Xolair Indications, Side Effects, and Warnings

Contents
  1. omalizumab (Xolair) Uses, Side Effects & Dosage
  2. What is omalizumab? How does it work (mechanism of action)?
  3. What is omalizumab used for?
  4. What are the side effects of omalizumab?
  5. What is the dosage for omalizumab?
  6. Which drugs or supplements interact with omalizumab?
  7. Is omalizumab safe to take if I'm pregnant or breastfeeding?
  8. How should I keep omalizumab stored?
  9. Xolair – Uses, Heart Attacks & Other Side Effects, and FDA Actions
  10. Xolair (omalizumab) dosing, indications, interactions, adverse effects, and more
  11. Chronic Idiopathic Urticaria
  12. Dosing Considerations
  13. 1-10%
  14. Reconstituted vials
  15. Indication and Important Safety Information
  16. omalizumab (Xolair) Uses, Side Effects & Dosage
  17. What is omalizumab? How does it work (mechanism of action)?
  18. What is omalizumab used for?
  19. What are the side effects of omalizumab?
  20. What is the dosage for omalizumab?
  21. Which drugs or supplements interact with omalizumab?
  22. Is omalizumab safe to take if I'm pregnant or breastfeeding?
  23. What else should you know about omalizumab?
  24. How should I keep omalizumab stored?
  25. Xolair – Uses, Heart Attacks & Other Side Effects, and FDA Actions
  26. Xolair (omalizumab) dosing, indications, interactions, adverse effects, and more
  27. Dosage Forms & Strengths
  28. powder for injection
  29. Chronic Idiopathic Urticaria
  30. Dosing Considerations
  31. 1-10%
  32. 150 mg (contents of 1 vial) per injection site Divide doses >150 mg among 2 or more injection sites Storage Storage Lyophilized powder Lyophilized powder Ship at controlled ambient temperature (≤30°C [≤86°F]) Store refrigerated at 2-8°C (36-46°F) Do not use beyond the expiration date stamped on carton Reconstituted vials Reconstituted vials Use solution within 8 hr following reconstitution when stored in the vial at 2-8ºC (36-46ºF), or within 4 hr of reconstitution when stored at room temperature Reconstituted vials should be protected from sunlight FormularyPatient Discounts Adding plans allows you to compare formulary status to other drugs in the same class. To view formulary information first create a list of plans. Your list will be saved and can be edited at any time. Adding plans allows you to: View the formulary and any restrictions for each plan. Manage and view all your plans together – even plans in different states. Compare formulary status to other drugs in the same class. Access your plan list on any device – mobile or desktop. Medscape prescription drug monographs are FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Source: https://reference.medscape.com/drug/xolair-omalizumab-343444 Indication and Important Safety Information
  33. Storage
  34. Storage
  35. Lyophilized powder
  36. Lyophilized powder
  37. Reconstituted vials
  38. Reconstituted vials
  39. Indication and Important Safety Information

omalizumab (Xolair) Uses, Side Effects & Dosage

Xolair Indications, Side Effects, and Warnings
Xolair Indications, Side Effects, and Warnings
Coronavirus COVID-19: Latest News and Information

  • Asthma Slideshow Pictures
  • Take the Asthma Quiz!
  • Asthma Myths and Facts

What is omalizumab? How does it work (mechanism of action)?

Omalizumab is an injectable drug that is used for treating asthma. Omalizumab is a protein that resembles one type of human antibody. Antibodies are proteins produced by the body that recognize foreign substances such as bacteria (that cause infection) and pollens (that cause allergies).

Once they recognize a foreign substance, the antibodies attach to receptors on two types of cells in tissues and blood, mast cells and basophils. These cells then release chemicals that cause an allergic reaction that leads to inflammation.

Omalizumab blocks the receptors on the surfaces of the mast cells and basophils to which antibodies attach, thereby preventing antibodies from attaching to the cells. As a result, the cells do not release their chemicals, and the allergic reaction and inflammation are prevented.

In asthmatic individuals, allergic reactions often cause attacks of asthma. Omalizumab reduces the attacks of asthma by preventing the allergic reactions caused by foreign substances.

  • Omalizumab was approved by the FDA in June 2003.
  • The brand name for omalizumab is Xolair.
  • Omalizumab is available in generic for sterile powder injection; 5 ml vial (150 mg).

What is omalizumab used for?

Omalizumab is a sterile injectable drug used for the treatment of asthma. 

What are the side effects of omalizumab?

The most common side effects observed in patients treated with omalizumab are: 

Use of omalizumab may also lead to serious, life-threatening allergic reactions (anaphylaxis) which manifest as bronchospasm with difficulty breathing, fainting, low blood pressure, and swelling of the tongue or throat.

