Artemisia Tridentata Pollen

Dosage for Artemisia Tridentata Pollen is highly individualized and must be determined by a specialist. There is no 'standard' dose because the extract is non-standardized. Dosing is generally divided into two distinct phases:

Build-Up Phase (Escalation)

• Frequency: Typically 1 to 3 times per week.
• Dose: Starts at an extremely low concentration (e.g., 1:100,000 w/v or 0.05 mL of a very dilute vial). The volume and concentration are gradually increased according to the patient's tolerance.
• Duration: Usually lasts 3 to 6 months until the 'Maintenance Dose' is reached.

Maintenance Phase

• Frequency: Once every 2 to 4 weeks.
• Dose: The highest dose tolerated by the patient without significant systemic reactions. This is often 0.2 mL to 0.5 mL of a 1:20 w/v or 1:10 w/v concentration.
• Duration: Immunotherapy is typically continued for 3 to 5 years to achieve long-lasting desensitization.

Artemisia Tridentata Pollen is used in children, generally starting at age 5. Dosing protocols are similar to adult protocols but require even more cautious escalation. Children are at a higher risk for systemic reactions if they have poorly controlled asthma. Use in children under age 5 is generally avoided due to the difficulty of the child communicating early symptoms of a systemic reaction.

Renal Impairment

No dosage adjustments are required for patients with kidney disease, as the extract is not cleared by the kidneys.

Hepatic Impairment

No dosage adjustments are required for patients with liver disease.

Elderly Patients

Caution is advised in elderly patients, primarily due to the increased likelihood of co-morbid cardiovascular disease. If an elderly patient requires epinephrine for an allergic reaction to the shot, their heart may be less able to tolerate the stress of the epinephrine.

• Administration: This medication MUST be administered by a healthcare professional via subcutaneous injection (usually in the back of the upper arm). It should NEVER be self-administered at home.
• Observation: Patients must remain in the medical office for at least 30 minutes after every injection. Most fatal reactions occur within this window.
• Storage: Vials must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. If the extract freezes, the proteins may denature, rendering it ineffective or potentially dangerous.
• Site Rotation: Injection sites should be rotated between arms to minimize local skin thickening or irritation.

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

• 1-week delay: Usually, the same dose can be given.
• 2-4 week delay: The dose may be held at the previous level or slightly reduced.
• Longer delays: Significant dose reductions or restarting the build-up phase may be necessary to ensure safety.

An 'overdose' in the context of immunotherapy usually refers to an injection given at too high a concentration or volume for the patient's current level of tolerance.

• Signs: Rapid onset of hives, swelling of the throat, wheezing, drop in blood pressure, or abdominal cramping.
• Emergency Measures: Administration of intramuscular epinephrine (EpiPen), oxygen, IV fluids, and antihistamines. If you suspect a reaction after leaving the office, call 911 or go to the nearest emergency room immediately.

> Important: Follow your healthcare provider's dosing instructions exactly. Do not attempt to alter your injection schedule without consulting your allergist.

Most patients undergoing immunotherapy with Artemisia Tridentata Pollen will experience some form of local reaction. These are generally not dangerous but can be uncomfortable.

• Local Swelling (Wheal): A raised, red bump at the injection site. This typically appears within minutes and may last for several hours. If the swelling is larger than a half-dollar (approx. 3 cm), inform your nurse.
• Pruritus (Itching): Intense itching at the site of the injection. This is a normal immune response to the pollen proteins.
• Erythema (Redness): Redness of the skin around the injection site, which may feel warm to the touch.
• Fatigue: Some patients report feeling 'wiped out' or tired for a few hours following their injection.

• Large Local Reactions: Swelling that extends beyond the elbow or involves a significant portion of the upper arm. These may require a dose adjustment for the next visit.
• Nasal Congestion: A mild 'flare' of hay fever symptoms shortly after the shot.
• Headache: Mild tension-type headaches following administration.

• Generalized Urticaria (Hives): Hives appearing on parts of the body far from the injection site (e.g., on the chest or legs).
• Angioedema: Swelling of the deeper layers of the skin, often around the eyes or lips.
• Vasovagal Reaction: Fainting or lightheadedness due to the needle stick rather than the extract itself.

