Oralair (Five-grass pollen sublingual tablet) is used in patients with allergic rhinitis caused by allergies to grass pollens (manifesting as rhinitis, runny nose, itching, and conjunctivitis.

Oralair (Five-grass pollen sublingual tablet) Uses:

• Grass pollen-induced allergic rhinitis:

  • Used for the immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in patients 5 to 65 years old who have a positive skin test or in vitro pollen-specific IgE antibody test for any of the 5 grass species in this product.
  • The rapid treatment of allergy symptoms is not recommended.

Oralair dose in Adults

Dosage potency as measured by the Index of Reactivity (IR). Note: Continue the therapy throughout the grass pollen season, beginning 4 months prior to the anticipated start of each season. It has not been shown safe to start the medication during the grass pollen season or to resume the medication after a missed dosage.

Oralair dose in the treatment of Grass pollen-induced allergic rhinitis: Sublingual:

• Adults ≤65 years:

  • 300 IR once a day.

Oralair dose in Adults

Note:

• Dosage strength expressed in Index of Reactivity (IR).
• Each grass pollen season should begin four months in advance, and therapy should continue all through it.
• It has not been shown safe to begin therapy during the grass pollen season or to resume it after a missed dosage.

Oralair Dose in the treatment of Grass pollen-induced allergic rhinitis:

• Children ≥5 years and Adolescents ≤17 years:

  • Sublingual:
    • Initial: Day 1: 100 IR once a day;
    • Day 2: 200 IR once a day;
    • Maintenance (Day 3 and thereafter): 300 IR once a day

• Adolescents ≥18 years:

  • Sublingual: 300 IR once a day

Pregnancy Category: B

• Studies on animal reproduction have not revealed any negative outcomes.

Use of five-grass pollen sublingual tablets during breastfeeding

• It is unknown if breast milk contains grass pollen allergen extract.
• According to the manufacturer of the product, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks to infant exposure, the benefits to the infant and the benefits to the mother.

Dose in Kidney Disease:

The manufacturer’s labeling doesn't provide any dosage adjustments.

Dose in Liver disease:

The manufacturer’s labeling doesn't provide any dosage adjustments.

Frequency of adverse reactions similar in adult and pediatric patients, unless otherwise noted.

Common Side Effects of Oralair (Five-grass pollen sublingual tablet):

• Gastrointestinal:

  • Oral itching

• Respiratory:

  • Throat irritation

Less Common Side Effects of Oralair (Five-grass pollen sublingual tablet):

• Cardiovascular:

  • Lip Edema

• Central Nervous System:

  • Voice Disorder
  • Oral Hypoesthesia
  • Oral Paresthesia

• Dermatologic:

  • Tongue Pruritus
  • Atopic Dermatitis
  • Pruritus Of Ear

• Gastrointestinal:

  • Abdominal Pain
  • Dyspepsia
  • Lip Pruritus
  • Stomatitis
  • Vomiting
  • Dysphagia
  • Esophageal Pain
  • Gastritis
  • Gastroesophageal Reflux Disease
  • Nausea

• Hypersensitivity:

  • Mouth Edema
  • Tongue Edema

• Respiratory:

  • Asthma
  • Pharyngeal Edema
  • Upper Respiratory Tract Infection
  • Cough
  • Tonsillitis
  • Oropharyngeal Pain

Contraindications to Oralair (Five-grass pollen sublingual tablet):

• Hypersensitivity to any inactive ingredient (microcrystalline cellulose, Mannitol, Croscarmellose sodium and Magnesium Stearate) in this product or any part of the formulation.
• Asthma that is severe, unstable, or uncontrolled
• Sublingual allergen immunotherapy history of severe local responses
• Any history of severe allergic reactions systemic;
• An eosinophilic history of esophagitis.

Canadian labeling: 

• If a patient does not have IgE antibodies, positive skin test results, or properly controlled challenge testing, immunotherapy is not recommended.
• Concomitant therapy using beta-blockers and ACE inhibitors
• Asthma severe/or unstable (FEV-1 below 70 percent of the predicted value)
• Any malignant disease
• Oral inflammation (eg oral mycosis or ulcerations, oral lichen planus)

Warnings and precautions

• Eosinophilic Esophagitis

  • It has been reported that eosinophilic gastropathy can be caused by use.
  • If patients experience persistent or severe gastroesophageal symptoms, such as dysphagia or chest discomfort, discontinue treatment and seek a diagnosis for eosinophilic reflux disease.

• Hypersensitivity reactions: [US Boxed Warning]

  • If you experience systemic allergic reactions, discontinue using the product.
  • Anaphylaxis and severe laryngopharyngeal limitations are examples of life-threatening, severe allergic reactions.
  • Patients with persistent or escalating local reactions should be re-evaluated and considered discontinuation.
  • Concomitant allergen immunotherapy may cause increased risk of systemic or local adverse reactions. Therapy initiated during grass pollen season could increase the likelihood of adverse reactions.

• Respiratory disease: [US-Boxed Warning]

  • Patients should not be treated if they have severe, unstable, or uncontrolled asthma.
  • Patients who require daily medication, have severe or moderate asthma, or both, have not been evaluated.
  • Withhold treatment if the patient has a severe asthma exacerbation.
  • Patients who experience asthma exacerbations frequently should be assessed and their treatment stopped.

Five-grass pollen sublingual tablet: Drug Interaction

Monitoring parameters:

• Signs/symptoms of hypersensitivity;
• After the administration of the first dose monitor patients for at least 30 minutes.

How to administer Oralair (Five-grass pollen sublingual tablet)?

Sublingual:

• Administer the first dose in a health care setting due to the potential for allergic reactions;
• After the first dose administration monitor patients for 30 minutes.
• Subsequent doses may be administered at home if well tolerated.
• Prior to delivery, take the sublingual tablet out of the blister.
• Place tablet(s) under tongue for one minute or more, or until totally dissolved, and then swallow.
• After handling the tablet, wash your hands.
• To avoid ingesting allergen extract, wait five minutes after the tablet has dissolved before having any food or liquids.
• Auto-injectable epinephrine should be made available to patients.

Mechanism of action:

• The following 5 pollens make up the grass pollen allergen extract:
  • Sweet vernal
  • timothy,
  • Orchard
  • Perennial rye, and
  • Kentucky blue grass.

Although the mechanism is still unclear, specific immunotherapy (SIT), which may induce a switch between T helper 2 and T helper 1 cells (Th2) responses, could result in decreased interleukin-4 and interleukin-5 and interleukin-10 (IL-10), the production of IgG blocking antibodies that competes with IgE antibodies for allergen binding and the proliferation of regulatory lymphocytes and cytokines, as well as decreases in mast cells and eosinophils.

International Brand Names of Five-grass pollen sublingual tablet:

• Oralair Adult Sample Kit
• Oralair Childrens and Adolescents Sample Kit
• Oralair
• Oralkair

Five-grass pollen sublingual tablet Brand Names in Pakistan:

There is no brand available in Pakistan.