It is recommended that patients be observed for these reactions for at least two hours after injection of omalizumab; however, these reactions can occur up to 24 hours or longer after the injections, and they have occurred even after one year of regular treatment. Since allergic reactions can occur after any dose, patients should carry medications for emergency self-treatment. In clinical trials cancer occurred more frequently in patients who took omalizumab.

Asthma is a chronic respiratory disease. See Answer

What is the dosage for omalizumab?

Omalizumab is injected under the skin. The recommended dose is 150-375 mg every 2 to 4 weeks. The dose and frequency is body weight and levels of serum IgE, a type of antibody that is important in promoting some types of allergic reactions. Doses greater than 150 mg should be divided and administered at different sites so that no more than 150 mg is administered at each injection site.

Which drugs or supplements interact with omalizumab?

Drug interaction studies have not been conducted with omalizumab.

Is omalizumab safe to take if I'm pregnant or breastfeeding?

Omalizumab has not been adequately studied in pregnant women.

Use of omalizumab by nursing mothers has not been adequately evaluated. Since antibodies similar to omalizumab are excreted in human breast milk, it is ly that omalizumab also is excreted in breast milk.

How should I keep omalizumab stored?

Omalizumab should be refrigerated between 2 C to 8 C (36 F to 46 F). When mixed with sterile water, the solution should be used within 8 hours if refrigerated between 2 C to 8 C (36 F to 46 F) or within 4 hours if stored at room temperature.

What is Asthma? Asthma Myths Debunked See Slideshow Symptoms & Signs FAQs & Doctor's Views Medications FDA Drug Labels on RxList.com Health News Health Features

By clicking “Submit,” I agree to the MedicineNet Terms and Conditions and Privacy Policy. I also agree to receive emails from MedicineNet and I understand that I may opt MedicineNet subscriptions at any time.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Source: https://www.medicinenet.com/omalizumab/article.htm

Xolair – Uses, Heart Attacks & Other Side Effects, and FDA Actions

Xolair Indications, Side Effects, and Warnings

On This Page Xolair Facts

  1. Used to TreatModerate to severe persistent allergic asthma and chronic hives (chronic idiopathic urticaria – CIU)
  2. ManufacturerGenentech Inc.

    and Novartis Pharmaceuticals Corporation

  3. Active IngredientOmalizumab
  4. FDA Approval2003

Home Xolair

Xolair (omalizumab) is an injectable prescription medication used to treat moderate to severe persistent allergic asthma and chronic hives (a condition called chronic idiopathic urticaria, or CIU). However, health complications in patients necessitated two FDA-approved label changes to the drug; one for anaphylaxis, which can be life-threatening, and another describing a slightly higher risk of heart and brain blood vessel problems, such as mini-strokes, heart attacks, chest pain, high blood pressure in the arteries of the lungs and blood clots.

Xolair (omalizumab) is an injectable medication used to treat patients with a moderate or severe type of asthma caused by allergens (allergic asthma) and a chronic type of hives with no identifiable cause (chronic idiopathic urticaria). But the drug has been linked to severe, life-threatening allergic reactions called anaphylaxis and other possible side effects.

A black box warning was added to the drug’s label in 2007, advising patients and physicians that anaphylaxis could occur at any time after taking Xolair.

In 2009, the U.S. Food and Drug Administration began evaluating safety findings of an ongoing study showing Xolair patients faced an increased risk of heart and brain blood-vessel problems.

The FDA finished its review of the study in 2014. While it found evidence of higher blood-vessel problems, there were flaws in the way the study was carried out.

Due to these flaws, the FDA could not “definitively confirm or determine the exact increased level of these risks.” Slightly higher rates of cancer were also observed in previous Xolair studies.

The FDA review did not find a difference in the rates of cancer, however, the flaws in the study also meant it couldn’t rule out the potential risk of cancer with Xolair.

The FDA initially approved the drug in 2003 for children 12 and older and adults. Novartis Pharmaceuticals Corporation and Genentech USA, Inc. announced in mid-2016 that the FDA had expanded Xolair users to include children as young as 6.

That made Xolair the first and only biologic treatment for patients 6 and older with uncontrolled moderate to severe persistent allergic asthma.

Xolair treats moderate to severe persistent asthma from allergies (allergic asthma) for patients 6 and older whose symptoms cannot be adequately controlled with inhaled corticosteroids.

Having allergic asthma means symptoms are caused by allergens, substances that trigger immune-system responses. The immune system releases immunoglobulin E.

Normal bronchiole tubeInflamed bronchiole tube

Too much immunoglobulin E can cause inflammation (swelling) in the body and in the airways in a person’s lungs. As the condition worsens, it can become difficult to breathe and may even result in an asthma attack.

