Artemisia Ludoviciana Pollen

Dosage for Artemisia Ludoviciana Pollen is highly individualized and is divided into two distinct phases: the Build-up Phase and the Maintenance Phase. There is no 'standard' dose that applies to all patients.

Build-up Phase

During this phase, the healthcare provider starts with an extremely dilute concentration (often 1:100,000 or 1:10,000 w/v). Injections are typically given once or twice a week. The dose is gradually increased with each injection—for example, 0.05 mL, 0.10 mL, 0.20 mL, etc.—until the patient reaches the 'Maintenance Dose.' This phase usually lasts 3 to 6 months.

Maintenance Phase

Once the effective dose is reached, the frequency of injections is decreased to once every 2 to 4 weeks. A common maintenance dose range for non-standardized extracts is 0.2 mL to 0.5 mL of the most concentrated vial (e.g., 1:20 w/v or 10,000 PNU/mL). This phase typically continues for 3 to 5 years to ensure long-lasting immunity.

Artemisia Ludoviciana Pollen is generally considered safe for use in children, typically starting around age 5. Dosing follows the same build-up and maintenance logic as adult dosing but may be adjusted based on the child's weight and sensitivity levels. Children should be closely monitored for systemic reactions, as they may have more difficulty communicating early symptoms of anaphylaxis.

Renal Impairment

No specific dosage adjustments are required for patients with renal (kidney) impairment, as the proteins are not cleared via traditional renal filtration mechanisms. However, overall health status should be considered.

Hepatic Impairment

No dosage adjustments are necessary for hepatic (liver) impairment.

Elderly Patients

Elderly patients may require more cautious dosing, especially if they have underlying cardiovascular disease. The risk-benefit ratio must be carefully evaluated because the use of epinephrine (the treatment for a severe reaction) may be more dangerous in patients with heart conditions.

1. 1Administration: This medication must only be administered by a trained healthcare professional in a clinical setting equipped to handle anaphylaxis.
2. 2Observation: Patients MUST remain in the doctor's office for at least 30 minutes after each injection to monitor for immediate systemic reactions.
3. 3Site Care: The injection is given subcutaneously (usually in the back of the upper arm). Do not rub the injection site afterward, as this can increase local swelling.
4. 4Timing: Injections should be avoided if the patient is currently experiencing an acute asthma flare or has a fever/infection.
5. 5Storage: Vials must be stored in a refrigerator between 2°C and 8°C (36°F to 46°F). Do not freeze.

If a dose is missed, the next dose may need to be reduced depending on how much time has passed.

• 1-2 weeks late: Usually, the same dose can be given.
• 3-4 weeks late: The dose may be reduced to the previous level.
• Over 4 weeks late: A significant reduction in dose or restarting the dilution series may be necessary to prevent a reaction.

An 'overdose' in the context of immunotherapy refers to receiving a dose higher than the patient's current tolerance level. This can lead to severe local reactions or systemic anaphylaxis. Symptoms include generalized hives, swelling of the throat, wheezing, and low blood pressure. Immediate treatment with epinephrine is required.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or frequency without medical guidance. Immunotherapy is a long-term commitment.

Most patients undergoing immunotherapy with Artemisia Ludoviciana Pollen will experience local reactions at the site of the injection. These are generally not dangerous but can be uncomfortable.

• Local Redness (Erythema): The area around the injection site may become red and warm. This typically appears within minutes and resolves within 24 hours.
• Swelling (Edema): A small 'wheal' or lump may form. If the swelling is larger than a half-dollar (approx. 3 cm), inform your doctor, as your next dose may need adjustment.
• Itching (Pruritus): Intense itching at the injection site is common. This can often be managed with topical hydrocortisone or oral antihistamines taken before the appointment.

• Fatigue: Some patients report feeling unusually tired for a few hours following an injection.
• Mild Nasal Congestion: A slight increase in hay fever symptoms may occur shortly after the injection as the body processes the allergen.
• Headache: Mild tension-type headaches have been reported following the build-up phase injections.

