Kidney Formula

Dosage for Astragalus Mongholicus Root extract is highly individualized and must be determined by an allergy specialist based on the patient's sensitivity levels.

Diagnostic Dosing

• Prick/Puncture Testing: Usually performed using a 1:10 or 1:20 w/v (weight/volume) concentration. A single drop is applied to the skin, and a sterile lancet is used to prick the epidermis.
• Intradermal Testing: If prick tests are negative but clinical suspicion remains high, a more dilute concentration (e.g., 1:100 to 1:1,000 w/v) may be injected into the dermis.

Immunotherapy Dosing (SCIT)

• Build-up Phase: Treatment typically starts with a very low dose (e.g., 0.05 mL of a 1:100,000 w/v dilution) administered once or twice weekly. The dose is gradually increased until the 'maintenance dose' is reached.
• Maintenance Phase: Once the effective dose is reached, the interval between injections is increased to every 2 to 4 weeks. A common maintenance volume is 0.5 mL of a 1:10 or 1:20 w/v concentration, though this varies significantly by patient tolerance.

Astragalus Mongholicus Root extract may be used in children, typically those aged 5 years and older. The dosing principles are similar to those for adults, but the starting dose may be even more conservative depending on the child's history of asthma or previous systemic reactions. Safety and efficacy in children under the age of 5 have not been extensively established for non-standardized extracts.

Renal Impairment

No specific dosage adjustments are required for patients with kidney disease, as the extract is not cleared via the kidneys in a way that would lead to toxicity. However, the patient's overall health and ability to tolerate a systemic reaction must be considered.

Hepatic Impairment

No dosage adjustments are necessary for patients with liver disease.

Elderly Patients

Older adults may have a reduced 'wheal and flare' response during skin testing due to age-related changes in skin reactivity. For immunotherapy, clinicians must carefully evaluate the patient’s cardiovascular status, as the use of epinephrine (the treatment for anaphylaxis) may pose higher risks in patients with underlying heart disease.

This medication is NEVER for self-administration at home during the initial phases.

1. 1Preparation: The site of injection (usually the posterior aspect of the upper arm) is cleaned with alcohol.
2. 2Administration: The extract is injected subcutaneously (under the skin). It must NOT be injected into a blood vessel.
3. 3Observation: Patients MUST remain in the doctor's office for at least 30 minutes following any injection. Most fatal or severe reactions occur within this window.
4. 4Storage: Concentrated extracts should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.

If an immunotherapy dose is missed, the schedule must be adjusted.

• If the delay is short (e.g., 1 week), the same dose may be repeated.
• If the delay is longer (e.g., 2-4 weeks), the dose may need to be reduced to ensure safety.
• If more than 4 weeks are missed, the build-up process may need to be restarted from a much lower concentration.

An 'overdose' in the context of allergenic extracts usually refers to a dose that exceeds the patient's current tolerance level, potentially leading to a systemic reaction.

• Signs: Hives, swelling of the throat, wheezing, low blood pressure, or rapid heart rate.
• Emergency Measures: Immediate administration of epinephrine (0.3 mg for adults), oxygen, and intravenous fluids. The patient should be transported to an emergency department for observation.

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

Most patients undergoing skin testing or immunotherapy with Astragalus Mongholicus Root will experience local reactions. These are generally considered a sign that the extract is active.

• Local Redness (Erythema): Redness at the injection site that usually appears within minutes and fades within a few hours.
• Swelling (Wheal): A raised, itchy bump at the injection site. For immunotherapy, a local reaction smaller than the size of a half-dollar is considered normal.
• Itching (Pruritus): Intense itching at the site of administration.
• Tenderness: The arm may feel slightly sore or 'heavy' for 24 hours following an injection.

• Large Local Reactions: Swelling that extends beyond the immediate injection site, sometimes involving the entire upper arm. This may require an adjustment in the next dose.
• Fatigue: Some patients report feeling unusually tired for several hours after their allergy shots.
• Mild Nasal Congestion: A slight 'flare-up' of hay fever symptoms shortly after treatment.

