efectos secundarios posibles de PALYNZIQ. Consulte de inmediato con su profesional de atención médica acerca de cualquier efecto secundario.

Notas importantes

Análisis de Phe sanguínea y la dieta

  • Su profesional de atención médica le monitoreará los niveles sanguíneos de Phe durante el tratamiento con PALYNZIQ.
  • Monitoree la cantidad de proteína y Phe que ingiera con las comidas o bebidas. Según sus niveles sanguíneos de Phe, puede que su profesional de atención médica le cambie la cantidad de proteína y Phe que usted debe ingerir con su dieta durante el tratamiento con PALYNZIQ. Siga las instrucciones de su profesional de atención médica sobre la cantidad de proteína y Phe que debe consumir en su dieta.

Dosis omitida

  • Si omite una dosis, aplíquese la dosis siguiente según el horario programado; no se administre 2 dosis de PALYNZIQ para compensar la dosis omitida.

Programa de vigilancia del embarazo

  • Hay un programa de vigilancia del embarazo para las mujeres que reciban PALYNZIQ durante el embarazo, o que queden embarazadas durante su tratamiento con PALYNZIQ o en el mes siguiente a su última dosis de PALYNZIQ. Este programa tiene la finalidad de recopilar información sobre la salud de la madre y del bebé durante el tratamiento con PALYNZIQ. Si desea averiguar cómo participar en este programa, comuníquese con su profesional de atención médica o llame a BioMarin al 1-866-906-6100.

Podrá notificar los efectos secundarios a BioMarin llamando al 1-866-906-6100.

Se le invita a notificar a la FDA cualquier efecto secundario negativo de los medicamentos de venta bajo receta médica. Visite www.fda.gov/medwatch, o llame al 1-800-FDA-1088.

Consulte la Información de prescripción completa que se adjunta (incluida una importante advertencia sobre el riesgo de anafilaxia) y la Guía del medicamento.

US-PAL-00233 0422

US-PAL-000279 0422

US-PAL-00218 0322

¿Qué es PALYNZIQ?

PALYNZIQ® (pegvaliase-pqpz) es un medicamento de venta bajo receta médica indicado para reducir los niveles sanguíneos de fenilalanina (Phe) en adultos con PKU (fenilcetonuria) que tienen niveles sanguíneos de Phe no controlados mayores de 600 micromol/l (10 mg/dl) con su tratamiento actual. Se le recomienda hablar sobre los posibles beneficios y riesgos de PALYNZIQ con su profesional de atención médica.

Important Safety Information
WARNING: RISK OF ANAPHYLAXIS
INFORMACIÓN IMPORTANTE DE SEGURIDAD
ADVERTENCIA: RIESGO DE ANAFILAXIS

Important Safety Information

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

PALYNZIQ can cause a severe allergic reaction (anaphylaxis) that may be life threatening and can happen any time during treatment with PALYNZIQ.

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) is a prescription medication used to lower blood levels of phenylalanine (Phe) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

Severe allergic reactions are a serious but common side effect of PALYNZIQ.

  • You will receive your first injection of PALYNZIQ in a healthcare setting where you will be closely watched for at least 1 hour after your injection for a severe allergic reaction
  • Your healthcare provider will prescribe auto-injectable epinephrine for you, and will teach you (or your caregiver) and your observer, if needed, when and how to use it if you have a severe allergic reaction
  • If you have a severe allergic reaction during treatment with PALYNZIQ, you will need to receive an injection of epinephrine immediately and get emergency medical help right away
  • Your healthcare provider will decide if you (or your caregiver) are able to give the PALYNZIQ injections, recognize the signs and symptoms of a severe allergic reaction, give an injection of epinephrine, and call for emergency help, if needed
  • Your healthcare provider may recommend that an adult observer (or your caregiver) be with you when you give your PALYNZIQ injection and for at least 1 hour after your injection to watch you for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of epinephrine and call for emergency medical help

Stop injecting PALYNZIQ and get emergency medical care right away if you have any of the following symptoms:

  • Fainting (passing out)
  • Dizziness or lightheadedness
  • Sudden confusion
  • Trouble breathing or wheezing
  • Chest discomfort or chest tightness
  • Fast heart rate
  • Swelling of your face, lips, eyes, or tongue
  • Throat tightness
  • Flushed skin
  • Skin rash, itching, or raised bumps on skin
  • Nausea, vomiting, or diarrhea
  • Losing control of urine or stools
 

Keep the auto-injectable epinephrine with you at all times during treatment with PALYNZIQ. Read the Patient Information that comes with the auto-injectable epinephrine that your healthcare provider prescribes for you for more information.

