Terms & Conditions

Welcome to the Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation ("Us" or "Our" or "We") website and thank you for visiting.

These Terms of Use (“Terms”) are a legal contract between You and Us (each a “Party” and collectively, "Everyone") and govern Your use of all the text, data, information, software, graphics, photographs and more (all of which We refer to as “Materials”) that We and Our affiliates may make available to You, as well as any services (“Services”) We may provide through any of Our websites (all of which are referred to in these Terms as this “Website”).

READ THESE TERMS CAREFULLY BEFORE BROWSING THIS WEBSITE. USING THIS WEBSITE INDICATES THAT YOU HAVE BOTH READ AND ACCEPT THESE TERMS. YOU CANNOT USE THIS WEBSITE IF YOU DO NOT ACCEPT THESE TERMS.

NOTE: THESE TERMS CONTAIN A DISPUTE RESOLUTION AND ARBITRATION PROVISION, INCLUDING CLASS ACTION WAIVER THAT AFFECTS YOUR RIGHTS UNDER THESE TERMS AND WITH RESPECT TO DISPUTES YOU MAY HAVE WITH THE COMPANY. YOU MAY OPT OUT OF THE BINDING INDIVIDUAL ARBITRATION AND CLASS ACTION WAIVER AS PROVIDED BELOW.

CHANGES

We may alter the Materials and Services We offer You and/or choose to modify, suspend or discontinue this Website at any time and without notifying You. We may also change, update, add or remove provisions (collectively, “modifications”) of these Terms from time to time. Because Everyone benefits from clarity, We promise to inform You of any modifications to these Terms by posting them on this Website.

If You object to any such modifications, Your only remedy is to cease using this Website. Continued use of this Website following notice of any such modifications indicates You acknowledge and agree to be bound by the modifications. Also, please know that these Terms may be replaced by legal notices or terms located on particular pages of this Website, as it may state in those notices or terms. These legal notices or terms are incorporated into these Terms and replace the provision(s) of these Terms that are stated as being replaced.

GENERAL USE

By using this Website, You promise that You are at least 18 years of age. If You are not yet 18 years old, You must have the permission of an adult to use this Website and agree to its Terms, and that adult must be a parent or legal guardian who is willing to be responsible for Your use of this Website.

We invite You to use this Website for individual, consumer purposes ("Permitted Purposes") – enjoy!

In these Terms we are granting You a limited, personal, non-exclusive and non-transferable license to use and to display the Materials; You may only use the Materials so long as you comply with these Terms. You have no other rights in this Website or any Materials and You may not modify, edit, copy, reproduce, create derivative works of, reverse engineer, alter, enhance or in any way exploit any of this Website or Materials in any way. If You make copies of any of this Website for Permitted Purposes, then We ask that, on all copies, You be sure to keep all of Our copyright and other proprietary notices as they appear on this Website.

Unfortunately, if You breach any of these Terms the above license will terminate automatically and You must immediately destroy any downloaded or printed Materials (and any copies thereof).

USING THIS WEBSITE AND THE WEBSITE’S SERVICES

We appreciate You visiting this Website and allow You to do just that – stop by and check it out, without even registering with Us!

PRIVACY POLICY

We respect the information that You provide to Us, and want You to fully understand exactly how We use that information. Please review Our Privacy Policy at https://www.gene.com/privacy-policy, which explains everything.

LINKS TO THIRD-PARTY SITES

We sometimes provide links on this Website to third-party websites. If You use these links, You will leave this Website. We are not obligated to review any third-party websites that You link to from this Website, We do not control any of the third-party websites, and We are not responsible for any third-party websites (or the products, services, or content available through any of them). Thus, We do not endorse or make any representations about such third-party websites, any information, software, products, services, or materials found there or any results that might come from using them. If You decide to access any of the third-party websites via links from this Website, You do this entirely at Your own risk and You must follow the privacy policies and terms and conditions for those third-party websites. Certain areas of this Website may allow You to interact and/or conduct transactions with one or more third-party websites, and, if applicable, may allow you to adjust your privacy settings for that third-party website account, so that Your activities on this Website can be shared with Your contacts via your third-party site account (such as social sharing via Facebook or Twitter).

