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Month: December 2022

New Indications for Biological Medications

Most of the medications used for treating diseases are chemically synthesized in a laboratory. Some newer medications, however, are derived from a variety of natural sources such as humans, animals, or microorganisms. These newer medications, often referred to as “biologicals,” are typically produced by using biotechnology and/or other cutting-edge methodologies. Biologicals represent a breakthrough advance in therapeutics as they may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.
Most allergic and immunological disorders have chronic uncontrolled inflammation as the primary underlying mechanism of the disease. This chronic inflammation often leads to organ dysfunction and the unwanted symptoms associated with such inflammation. The inflammatory process is mediated by various chemical substances such as antibodies and cytokines. The biological medications (i.e., biologicals) target these inflammatory mediators and suppress or block their actions resulting in better control of the disease.

  • XOLAIR (i.e., omalizumab) was the first biological approved by the FDA for the treatment of asthma. It was initially approved for adults in 2003 and later approved for children in 2006. Xolair acts by blocking the “allergy” antibody, commonly called IgE, which acts as a mediator of many disorders of immediate hypersensitivity.
    Xolair is used for adult and pediatric patients who are 6 years of age and older with moderate to severe persistent asthma, whose symptoms are inadequately controlled with inhaled corticosteroids, who have a positive allergy skin test or an in vitro (i.e., in the test tube) reactivity to a perennial aeroallergen such as dust mites. It is administered by subcutaneous (SQ) injections on a regular basis (i.e., every 4 weeks). The dose and frequency of administration depend on the IgE level and the weight of the patient. The IgE level is determined by a blood test.
    After getting the approval for the treatment of moderate to severe persistent asthma, Xolair subsequently was also approved for the treatment of chronic idiopathic urticaria (i.e., chronic hives) in patients ≥ 12 years of age who remain symptomatic despite H1 antihistamine (e.g., Clarinex, Claritin, Allegra, Zyrtec, Xyzal, Benadryl) treatment. Xolair has helped numerous individuals suffering from chronic hives.
    More recently, Xolair has received an additional indication for the add-on maintenance treatment of nasal polyps in adult patients ≥ 18 years of age who have an inadequate response to nasal corticosteroids (e.g., Flonase, Nasonex, Nasacort AQ, Rhinocort AQ, Qnasl)
  • NUCALA (i.e., mepolizumab) is a biological drug that blocks a cytokine called IL-5. It was approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 6 years and older. The approved recommended dosage is 100 mg once every 4 weeks given as a subcutaneous (SQ) injection.
    Later, Nucala also was approved for:

    • Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (i.e., CRSwNP) in adult patients 18 years of age and older with an inadequate response to nasal corticosteroids
    • Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (i.e., EGPA)
    • Treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (i.e., HES)
  • FASENRA (i.e., benralizumab) is indicated for the add-on maintenance treatment in patients with severe eosinophilic asthma aged 12 years and older. It acts by rapidly depleting eosinophils which cause tissue damage when excessively activated and accumulated. The maintenance dose is 30 mg. injected subcutaneously (SQ) under the skin every 8 weeks.
  • DUPIXENT (i.e., dupilumab) acts by blocking 2 pro-inflammatory cytokines called IL-4 and IL-13. It is administered every 2 weeks as a subcutaneous (SQ) injection under the skin.

It is used to treat:

  • Adults and children 6 months of age and older with moderate to severe eczema (i.e., atopic dermatitis) that is not well controlled with prescription therapies used on the skin (i.e., topical), or who cannot use topical therapies
  • With other asthma medications for the maintenance treatment of moderate to severe eosinophilic or oral steroid-dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medications
  • With other medications for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled
  • Adults and children 12 years of age and older, who weigh at least 88 pounds (i.e., 40 kg), with eosinophilic esophagitis (EoE)
  • Adults with prurigo nodularis (PN)


  • TEZSPIRE (i.e., tezepelumab) is the most recent biological medication that was approved by the FDA for treatment of asthma. It is a medication that blocks the cytokine TSLP, a cytokine which plays a prominent role at the top of the inflammatory pathway. It is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
    Tezspire can be used without checking for any biomarker levels such as IgE. It can also be used in most phenotypes of asthma and is not restricted to only be used in eosinophilic asthma as with some other biologicals. It is administered as an injection subcutaneously (SQ) under the skin in a single dose of 210 mg. every 4 weeks.

The board certified allergy doctors at Black & Kletz Allergy see both adult and pediatric patients and have over 50 decades of experience in the field of allergy, asthma, and immunology. Black & Kletz Allergy has 3 convenient locations with on-site parking located in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. The Washington, DC and McLean, VA offices are Metro accessible and we offer a free shuttle that runs between the McLean, VA office and the Spring Hill metro station on the silver line. To schedule an appointment, please call any of our offices or you may click Request an Appointment and we will respond within 24 hours by the next business day. We have been servicing the greater Washington, DC metropolitan area for over 50 years and we look forward to providing you with the highest state-of-the-art allergy care in a friendly and approachable environment.