Xolair blocks immunoglobulin E and may be a part of a treatment plan for people who suffer from allergic asthma.

Asthma is a chronic disease that affects a person’s airways, causing them to swell, narrow and react strongly to allergens and other irritants. As the airways react and continue to narrow, less air can get through to your lungs.

Common asthma triggers include:

  • Animals (pet hair or dander)
  • Cockroaches
  • Changes in weather (usually colder temperatures)
  • Exercise
  • Pollen
  • Certain medications (such as aspirin and other NSAIDs)
  • Dust mites
  • Strong emotions or stress
  • Chemicals in the air or food
  • Mold
  • Respiratory infections (such as the common cold)
  • Tobacco smoke

Asthma can lead to symptoms such as wheezing (a whistling sound when you breathe), coughing (especially early in the morning or at night), chest tightness and shortness of breath. If symptoms of asthma worsen, it’s called an asthma attack. Severe asthma attacks may require emergency care and can even be life-threatening.

Asthma affects people of all ages, but it most often begins in childhood. In the United States, more than 25 million people are living with asthma, and approximately 7 million of those people are children. There is no cure for asthma, but it can be managed with quick-relief and long-term medications, and symptoms can sometimes improve over time.

Chronic idiopathic urticaria is the most common type of chronic hives. Xolair treats this condition in patients 12 and older who have persistent symptoms despite using anti-allergy drugs such as H1-antihistamines, or histamine blockers.

Urticaria is the medical term for hives, which are red and often itchy, sometimes painful, bumps on the skin that are usually caused by an allergic reaction to a drug or food.

During an allergic reaction, the body releases chemicals called histamines that can make the skin swell into hives.

Hives can also be caused by other conditions such as infections, stress and certain autoimmune conditions.

Urticaria — or hives — are considered chronic when the condition lasts for 6+ weeks

When hives last for six weeks or longer, the condition is considered chronic. In about three 10 cases, the cause of hives is known. But in seven 10 cases of chronic hives, a cause cannot be determined.

This is diagnosed as chronic idiopathic urticaria (CIU), and it is the most common type of chronic hives, mostly occurring between the ages of 20 and 40.

 Women are more ly than men to have CIU, experiencing flares that last anywhere from one to five years or longer.

In rare cases, hives can cause swelling in a person’s airways making it difficult to breathe and requiring emergency treatment. If not immediately treated, this dangerous occurrence can even result in death.

Xolair is administered via injection, as pictured above

Xolair is an injectable prescription medicine administered by a health provider in a health care setting. It is a subcutaneous injection, meaning it is given in the fatty layer of tissue just under the skin. Subcutaneous injection sites can include the upper arms, abdomen in the belly area and front of the thighs.

The National Institutes of Health (NIH) advises rotating injection sites to keep the skin healthy, as repeated injections in the same location can cause scarring and hardening of tissues that can interfere with subsequent administration and absorption of medication.

Xolair is administered in dosages of 150 milligrams to 375 milligrams every two to four weeks. Levels of immunoglobulin E and body weight are used to determine dosing and frequency. A patient’s physician should periodically reassess the need for continued treatment the severity of the disease and overall management of asthma symptoms.

Fact Doses should be adjusted for any significant changes in body weight when receiving Xolair for the treatment of allergic asthma.

When receiving Xolair for the treatment of allergic asthma, doses should be adjusted for any significant changes in body weight.

Re-testing of immunoglobulin E (IgE) levels during treatment cannot be used as a guide for subsequent dose determinations and adjustments, due to the fact that total IgE levels are elevated as a result of treatment and will remain elevated for up to one year following the discontinuation of the asthma medication.

Dosing of Xolair in patients being treated for chronic idiopathic urticaria is not determined by IgE levels or body weight.

Rather, treatments are administered by subcutaneous injection every four weeks in dosages of 150 milligrams or 300 milligrams.

A patient’s physician should periodically reassess the need for continued treatment as the appropriate duration of Xolair therapy for chronic idiopathic urticaria has not yet been evaluated.

Xolair injections take approximately five to 10 seconds to administer due to the consistency of the solution being slightly viscous (thick and sticky). Each vial delivers 150 milligrams. If more than 150 milligrams is required, the doses need to be divided among two or more injection sites.

Studies have not yet determined the maximum tolerated dose of Xolair. When administering single doses of up to 4,000 milligrams to patients, no toxicity was reported. The highest cumulative dose administered to patients was 44,000 milligrams over a 20-week period with no adverse events or resulting toxicity associated with the higher dosing amount.

Xolair is not without side effects, ranging from mild to severe, and even life-threatening. Anaphylaxis can occur after one dose or many doses. It can also occur immediately after receiving the injection or days later.