UNAUTHORIZED ACTIVITIES

To be clear, We authorize Your use of this Website only for Permitted Purposes. Any other use of this Website beyond the Permitted Purposes is prohibited and unauthorized. This is because as between You and Us, all rights in this Website remain Our property.

Unauthorized use of this Website may result in violation of various United States and international copyright laws. Because we prefer keeping this relationship drama-free, We want to give You examples of things to avoid. So, unless You have written permission from Us, You are not authorized to use this Website in any of the following ways (these are examples only and the list below is not a complete list of everything that You are not permitted to do):

For any public or commercial purpose which includes use of this Website on another site or through a networked computer environment;
In a manner that modifies, publicly displays, publicly performs, reproduces or distributes any of this Website;
In a manner that violates any local, state, national, foreign, or international statute, regulation, rule, order, treaty, or other law;
To stalk, harass, or harm another individual;
To impersonate any person or entity or otherwise misrepresent Your affiliation with a person or entity;
To interfere with or disrupt this Website or servers or networks connected to this Website;
To use any data mining, robots, or similar data gathering or extraction methods in connection with this Website; or
Attempt to gain unauthorized access to any portion of this Website or any other accounts, computer systems, or networks connected to this Website, whether through hacking, password mining, or any other means.

You agree to hire attorneys to defend Us if You violate these Terms and that violation results in a problem for Us. You also agree to pay any damages that We may end up having to pay as a result of Your violation. You alone are responsible for any violation of these Terms by You. We reserve the right to assume the exclusive defense and control of any matter otherwise subject to indemnification by You and, in such case, You agree to cooperate with Our defense of such claim.

PROPRIETARY RIGHTS

"Genentech" is a trademark that belongs to Us. Other trademarks, names and logos on this Website are the property of their respective owners.

Unless otherwise specified in these Terms, all Materials, including the arrangement of them on this Website are Our sole property, Copyright © 2017. All rights not expressly granted in these terms are reserved. Except as otherwise required or limited by applicable law, any reproduction, distribution, modification, retransmission, or publication of any copyrighted material is strictly prohibited without the express written consent of the copyright owner or licensee.

DISCLAIMER OF WARRANTIES

THIS WEBSITE IS PROVIDED "AS IS" AND "WITH ALL FAULTS" AND THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THIS WEBSITE IS WITH YOU.

WE EXPRESSLY DISCLAIM ALL WARRANTIES OF ANY KIND (EXPRESS, IMPLIED OR STATUTORY) WITH RESPECT TO THIS WEBSITE, WHICH INCLUDES BUT IS NOT LIMITED TO, ANY IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, TITLE, NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS, AND ACCURACY OR TIMELINESS OF THE INFORMATION PROVIDED.

THIS MEANS THAT WE DO NOT PROMISE YOU THAT THE WEBSITE IS FREE OF PROBLEMS. Without limiting what we just stated, We make no warranty that this Website will meet Your requirements or that this Website will be uninterrupted, timely, secure, or error free or that defects in this Website will be corrected. We make no warranty as to any results that come from the use of this Website or as to the accuracy or reliability of any information obtained through this Website. No advice or information, whether oral or written, obtained by You through this Website or from Us or Our subsidiaries/other affiliated companies shall create any warranty. We disclaim all equitable indemnities.

