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 U.S. Territories; 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 U.S. Territories; 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

INDICATION

XOLAIR® (omalizumab) IS INDICATED FOR:

  • Moderate to severe persistent asthma in patients 6 years of age and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.
  • Chronic idiopathic urticaria in patients 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

Limitations of Use:

  • XOLAIR is not indicated for treatment of other allergic conditions or other forms of urticaria.
  • XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

CONTRAINDICATIONS

The use of XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis

Anaphylaxis has been reported to occur after administration of XOLAIR in asthma premarketing clinical trials and in postmarketing spontaneous reports. The frequency of anaphylaxis attributed to XOLAIR use was estimated to be 0.1% and at least 0.2% (based on an estimated exposure of about 57,300 patients from June 2003 through December 2006), respectively.

A case-control study showed that among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Anaphylaxis occurred with the first dose of XOLAIR in 2 patients and with the fourth dose in 1 patient; the time to onset of anaphylaxis was 90 minutes after administration in 2 patients and 2 hours after administration in 1 patient. Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

Malignancy

Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (eg, elderly, current smokers) is not known.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non–XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

Acute Asthma Symptoms

XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.

Corticosteroid Reduction

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions

In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

Fever, Arthralgia, and Rash

In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

Parasitic (Helminth) Infection

Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests

Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma patients, because these levels may not reflect steady state free IgE levels.

ADVERSE REACTIONS

Indication-Specific Adverse Reactions

Asthma:

In patients ≥2 years of age, the most commonly observed adverse reactions (≥1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were: arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).

In pediatric patients 6 to >12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

Injection Site Reactions

In adults and adolescents, injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred more frequently in XOLAIR-treated patients compared with patients in the placebo group (12% vs 9%, respectively).

Chronic Idiopathic Urticaria:

In patients ≥12 years of age, the most commonly observed adverse reactions: (≥2% XOLAIR-treated patients and more frequent than in placebo) from 3 placebo-controlled CIU studies (Day 1 to Week 12) for XOLAIR 150 mg and 300 mg, respectively, were: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Injection site reactions of any severity occurred during the trials in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma

A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non–XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non–XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR -treated patients (13.4) compared to non–XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

Pregnancy

The data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.

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 Boxed WARNING and Medication Guide, for additional Important Safety Information.