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Resources & Support at a Glance

Additional XOLAIR Resources

Click below for more program services and information.

The XOLAIR Specialty Pharmacy Network

Specialty pharmacies are part of the XOLAIR Specialty Pharmacy chosen to dispense XOLAIR to your office.

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The XOLAIR Specialty Pharmacy Network

The specialty pharmacies listed below are part of the XOLAIR Specialty Pharmacy chosen to dispense XOLAIR to your office.

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Name Telephone Fax Web Site
Accredo (866) 839-2162 (866) 531-1025 www.accredo.com
Acro Specialty Pharmacy (800) 906-7798 (877) 381-3806 www.acropharmacy.com
Aetna Specialty Pharmacy* (866) 782-2779 (866) 329-2779 www.aetna.com/individuals-families/pharmacy.html
BriovaRx (800) 835-3784 (800) 351-3616 www.briovarx.com
CIGNA Specialty Pharmacy* (855) 577-6313 (866) 876-8966 teldrug.healthcare.cigna.com
CVS Caremark (800) 237-2767 (800) 323-2445 www.cvsspecialty.com
MagellanRx (formerly ICORE) (866) 554-2673 (866) 364-2673 www.icorehealthcare.com
ModernHEALTH (featuring TLCRx) (888) 355-4191 (888) 355-4192 www.modernhealthinc.com/pharmacies/tlcrx
OptumRx (UnitedHealthGroup) (888) 293-9309 (800) 853-3844 www.optumrx.com
Prime Specialty Pharmacy (877) 627-6337 (877) 828-3939 www.primetherapeutics.com/specialty
Senderra Rx (888) 777-5547 (888) 777-5645 www.senderrarx.com
Special Care Pharmacy Services (888) 727-1727 (888) 341-1586 www.scpspr.com
Walgreens Specialty Pharmacy (866) 823-2712 (877) 231-8302 www.walgreenshealth.com
Name:
Accredo
Tel:
(866) 839-2162
Fax:
(866) 531-1025
Web Site:
www.accredo.com
Name:
Acro Specialty Pharmacy
Tel:
(800) 906-7798
Fax:
(877) 381-3806
Web Site:
www.acropharmacy.com
Name:
Aetna Specialty Pharmacy*
Tel:
(866) 782-2779
Fax:
(866) 329-2779
Web Site:
www.aetna.com/individuals-families/pharmacy.html
Name:
BriovaRx
Tel:
(855) 577-6313
Fax:
(866) 876-8966
Web Site:
www.briovarx.com
Name:
CIGNA Specialty Pharmacy*
Tel:
(800) 835-3784
Fax:
(800) 351-3616
Web Site:
teldrug.healthcare.cigna.com
Name:
CVS Caremark
Tel:
(800) 237-2767
Fax:
(800) 323-2445
Web Site:
www.cvsspecialty.com
Name:
MagellanRx (formerly ICORE)
Tel:
(866) 554-2673
Fax:
(866) 364-2673
Web Site:
www.icorehealthcare.com
Name:
ModernHEALTH (featuring TLCRx)
Tel:
(888) 355-4191
Fax:
(888) 355-4192
Web Site:
www.modernhealthinc.com/pharmacies/tlcrx
Name:
OptumRx (UnitedHealthGroup)
Tel:
(888) 293-9309
Fax:
(800) 853-3844
Web Site:
www.optumrx.com
Name:
Prime Specialty Pharmacy
Tel:
(877) 627-6337
Fax:
(877) 828-3939
Web Site:
www.primetherapeutics.com/specialty
Name:
Senderra Rx
Tel:
(888) 777-5547
Fax:
(888) 777-5645
Web Site:
www.senderrarx.com
Name:
Special Care Pharmacy Services
Tel:
(888) 727-1727
Fax:
(888) 341-1586
Web Site:
www.scpspr.com
Name:
Walgreens Specialty Pharmacy
Tel:
(866) 823-2712
Fax:
(877) 231-8302
Web Site:
www.walgreenshealth.com

We work with these specialty pharmacies to make patient and clinical support available to XOLAIR patients and their prescribers. Additional specialty pharmacies are available as well.

*These pharmacies are only eligible to dispense to plan members of payer owner.

NOTE: Genentech USA, Inc. and Novartis Pharmaceuticals Corporation do not influence or advocate the use of any one distributor. We make no representation or guarantee concerning coverage or reimbursement for any service or item.