While there may be information contained within the Website or Services related to certain medical conditions and/or their treatment, should a medical condition exist, consult with your own physician or health care professional. THE CONTENT AVAILABLE THROUGH THE WEBSITE, OR COMMUNICATED TO YOU DIRECTLY THROUGH THE SERVICES, IS FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY AND IS NOT A SUBSTITUTE FOR MEDICAL JUDGMENT, ADVICE, DIAGNOSIS, OR TREATMENT OF ANY HEALTH CONDITION OR PROBLEM. You should not rely on information contained via the Website for diagnosing, treating, curing, preventing, managing or otherwise addressing health problems. Questions should be addressed to a physician or other health care professional. WE DO NOT, THROUGH THE WEBSITE OR OTHERWISE, PROVIDE MEDICAL ADVICE, MEDICAL PRESCRIPTIONS, TREATMENTS OR DIAGNOSTIC SERVICES. Your doctor or other health care professional, as a learned intermediary, is in the best position to assess, and provide information, about Your medical condition and any treatment options. Use of the Website or Services does not in and of itself create an express or implied physician-patient relationship. In using the Website or Services, You agree that We are not, or will not be, liable or otherwise responsible for any decision made or any action taken or any action not taken due to Your use of the Website or Services. PLEASE CONSULT YOUR HEALTHCARE PROVIDER FOR ALL MEDICAL ADVICE OR QUESTIONS.

LIMITATION OF LIABILITY

WE WILL NOT BE LIABLE TO YOU FOR ANY DAMAGES RESULTING FROM YOUR DISPLAYING, COPYING, USING, OR DOWNLOADING ANY MATERIALS TO OR FROM THIS WEBSITE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL WE BE LIABLE TO YOU FOR ANY INDIRECT, EXTRAORDINARY, EXEMPLARY, PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF DATA, REVENUE, PROFITS, USE OR OTHER ECONOMIC ADVANTAGE) HOWEVER ARISING, EVEN IF WE KNOW THERE IS A POSSIBILITY OF SUCH DAMAGE.

LOCAL LAWS; EXPORT CONTROL

We control and operate this Website from Our headquarters in the United States of America and this Website may not be appropriate or available for use in other locations. If You use this Website outside the United States of America, You are solely responsible for following applicable local laws.

FEEDBACK

Any submissions by You to Us (e.g., comments, questions, suggestions, materials – collectively, “Feedback”) no matter how submitted, (e.g., call, fax, email) will be treated as both non-confidential and non-proprietary. You hereby assign all right, title, and interest in, and We are free to use, without any attribution or compensation to You, any ideas, know-how, concepts, techniques, or other intellectual property and proprietary rights contained in the Feedback, whether or not patentable, for any purpose whatsoever, including but not limited to, developing, manufacturing, having manufactured, licensing, marketing, and selling, directly or indirectly, products and services using such Feedback. You understand and agree that We are not obligated to use, display, reproduce, or distribute any such ideas, know-how, concepts, or techniques contained in the Feedback, and You have no right to compel such use, display, reproduction, or distribution.

DISPUTE RESOLUTION AND ARBITRATION; CLASS ACTION WAIVER

Please Read This Provision Carefully. It Affects Your Legal Rights.

This Provision allows us to promptly and efficiently resolve any dispute (e.g., claim or controversy, whether based in contract, statute, regulation, ordinance, tort – including, but not limited to, fraud, misrepresentation, fraudulent inducement, or negligence – or any other legal or equitable theory, and includes the validity, enforceability or scope of this Provision) that may arise between You and Us. Effectively, then, “dispute” is given the broadest meaning enforceable by law and includes any claims against other parties relating to services or products provided or billed to You (such as Our licensors, suppliers, dealers or third-party vendors) whenever You also assert claims against Us in the same proceeding.

This Provision provides that all disputes between You and Us shall be resolved by binding arbitration because acceptance of these Terms constitutes a waiver of Your right to litigation claims and all opportunity to be heard by a judge or jury. To be clear, there is no judge or jury in arbitration, and court review of an arbitration award is limited. The arbitrator must follow this agreement and can award the same damages and relief as a court (including attorney’s fees). You may, however, opt-out of this Provision which means You would have a right or opportunity to bring claims in a court, before a judge or jury, and/or to participate in or be represented in a case filed in court by others (including, but not limited to, class actions). EVERYONE AGREES THAT, EXCEPT AS PROVIDED BELOW, ANY AND ALL DISPUTES, AS DEFINED ABOVE, WHETHER PRESENTLY IN EXISTENCE OR BASED ON ACTS OR OMISSIONS IN THE PAST OR IN THE FUTURE, WILL BE RESOLVED EXCLUSIVELY AND FINALLY BY BINDING ARBITRATION RATHER THAN IN COURT IN ACCORDANCE WITH THIS PROVISION.