> Warning: Stop your immunotherapy treatment and call your doctor or emergency services immediately if you experience any of the following signs of anaphylaxis:

• Respiratory Distress: Difficulty breathing, wheezing, or a persistent cough. This indicates the airway is narrowing.
• Laryngeal Edema: A feeling of 'fullness' in the throat, difficulty swallowing, or a hoarse voice.
• Hypotension (Low Blood Pressure): Feeling faint, dizzy, or suddenly confused. This can lead to loss of consciousness.
• Gastrointestinal Distress: Sudden, severe abdominal cramps, vomiting, or diarrhea.
• Cyanosis: A bluish tint to the lips or fingernails, indicating a lack of oxygen.

There are no known long-term systemic toxicities associated with Artemisia Tridentata Pollen extracts. Unlike steroids or other immunosuppressants, allergenic extracts do not cause organ damage or increase the risk of infection. The primary 'long-term' effect is the desired one: a significant reduction in allergy symptoms and a decreased risk of developing asthma in children with allergic rhinitis.

Artemisia Tridentata Pollen, like all allergenic extracts, carries a class-wide FDA Black Box Warning regarding the risk of severe anaphylaxis.

Summary of Warning:

• Allergenic extracts can cause severe, life-threatening systemic reactions, including anaphylaxis.
• They should only be administered in a medical setting prepared to treat anaphylaxis (equipped with epinephrine, oxygen, and airway management tools).
• Patients with unstable or severe asthma are at a significantly higher risk of fatal reactions.
• Patients must be observed for at least 30 minutes post-injection.
• Patients taking beta-blockers may be resistant to the effects of epinephrine used to treat a reaction.

Report any unusual or persistent symptoms to your healthcare provider immediately. Your safety depends on open communication about how you feel after each dose.

Artemisia Tridentata Pollen is a potent biological product. Safety is maintained through strict adherence to clinical protocols. It is essential that patients are healthy on the day of their injection. If you have a fever, a severe 'flare' of your allergies, or if your asthma is acting up, your injection should be postponed. The immune system is already 'primed' during these times, making a systemic reaction to the shot more likely.

Warning: Risk of Anaphylaxis. This product can cause life-threatening allergic reactions. Administration must occur in a clinical setting under the supervision of a physician. Patients must be monitored for a minimum of 30 minutes. Severe asthma is a contraindication to escalating doses. See the full prescribing information for complete details on emergency management.

• 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 sagebrush pollen season (late summer/early fall).
• Asthma Monitoring: If you have asthma, your 'peak flow' or FEV1 (forced expiratory volume) may be checked before each shot. If your lung function is significantly below your personal best, the shot will be withheld.
• Infection: Do not receive an injection if you have an active viral or bacterial infection, as this can lower your threshold for a systemic reaction.
• Injection Technique: The extract must be given subcutaneously. Accidental intravenous injection can cause immediate, severe anaphylaxis.

While routine blood work (like liver or kidney tests) is not needed for Artemisia Tridentata Pollen, the following monitoring is standard:

• 30-Minute Wait: Strict adherence to the post-injection waiting period.
• Symptom Diary: Patients are encouraged to track any 'late' reactions that occur after leaving the office.
• Asthma Control Test (ACT): Periodic assessment of asthma stability.
• Skin Test Re-evaluation: Occasionally, your doctor may repeat skin testing after several years to see if your sensitivity has decreased.

Generally, this medication does not affect your ability to drive. However, if you experience a systemic reaction or feel lightheaded/fatigued after your shot, you should not drive until the symptoms have completely resolved.

Alcohol should be avoided for several hours before and after your allergy injection. Alcohol causes vasodilation (widening of the blood vessels), which can increase the speed at which the allergen is absorbed into the bloodstream, potentially increasing the risk of a systemic reaction.

Immunotherapy should not be stopped abruptly if you intend to maintain your progress. However, if you must stop, there is no 'withdrawal' syndrome. You simply lose the progress toward desensitization. If you stop for more than a few weeks and wish to restart, your doctor will need to significantly lower your dose to ensure safety.