If not immediately treated, anaphylaxis can be deadly. The FDA reviewed a study that found Xolair patients had a slightly increased risk of problems involving the heart and blood vessels in the brain.

But the FDA could not determine a level of risk.

Other common side effects of Xolair include:

  • Pain at the site of the injection
  • Pain, especially in the arms and legs
  • Feeling tired
  • Bone fractures
  • Dizziness
  • Skin rash
  • Pain or discomfort of the ears

Pediatric patients (ages six to 12) may experience slightly different side effects, including common cold symptoms, headache, fever, sore throat, earache or ear infection, abdominal pain, nausea, vomiting and nose bleeds.

Side effects in patients who are being treated for CIU:

  • Nausea
  • Swelling of the inside of your nose, throat or sinuses
  • Joint pain
  • Headaches
  • Cough
  • Upper respiratory tract infection

Injection site reactions include swelling, erythema (redness of the skin caused by increased blood flow in the capillaries in the lower layers of skin), pain, itching, bleeding and hives.

Serious side effects of Xolair include:CancerPatients receiving Xolair may have a higher risk of certain types of cancer.Inflammation of blood vessels Symptoms include chest pain, shortness of breath, or a feeling of pins and needles or numbness of the arms and legs.Fever, muscle aches and rashThese symptoms can occur one to five days after receiving Xolair.Parasitic infectionThis side effect can occur after receiving Xolair in patients who are at high-risk for parasite (worm) infections.High blood levels of a certain antibody (serum total IgE)

No formal drug interaction studies have been performed with Xolair. In patients with allergic asthma, the combined use of Xolair and allergen immunotherapy (commonly referred to as allergy shots) has not been evaluated. Similarly, it is unknown what interactions might occur in patients with CIU using Xolair and other immunosuppressive therapies simultaneously.

Did You Know No formal drug interaction studies have been performed with Xolair.

Adequate and well-controlled studies in pregnant women using Xolair have not been conducted, and therefore, the data is insufficient to inform patients on associated risk. wise, for breastfeeding mothers, it is unknown if Xolair is present in breast milk.

In 2006, 2010 and 2012, Genentech and Novartis were hit with whistleblower lawsuits filed by Frank Garcia, Stephen Fauci and Allison Kelly, respectively, all former employees of the drug companies. Federal law allows whistleblowers to file suits on behalf of the government alleging fraud. If the government wins, whistleblowers receive a portion of the award.

Genentech, whose San Francisco headquarters is pictured above, was hit with whistleblower actions by former employees

With former employees accusing Genentech and Novartis of wrongdoing in the marketing and sales of Xolair, and with post-marketing studies and reports linking the use of Xolair to serious side effects, such as life-threatening anaphylaxis, heart attacks, mini-strokes, blood clots in the lungs, high blood pressure in the arteries of the lungs, and possibly even cancer, the drug companies may face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Fact Plaintiffs claimed that the manufacturers misbranded Xolair, making it ineligible for reimbursement under government health care programs.

The whistleblowers further claimed that Genentech and Novartis had misbranded Xolair “making it ineligible for reimbursement” under government health care programs, such as Medicare and Medicaid.

Additionally, the whistleblowers claimed that health care providers were induced to submit claims for reimbursement at improper rates by using improper medical codes for the administration of Xolair.

But on June 17, 2016, the U.S. Court of Appeals affirmed a district court’s ruling to dismiss the federal claims with prejudice (meaning they cannot be amended, revised and refiled). The court found the whistleblowers failed to make their complaints with “sufficient particularity” (not clearly enough).

However, the appeals court found a procedural error and sent that part back to the district court, providing the whistleblowers an opportunity to amend and refile those claims.

With former employees accusing Genentech and Novartis of wrongdoing in the marketing and sales of Xolair, and with post-marketing studies and reports linking the use of Xolair to serious side effects, such as life-threatening anaphylaxis, heart attacks, mini-strokes, blood clots in the lungs, high blood pressure in the arteries of the lungs, and possibly even cancer, the drug companies are ly to face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Future Claims Incoming Drug companies are ly to face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Law firms across the country are currently discussing legal options with injured consumers and preparing to file lawsuits on behalf of patients who have suffered serious side effects or even death after receiving Xolair treatments.

Please seek the advice of a medical professional before making health care decisions.