• Generalized Urticaria (Hives): Hives appearing on parts of the body away from the injection site. This is a sign of a systemic reaction.
• Angioedema: Swelling of the lips, eyelids, or face.
• Persistent Cough: A dry, hacking cough that starts shortly after the injection.

> Warning: Stop taking Artemisia Ludoviciana Pollen and call your doctor or emergency services immediately if you experience any of these symptoms of anaphylaxis:

• Wheezing or Difficulty Breathing: This indicates bronchospasm (narrowing of the airways).
• Throat Tightness: A feeling that the throat is closing or difficulty swallowing (laryngeal edema).
• Rapid or Weak Pulse: Signs of cardiovascular distress or a drop in blood pressure.
• Dizziness or Fainting: Known as syncope, this can occur if blood pressure drops significantly (anaphylactic shock).
• Nausea and Vomiting: Systemic allergic reactions often involve the gastrointestinal tract.

There are no known long-term 'toxic' effects of Artemisia Ludoviciana Pollen on organs like the liver or kidneys. The primary long-term effect is the desired change in the immune system. However, patients with pre-existing autoimmune diseases should be monitored, as there is a theoretical (though largely unproven) risk that chronic immune stimulation could affect their condition.

WARNING: SEVERE ALLERGIC REACTIONS

Artemisia Ludoviciana Pollen, like all allergenic extracts, can cause severe, life-threatening systemic allergic reactions, including anaphylaxis.

• Injections must be administered in a healthcare setting by personnel prepared to treat anaphylaxis.
• Patients must be observed for at least 30 minutes post-injection.
• Patients with unstable or severe asthma are at increased risk for fatal reactions.
• Patients taking beta-blockers may be resistant to the effects of epinephrine.

Report any unusual symptoms to your healthcare provider. Keeping a 'symptom diary' can help your allergist fine-tune your dosage safely.

Artemisia Ludoviciana Pollen is a potent biological extract. It is not a 'natural supplement' in the sense of being unregulated; it is a pharmaceutical-grade allergen. The most critical safety factor is the prevention and management of anaphylaxis. Patients must be in relatively good health on the day of their injection. If you are experiencing an asthma flare, have a fever over 100°F, or are feeling significantly unwell, your injection should be postponed.

No FDA black box warnings are currently mandated for non-standardized extracts in the same format as some sublingual tablets; however, the standard prescribing information for all injectable allergenic extracts contains 'Boxed Warnings' regarding the risk of severe systemic reactions. These warnings emphasize that the product is not for self-administration and requires a 30-minute medical observation period.

• Allergic Reactions / Anaphylaxis Risk: This is the primary risk. The risk is highest during the build-up phase and during the peak of the natural pollen season when the patient's 'allergic load' is already high.
• Asthma Status: Patients with uncontrolled asthma (FEV1 < 80% of predicted) should not receive immunotherapy injections, as they are at the highest risk for a fatal respiratory reaction.
• Cardiovascular Disease: Patients with severe heart disease may not tolerate the physiological stress of a systemic reaction or the epinephrine required to treat it.
• Autoimmune Disorders: Use with caution in patients with active autoimmune diseases (e.g., Lupus, Rheumatoid Arthritis), as the effect of immunotherapy on these conditions is not fully understood.

• Lung Function: For asthmatic patients, a peak flow meter or spirometry may be used before each injection to ensure the airways are clear.
• Skin Testing: Periodic re-evaluation of skin test sensitivity may be performed, though it does not always correlate perfectly with clinical improvement.
• Observation: The 30-minute post-injection wait is the most critical form of monitoring.

Generally, Artemisia Ludoviciana Pollen does not cause impairment. However, if a patient experiences a systemic reaction or receives epinephrine, they should not drive until cleared by a physician. Some patients feel 'foggy' or tired after an injection and should wait until they feel alert.

Alcohol should be avoided for several hours before and after an injection. Alcohol causes vasodilation (widening of blood vessels), which can potentially speed up the absorption of the allergen and increase the risk of a systemic reaction.