Pre-Arbitration Claim Resolution

A party who intends to seek arbitration or pursue a claim in court must first send to the other a written Notice of Dispute (“Notice”). The Notice to Us should be sent by email to legal-lrcoptout-d@gene.com. The Notice must include (1)Your name, address, and email address; (2) a description of the nature and basis of the claim or dispute including any relevant facts regarding your use of the Materials, Services, and/or Website; (3) an explanation of the specific relief sought, including the total damages You seek, if any, and the basis for the damage calculations; (4) Your personally signed statement verifying the accuracy of the contents of the Notice; and (5) if You have retained an attorney, Your signed statement authorizing Us to disclose personal information about You to Your attorney if necessary in resolving Your claim. The Notice must also be individualized, meaning it can only concern Your dispute and no other person’s dispute. You also agree that, after sending the Notice, at Our request you will personally participate in a discussion by telephone with Us to facilitate resolving your claim before arbitration is initiated. We also agree to participate in a telephone discussion at your request. If We and You do not reach an agreement to resolve the claim within 60 days after the Notice is received, You or We may commence an arbitration proceeding or you may pursue Your dispute in court only under the circumstances described below. If either You or We send the other an incomplete Notice, the 60-day period begins only after a complete Notice is received, and if either You or We request a telephone discussion, the 60-day period begins only after the discussion has happened. Compliance with these pre-arbitration Notice and dispute resolution procedures are a condition precedent to initiating arbitration. You may pursue Your dispute in a court only under the circumstances described below.

Exclusions from Arbitration/Right to Opt Out

Notwithstanding the above, You or We may choose to pursue a Dispute in court and not by arbitration if: (a) The dispute qualifies for initiation in small claims court; or (b) YOU OPT-OUT OF THESE ARBITRATION PROCEDURES WITHIN 30 DAYS FROM THE DATE THAT YOU FIRST CONSENT TO THIS AGREEMENT (the “Opt-Out Deadline”). You may opt-out of this Provision by emailing Us at legal-lrcoptout-d@gene.com the following information: (1) Your name; (2) Your address; (3) A clear statement that You do not wish to resolve disputes with Us through arbitration. The opt-out email must also be individualized, meaning it can only concern Your rights and no other person’s rights. We promise that Your decision to opt-out of this Arbitration Provision will not negatively affect Your relationship with Us. But, We do have to enforce the Opt-Out Deadline, so keep in mind that any opt-out request received after the Opt-Out Deadline will not be valid and You must pursue Your dispute in arbitration or small claims court.

Arbitration Procedures

If this Provision applies and the dispute is not resolved as provided above (Pre-Arbitration Claim Resolution) either You or We may initiate arbitration proceedings. National Arbitration and Mediation (“NAM”), www.namadr.com, will arbitrate all disputes, and the arbitration will be conducted before a single arbitrator. Any dispute shall be arbitrated on an individual basis; class arbitrations and class actions are not permitted, and You and we Agree not to bring any claims as part of a class action or to bring any claims on behalf of or purporting to represent more than one claimant. All issues shall be for the arbitrator to decide, including the scope of this Provision. You and we agree that the party initiating arbitration must submit a signed certification to NAM that they have complied with the pre-arbitration Notice and dispute resolution procedures, before initiating arbitration.

Any arbitration shall be conducted in accordance with the applicable NAM rules, including the Comprehensive Dispute Resolution Rules and Procedures and the Mass Filing Dispute Resolutions Rules and Procedures, as applicable. The NAM rules and additional information about NAM are available at www.namadr.com. This Provision governs in the event it conflicts with the applicable arbitration rules. Under no circumstances will class action procedures or rules apply to the arbitration.

