Clearlife Extra Strength

Dosage for Ambrosia Artemisiifolia Whole is highly individualized and must be determined by a board-certified allergist or immunologist. There is no 'one-size-fits-all' dose.

Immunotherapy (SCIT)

Treatment typically consists of two phases:

1. 1Build-up Phase: This phase involves weekly injections starting at an extremely low concentration (e.g., 0.05 mL of a 1:100,000 w/v dilution). The dose is gradually increased every 7 days until the 'Maintenance Dose' is reached. This process usually takes 3 to 6 months.
2. 2Maintenance Phase: Once the target dose is reached (typically 0.5 mL of a 1:100 or 1:20 w/v concentration), the frequency of injections is decreased to once every 2 to 4 weeks. Treatment is generally continued for 3 to 5 years to achieve long-term desensitization.

Ambrosia Artemisiifolia Whole may be used in children, typically starting at age 5. The dosing schedule is similar to that of adults but requires even more cautious escalation. Clinical studies have shown that early intervention with immunotherapy in children can prevent the development of asthma (the 'allergic march'). However, 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 specific dosage adjustments are required for patients with renal impairment, as the proteins are metabolized locally and not cleared significantly by the kidneys.

Hepatic Impairment

No dosage adjustments are necessary for patients with liver disease.

Elderly Patients

Caution is advised in patients over age 65. The primary concern is the patient's ability to tolerate a systemic reaction or the use of epinephrine if an emergency occurs. Patients with underlying cardiovascular disease should be evaluated thoroughly before starting treatment.

• Subcutaneous Injection: These MUST be administered in a clinical setting under the supervision of a physician prepared to treat anaphylaxis. The injection is given in the posterior aspect of the upper arm.
• Observation: Patients must remain in the clinic for at least 30 minutes following every injection to monitor for serious allergic reactions.
• Storage: Extracts must be kept refrigerated at 2°C to 8°C (36°F to 46°F). Freezing will denature the proteins and render the extract ineffective.
• Avoidance: Do not exercise vigorously for 2 hours before or after an injection, as increased blood flow can accelerate the absorption of the allergen and increase the risk of a systemic reaction.

If a dose is missed during the build-up phase, the next dose may need to be reduced or the previous dose repeated to ensure safety. If a dose is missed during the maintenance phase by more than 2 weeks, the allergist will typically reduce the dose for the next injection and then gradually build back up. Never attempt to 'double up' on doses.

An overdose of Ambrosia Artemisiifolia Whole occurs if too much allergen is injected or if the dose is escalated too quickly. The primary sign of overdose is a systemic allergic reaction or anaphylaxis.

Signs of Overdose/Reaction:

• Hives (urticaria) or generalized itching
• Swelling of the throat or tongue
• Wheezing or difficulty breathing
• Rapid drop in blood pressure (hypotension)
• Dizziness or fainting

In the event of an overdose, epinephrine (0.3mg for adults) must be administered intramuscularly immediately, and emergency services (911) should be contacted.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.

Most patients undergoing treatment with Ambrosia Artemisiifolia Whole will experience local reactions. These are generally considered a sign that the immune system is responding to the therapy.

• Injection Site Redness (Erythema): A red patch at the site of the shot, which may feel warm to the touch. This usually appears within minutes and resolves within 24 hours.
• Swelling (Edema): A small bump or 'wheal' at the injection site. If the swelling is larger than the size of a half-dollar (approx. 3cm), notify your doctor, as the next dose may need adjustment.
• Itching (Pruritus): Localized itching at the site of administration. This can often be managed with over-the-counter antihistamines.

• Fatigue: Many patients report feeling 'wiped out' or excessively tired for a few hours after their immunotherapy session.
• Increased Allergy Symptoms: A temporary flare-up of hay fever symptoms, such as sneezing, runny nose, or itchy eyes, shortly after the injection.
• Headache: Mild to moderate tension-type headaches have been reported following dose escalation.

• Generalized Hives: Itching and welts appearing on parts of the body away from the injection site.
• Gastrointestinal Distress: Nausea, abdominal cramping, or diarrhea, which can be early signs of a systemic allergic response.
• Lymphadenopathy: Swelling of the lymph nodes near the injection site (usually the axillary nodes in the armpit).