> Important: Always discuss your complete medical history, especially any heart or lung conditions, with your healthcare provider before starting Artemisia Tridentata Pollen.

There are few absolute 'drug-drug' contraindications, but the following are critical:

• Beta-Blockers (e.g., Propranolol, Atenolol, Metoprolol): These are often used for high blood pressure or heart conditions. They are generally contraindicated in patients receiving immunotherapy because they block the effects of epinephrine. If a patient on a beta-blocker has anaphylaxis, the standard treatment (epinephrine) may not work, making the reaction potentially fatal.

• ACE Inhibitors (e.g., Lisinopril, Enalapril): These blood pressure medications may increase the risk of severe systemic reactions or worsen the hypotension (low blood pressure) associated with anaphylaxis. Use requires a careful risk-benefit analysis by your physician.
• MAOIs (Monoamine Oxidase Inhibitors): Used for depression. These can interfere with the metabolism of epinephrine, potentially leading to a hypertensive crisis if epinephrine is administered for an allergy shot reaction.
• Tricyclic Antidepressants (e.g., Amitriptyline): Similar to MAOIs, these can potentiate the effect of epinephrine on the cardiovascular system.

• Antihistamines (e.g., Cetirizine, Loratadine): While often used to manage allergy symptoms, taking an antihistamine right before a skin test will cause a 'false negative' result. For immunotherapy, some doctors recommend taking them to reduce local reactions, but be aware they can mask the early 'warning signs' of a systemic reaction (like mild itching or hives).
• Other Allergenic Extracts: If you are receiving multiple types of allergy shots (e.g., for grass, dust mites, and sagebrush), the cumulative 'allergen load' can increase the risk of a reaction. These are often administered in separate arms.

• Alcohol: As mentioned previously, alcohol can increase the rate of allergen absorption and should be avoided on the day of the injection.
• Spicy Foods: In some highly sensitive individuals, very spicy foods can cause mild vasodilation and may theoretically increase the risk of a reaction if consumed immediately after a shot.

• St. John's Wort: May theoretically interact with medications used to treat anaphylaxis.
• Feverfew / Ginkgo Biloba: These have mild anti-platelet effects but generally do not interfere with the mechanism of immunotherapy. Always inform your doctor of all supplements.

• Skin Prick Tests: Artemisia Tridentata Pollen extract will interfere with future skin tests for the same allergen (this is the intended effect).
• In Vitro Allergy Tests (e.g., RAST or ImmunoCAP): Immunotherapy will lead to an increase in specific IgG4 levels and a gradual decrease in specific IgE levels over several years. This is a marker of treatment success rather than an 'interference.'

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

Artemisia Tridentata Pollen extract must NEVER be used in the following circumstances:

• Severe or Uncontrolled Asthma: Patients with an FEV1 consistently below 70% of their predicted value or those with frequent exacerbations are at an unacceptably high risk of a fatal reaction to immunotherapy.
• Recent Myocardial Infarction (Heart Attack): Within the last 3-6 months. The stress of a potential systemic reaction and the subsequent need for epinephrine could cause further cardiac damage.
• Unstable Angina: Similar to heart attack risks, the cardiovascular system must be stable enough to handle the potential stress of anaphylaxis treatment.
• Hypersensitivity to Inactive Ingredients: Such as a known severe allergy to phenol or glycerin, which are used as preservatives and stabilizers in the extract.

These conditions require a careful 'risk vs. benefit' discussion between the patient and the allergist:

• Autoimmune Diseases: There is a theoretical concern that stimulating the immune system with AIT could worsen conditions like Lupus or Rheumatoid Arthritis, though clinical evidence for this is limited.
• Malignancy (Cancer): Patients undergoing active chemotherapy or with advanced cancer are generally not started on immunotherapy.
• Beta-Blocker Therapy: As discussed, this makes treating a reaction much more difficult.
• Young Children (< 5 years old): Due to their inability to describe early symptoms of a reaction.

Patients allergic to Artemisia tridentata often show cross-reactivity with other members of the Artemisia genus, such as Artemisia vulgaris (Mugwort). They may also experience Oral Allergy Syndrome (OAS), where eating certain foods (like celery, carrots, or certain spices) causes itching in the mouth. This is because the proteins in those foods are structurally similar to the proteins in sagebrush pollen.