Immunotherapy can be stopped at any time, but stopping before the 3-5 year mark usually results in the return of allergy symptoms. There is no 'withdrawal syndrome,' but the clinical benefits will gradually fade. If you wish to stop, discuss a tapering or exit strategy with your allergist.

> Important: Discuss all your medical conditions, especially respiratory and heart issues, with your healthcare provider before starting Artemisia Ludoviciana Pollen.

While there are few absolute drug-drug contraindications, certain combinations significantly increase the risk of a poor outcome during a reaction:

• Beta-Blockers (e.g., Propranolol, Metoprolol): These are often contraindicated. If a patient on a beta-blocker has an anaphylactic reaction to the pollen extract, the beta-blocker prevents epinephrine from working effectively. This can lead to an 'irreversible' and potentially fatal allergic reaction.

• ACE Inhibitors (e.g., Lisinopril): These medications may increase the risk of more severe systemic reactions or interfere with the body's natural compensatory mechanisms during an allergic event.
• MAO Inhibitors (e.g., Phenelzine): These can potentiate the effect of epinephrine, leading to dangerously high blood pressure if an allergic reaction needs to be treated.
• Other Immunotherapy: If you are receiving 'allergy shots' for other substances (like mold or dust mites) at the same time, the doses must be carefully coordinated to avoid overwhelming the immune system.

• Tricyclic Antidepressants (e.g., Amitriptyline): Similar to MAOIs, these can affect how the body responds to epinephrine.
• Systemic Corticosteroids: While often used to treat allergies, high doses of prednisone can suppress the immune response you are trying to build, potentially making the immunotherapy less effective.

• Cross-Reactive Foods: Patients allergic to Artemisia (Mugwort) may experience 'Oral Allergy Syndrome.' This is a reaction to foods that contain proteins similar to the pollen, such as celery, carrots, spices (coriander, anise), and certain fruits. Eating these foods immediately before or after an injection might increase the risk of a reaction.
• Alcohol: As mentioned, alcohol can increase the rate of allergen absorption and should be avoided.

• Immune Stimulants (e.g., Echinacea, Elderberry): There is limited data, but these might theoretically interfere with the controlled immune modulation of immunotherapy.
• St. John's Wort: May interact with medications used to treat allergic reactions.

• Skin Prick Tests: Taking antihistamines (like Zyrtec or Benadryl) will suppress the skin's reaction to allergens, leading to false-negative results. These must be stopped 3-7 days before testing.
• Total IgE: Immunotherapy may cause a transient rise in total IgE levels followed by a long-term decrease.

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

Artemisia Ludoviciana Pollen must NEVER be used in the following circumstances:

1. 1Severe, Uncontrolled Asthma: Patients with a baseline FEV1 of less than 80% of predicted or those who have had a recent acute exacerbation. The risk of a fatal respiratory reaction is too high.
2. 2Previous Severe Reaction to Immunotherapy: If a patient has previously experienced life-threatening anaphylaxis to this specific extract, the risks usually outweigh the benefits.
3. 3Beta-Blocker Therapy: Due to the inability to treat a reaction with epinephrine effectively.
4. 4Acute Infection or Fever: The immune system is already stressed, increasing the risk of an adverse reaction to the extract.

Conditions requiring careful risk-benefit analysis include:

• Pregnancy: Immunotherapy is generally not started during pregnancy, but if a woman is already on a stable maintenance dose and tolerating it well, it may be continued.
• Severe Cardiovascular Disease: The risk of using epinephrine in these patients is a significant concern.
• Malignancy (Cancer): The focus of the immune system should remain on the primary illness.
• Young Children (under age 5): Difficulty in communicating symptoms and the trauma of frequent injections are considerations.

Patients sensitive to Artemisia Ludoviciana often show cross-sensitivity to other members of the Artemisia genus (like A. vulgaris or Common Mugwort) and other members of the Asteraceae family (Ragweed, Daisies, Chrysanthemums). If you are highly allergic to Ragweed, your doctor will use extra caution with Artemisia extracts.

> Important: Your healthcare provider will evaluate your complete medical history, including your current asthma control and heart health, before prescribing Artemisia Ludoviciana Pollen.

