Ambrosia Artemisiifolia Pollen

For the treatment of ragweed-induced allergic rhinitis, the standard adult dosage for sublingual Ambrosia Artemisiifolia Pollen extract (such as Ragwitek) is one tablet (12 Amb a 1-Unit) daily.

Therapy should ideally be initiated at least 12 weeks before the expected onset of the ragweed pollen season and continued throughout the entire season. Some healthcare providers may recommend year-round (perennial) treatment to maintain higher levels of immune tolerance, although the seasonal approach is the standard FDA-approved protocol. For subcutaneous immunotherapy (injections), the dosage is highly individualized, beginning with a 'build-up phase' of weekly injections followed by a 'maintenance phase' every 2 to 4 weeks.

Ambrosia Artemisiifolia Pollen sublingual tablets are approved for use in children and adolescents aged 5 to 17 years. The dosage is the same as the adult dose: one 12 Amb a 1-Unit tablet daily. The treatment must be initiated 12 weeks prior to the ragweed season. Clinical data suggest that the safety profile in children is similar to that in adults, though younger children should be monitored closely for any signs of oral discomfort or difficulty breathing. Use in children under the age of 5 is not currently recommended due to insufficient safety data.

Renal Impairment

No dosage adjustments are typically required for patients with renal impairment, as the extract is not cleared through the kidneys in a manner that would lead to systemic accumulation. However, clinical trials generally excluded patients with severe renal disease.

Hepatic Impairment

There are no specific dosage adjustments provided for hepatic impairment. The metabolic pathway of the allergenic proteins (proteolysis) does not rely on hepatic CYP450 enzymes.

Elderly Patients

While approved for use up to age 65, there is limited data on patients older than 65. Healthcare providers should exercise caution, particularly regarding the patient's ability to manage potential systemic reactions or the presence of co-morbidities like cardiovascular disease.

Sublingual tablets must be administered with specific care to ensure efficacy and safety:

1. 1Timing: Take the tablet at the same time every day.
2. 2Administration: Place the tablet under the tongue. Do not swallow for at least one minute to allow for mucosal absorption.
3. 3Food and Drink: Do not eat or drink for at least five minutes after the tablet has dissolved.
4. 4First Dose: The very first dose must be taken in a healthcare setting (such as a doctor's office) where the patient can be observed for at least 30 minutes to monitor for signs of anaphylaxis.
5. 5Storage: Store at room temperature (20°C to 25°C / 68°F to 77°F) in the original blister pack to protect from moisture.

If a dose is missed, the patient should take the next scheduled dose the following day. Do not take two doses in one day to make up for a missed dose. If more than one dose is missed, or if therapy is interrupted for several days, contact your healthcare provider before resuming, as a dose adjustment or re-observation in the clinic may be necessary.

Taking more than the prescribed dose of Ambrosia Artemisiifolia Pollen increases the risk of severe local and systemic allergic reactions. Symptoms of overdose may include severe swelling of the mouth/throat, difficulty swallowing, or systemic hives. In the event of an accidental overdose, seek emergency medical attention or contact a poison control center immediately.

> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without medical guidance, as this can affect the success of the desensitization process.

Because Ambrosia Artemisiifolia Pollen is an allergen, local reactions in the mouth and throat are extremely common, especially during the first week of treatment. These side effects are typically mild to moderate and include:

• Oral Pruritus: Itching of the mouth or tongue (reported in up to 40% of patients).
• Throat Irritation: A scratchy or 'tight' feeling in the throat.
• Ear Pruritus: Itching inside the ears, which is a common referred sensation from the throat.
• Mouth Edema: Mild swelling of the lips or tongue.
• Paraesthesia Oral: A tingling or 'pins and needles' sensation in the mouth.

These symptoms usually appear within minutes of administration and typically resolve within 30 to 60 minutes. Most patients find that these local reactions diminish in intensity after the first 7 to 10 days of consistent use.

• Nausea and Abdominal Pain: Some patients may experience stomach upset if the extract is swallowed too quickly.
• Urticaria: Hives or itchy skin rashes elsewhere on the body.
• Dyspnea: Mild shortness of breath or chest tightness.
• Oropharyngeal Swelling: More significant swelling of the back of the throat.
• Glossodynia: Pain or burning of the tongue.

• Eosinophilic Esophagitis (EoE): A chronic immune system disease where eosinophils (a type of white blood cell) build up in the lining of the esophagus, leading to difficulty swallowing or chest pain.
• Severe Laryngopharyngeal Edema: Swelling of the larynx that may obstruct the airway.
• Systemic Allergic Reactions: Reactions involving multiple organ systems (e.g., simultaneous hives, vomiting, and dizziness).