Authorized XOLAIR Wholesale Distributors

Buy and bill terms are available to eligible community physicians who purchase XOLAIR from one of the following specialty pharmacies.

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Authorized XOLAIR Wholesale Distributors

Buy and bill terms are available to eligible community physicians who purchase XOLAIR from one of the following specialty pharmacies.

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Name Telephone Fax Web Site
CVS Caremark 800-237-2767 800-323-2445 www.cvscaremarkspecialtyrx.com
CuraScript Specialty Distribution (aka Priority Healthcare Distribution) 877-599-7748 866-277-4024 www.curascript.com
McKesson Specialty Health 800-482-6700 800-289-9285 mscs.mckesson.com
Cardinal Specialty Distribution 877-453-3972 888-345-4916 specialtyonline.cardinalhealth.com
Name:
CVS Caremark Specialty Pharmacy
Tel:
800-237-2767
Fax:
800-323-2445
Web Site:
www.cvscaremarkspecialtyrx.com
Name:
CuraScript Specialty Distribution (aka Priority Healthcare Distribution)
Tel:
877-599-7748
Fax:
866-277-4024
Web Site:
www.curascript.com
Name:
McKesson Specialty Health
Tel:
800-482-6700
Fax:
800-289-9285
Web Site:
mscs.mckesson.com
Name:
Cardinal Specialty Distribution
Tel:
877-453-3972
Fax:
888-345-4916
Web Site:
specialtyonline.cardinalhealth.com

For additional questions and program terms, please call (877) 336-8454 from 9 a.m.- 5 p.m. Pacific Time (PT), Monday through Friday, or email GenentechCPDP@gene.com.

NOTE: Genentech USA, Inc. and Novartis Pharmaceuticals Corporation do not influence or advocate the use of any one distributor. We make no representation or guarantee of service or coverage of any item.

The Genentech Spoilage Replacement Program

If the XOLAIR prescribed for a labeled indication was spoiled and unable to be administered, the product might be eligible for replacement through the Genentech Spoilage Replacement Program.*

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The Genentech Spoilage Replacement Program

If the XOLAIR prescribed for a labeled indication was spoiled or unable to be administered, the Genentech Spoilage Replacement Program might be able to provide you with a new supply.*

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Prerequisites for Replacement

You might be eligible for replacement of XOLAIR if the drug has been reconstituted and has not been administered, billed, or reimbursed and is unusable due to one of the following events:

  • XOLAIR was reconstituted and patient missed the appointment due to circumstances beyond his or her control
  • XOLAIR was accidentally dropped or mishandled while in transit
  • XOLAIR was not appropriately refrigerated or was frozen
  • XOLAIR incurred an admixture error

*Subject to certain limitations and conditions. The Spoilage Replacement Program covers infused or injected Genentech products.

Genentech USA, Inc. retains the right to discontinue its entire Spoilage Replacement Program for a particular account/physician who it determines, in its sole discretion, has misused this policy.

Genentech USA, Inc. has the right to modify or discontinue this program at any time without notice.

*Subject to certain limitations and conditions. The Spoilage Replacement Program covers infused or injected Genentech products.

There are key steps you need to take to receive replacement product vials of XOLAIR.

See the XOLAIR replacement procedure

For all quality- or stability-related issues, please contact
Genentech Medical Communications at 800-821-8590.

For expired product returns, please contact
Genentech Customer Operations at 800-551-2231.

INDICATION

XOLAIR® (omalizumab) IS INDICATED FOR adults and adolescents (12 years of age and above):

  • With moderate to severe persistent asthma 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.

  • With chronic idiopathic urticaria 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 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 postapproval 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 ≥12 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%).

Injection Site Reactions

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 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.

USE IN SPECIFIC POPULATIONS

Pregnancy (Category B)

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XOLAIR during pregnancy. Encourage patients to call 1-866-4XOLAIR (1-866-496-5247) or visit www.xolairpregnancyregistry.com for information about the pregnancy exposure registry and the enrollment procedure. Adequate and well-controlled studies with XOLAIR have not been conducted in pregnant women. XOLAIR should be used during pregnancy only if clearly needed.

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.

©2016 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved.

This Web site is a service of Genentech USA, Inc. and Novartis Pharmaceuticals Corporation and is intended for U.S. Healthcare Professionals only.