> Important: Your healthcare provider will evaluate your complete medical history and current health status before prescribing Artemisia Tridentata Pollen.

• FDA Pregnancy Category C: There are no adequate and well-controlled studies of Artemisia Tridentata Pollen in pregnant women.
• Risk Summary: The primary risk during pregnancy is not the extract itself, but the potential for a systemic reaction (anaphylaxis) in the mother. Anaphylaxis can cause maternal hypotension, which leads to fetal hypoxia (lack of oxygen to the baby).
• Clinical Guidance: It is generally recommended not to start a new course of immunotherapy during pregnancy. However, if a patient is already on a 'Maintenance Dose' and is tolerating it well, the allergist may choose to continue the shots at the same or a slightly reduced dose throughout the pregnancy.

Artemisia Tridentata Pollen proteins are not known to pass into breast milk in any significant amount. Immunotherapy is considered safe for breastfeeding mothers. There is no evidence that it causes any harm to the nursing infant or affects milk production.

• Approved Age: Generally safe for children aged 5 and older.
• Benefits: Studies have shown that AIT in children can prevent the 'allergic march'—the progression from allergic rhinitis to the development of asthma.
• Precautions: Children must be closely monitored for local reactions, as they may scratch the site, leading to secondary skin infections.

• Cardiovascular Risk: Patients over age 65 are more likely to have underlying heart disease, which increases the risk of complications if a systemic reaction occurs.
• Reduced Reserve: The elderly may have less 'physiological reserve' to handle the stress of anaphylaxis.
• Polypharmacy: Increased likelihood of being on interfering medications like beta-blockers or ACE inhibitors.

No dosage adjustments or special precautions are necessary for patients with impaired kidney function. The proteins in the extract are processed by the immune system and are not dependent on renal clearance.

No dosage adjustments are necessary for patients with liver disease. The liver does not play a role in the 'metabolism' of allergenic extracts.

> Important: Special populations require individualized medical assessment and frequent monitoring by an allergy specialist.

Artemisia Tridentata Pollen extract functions as an immunomodulator. It does not target a single receptor like a traditional drug. Instead, it introduces specific allergens (proteins) to the immune system in a controlled, gradual manner. This induces peripheral T-cell tolerance. The key molecular events include:

• T-reg Induction: Promoting the growth of CD4+ CD25+ Foxp3+ regulatory T-cells.
• Cytokine Shift: Reducing the production of IL-4 and IL-5 (pro-allergic) and increasing IL-10 and TGF-beta (anti-inflammatory).
• B-cell Modulation: Shifting antibody production from IgE to IgG4.

• Dose-Response: There is a clear dose-response relationship in AIT. Higher doses (within the maintenance range) are generally more effective than low doses, but they also carry a higher risk of side effects.
• Onset of Effect: The clinical effect is slow. Patients rarely notice improvement during the first few months (build-up phase). Significant symptom reduction typically begins after 6-12 months of maintenance therapy.
• Duration of Effect: One of the unique aspects of AIT is that its effects can persist for years after the treatment is discontinued, provided the patient completed a full 3-5 year course.

| Parameter | Value |

|---|---|

| Bioavailability | N/A (Subcutaneous absorption into lymphatics) |

| Protein Binding | N/A (Processed by Antigen Presenting Cells) |

| Half-life | N/A (Biological degradation of proteins) |

| Tmax | 15-30 minutes for local skin reaction |

| Metabolism | Proteolysis in lysosomes of immune cells |

| Excretion | Cellular metabolic pathways |

• Composition: A complex aqueous mixture of proteins, glycoproteins, and polysaccharides derived from the pollen of Artemisia tridentata.
• Molecular Weight: Ranges from 10 kDa to over 70 kDa for various allergenic fractions.
• Solubility: Highly soluble in buffered saline or glycerin-water mixtures.

Artemisia Tridentata Pollen is a Non-Standardized Pollen Allergenic Extract. It belongs to the broader category of Biological Response Modifiers used for Allergen Immunotherapy. Related medications include extracts for Ragweed, Timothy Grass, and various tree pollens.