If you have a severe allergic reaction, do not continue to take PALYNZIQ until you talk with your healthcare provider. Your healthcare provider will tell you if you can continue treatment with PALYNZIQ.

People taking PALYNZIQ have also experienced allergic reactions other than anaphylaxis. Talk to your healthcare provider if you experience any allergic reactions when taking PALYNZIQ.

PALYNZIQ REMS: PALYNZIQ is available only through a restricted program called the PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Talk to your healthcare provider about the PALYNZIQ REMS and how to enroll.

What should I tell my healthcare provider BEFORE starting PALYNZIQ?

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.

Before injecting PALYNZIQ, talk to your healthcare provider right away if you cannot or will not use auto-injectable epinephrine to treat a severe allergic reaction. If you are pregnant or plan to become pregnant while taking PALYNZIQ, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ during pregnancy to you and your unborn baby. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the best way to feed your baby if you take PALYNZIQ.

Before injecting PALYNZIQ, read the Medication Guide and Instructions for Use that come with your PALYNZIQ injection.

What should I watch for AFTER starting PALYNZIQ?

PALYNZIQ may cause serious side effects, including:

  • Severe allergic reactions (anaphylaxis)
  • Other allergic reactions to PALYNZIQ can happen during treatment with PALYNZIQ. Contact your healthcare provider right away if you have any of the following symptoms of an allergic reaction including: rash, itching, or swelling of the face, lips, eyes, or tongue. Your healthcare provider may change your dose of PALYNZIQ, stop your treatment with PALYNZIQ for a period of time, or prescribe medicine for you to take before your PALYNZIQ injection to help reduce the symptoms of an allergic reaction

The most common side effects of PALYNZIQ include injection site reactions (such as redness, itching, pain, bruising, rash, swelling, or tenderness), joint pain, headache, skin reactions that spread and last at least 14 days (such as itching, rash, or redness), nausea, stomach pain, vomiting, cough, mouth and throat pain, itching, diarrhea, stuffy nose, feeling very tired, dizziness, anxiety, and low levels of Phe in your blood.

These are not all of the possible side effects of PALYNZIQ. Speak with your healthcare provider right away about any side effects.

Important notes

Blood Phe testing and diet

  • Your healthcare provider will monitor your blood Phe levels during PALYNZIQ treatment
  • Monitor the amount of protein and Phe that you eat or drink. Your healthcare provider may change the amount of protein and Phe you should have in your diet during treatment with PALYNZIQ, depending on the levels of Phe in your blood. Follow your healthcare provider’s instructions about the amount of protein and Phe you should have in your diet

Missed dose

  • If a dose is missed, take your next dose as scheduled and do not take 2 doses of PALYNZIQ to make up for the missed dose

Pregnancy Surveillance Program

  • There is a pregnancy surveillance program for females who take PALYNZIQ during pregnancy, or who become pregnant while receiving PALYNZIQ or within 1 month after their last dose of PALYNZIQ. The purpose of this program is to collect information about the health of you and your baby while taking PALYNZIQ. Talk to your healthcare provider about how you can take part in this program or call BioMarin at 1-866-906-6100

You may report side effects to BioMarin at 1-866-906-6100.

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 full Prescribing Information, including an important warning for risk of anaphylaxis, and the Medication Guide.

US-PAL-00233 0422

US-PAL-00218 0322

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) is a prescription medication used to lower blood levels of phenylalanine (Phe) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

 

INFORMACIÓN IMPORTANTE DE SEGURIDAD

 

¿Cuál es la información más importante que debo conocer sobre PALYNZIQ?

PALYNZIQ puede causar una reacción alérgica grave (anafilaxia) que podría ser mortal y producirse en cualquier momento durante el tratamiento con PALYNZIQ.

¿Qué es PALYNZIQ?