Artemisia Ludoviciana Pollen is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women.

• Risk Summary: The primary risk during pregnancy is a systemic allergic reaction (anaphylaxis) in the mother, which can cause uterine contractions and fetal hypoxia (lack of oxygen).
• Clinical Considerations: Most allergists will not initiate the build-up phase during pregnancy because the risk of reaction is highest then. However, if a patient has reached a stable maintenance dose and is showing no adverse effects, the treatment is often continued throughout pregnancy to maintain the allergy-protective benefits.

It is not known whether Artemisia Ludoviciana Pollen proteins are excreted in human milk. However, since these are large proteins that are processed locally in the mother's immune system, it is highly unlikely that they would reach the infant in significant quantities through breast milk. Immunotherapy is generally considered compatible with breastfeeding.

Immunotherapy is widely used in children. It is particularly valued in pediatric populations because there is evidence suggesting that treating allergic rhinitis with immunotherapy can prevent the later development of asthma (the 'Allergic March').

• Age Limit: Usually not recommended for children under age 5 due to cooperation issues and the difficulty of monitoring for early signs of anaphylaxis.
• Growth: There is no evidence that allergenic extracts affect growth or development.

Clinical studies for allergenic extracts often do not include sufficient numbers of subjects aged 65 and over.

• Precautions: Older adults are more likely to have co-morbidities like coronary artery disease or COPD, which increase the risk of complications from a systemic reaction.
• Polypharmacy: The higher likelihood of being on beta-blockers or ACE inhibitors makes this population higher risk.

No specific studies have been conducted in patients with renal impairment. However, given the nature of the product (biological proteins), renal clearance is not the primary pathway of elimination, and dose adjustments are not typically required.

Liver function does not affect the processing of allergenic extracts. No dosage adjustments are necessary for patients with liver disease.

> Important: Special populations require individualized medical assessment. Always inform your allergist if you become pregnant or develop new health conditions during the course of your 3-5 year treatment.

Artemisia Ludoviciana Pollen acts as an immunomodulator. The primary molecular mechanism involves the induction of peripheral T-cell tolerance. This is achieved by:

1. 1Induction of Treg Cells: These cells produce IL-10, which suppresses IgE production and inhibits mast cell activation.
2. 2B-cell Class Switching: The immune system shifts from producing IgE (allergic) to producing IgG4 (protective). IgG4 acts as a 'decoy' or 'blocking antibody' that binds to the pollen allergens before they can reach the IgE on mast cells.
3. 3Reduction in Tissue Inflammation: Over time, there is a decrease in the recruitment of eosinophils and basophils to the nasal and bronchial mucosa.

• Dose-Response: There is a clear dose-response relationship in immunotherapy; higher doses (up to the patient's limit of tolerance) generally result in better long-term symptom relief.
• Onset of Effect: Clinical improvement is rarely seen immediately. It typically takes 3 to 6 months (reaching the maintenance phase) to notice a reduction in symptoms.
• Duration of Effect: If a full 3-5 year course is completed, the 'immunological memory' can provide relief for many years after the injections are stopped.

| Parameter | Value |

|---|---|

| Bioavailability | N/A (Subcutaneous local action) |

| Protein Binding | N/A (Processed by immune cells) |

| Half-life | Proteins: Hours; Immune Effect: Years |

| Tmax | Local peak concentration within 1-2 hours |

| Metabolism | Proteolysis (Tissue-based) |

| Excretion | Minimal (Recycled amino acids) |

• Composition: A complex mixture of proteins, glycoproteins, and polysaccharides derived from the pollen of Artemisia ludoviciana.
• Source: Natural pollen collected from the White Sagebrush plant, defatted and extracted in an aqueous buffer.
• Solubility: Highly soluble in water and physiological saline.

Artemisia Ludoviciana Pollen is a 'Non-Standardized Pollen Allergenic Extract.' It is part of the broader category of Allergen Immunotherapy (AIT). Related medications include standardized extracts (like Short Ragweed or Grasses) and other non-standardized tree and weed pollens used in 'allergy shots.'