An administrative conference with NAM shall be conducted in each arbitration proceeding, and You and a Genentech representative shall appear at the administrative conference via telephone. If You initiated the arbitration and You fail to appear at the administrative conference, regardless of whether Your counsel attends, NAM will administratively close the arbitration proceeding without prejudice, unless You show good cause as to why You were not able to attend the conference. If We initiated the arbitration and a Genentech representative fails to appear at the administrative conference, regardless of whether our counsel attends, NAM will administratively close the arbitration proceeding without prejudice, unless We show good cause as to why the representative was not able to attend the conference.

Because this Website and these Terms concern interstate commerce, the Federal Arbitration Act (“FAA”) governs the arbitrability of all disputes. However, the arbitrator will apply applicable substantive law consistent with the FAA and the applicable statute of limitations or condition precedent to suit.

Arbitration Award – The arbitrator may award on an individual basis any relief that would be available pursuant to applicable law, and will not have the power to award relief to, against or for the benefit of any person who is not a party to the proceeding. The arbitrator will make any award in writing but need not provide a statement of reasons unless requested by a party. Such award will be final and binding on the parties, except for any right of appeal provided by the FAA, and may be entered in any court having jurisdiction over the parties for purposes of enforcement.

Location of Arbitration – You or We may initiate arbitration in either New York or the federal judicial district that includes Your billing address. In the event that You select the latter, We may transfer the arbitration to New York so long as We agree to pay any additional fees or costs which the arbitrator determines You incur as a result of the transfer. You and a Genentech representative will be required to attend the arbitration hearing.

Payment of Arbitration Fees and Costs – Responsibility for the payment of arbitration fees (including filing, arbitrator, and hearing fees) will be governed by the NAM rules unless you qualify for a fee waiver under applicable law, in which case you agree to provide us the option of paying the arbitrator before seeking to initiate any other form of dispute resolution, including litigation. Each Party shall be responsible for its own attorney fees and costs incurred in such arbitration unless the arbitrator awards sanctions or determines that the substance of the claim, defense, or relief sought is frivolous or brought for an improper purpose, in which case the arbitrator may order You or Us to pay the other side’s attorney fees or costs.

Class Action Waiver

You and We agree that, to the fullest extent permitted by law, each Party may bring claims (whether in court or arbitration) only in an individual capacity, and agree not to participate in any claim against the other as a plaintiff, claimant, or class member in any class, collective, consolidated, private attorney general, or representative proceeding.

Except as otherwise provided in this Provision, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of a class or representative proceeding or claims (such as a class action, consolidated action or private attorney general action) unless both You and We specifically agree to allow such claims or proceedings following initiation of the arbitration.

Jury Waiver

You understand and agree that by accepting this Provision in these Terms, You and We are each waiving the right to a jury trial or a trial before a judge in a public court. In the absence of this Provision, You and We might otherwise have had a right or opportunity to bring disputes in a court, before a judge or jury, and/or to participate or be represented in a case filed in court by others. Except as otherwise provided below, those rights are waived. Other rights that You would have if You went to court (e.g.,, the rights to both appeal and certain types of discovery) may be more limited or may also be waived.

Mass Filing and Batching Process

For purposes of efficient administration, in the event twenty-five (25) or more substantially similar demands for arbitration are filed by or with the assistance or coordination of the same law firm, group of law firms, or organization (“Mass Filing”), the parties agree that (1) NAM (or another arbitration provider selected by the parties or by the court if NAM is unavailable), shall administer the Mass Filing in batches of 25 per batch (if, after batching, fewer than 25 demands remain, then the final batch will consist of the remaining demands); (ii) a single, different arbitrator shall be designated for each batch (unless the parties agree otherwise) selected in accordance with the applicable NAM rules; (iii) no other demands for arbitration that are part of the Mass Filing may be filed, processed, or adjudicated until the prior batch of 25 is filed, processed, and adjudicated, (iv) any arbitration fees associated with a demand for arbitration included in a Mass Filing shall only be assessed after the demand for arbitration is included in a set of batch proceedings and that batch is properly designated for filing, processing, and adjudication; and (vi) that the staged process of batched proceedings, with each set including 25 demands, shall continue until each demand (including Your demand) is adjudicated or otherwise resolved.