> Warning: Stop taking Ambrosia Artemisiifolia Pollen and call your doctor or emergency services immediately if you experience any of the following signs of a systemic allergic reaction (anaphylaxis):

• Angioedema: Severe swelling of the face, lips, tongue, or throat that makes breathing or swallowing difficult.
• Wheezing or Stridor: High-pitched breathing sounds or significant chest tightness.
• Dizziness or Syncope: A sudden drop in blood pressure leading to lightheadedness or fainting.
• Rapid or Weak Pulse: Signs of cardiovascular distress.
• Persistent Vomiting or Diarrhea: Often a sign of a systemic reaction in the context of allergen exposure.

Long-term use of Ambrosia Artemisiifolia Pollen is generally well-tolerated. The most significant long-term risk is the development of Eosinophilic Esophagitis (EoE). Patients should report any persistent or worsening difficulty swallowing or heartburn to their doctor. On the positive side, the long-term 'effect' is intended to be a permanent or semi-permanent reduction in allergy symptoms even after the medication is discontinued (typically after 3 years of therapy).

Ambrosia Artemisiifolia Pollen extracts (such as Ragwitek) carry an FDA Black Box Warning regarding the risk of severe allergic reactions.

• Anaphylaxis Risk: The treatment can cause life-threatening allergic reactions, including anaphylaxis, which may be fatal.
• Observation: The first dose must be administered in a healthcare setting under the supervision of a physician prepared to treat anaphylaxis.
• Auto-Injectable Epinephrine: Patients must be prescribed and trained on how to use an auto-injectable epinephrine device (e.g., EpiPen) while taking this medication.
• Contraindications: Patients with unstable asthma or those who cannot use epinephrine (due to certain medical conditions) should not use this product.

Report any unusual symptoms or worsening of your condition to your healthcare provider immediately. Monitoring for late-phase reactions is essential, especially during the initiation phase of therapy.

Ambrosia Artemisiifolia Pollen is a potent biological extract. It is not a standard medication for immediate symptom relief but a long-term immunotherapy. Patients must be aware that they are intentionally exposing themselves to the substance they are allergic to, which carries inherent risks. Communication with an allergist or immunologist is vital throughout the treatment duration.

WARNING: SEVERE ALLERGIC REACTIONS

• Ambrosia Artemisiifolia Pollen can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema.
• Do not administer the first dose at home. The first dose must be supervised by a healthcare professional.
• Patients must be prescribed auto-injectable epinephrine and be instructed on its proper use.
• Severe reactions can occur even after the first dose has been tolerated. Patients should be aware of the signs of anaphylaxis at all times.

• Asthma: Patients with uncontrolled or severe asthma are at a much higher risk for life-threatening reactions. Asthma status must be stable before starting and during the course of treatment. If a patient experiences an asthma flare-up, they should consult their doctor before taking the next dose.
• Eosinophilic Esophagitis (EoE): This medication has been associated with the development of EoE. Patients with a history of EoE or those who develop persistent gastrointestinal symptoms (difficulty swallowing, food impaction, chest pain) must discontinue the medication.
• Oral Inflammation/Injury: If you have oral inflammation (e.g., mouth sores, thrush) or have had recent oral surgery or tooth extraction, treatment should be paused until the mouth has fully healed to prevent excessive absorption of the allergen.
• Autoimmune Diseases: Use with caution in patients with active autoimmune or multi-organ inflammatory diseases, as immunotherapy may potentially exacerbate these conditions.

While there are no standard blood tests (like liver or kidney function) required for this medication, clinical monitoring is essential:

• First Dose Observation: A 30-minute post-dose observation period in the clinic.
• Symptom Tracking: Patients should keep a log of local reactions to discuss with their doctor.
• Asthma Control: Regular peak flow monitoring or symptom checks for patients with co-existing asthma.
• Epinephrine Check: Ensure the patient's epinephrine auto-injectors are not expired at every follow-up visit.

Ambrosia Artemisiifolia Pollen does not typically cause drowsiness or cognitive impairment. However, if a patient experiences a systemic reaction, dizziness, or lightheadedness, they should not drive or operate machinery and should seek emergency care.

There is no direct chemical interaction between alcohol and ragweed pollen extract. However, alcohol can increase blood flow to the oral mucosa (vasodilation), which might theoretically increase the absorption rate of the allergen. It is generally advised to avoid alcohol immediately before and after taking the sublingual tablet.