Source: https://www.drugwatch.com/xolair/

Xolair (omalizumab) dosing, indications, interactions, adverse effects, and more

Xolair Indications, Side Effects, and Warnings

  • 150mg/1.2mL (125mg/mL) after reconstition

Moderate-to-severe persistent asthma with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids

150-375 mg SC q2-4Weeks

Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information)

Chronic Idiopathic Urticaria

Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment

150-300 mg SC q4weeks

Dosing in CIU patients is not dependent on serum IgE level or body weight

Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy

Dosing Considerations

Not indicated for treatment of other allergic conditions or other forms of urticaria

Not indicated for the relief of acute bronchospasm or status asthmaticus

1-10%

Pain (7%)

Arthralgia (8%)

Fracture (2%)

Fatigue (3%)

Dermatitis (2%)

Arm pain (4%)

Leg pain (4%)

Dizziness (3%)

Earache (2%)

Pruritus (2%)

Nasopharyngitis (3%)

Pyrexia (3%)

Upper abdominal pain (3%)

Pharyngitis streptococcal (3%)

Otitis media (3%)

Viral gastroenteritis (3%)

Epistaxis (3%)

Reconstituted vials

  • Use solution within 8 hr following reconstitution when stored in the vial at 2-8ºC (36-46ºF), or within 4 hr of reconstitution when stored at room temperature
  • Reconstituted vials should be protected from sunlight

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

Medscape prescription drug monographs are FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

Source: https://reference.medscape.com/drug/xolair-omalizumab-343444

Indication and Important Safety Information

Xolair Indications, Side Effects, and Warnings

omalizumab (Xolair) Uses, Side Effects & Dosage

Xolair Indications, Side Effects, and Warnings
Xolair Indications, Side Effects, and Warnings
Coronavirus COVID-19: Latest News and Information

  • Asthma Slideshow Pictures
  • Take the Asthma Quiz!
  • Asthma Myths and Facts

What is omalizumab? How does it work (mechanism of action)?

Omalizumab is an injectable drug that is used for treating asthma. Omalizumab is a protein that resembles one type of human antibody. Antibodies are proteins produced by the body that recognize foreign substances such as bacteria (that cause infection) and pollens (that cause allergies).

Once they recognize a foreign substance, the antibodies attach to receptors on two types of cells in tissues and blood, mast cells and basophils. These cells then release chemicals that cause an allergic reaction that leads to inflammation.

Omalizumab blocks the receptors on the surfaces of the mast cells and basophils to which antibodies attach, thereby preventing antibodies from attaching to the cells. As a result, the cells do not release their chemicals, and the allergic reaction and inflammation are prevented.

In asthmatic individuals, allergic reactions often cause attacks of asthma. Omalizumab reduces the attacks of asthma by preventing the allergic reactions caused by foreign substances.

  • Omalizumab was approved by the FDA in June 2003.
  • The brand name for omalizumab is Xolair.
  • Omalizumab is available in generic for sterile powder injection; 5 ml vial (150 mg).

What is omalizumab used for?

Omalizumab is a sterile injectable drug used for the treatment of asthma. 

What are the side effects of omalizumab?

The most common side effects observed in patients treated with omalizumab are: 

Use of omalizumab may also lead to serious, life-threatening allergic reactions (anaphylaxis) which manifest as bronchospasm with difficulty breathing, fainting, low blood pressure, and swelling of the tongue or throat.

It is recommended that patients be observed for these reactions for at least two hours after injection of omalizumab; however, these reactions can occur up to 24 hours or longer after the injections, and they have occurred even after one year of regular treatment. Since allergic reactions can occur after any dose, patients should carry medications for emergency self-treatment. In clinical trials cancer occurred more frequently in patients who took omalizumab.

Asthma is a chronic respiratory disease. See Answer

What is the dosage for omalizumab?

Omalizumab is injected under the skin. The recommended dose is 150-375 mg every 2 to 4 weeks. The dose and frequency is body weight and levels of serum IgE, a type of antibody that is important in promoting some types of allergic reactions. Doses greater than 150 mg should be divided and administered at different sites so that no more than 150 mg is administered at each injection site.

Which drugs or supplements interact with omalizumab?

Drug interaction studies have not been conducted with omalizumab.

Is omalizumab safe to take if I'm pregnant or breastfeeding?

Omalizumab has not been adequately studied in pregnant women.

Use of omalizumab by nursing mothers has not been adequately evaluated. Since antibodies similar to omalizumab are excreted in human breast milk, it is ly that omalizumab also is excreted in breast milk.

What else should you know about omalizumab?

How should I keep omalizumab stored?

Omalizumab should be refrigerated between 2 C to 8 C (36 F to 46 F). When mixed with sterile water, the solution should be used within 8 hours if refrigerated between 2 C to 8 C (36 F to 46 F) or within 4 hours if stored at room temperature.