> Warning: Stop taking Ambrosia Artemisiifolia Whole and call your doctor immediately or seek emergency care if you experience any of these symptoms of anaphylaxis.

• Angioedema: Rapid swelling of the lips, tongue, or face that can obstruct the airway.
• Bronchospasm: Sudden wheezing, chest tightness, or shortness of breath. This is particularly dangerous in patients with pre-existing asthma.
• Hypotension: A sudden drop in blood pressure, leading to feeling lightheaded, confused, or fainting.
• Uterine Contractions: In rare cases, systemic reactions can cause uterine cramping in pregnant women.

There are no known long-term 'toxic' effects of Ambrosia Artemisiifolia Whole, as it is a natural protein extract. The primary long-term risk is the development of 'late-phase' reactions, which occur 6 to 12 hours after an injection. These typically manifest as significant swelling of the arm. While not usually dangerous, they require a modification of the dosing schedule.

While the 'Whole' extract vials themselves may not always carry a unified black box warning, the FDA requires a Black Box Warning for all Sublingual Immunotherapy (SLIT) products containing ragweed (such as Ragwitek), which applies to the clinical use of these extracts:

WARNING: RISK OF SEVERE ALLERGIC REACTIONS

• Ambrosia Artemisiifolia extracts can cause life-threatening allergic reactions such as anaphylaxis.
• Do not administer to patients with severe, unstable, or uncontrolled asthma.
• Observe patients in the office for at least 30 minutes following the initial dose.
• Prescribe auto-injectable epinephrine to all patients receiving this therapy for home use (in the case of SLIT).

Report any unusual symptoms to your healthcare provider.

Ambrosia Artemisiifolia Whole is a high-risk biological product that must be handled with extreme care. It is intended only for use by physicians who are experienced in the administration of allergenic extracts and the treatment of anaphylaxis. Patients must be informed that the risk of a systemic reaction is present with every single dose, even if they have tolerated previous doses well.

No FDA black box warnings exist for the generic 'Ambrosia Artemisiifolia Whole' non-standardized extract vials specifically, but the class-wide warning for ragweed immunotherapy products emphasizes that severe, life-threatening anaphylaxis can occur. Patients with uncontrolled asthma are at the highest risk for fatal outcomes and should not receive this treatment.

• Asthma Control: Patients must have their asthma well-controlled before receiving an injection. If you are experiencing a 'flare-up' or your peak flow meter readings are low, the injection must be postponed.
• Beta-Blocker Use: Patients taking beta-blockers (often prescribed for high blood pressure or glaucoma) may be resistant to the effects of epinephrine. This makes treating a systemic reaction much more difficult and potentially life-threatening.
• Cardiovascular Disease: Patients with unstable angina, recent myocardial infarction, or severe hypertension may not be able to tolerate the physiological stress of a systemic reaction or the emergency medications used to treat it.
• Infection/Illness: If you have a fever or a respiratory infection, notify your doctor. Injections are typically held until the illness has resolved to avoid complicating the immune response.

• 30-Minute Wait: This is a non-negotiable requirement. Most fatal reactions to immunotherapy occur within 30 minutes of the injection.
• Lung Function: For asthmatic patients, a quick spirometry or peak flow test may be performed before each injection.
• Skin Site Inspection: The physician or nurse will inspect the site of the previous injection to check for large delayed reactions before giving the next dose.

Ambrosia Artemisiifolia Whole does not typically cause sedation. However, if a patient experiences a systemic reaction or receives epinephrine, they should not drive or operate machinery until they have been cleared by a medical professional. Some patients may feel lightheaded after an injection due to a vasovagal response (fainting at the sight of a needle).

Alcohol consumption should be avoided for several hours before and after receiving an injection. Alcohol can cause vasodilation (widening of blood vessels), which may increase the rate of allergen absorption and potentially trigger a more severe reaction.

If treatment is discontinued for more than a few weeks, it cannot be restarted at the previous dose. A 'step-back' protocol must be followed. If a patient experiences a severe systemic reaction, the physician will conduct a risk-benefit analysis to determine if immunotherapy should be stopped permanently.