Treatment is usually continued for 3 years to achieve long-lasting desensitization. If treatment is stopped prematurely, the allergy symptoms may return during the next ragweed season. There is no 'withdrawal syndrome' associated with stopping this medication, but the clinical benefits will be lost. If you must stop due to side effects, always do so under a doctor's guidance.

> Important: Discuss all your medical conditions, especially respiratory or esophageal issues, with your healthcare provider before starting Ambrosia Artemisiifolia Pollen.

There are no specific drugs that are 'chemically' incompatible with Ambrosia Artemisiifolia Pollen in the way traditional drugs interact. However, certain medications make the management of a potential allergic reaction dangerous:

• Beta-Blockers (e.g., Propranolol, Atenolol): These drugs can block the effects of epinephrine. If a patient on beta-blockers has anaphylaxis from the pollen extract, the emergency epinephrine may not work effectively, leading to a life-threatening situation.
• Alpha-Blockers and Ergot Alkaloids: These may also interfere with the treatment of anaphylaxis.

• MAO Inhibitors (MAOIs) and Tricyclic Antidepressants: These medications can potentiate the effects of epinephrine or cause unpredictable blood pressure changes during a systemic reaction. While not strictly contraindicated, the risk-benefit ratio must be carefully weighed by the prescribing physician.
• Other Immunotherapy: Taking multiple types of immunotherapy (e.g., grass pollen tablets and ragweed tablets) simultaneously may increase the cumulative risk of local or systemic side effects. Healthcare providers often recommend staggering the administration of different sublingual treatments.

• Antihistamines (e.g., Cetirizine, Loratadine): While often used to manage local side effects, high doses of antihistamines might mask the early warning signs of a more serious systemic reaction.
• Corticosteroids: Systemic steroids may reduce the effectiveness of the immunotherapy by suppressing the very immune response the treatment is trying to modulate, though this is more of a concern with high-dose long-term use.

• Oral Allergy Syndrome (OAS): Patients allergic to ragweed may also experience itching in the mouth when eating certain foods (like melons, bananas, or zucchini) due to cross-reactivity. Taking the pollen extract might temporarily worsen these food-related symptoms.
• High-Fat Meals: While food does not interact chemically, taking the tablet immediately after a meal might interfere with the required contact time with the sublingual mucosa.

There is limited data on herbal interactions. However, supplements that affect the immune system (like Echinacea or high-dose Astragalus) should be discussed with an allergist, as they could theoretically interfere with the desensitization process.

• Skin Prick Testing: Ambrosia Artemisiifolia Pollen therapy will eventually decrease the wheal-and-flare response on an allergy skin test. This is an expected clinical outcome rather than an 'interference.'
• Specific IgE Blood Tests: Over time, levels of ragweed-specific IgE may fluctuate, while IgG4 levels will typically rise. This reflects the success of the therapy.

For each major interaction, the primary concern is either the masking of symptoms or the interference with emergency rescue medications.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially those for blood pressure or heart conditions.

Ambrosia Artemisiifolia Pollen must NEVER be used in the following circumstances:

• Severe, Unstable, or Uncontrolled Asthma: Immunotherapy can trigger severe bronchospasm in these patients, which can be fatal.
• History of Severe Systemic Allergic Reaction: Patients who have previously experienced life-threatening anaphylaxis to ragweed allergenic extracts should not use this product.
• Eosinophilic Esophagitis (EoE): Patients with a confirmed diagnosis of EoE are at risk for worsening their condition or experiencing severe esophageal complications.
• Hypersensitivity to Excipients: Any known allergy to the inactive ingredients in the tablet (such as gelatin, mannitol, or sodium hydroxide).

In these cases, the healthcare provider must perform a careful risk-benefit analysis:

• Oral Conditions: Active oral herpes, lichen planus, or large open sores in the mouth. Treatment should be delayed until these resolve.
• Medical Conditions Impairing Epinephrine Use: Conditions such as severe coronary artery disease or uncontrolled hypertension where the use of epinephrine (in case of anaphylaxis) would be exceptionally risky.
• Pregnancy Initiation: While generally safe to continue if already established, most clinicians avoid starting immunotherapy during pregnancy due to the risk of anaphylaxis to the mother and fetus.

Patients sensitive to Ambrosia Artemisiifolia may also show cross-sensitivity to other members of the Asteraceae (Compositae) family, including:

• Other Ragweed Species: Ambrosia trifida (Great Ragweed).
• Common Plants: Chrysanthemums, marigolds, daisies, and sunflowers.
• Certain Foods: Melons (cantaloupe, watermelon), bananas, and cucumber.