What is Asthma? Asthma Myths Debunked See Slideshow Symptoms & Signs FAQs & Doctor's Views Medications FDA Drug Labels on RxList.com Health News Health Features

By clicking “Submit,” I agree to the MedicineNet Terms and Conditions and Privacy Policy. I also agree to receive emails from MedicineNet and I understand that I may opt MedicineNet subscriptions at any time.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Source: https://www.medicinenet.com/omalizumab/article.htm

Xolair – Uses, Heart Attacks & Other Side Effects, and FDA Actions

Xolair Indications, Side Effects, and Warnings

On This Page Xolair Facts

  1. Used to TreatModerate to severe persistent allergic asthma and chronic hives (chronic idiopathic urticaria – CIU)
  2. ManufacturerGenentech Inc.

    and Novartis Pharmaceuticals Corporation

  3. Active IngredientOmalizumab
  4. FDA Approval2003

Home Xolair

Xolair (omalizumab) is an injectable prescription medication used to treat moderate to severe persistent allergic asthma and chronic hives (a condition called chronic idiopathic urticaria, or CIU). However, health complications in patients necessitated two FDA-approved label changes to the drug; one for anaphylaxis, which can be life-threatening, and another describing a slightly higher risk of heart and brain blood vessel problems, such as mini-strokes, heart attacks, chest pain, high blood pressure in the arteries of the lungs and blood clots.

Xolair (omalizumab) is an injectable medication used to treat patients with a moderate or severe type of asthma caused by allergens (allergic asthma) and a chronic type of hives with no identifiable cause (chronic idiopathic urticaria). But the drug has been linked to severe, life-threatening allergic reactions called anaphylaxis and other possible side effects.

A black box warning was added to the drug’s label in 2007, advising patients and physicians that anaphylaxis could occur at any time after taking Xolair.

In 2009, the U.S. Food and Drug Administration began evaluating safety findings of an ongoing study showing Xolair patients faced an increased risk of heart and brain blood-vessel problems.

The FDA finished its review of the study in 2014. While it found evidence of higher blood-vessel problems, there were flaws in the way the study was carried out.

Due to these flaws, the FDA could not “definitively confirm or determine the exact increased level of these risks.” Slightly higher rates of cancer were also observed in previous Xolair studies.

The FDA review did not find a difference in the rates of cancer, however, the flaws in the study also meant it couldn’t rule out the potential risk of cancer with Xolair.

The FDA initially approved the drug in 2003 for children 12 and older and adults. Novartis Pharmaceuticals Corporation and Genentech USA, Inc. announced in mid-2016 that the FDA had expanded Xolair users to include children as young as 6.

That made Xolair the first and only biologic treatment for patients 6 and older with uncontrolled moderate to severe persistent allergic asthma.

Xolair treats moderate to severe persistent asthma from allergies (allergic asthma) for patients 6 and older whose symptoms cannot be adequately controlled with inhaled corticosteroids.

Having allergic asthma means symptoms are caused by allergens, substances that trigger immune-system responses. The immune system releases immunoglobulin E.

Normal bronchiole tubeInflamed bronchiole tube

Too much immunoglobulin E can cause inflammation (swelling) in the body and in the airways in a person’s lungs. As the condition worsens, it can become difficult to breathe and may even result in an asthma attack.

Xolair blocks immunoglobulin E and may be a part of a treatment plan for people who suffer from allergic asthma.

Asthma is a chronic disease that affects a person’s airways, causing them to swell, narrow and react strongly to allergens and other irritants. As the airways react and continue to narrow, less air can get through to your lungs.

Common asthma triggers include:

  • Animals (pet hair or dander)
  • Cockroaches
  • Changes in weather (usually colder temperatures)
  • Exercise
  • Pollen
  • Certain medications (such as aspirin and other NSAIDs)
  • Dust mites
  • Strong emotions or stress
  • Chemicals in the air or food
  • Mold
  • Respiratory infections (such as the common cold)
  • Tobacco smoke

Asthma can lead to symptoms such as wheezing (a whistling sound when you breathe), coughing (especially early in the morning or at night), chest tightness and shortness of breath. If symptoms of asthma worsen, it’s called an asthma attack. Severe asthma attacks may require emergency care and can even be life-threatening.

Asthma affects people of all ages, but it most often begins in childhood. In the United States, more than 25 million people are living with asthma, and approximately 7 million of those people are children. There is no cure for asthma, but it can be managed with quick-relief and long-term medications, and symptoms can sometimes improve over time.

Chronic idiopathic urticaria is the most common type of chronic hives. Xolair treats this condition in patients 12 and older who have persistent symptoms despite using anti-allergy drugs such as H1-antihistamines, or histamine blockers.

Urticaria is the medical term for hives, which are red and often itchy, sometimes painful, bumps on the skin that are usually caused by an allergic reaction to a drug or food.

During an allergic reaction, the body releases chemicals called histamines that can make the skin swell into hives.