> Important: Discuss all your medical conditions with your healthcare provider before starting Ambrosia Artemisiifolia Whole.

• Beta-Adrenergic Blockers (Beta-Blockers): Examples include propranolol, metoprolol, and atenolol. These drugs block the receptors that epinephrine needs to act upon. If a patient on a beta-blocker has anaphylaxis from Ambrosia Artemisiifolia Whole, the standard treatment (epinephrine) may fail, leading to death. This is an absolute contraindication in many clinical settings.

• ACE Inhibitors: Drugs like lisinopril or enalapril may increase the risk of more severe systemic reactions or interfere with the body's compensatory mechanisms during an allergic event.
• MAO Inhibitors (MAOIs): Used for depression (e.g., phenelzine). These can potentiate the effects of epinephrine, leading to a hypertensive crisis if emergency treatment is required for an allergy shot reaction.
• Tricyclic Antidepressants: Similar to MAOIs, these can increase the cardiovascular sensitivity to epinephrine.

• Other Allergenic Extracts: If you are receiving multiple types of allergy shots (e.g., ragweed plus mold or dust mites), the cumulative 'allergen load' can increase the risk of a systemic reaction. These are often given in separate arms.
• Antihistamines: While often used to manage side effects, taking a high-dose antihistamine before a skin test will result in a 'false negative' result because the drug blocks the very reaction the test is trying to measure.

• Oral Allergy Syndrome (OAS): Patients allergic to Ambrosia Artemisiifolia may experience itching or swelling of the mouth when eating certain foods, such as bananas, melons (watermelon, cantaloupe), cucumber, and zucchini. This is due to cross-reactivity between the proteins in the pollen and the fruit. This is not a drug-drug interaction but a related clinical phenomenon.
• High-Fat Meals: No known interaction with the extract itself, but heavy meals may complicate the management of gastrointestinal symptoms during anaphylaxis.

• Feverfew and Echinacea: Some herbal supplements from the Asteraceae family (the same family as ragweed) may theoretically increase sensitivity, though clinical data is limited. Always inform your allergist of any herbal products you use.
• St. John's Wort: May interact with emergency medications if they are needed.

• Skin Prick Testing: Ambrosia Artemisiifolia Whole is used for this test. However, the presence of the drug in the system during immunotherapy will gradually decrease the 'wheal and flare' response over time, which is used to monitor the effectiveness of the treatment.
• Total IgE and Specific IgE (RAST/ImmunoCAP): Treatment with the extract will initially cause a rise in specific IgE, followed by a long-term decline and a rise in IgG4.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.

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

1. 1Severe or Uncontrolled Asthma: If the patient's FEV1 (Forced Expiratory Volume) is consistently below 70% of predicted values, the risk of a fatal bronchospasm during a reaction is too high.
2. 2History of Severe Anaphylaxis to Ragweed: If a patient has had a near-fatal reaction to ragweed exposure in the past, the risks of immunotherapy may outweigh the benefits.
3. 3Active Malignancy: Immunotherapy involves modulating the immune system, which is generally avoided in patients undergoing active cancer treatment.
4. 4Acute Infection: Treatment should not be initiated or continued during an acute febrile illness.

These conditions require a careful risk-benefit analysis by the physician:

• Beta-Blocker Therapy: As noted, this complicates emergency treatment. In some cases, a patient may be switched to a different blood pressure medication before starting allergy shots.
• Autoimmune Disorders: Conditions like Lupus (SLE) or Rheumatoid Arthritis may be exacerbated by the immune stimulation of immunotherapy.
• Severe Atopic Dermatitis: Flare-ups of eczema can occur during the build-up phase.

Patients who are allergic to Ambrosia Artemisiifolia Whole are highly likely to be cross-sensitive to other members of the Asteraceae (Compositae) family, including:

• Chrysanthemums
• Marigolds
• Daisies
• Sunflowers
• Dandelions

Exposure to these plants or their extracts may increase the baseline level of inflammation, making the patient more prone to a reaction from their immunotherapy dose.

> Important: Your healthcare provider will evaluate your complete medical history before prescribing Ambrosia Artemisiifolia Whole.