PALYNZIQ® (pegvaliase-pqpz) es un medicamento de venta bajo receta médica indicado para reducir los niveles sanguíneos de fenilalanina (Phe) en adultos con PKU (fenilcetonuria) que tienen niveles sanguíneos de Phe no controlados mayores de 600 micromol/l (10 mg/dl) con su tratamiento actual. Se le recomienda hablar sobre los posibles beneficios y riesgos de PALYNZIQ con su profesional de atención médica.

Las reacciones alérgicas graves son un efecto secundario serio pero frecuente de PALYNZIQ.

  • Usted recibirá su primera inyección de PALYNZIQ en un entorno médico donde permanecerá bajo atenta vigilancia durante al menos 1 hora después de que se la administren, para poder detectar toda aparición de una reacción alérgica grave.
  • Su profesional de atención médica le recetará epinefrina autoinyectable y les enseñará a usted (o a su cuidador) y a su observador (de ser necesario) cuándo y cómo usarla en caso de que sufra una reacción alérgica grave.
  • Si usted sufre una reacción alérgica grave durante su tratamiento con PALYNZIQ, tendrá que recibir inmediatamente una inyección de epinefrina y conseguir ayuda médica de emergencia enseguida.
  • Su profesional de atención médica decidirá si usted (o su cuidador) es capaz de administrar las inyecciones de PALYNZIQ, reconocer los signos y síntomas de una reacción alérgica grave, administrar una inyección de epinefrina y llamar para solicitar ayuda de emergencia (si es necesario).
  • Su profesional de atención médica podría recomendarle que esté en presencia de un observador (o su cuidador) adulto cuando se administre su inyección de PALYNZIQ y durante al menos 1 hora después de aplicársela; dicha persona deberá estar pendiente de la aparición de signos y síntomas de una reacción alérgica grave y, de ser necesario, administrarle una inyección de epinefrina y llamar para solicitar ayuda médica de emergencia.

Deje de inyectarse PALYNZIQ y consiga inmediatamente ayuda médica de emergencia si presenta cualquiera de los siguientes síntomas:

  • Desmayo (pérdida del conocimiento)
  • Mareos o sensación de aturdimiento
  • Confusión repentina
  • Sibilancias o dificultad para respirar
  • Malestar u opresión en el pecho
  • Frecuencia cardíaca rápida
  • Hinchazón de la cara, los labios, los ojos o la lengua
  • Opresión en la garganta
  • Rubor de la piel
  • Erupción, picazón o ronchas en la piel
  • Náuseas, vómitos o diarrea
  • Pérdida del control de la orina o las heces
 

Tenga consigo la epinefrina autoinyectable en todo momento durante el tratamiento con PALYNZIQ. Para obtener más información, lea la Información del paciente que acompaña a la epinefrina autoinyectable recetada por su profesional de atención médica.

Si usted sufre una reacción alérgica grave, interrumpa el tratamiento con PALYNZIQ hasta que consulte con su profesional de atención médica. Su profesional de atención médica le dirá si puede continuar el tratamiento con PALYNZIQ.

Algunas personas tratadas con PALYNZIQ también han sufrido reacciones alérgicas que no son anafilácticas. Consulte con su profesional de atención médica si sufre alguna reacción alérgica mientras reciba PALYNZIQ.

Programa REMS de PALYNZIQ: PALYNZIQ está disponible únicamente de forma restringida a través del Programa REMS (Estrategia de evaluación y mitigación de riesgos) de PALYNZIQ. Consulte con su profesional de atención médica sobre el Programa REMS de PALYNZIQ y lo que debe hacer para inscribirse.

¿Qué debo decirle a mi profesional de atención médica ANTES de comenzar a recibir PALYNZIQ?

Informe a su profesional de atención médica acerca de todos los medicamentos que use, incluidos los de venta con y sin receta médica, las vitaminas y los suplementos a base de hierbas.

Antes de inyectarse PALYNZIQ, consulte de inmediato con su profesional de atención médica si no puede o no quiere usar epinefrina autoinyectable para tratar una reacción alérgica grave. Si está embarazada o piensa quedar embarazada mientras reciba PALYNZIQ, consulte con su profesional de atención médica para averiguar los riesgos y beneficios que el uso de PALYNZIQ durante el embarazo podría tener para usted y su bebé en gestación. Si usted recibe PALYNZIQ y está amamantando o piensa amamantar, consulte con su profesional de atención médica para saber cuál es la mejor manera de alimentar a su bebé.