Hives can also be caused by other conditions such as infections, stress and certain autoimmune conditions.

Urticaria — or hives — are considered chronic when the condition lasts for 6+ weeks

When hives last for six weeks or longer, the condition is considered chronic. In about three 10 cases, the cause of hives is known. But in seven 10 cases of chronic hives, a cause cannot be determined.

This is diagnosed as chronic idiopathic urticaria (CIU), and it is the most common type of chronic hives, mostly occurring between the ages of 20 and 40.

 Women are more ly than men to have CIU, experiencing flares that last anywhere from one to five years or longer.

In rare cases, hives can cause swelling in a person’s airways making it difficult to breathe and requiring emergency treatment. If not immediately treated, this dangerous occurrence can even result in death.

Xolair is administered via injection, as pictured above

Xolair is an injectable prescription medicine administered by a health provider in a health care setting. It is a subcutaneous injection, meaning it is given in the fatty layer of tissue just under the skin. Subcutaneous injection sites can include the upper arms, abdomen in the belly area and front of the thighs.

The National Institutes of Health (NIH) advises rotating injection sites to keep the skin healthy, as repeated injections in the same location can cause scarring and hardening of tissues that can interfere with subsequent administration and absorption of medication.

Xolair is administered in dosages of 150 milligrams to 375 milligrams every two to four weeks. Levels of immunoglobulin E and body weight are used to determine dosing and frequency. A patient’s physician should periodically reassess the need for continued treatment the severity of the disease and overall management of asthma symptoms.

Fact Doses should be adjusted for any significant changes in body weight when receiving Xolair for the treatment of allergic asthma.

When receiving Xolair for the treatment of allergic asthma, doses should be adjusted for any significant changes in body weight.

Re-testing of immunoglobulin E (IgE) levels during treatment cannot be used as a guide for subsequent dose determinations and adjustments, due to the fact that total IgE levels are elevated as a result of treatment and will remain elevated for up to one year following the discontinuation of the asthma medication.

Dosing of Xolair in patients being treated for chronic idiopathic urticaria is not determined by IgE levels or body weight.

Rather, treatments are administered by subcutaneous injection every four weeks in dosages of 150 milligrams or 300 milligrams.

A patient’s physician should periodically reassess the need for continued treatment as the appropriate duration of Xolair therapy for chronic idiopathic urticaria has not yet been evaluated.

Xolair injections take approximately five to 10 seconds to administer due to the consistency of the solution being slightly viscous (thick and sticky). Each vial delivers 150 milligrams. If more than 150 milligrams is required, the doses need to be divided among two or more injection sites.

Studies have not yet determined the maximum tolerated dose of Xolair. When administering single doses of up to 4,000 milligrams to patients, no toxicity was reported. The highest cumulative dose administered to patients was 44,000 milligrams over a 20-week period with no adverse events or resulting toxicity associated with the higher dosing amount.

Xolair is not without side effects, ranging from mild to severe, and even life-threatening. Anaphylaxis can occur after one dose or many doses. It can also occur immediately after receiving the injection or days later.

If not immediately treated, anaphylaxis can be deadly. The FDA reviewed a study that found Xolair patients had a slightly increased risk of problems involving the heart and blood vessels in the brain.

But the FDA could not determine a level of risk.

Other common side effects of Xolair include:

  • Pain at the site of the injection
  • Pain, especially in the arms and legs
  • Feeling tired
  • Bone fractures
  • Dizziness
  • Skin rash
  • Pain or discomfort of the ears

Pediatric patients (ages six to 12) may experience slightly different side effects, including common cold symptoms, headache, fever, sore throat, earache or ear infection, abdominal pain, nausea, vomiting and nose bleeds.

Side effects in patients who are being treated for CIU:

  • Nausea
  • Swelling of the inside of your nose, throat or sinuses
  • Joint pain
  • Headaches
  • Cough
  • Upper respiratory tract infection

Injection site reactions include swelling, erythema (redness of the skin caused by increased blood flow in the capillaries in the lower layers of skin), pain, itching, bleeding and hives.

Serious side effects of Xolair include:CancerPatients receiving Xolair may have a higher risk of certain types of cancer.Inflammation of blood vessels Symptoms include chest pain, shortness of breath, or a feeling of pins and needles or numbness of the arms and legs.Fever, muscle aches and rashThese symptoms can occur one to five days after receiving Xolair.Parasitic infectionThis side effect can occur after receiving Xolair in patients who are at high-risk for parasite (worm) infections.High blood levels of a certain antibody (serum total IgE)

No formal drug interaction studies have been performed with Xolair. In patients with allergic asthma, the combined use of Xolair and allergen immunotherapy (commonly referred to as allergy shots) has not been evaluated. Similarly, it is unknown what interactions might occur in patients with CIU using Xolair and other immunosuppressive therapies simultaneously.

