Terms and Conditions for Drug Out-of-Pocket Costs

By using the XOLAIR Co-pay Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described:

  • This XOLAIR Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program
  • This XOLAIR Co-pay Program is not health insurance or a benefit plan. Distribution or use of the XOLAIR Co-pay Program does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all XOLAIR Co-pay Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the XOLAIR Co-pay Program, as may be required
  • The XOLAIR Co-pay Program is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other healthcare or pharmaceutical assistance programs (such as Genentech® Access to Care Foundation (GATCF) or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the XOLAIR Co-pay Program agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer
  • The XOLAIR Co-pay Program will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this XOLAIR Co-pay Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this XOLAIR Co-pay Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This XOLAIR Co-pay Program is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this XOLAIR Co-pay Program must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the XOLAIR Co-pay Program as provided for under the applicable insurance or as otherwise required by contract or law. The XOLAIR Co-pay Program may not be sold, purchased, traded, or offered for sale, purchase, or trade. The XOLAIR Co-pay Program is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient's ability to meet and maintain all requirements as set forth by the program. Genentech will periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law, and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (eg, MA, CA)
  • The patient or their guardian must be 18 years or older to receive XOLAIR Co-pay Program assistance. This XOLAIR Co-pay Program is (1) void if the card is reproduced; (2) void where prohibited by law; (3) only valid in the United States and Puerto Rico; and (4) only valid for XOLAIR. Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or either company's products to patients. Genentech, Inc. and Novartis Pharmaceuticals Corporation reserve the right to rescind, revoke, or amend the program without notice at any time

Terms and Conditions for Administration Out-of-Pocket Costs

By using the XOLAIR Administration Co-pay Program, the patient acknowledges and confirms that at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described below. If you choose to enroll in the XOLAIR Drug Co-pay Program, you must enroll into that program separately and meet all eligibility criteria:

  • The XOLAIR Administration Co-pay Program provides administration co-pay assistance for eligible patients. Once enrolled, eligible patients pay $5 per XOLAIR administration co-pay until a maximum of $1,000 of co-pay assistance per 12-month period is reached
  • This XOLAIR Administration Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance. Patients using Medicare, Medicaid, or any other federal or state government funded program (collectively, "Government Programs") to pay for their medications are not eligible. Patients who start utilizing any government coverage during their enrollment period will no longer be eligible for the program. The XOLAIR Administration Co-pay Program is not valid for Massachusetts, Michigan, Minnesota or Rhode Island residents, is void where prohibited by law, and is subject to state specific restrictions
  • This XOLAIR Administration Co-pay Program is not health insurance or a benefit plan. Distribution or use of the XOLAIR Administration Co-pay Program does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all XOLAIR Administration Co-pay Program benefits or reimbursement received, to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the XOLAIR Administration Co-pay Program, as may be required
  • The XOLAIR Administration Co-pay Program is valid for medications the patient receives for free from Genentech. The XOLAIR Administration Co-pay Program is not valid for medications the patient receives for free or is otherwise subsidized by a non-Genentech charitable organization or health care plan. Patient, guardian, prescriber, hospital, and any other person using or administering the XOLAIR Administration Co-pay Program agree not to seek reimbursement for any part of the benefit received by the recipient through the offer
  • The XOLAIR Administration Co-pay Program will be accepted by participating physician offices or hospitals. To qualify for the benefits of this XOLAIR Administration Co-pay Program, the patient may be required to pay out-of-pocket expenses for each administration expense. The amount of the XOLAIR Administration Co-pay benefit cannot exceed the patient's out-of-pocket expenses for the cost of administration expense with XOLAIR. Once enrolled, this XOLAIR Administration Co-pay Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This XOLAIR Administration Co-pay Program is only available with a valid prescription for XOLAIR and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription, except the XOLAIR Drug Co-pay Program or other XOLAIR support program
  • Use of this XOLAIR Administration Co-pay Program must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, physician offices, and hospitals are obligated to inform third-party payers about the use of the XOLAIR Administration Co-pay Program as provided for under the applicable insurance or as otherwise required by contract or law. The XOLAIR Administration Co-pay Program may not be sold, purchased, traded or offered for sale, purchase or trade. The XOLAIR Administration Co-pay Program is limited to 1 enrollment per person during this offering period and is not transferable. This program expires within 12 months from enrollment. This program is not valid where prohibited by law
  • The patient or their guardian must be 18 years or older to receive XOLAIR Administration Co-pay Program assistance. This XOLAIR Administration Co-pay Program is: (1) Void if the card is reproduced; (2) Void where prohibited by law; (3) Only valid in the United States and Puerto Rico; and (4) Only valid for administration with XOLAIR. Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or either company's products to patients. Genentech, Inc. and Novartis Pharmaceuticals Corporation reserve the right to rescind, revoke, or amend the program without notice at any time
Indication and Important Safety Information

What is XOLAIR?

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

  • moderate to severe persistent asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens.
  • chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.

XOLAIR is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

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 your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.

Do not receive 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 any other allergies (such as food allergy or seasonal allergies)
  • 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 XOLAIR.

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

How should I receive XOLAIR?

  • XOLAIR should be given by your healthcare provider, in a healthcare setting.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency.
  • In patients 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 or hive medicine unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • See, "What is the most important information I should know about XOLAIR" regarding the risk of anaphylaxis.
  • 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 who take XOLAIR 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 this is caused by XOLAIR.

The most common side effects of XOLAIR:

  • In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds.
  • In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

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.