Antes de inyectarse PALYNZIQ, lea la Guía del medicamento y las Instrucciones de uso que se adjuntan a la inyección de PALYNZIQ.

¿De qué debo estar pendiente DESPUÉS de comenzar a recibir PALYNZIQ?

PALYNZIQ puede causar efectos secundarios serios, tales como:

  • Reacciones alérgicas graves (anafilaxia)
  • Durante el tratamiento con PALYNZIQ pueden surgir otras reacciones alérgicas a PALYNZIQ. Comuníquese de inmediato con su profesional de atención médica si tiene alguno de los síntomas siguientes de reacción alérgica: sarpullido, picazón o hinchazón de la cara, los labios, los ojos o la lengua. Su profesional de atención médica podría cambiarle la dosis de PALYNZIQ, interrumpirle el tratamiento con PALYNZIQ durante cierto tiempo o recetarle un medicamento para que lo use antes de su inyección de PALYNZIQ, a fin de ayudar a reducir los síntomas de una reacción alérgica.

Los efectos secundarios más frecuentes de PALYNZIQ comprenden: reacciones en el lugar de la inyección (como enrojecimiento, picazón, dolor, moretones, sarpullido, hinchazón o sensibilidad al tacto); dolor en las articulaciones; dolor de cabeza; reacciones de la piel que se diseminan y duran al menos 14 días (como picazón, sarpullido o enrojecimiento); náuseas; dolor en el estómago, la boca y la garganta; vómitos; tos; picazón; diarrea; congestión nasal; sensación de cansancio extremo; mareos; ansiedad, y bajos niveles sanguíneos de Phe.

Estos no son todos los efectos secundarios posibles de PALYNZIQ. Consulte de inmediato con su profesional de atención médica acerca de cualquier efecto secundario.

Notas importantes

Análisis de Phe sanguínea y la dieta

  • Su profesional de atención médica le monitoreará los niveles sanguíneos de Phe durante el tratamiento con PALYNZIQ.
  • Monitoree la cantidad de proteína y Phe que ingiera con las comidas o bebidas. Según sus niveles sanguíneos de Phe, puede que su profesional de atención médica le cambie la cantidad de proteína y Phe que usted debe ingerir con su dieta durante el tratamiento con PALYNZIQ. Siga las instrucciones de su profesional de atención médica sobre la cantidad de proteína y Phe que debe consumir en su dieta.

Dosis omitida

  • Si omite una dosis, aplíquese la dosis siguiente según el horario programado; no se administre 2 dosis de PALYNZIQ para compensar la dosis omitida.

Programa de vigilancia del embarazo

  • Hay un programa de vigilancia del embarazo para las mujeres que reciban PALYNZIQ durante el embarazo, o que queden embarazadas durante su tratamiento con PALYNZIQ o en el mes siguiente a su última dosis de PALYNZIQ. Este programa tiene la finalidad de recopilar información sobre la salud de la madre y del bebé durante el tratamiento con PALYNZIQ. Si desea averiguar cómo participar en este programa, comuníquese con su profesional de atención médica o llame a BioMarin al 1-866-906-6100.

Podrá notificar los efectos secundarios a BioMarin llamando al 1-866-906-6100.

Se le invita a notificar a la FDA cualquier efecto secundario negativo de los medicamentos de venta bajo receta médica. Visite www.fda.gov/medwatch, o llame al 1-800-FDA-1088.

Consulte la Información de prescripción completa (incluida una importante advertencia sobre el riesgo de anafilaxia) y la Guía del medicamento.

US-PAL-00233 0422

US-PAL-00218 0322

¿Qué es PALYNZIQ?

PALYNZIQ® (pegvaliase-pqpz) es un medicamento de venta bajo receta médica indicado para reducir los niveles sanguíneos de fenilalanina (Phe) en adultos con PKU (fenilcetonuria) que tienen niveles sanguíneos de Phe no controlados mayores de 600 micromol/l (10 mg/dl) con su tratamiento actual. Se le recomienda hablar sobre los posibles beneficios y riesgos de PALYNZIQ con su profesional de atención médica.