Did You Know No formal drug interaction studies have been performed with Xolair.

Adequate and well-controlled studies in pregnant women using Xolair have not been conducted, and therefore, the data is insufficient to inform patients on associated risk. wise, for breastfeeding mothers, it is unknown if Xolair is present in breast milk.

In 2006, 2010 and 2012, Genentech and Novartis were hit with whistleblower lawsuits filed by Frank Garcia, Stephen Fauci and Allison Kelly, respectively, all former employees of the drug companies. Federal law allows whistleblowers to file suits on behalf of the government alleging fraud. If the government wins, whistleblowers receive a portion of the award.

Genentech, whose San Francisco headquarters is pictured above, was hit with whistleblower actions by former employees

With former employees accusing Genentech and Novartis of wrongdoing in the marketing and sales of Xolair, and with post-marketing studies and reports linking the use of Xolair to serious side effects, such as life-threatening anaphylaxis, heart attacks, mini-strokes, blood clots in the lungs, high blood pressure in the arteries of the lungs, and possibly even cancer, the drug companies may face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Fact Plaintiffs claimed that the manufacturers misbranded Xolair, making it ineligible for reimbursement under government health care programs.

The whistleblowers further claimed that Genentech and Novartis had misbranded Xolair “making it ineligible for reimbursement” under government health care programs, such as Medicare and Medicaid.

Additionally, the whistleblowers claimed that health care providers were induced to submit claims for reimbursement at improper rates by using improper medical codes for the administration of Xolair.

But on June 17, 2016, the U.S. Court of Appeals affirmed a district court’s ruling to dismiss the federal claims with prejudice (meaning they cannot be amended, revised and refiled). The court found the whistleblowers failed to make their complaints with “sufficient particularity” (not clearly enough).

However, the appeals court found a procedural error and sent that part back to the district court, providing the whistleblowers an opportunity to amend and refile those claims.

With former employees accusing Genentech and Novartis of wrongdoing in the marketing and sales of Xolair, and with post-marketing studies and reports linking the use of Xolair to serious side effects, such as life-threatening anaphylaxis, heart attacks, mini-strokes, blood clots in the lungs, high blood pressure in the arteries of the lungs, and possibly even cancer, the drug companies are ly to face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Future Claims Incoming Drug companies are ly to face lawsuits stemming from personal injury claims made by injured patients using Xolair.

Law firms across the country are currently discussing legal options with injured consumers and preparing to file lawsuits on behalf of patients who have suffered serious side effects or even death after receiving Xolair treatments.

Please seek the advice of a medical professional before making health care decisions.

Source: https://www.drugwatch.com/xolair/

Xolair (omalizumab) dosing, indications, interactions, adverse effects, and more

Xolair Indications, Side Effects, and Warnings

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 150mg/1.2mL (125mg/mL) after reconstition

Moderate-to-severe persistent asthma with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids

150-375 mg SC q2-4Weeks

Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information)

Chronic Idiopathic Urticaria

Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment

150-300 mg SC q4weeks

Dosing in CIU patients is not dependent on serum IgE level or body weight

Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy

Dosing Considerations

Not indicated for treatment of other allergic conditions or other forms of urticaria

Not indicated for the relief of acute bronchospasm or status asthmaticus

1-10%

Pain (7%)

Arthralgia (8%)

Fracture (2%)

Fatigue (3%)

Dermatitis (2%)

Arm pain (4%)

Leg pain (4%)

Dizziness (3%)

Earache (2%)

Pruritus (2%)

Nasopharyngitis (3%)

Pyrexia (3%)

Upper abdominal pain (3%)

Pharyngitis streptococcal (3%)

Otitis media (3%)

Viral gastroenteritis (3%)

Epistaxis (3%)

150 mg (contents of 1 vial) per injection site

Divide doses >150 mg among 2 or more injection sites

Storage

Storage

Lyophilized powder

Lyophilized powder

  • Ship at controlled ambient temperature (≤30°C [≤86°F])
  • Store refrigerated at 2-8°C (36-46°F)
  • Do not use beyond the expiration date stamped on carton

Reconstituted vials

Reconstituted vials

  • Use solution within 8 hr following reconstitution when stored in the vial at 2-8ºC (36-46ºF), or within 4 hr of reconstitution when stored at room temperature
  • Reconstituted vials should be protected from sunlight

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

Medscape prescription drug monographs are FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

Source: https://reference.medscape.com/drug/xolair-omalizumab-343444

Indication and Important Safety Information

Xolair Indications, Side Effects, and Warnings