Cold Weather Allergies

Cold Weather AllergiesNow that it is turning cold in the Washington, DC, Northern Virginia, and Maryland metropolitan area, some allergic individuals are happy because they have a respite from their pollen (e.g., trees, grasses, weeds) allergies which tend to bother them in the Spring, Summer, and/or Fall.   Others however, are not as happy, as they either continue to have their allergy symptoms or develop their allergy symptoms only in the colder weather.  These individuals are allergic to other allergens such as dust mites, molds, pets, or cockroaches, to name a few.

Dust mites, molds, pets, and cockroaches are allergens that are generally considered “indoor” allergens; however, molds are found both indoors and outdoors.  Molds are particularly a problem in the Washington, DC metro area as Washington, DC was built on a swamp and the mold counts tend to be high in the area throughout the year.  The 2 most common conditions caused by these allergens are allergic rhinitis (i.e., hay fever) and allergic conjunctivitis (i.e., eye allergies).  The classic symptoms of allergic rhinitis may include sneezing, runny nose, nasal congestion, post-nasal drip, itchy nose, itchy throat, sinus congestion, sinus headaches, and/or snoring.  The typical symptoms of allergic conjunctivitis may include itchy eyes, watery eyes, puffy eyes, and/or redness of the eyes.  Another common malady that can arise from these allergens is asthma.  Asthmatics typically complain of wheezing, chest tightness, coughing, and/or shortness of breath.  Reducing one’s exposure to dust mites, molds, pets, and/or cockroaches is generally the first step in managing allergic rhinitis, allergic conjunctivitis, or asthma in most individuals.  It should be noted that exposure to cockroaches is a fairly common cause of asthma exacerbations in inner city asthmatic children.  Medications are also frequently utilized in order to better control the unwanted allergy or asthma symptoms.  Allergy immunotherapy (allergy shots, allergy injections, allergy desensitization, allergy hyposensitization) is a staple in the treatment of all 3 conditions.  Allergy immunotherapy has been around for more than 100 years and it is effective in 80-85% of individuals who take allergy shots.

There is a subset of individuals who are bothered just by the cold air and not the allergens associated with the Winter.  These patients have vasomotor rhinitis and may experience hay fever-like symptoms (i.e., runny nose, nasal, congestion, post-nasal drip) with just the exposure to cold air.  Vasomotor rhinitis is a nonallergic condition that is caused by irritants such as cold air, strong scents, chemicals, pollutants, etc.  In addition to these hay fever-like symptoms, the cold air may contribute to nose bleeds (i.e., epistaxis), watery eyes, and redness of the eyes.

The cold air does not only affect the eyes, nose and lungs when it comes to allergic and nonallergic conditions that are diagnosed and treated by board certified allergists like the ones at Black & Kletz Allergy.  The skin is affected by the cold quite often and can be extremely annoying and even serious for some individuals.  There are 4 cold-related conditions that fall under a similar category that affect the skin.   These diseases are similar, but differ mainly by their severity.  These 4 disorders include cold-induced pruritus, cold-induced urticaria, cold-induced angioedema, and cold-induced anaphylaxis.  In cold-induced pruritus, the cold air will cause an individual to have itchy skin.  A person with cold-induced urticaria will develop hives with cold exposure.  People with cold-induced angioedema will develop swelling episodes when exposed to the cold.  Lastly and most seriously, some individuals may develop life-threatening anaphylaxis when they are exposed to the cold.  It is important that a patient be prescribed a self-injectable epinephrine device (e.g., EpiPen, Auvi-Q, Adrenaclick) for patients with cold-induced angioedema and/or cold-induced anaphylaxis.  It is also important to note that any individual who needs to use a self-injectable epinephrine device should go immediately to the closest emergency room after using the device.

In addition to the 4 cold-related conditions mentioned above that affect the skin, some individuals may experience a change in the color of their skin with associated coldness, numbness, and stinging sensation.  The color change is typically a whitish or bluish color.  These individuals may have either Raynaud’s disease (i.e., primary Raynaud’s) or Raynaud’s phenomenon (i.e., secondary Raynaud’s) depending on whether there is an underlying medical problem.  Raynaud’s disease is not associated with an underlying medical disorder and is more common than Raynaud’s phenomenon, which is associated with an underlying medical condition.  The medical conditions most commonly associated with Raynaud’s phenomenon include connective tissue diseases (e.g., systemic lupus erythematosus, Sjögren’s syndrome, scleroderma, rheumatoid arthritis), smoking, injuries to the hands and/or feet, carpal tunnel syndrome, atherosclerosis, and certain medications (e.g., beta blockers, ADHD medications, migraine headache medications).

The board certified allergy doctors at Black & Kletz Allergy will promptly respond to any questions regarding cold-induced disorders and any other allergic or immunologic disorders.  We have been treating cold-indued disorders for over 50 years and have offices in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA.  We treat both adult and pediatric patients.  All 3 offices at Black & Kletz Allergy offer on-site parking and the Washington, DC and McLean, VA offices are Metro accessible.  There is a free shuttle that runs between our McLean, VA office and the Spring Hill metro station on the silver line.  If you are concerned that you may have a cold-induced condition or any other allergy, asthma, sinus, skin, or immunology problem, please call us to schedule an appointment.  You may also click Request an Appointment and we will reply within 24 hours by the next business day.  At Black & Kletz Allergy, we strive to improve the quality of life in allergic individuals in a professional and welcoming setting.