> Important: Your healthcare provider will evaluate your complete medical history, including your respiratory health and any history of esophageal issues, before prescribing Ambrosia Artemisiifolia Pollen.

Ambrosia Artemisiifolia Pollen is classified under the older FDA Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not shown a risk to the fetus. However, because systemic allergic reactions (anaphylaxis) can cause placental hypoperfusion (reduced blood flow to the baby), healthcare providers generally do not initiate this therapy during pregnancy. If a woman becomes pregnant while already on a stable maintenance dose and is tolerating it well, the physician may decide to continue the treatment, as the risk of stopping and restarting later may outweigh the risk of continuing.

It is unknown whether the allergenic proteins or their metabolites are excreted in human milk. Because these are large proteins that are largely degraded in the maternal digestive system or processed locally in the oral mucosa, the risk to a nursing infant is considered very low. The decision to breastfeed while taking Ambrosia Artemisiifolia Pollen should be made in consultation with a healthcare provider, weighing the benefits of breastfeeding against the maternal need for the medication.

Sublingual ragweed extract is FDA-approved for children as young as 5 years of age. Clinical trials have demonstrated that the safety and efficacy profile in children (5-17 years) is comparable to that in adults. It is essential that parents or caregivers are trained in the administration of the tablet and the use of the epinephrine auto-injector. This treatment is NOT approved for children under age 5, as they may be unable to follow the instructions to keep the tablet under the tongue and are at a higher risk for airway obstruction if swelling occurs.

Clinical studies of Ambrosia Artemisiifolia Pollen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of concomitant diseases (like heart disease) and other drug therapies (like beta-blockers) that could complicate the management of a systemic allergic reaction.

No specific studies have been conducted in patients with renal impairment. However, since the allergens are proteins that undergo local proteolysis rather than renal excretion, no dosage adjustment is expected to be necessary for patients with mild to moderate renal disease. Severe renal impairment should be discussed with a specialist.

No specific studies have been conducted in patients with hepatic impairment. The metabolism of allergenic extracts does not involve the liver's cytochrome P450 system. Therefore, hepatic impairment is not expected to significantly alter the pharmacokinetics or safety of the drug.

> Important: Special populations require individualized medical assessment. Always inform your specialist about your pregnancy status or any chronic health conditions.

Ambrosia Artemisiifolia Pollen extract functions through the induction of immunological tolerance. The primary allergen, Amb a 1, is a 38-kDa glycoprotein. When administered sublingually, it is taken up by oral Langerhans cells (dendritic cells). These cells process the allergen and migrate to local lymph nodes, where they present the allergen peptides to naïve T-cells.

This process promotes the differentiation of Regulatory T-cells (Tregs) that produce IL-10 and TGF-beta. These cytokines suppress the Th2-driven allergic response and induce B-cells to produce IgG4 instead of IgE. IgG4 acts as a 'blocking antibody' that competes with IgE for allergen binding on mast cells and basophils, thereby preventing the release of inflammatory mediators like histamine.

The pharmacodynamic effect is measured by a decrease in the Total Combined Score (TCS), which includes both a daily symptom score and a daily medication use score. The onset of effect is not immediate; it requires several weeks to months of daily administration to achieve the necessary immunological shift. The duration of effect can last for several years after a full 3-year course of treatment is completed, a phenomenon known as 'disease modification.'

| Parameter | Value |

|---|---|

| Bioavailability | Low (primarily local mucosal uptake) |

| Protein Binding | N/A (Biological protein) |

| Half-life | N/A (Degraded by proteases) |

| Tmax | Minutes (for mucosal capture) |

| Metabolism | Local proteolysis into peptides/amino acids |

| Excretion | Minimal systemic excretion |

• Molecular Formula: Complex biological mixture (Primary component Amb a 1)
• Molecular Weight: Amb a 1 is approximately 38,000 Daltons.
• Solubility: Soluble in aqueous buffers and saliva.
• Structure: The extract contains a standardized mixture of proteins, glycoproteins, and polysaccharides derived from the pollen of Ambrosia artemisiifolia.

Ambrosia Artemisiifolia Pollen is classified as a Standardized Pollen Allergenic Extract [EPC]. It is part of the broader group of Allergen Immunotherapy (AIT) products. Related medications include grass pollen extracts (e.g., Oralair, Grastek) and dust mite extracts (e.g., Odactra).