You agree to cooperate in good faith with Us and the arbitration provider to implement such a batch approach or other similar approach to provide for an efficient resolution of claims, including the payment of single filing and administrative fees for batches of claims. Any disagreement between the parties as to whether the batch arbitration procedure applies or as to the process or procedure for batching shall be resolved by a procedural arbitrator appointed by NAM. The batch arbitration procedure set forth herein shall in no way be interpreted as authorizing class arbitration of any kind. We reserve our right to raise unique defenses as to each claimant in connection with this process, and You reserve all rights to raise unique claims, facts, and defenses in connection with Your claims. While NAM shall batch the claims for organizational purposes, it shall not consolidate them for decision on the merits and shall decide each case on the merits individually. If Your demand for arbitration is included in the Mass Filing, Your claims will remain tolled until your demand for arbitration is decided, withdrawn, or is settled.

Severability

If any clause within this Provision (other than the Class Action Waiver and Mass Filing and Batching Process clauses above) is found to be illegal or unenforceable, that clause will not apply, but all enforceable provisions will remain valid. If the Class Action Waiver clause is found to be illegal or unenforceable, this entire Provision will be unenforceable and the dispute will be decided by a court. If the Mass Filing and Batching Process clause is found to be illegal or unenforceable, the Class Action Waiver will still apply, but the rest of this Provision will be unenforceable and the dispute will be decided by a court.

Continuation

This Provision shall survive the termination of Your account with Us or Our affiliates and Your discontinued use of this Website.

GENERAL

We think direct communication resolves most issues – if We feel that You are not complying with these Terms, We will tell You. We will even provide You with recommended necessary corrective action(s) because We value this relationship.

However, certain violations of these Terms, as determined by Us, may require immediate termination of Your access to this Website without prior notice to You. The Federal Arbitration Act, California state law and applicable U.S. federal law, without regard to the choice or conflicts of law provisions, will govern these Terms. Foreign laws do not apply. Except for disputes subject to arbitration as described above, any disputes relating to these Terms or this Website will be heard in the courts located in San Francisco County, California. If any of these Terms are deemed inconsistent with applicable law, then such term(s) shall be interpreted to reflect the intentions of the parties, and no other terms will be modified. By choosing not to enforce any of these Terms, We are not waiving Our rights. These Terms are the entire agreement between You and Us and, therefore, supersede all prior or contemporaneous negotiations, discussions or agreements between Everyone about this Website. The proprietary rights, disclaimer of warranties, representations made by You, indemnities, limitations of liability and general provisions shall survive any termination of these Terms.

CONTACT US

If You have any questions about these Terms or otherwise need to contact Us for any reason, You can reach Us at Genentech, Inc. 1 DNA Way South San Francisco, CA 94080 or by phone at (650) 225-1000, or Novartis Pharmaceuticals Corporation by phone at 1-886-4XOLAIR (1-886-495-6524).

What is XOLAIR?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.
food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.
chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.
XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems.

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

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

wheezing, shortness of breath, cough, chest tightness, or trouble breathing
low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
flushing, itching, hives, or feeling warm
swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
have sudden breathing problems (bronchospasm)
have ever had a severe allergic reaction called anaphylaxis
have or have had a parasitic infection
have or have had cancer
are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

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

How should I receive and use XOLAIR?

When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
In people with asthma, CRSwNP, and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
Do not decrease or stop taking any of your other asthma, CRSwNP, hive medicine, food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

Cancer. Cases of cancer were observed in some people who received XOLAIR.
Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR:

In adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.
In adults with chronic rhinosinusitis with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.
In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
In people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information and Instructions for Use.