Pregnancy Category C. There are no adequate and well-controlled studies of Ambrosia Artemisiifolia Whole in pregnant women.

• Initiation: It is standard clinical practice NOT to start immunotherapy during pregnancy. The risk of a systemic reaction (anaphylaxis) can cause fetal hypoxia (lack of oxygen) or trigger uterine contractions, leading to miscarriage or preterm labor.
• Maintenance: If a woman is already on a stable maintenance dose and becomes pregnant, the treatment is usually continued, as the risk of a reaction is much lower than during the build-up phase. However, the dose is typically not increased during the pregnancy.

It is generally considered safe to continue ragweed immunotherapy while breastfeeding. The large protein molecules in the extract are not expected to pass into breast milk in any significant or harmful quantity. There is no evidence of adverse effects on the nursing infant.

Ambrosia Artemisiifolia Whole is frequently used in children. The American Academy of Pediatrics (AAP) and AAAAI note that immunotherapy is effective in children as young as 5 years old. It is particularly valued for its potential to prevent the development of new sensitivities and to reduce the risk of the child developing asthma later in life. It is NOT recommended for children under 5 because they cannot adequately describe the early 'aura' of an impending allergic reaction.

In patients over 65, the decision to use Ambrosia Artemisiifolia Whole must be made with caution. The aging immune system (immunosenescence) may result in a less robust response to the therapy. More importantly, elderly patients are more likely to have underlying cardiovascular conditions or be taking multiple medications (polypharmacy) that increase the risk of complications from a systemic reaction.

No dosage adjustments are needed. The metabolic pathway of the allergenic proteins does not involve renal filtration. However, if a patient has severe kidney disease, their overall physiological reserve to handle an anaphylactic event should be considered.

No adjustments are required for patients with liver impairment. The liver does not play a primary role in the processing of these injected proteins.

> Important: Special populations require individualized medical assessment.

Ambrosia Artemisiifolia Whole acts as an active immunotherapeutic agent. The primary allergens in the extract, particularly Amb a 1 (a 38-kDa acidic glycoprotein), are captured by dendritic cells at the site of administration. These cells process the allergens and present them to T-lymphocytes. In an allergic individual, this presentation usually favors a Th2 response. Immunotherapy forces the system toward 'immune tolerance.' This is achieved by:

1. 1T-cell Anergy: Making the Th2 cells less responsive to the allergen.
2. 2Treg Induction: Increasing the population of CD4+ CD25+ regulatory T cells.
3. 3Antibody Switching: Inducing B-cells to produce IgG4 instead of IgE. IgG4 acts as a 'decoy' or 'blocking' antibody.

The pharmacodynamic effect of Ambrosia Artemisiifolia Whole is delayed and cumulative. Unlike an antihistamine which works in 30 minutes, the 'drug effect' of this extract takes months to manifest. The duration of effect is one of its most unique features; successful completion of a 3-5 year course can result in 10-15 years of symptom relief, a phenomenon known as 'disease modification.'

| Parameter | Value |

|---|---|

| Bioavailability | N/A (Biological/Local) |

| Protein Binding | Minimal (Local Tissue Binding) |

| Half-life | Days (Proteins); Years (Immune Memory) |

| Tmax | 1-2 hours (Systemic absorption of trace proteins) |

| Metabolism | Proteolysis (Extracellular and Lysosomal) |

| Excretion | Renal (Trace metabolites) |

• Composition: A complex aqueous extract containing proteins, glycoproteins, and polysaccharides.
• Molecular Weight: Ranges from 10 kDa to over 60 kDa (for various Amb a allergens).
• Solubility: Highly soluble in buffered saline solutions.
• Source: Defatted whole plant or pollen of Ambrosia artemisiifolia.

Ambrosia Artemisiifolia Whole is classified as a Non-Standardized Plant Allergenic Extract. It is grouped with other weeds such as Artemisia vulgaris (Mugwort) and Chenopodium album (Lamb's Quarter). While it shares some EPC (Established Pharmacologic Class) tags with adrenergic agonists in some databases, this is due to its clinical association with the emergency use of epinephrine and its role in complex immunological signaling pathways.