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The first and only enzyme therapy approved for adults living with PKU.

WARNING: RISK OF ANAPHYLAXIS

PALYNZIQ可引起严重的过敏反应(过敏反应)，可能危及生命，并可能在使用PALYNZIQ治疗期间的任何时间发生.

For more information, 请阅读下面的重要安全信息或参阅完整的处方信息和用药指南 PALYNZIQ.com.

PALYNZIQ® (pegvaliase-pqpz)注射液是fda批准的首个用于目前治疗中血液苯丙氨酸(苯丙氨酸)水平高于600微mol/L (10 mg/dL)的成人苯丙酮尿症患者的酶替代疗法. PALYNZIQ是一种每日一次的自我给药治疗，独立于苯丙氨酸羟化酶(PAH)酶起作用, so it is an option for all eligible adult patients living with PKU.

PALYNZIQ REMS: PALYNZIQ is available only through the PALYNZIQ REMS, a restricted distribution program.

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Important Safety Information

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliasase -pqpz)是一种处方药，用于降低PKU(苯丙酮尿症)患者血液中苯丙氨酸(Phe)的水平，这些患者在目前的治疗中血液中苯丙氨酸水平不受控制，高于600微mol/L (10 mg/dL). 您应该与您的医疗保健提供者讨论PALYNZIQ的潜在益处和风险.

What is the most important information I should know about PALYNZIQ?
PALYNZIQ可引起严重的过敏反应(过敏反应)，可能危及生命，并可能在使用PALYNZIQ治疗期间的任何时间发生.

PALYNZIQ® (Pal-lin-zeek) (pegvaliasase -pqpz)是一种处方药，用于降低PKU(苯丙酮尿症)患者血液中苯丙氨酸(Phe)的水平，这些患者在目前的治疗中血液中苯丙氨酸水平不受控制，高于600微mol/L (10 mg/dL). 您应该与您的医疗保健提供者讨论PALYNZIQ的潜在益处和风险.

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

  • 您将在医疗机构接受第一次注射PALYNZIQ，注射后您将被密切观察至少1小时，以防止严重的过敏反应
  • 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, 你需要立即接受肾上腺素注射，并立即获得紧急医疗帮助
  • 您的医疗保健提供者将决定您(或您的护理人员)是否能够进行PALYNZIQ注射, recognize the signs and symptoms of a severe allergic reaction, give an injection of epinephrine, and call for emergency help, if needed
  • 您的医疗保健提供者可能会建议您在注射PALYNZIQ时请一位成人观察员(或您的护理人员)与您在一起，并在注射后至少1小时观察您是否有严重过敏反应的迹象和症状, if needed, give you an injection of epinephrine and call for emergency medical help

如果您出现以下任何症状，请停止注射PALYNZIQ并立即接受紧急医疗护理:

  • 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

在使用PALYNZIQ治疗期间，请始终随身携带自动注射肾上腺素. 请阅读您的医疗保健提供者为您开具的自动注射肾上腺素附带的患者信息以获取更多信息.

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. 如果您在服用PALYNZIQ时出现任何过敏反应，请咨询您的医疗保健提供者.

PALYNZIQ REMS: PALYNZIQ只能通过一个名为PALYNZIQ REMS(风险评估和缓解策略)的受限程序获得。. 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包括处方药和非处方药、维生素和草药补充剂.

Before injecting PALYNZIQ, talk to your healthcare provider right away 如果你不能或不会使用自动注射肾上腺素来治疗严重的过敏反应. If you are pregnant or plan to become pregnant while taking PALYNZIQ, 与您的医疗保健提供者讨论怀孕期间服用PALYNZIQ对您和您未出生的宝宝的风险和益处. If you are breastfeeding or plan to breastfeed, 如果您服用PALYNZIQ，请咨询您的医疗保健提供者，了解喂养宝宝的最佳方式.

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. 如果你有以下任何过敏反应症状，请立即联系你的医疗保健提供者，包括:皮疹, 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, 或者在注射PALYNZIQ之前给你开一些药，以帮助减轻过敏反应的症状

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. 在使用PALYNZIQ治疗期间，您的医疗保健提供者可能会改变您饮食中应该摄入的蛋白质和Phe的量, depending on the levels of Phe in your blood. 按照你的医疗保健提供者的指示，你应该在你的饮食中摄入多少蛋白质和Phe

Missed dose

  • If a dose is missed, 按照计划服用下一剂，不要服用2剂PALYNZIQ来弥补错过的剂量

Pregnancy Surveillance Program

  • There is a pregnancy surveillance program for females who take PALYNZIQ during pregnancy, 或在服用PALYNZIQ期间怀孕或在最后一次服用PALYNZIQ后1个月内怀孕. 本程序的目的是收集有关您和您的宝宝在服用PALYNZIQ期间的健康信息. 请咨询您的医疗保健提供者，了解如何参加该计划，或致电澳门正规博彩十大排行平台 1-866-906-6100

You may report side effects to 澳门正规博彩十大排行平台 at 1-866-906-6100.

You are encouraged to report negative side effects of prescription drugs to the 澳门十大博彩正规游戏平台. Visit www.fda.gov/medwatch or call 1-800-澳门十大博彩正规游戏平台-1088.

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

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We maximize the impact of genetic innovation to develop transformative therapies.

澳门正规博彩十大排行平台追求的每一种候选药物都是基于对其所要解决的疾病的遗传学和潜在生物学的基本理解.

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