• Systemic Hives (Urticaria): Hives appearing on parts of the body far from the injection site.
• Angioedema: Swelling of the deeper layers of the skin, often around the eyes or lips.
• Vasovagal Syncope: Fainting or lightheadedness due to the needle prick or the stress of the procedure, rather than the extract itself.

> Warning: Stop taking Astragalus Mongholicus Root injections and call your doctor immediately or seek emergency care if you experience any of these symptoms of anaphylaxis:

• Respiratory Distress: Difficulty breathing, wheezing, or a high-pitched sound when breathing (stridor).
• Throat Tightness: A feeling that the throat is closing or difficulty swallowing.
• Cardiovascular Collapse: A sudden drop in blood pressure, feeling faint, or loss of consciousness.
• Generalized Flushing: A warm, red feeling spreading across the entire body.
• Abdominal Cramping: Sudden, severe stomach pain, nausea, or vomiting.

There are no known long-term toxicities associated with the proper use of Astragalus Mongholicus Root allergenic extracts. Unlike many medications, immunotherapy is designed to eventually be discontinued once the patient has achieved long-term tolerance (usually after 3 to 5 years of treatment). The goal is a permanent modification of the immune system.

While non-standardized plant extracts may not always carry a specific 'Black Box' on the physical label in the same way as high-risk pharmaceuticals, the FDA requires all allergenic extracts to carry a general warning regarding the risk of severe systemic reactions.

Summary of Warning: This product can cause severe, life-threatening systemic reactions, including anaphylaxis. It must only be administered by healthcare providers experienced in the treatment of anaphylaxis and in a facility equipped with emergency supplies (epinephrine, oxygen, airway management). Patients with unstable asthma are at a significantly higher risk for fatal reactions.

Report any unusual symptoms or delayed reactions (those occurring after you leave the clinic) to your healthcare provider immediately.

Astragalus Mongholicus Root allergenic extract is a potent biological substance. It is intended for use only by physicians who are specifically trained in allergy and immunology. Patients must be informed that while the goal of treatment is to reduce allergy symptoms, the treatment itself carries a risk of triggering the very symptoms it aims to treat.

No specific FDA black box warning exists for Astragalus Mongholicus Root specifically, but it falls under the mandatory class-wide warning for all allergenic extracts. This warning emphasizes that the product can cause anaphylaxis and should only be used in settings where emergency resuscitation is possible. It also highlights that patients with severe or poorly controlled asthma should not receive immunotherapy due to the risk of fatal bronchospasm.

• Anaphylaxis Risk: This is the primary concern. Every injection carries a statistical risk of a systemic reaction. Patients should be evaluated for wellness (no current fever or asthma flare) before every dose.
• Asthma Status: Patients with symptomatic asthma or a significantly reduced FEV1 (forced expiratory volume) are at the highest risk for a fatal reaction. Immunotherapy should be withheld if the patient is experiencing an asthma exacerbation.
• Cardiovascular Disease: Patients with pre-existing heart conditions may not tolerate the stress of a systemic reaction or the effects of epinephrine used to treat it.
• Infection: Injections should be deferred if the patient has an acute infection or fever, as this can lower the threshold for a systemic reaction.

• Observation Period: A mandatory 30-minute wait after each injection.
• Lung Function: For asthmatic patients, a peak flow meter or spirometry may be used before the injection to ensure the airway is stable.
• Site Inspection: The injection site should be checked for large local reactions before the patient leaves and again at the next visit.

Most patients can drive after their 30-minute observation period. However, if a patient feels lightheaded, fatigued, or experiences a systemic reaction, they should not drive until cleared by a medical professional.

While there is no direct chemical interaction between alcohol and the extract, alcohol consumption can increase blood flow to the skin and may potentially accelerate the absorption of the allergen or mask the early symptoms of a reaction. It is generally advised to avoid alcohol for several hours after an injection.

Immunotherapy is typically discontinued after 3 to 5 years if the patient is asymptomatic. There is no 'withdrawal' syndrome, but stopping too early (e.g., in the first year) usually results in the return of allergy symptoms. If a patient develops a severe systemic reaction that cannot be managed by dose reduction, the treatment may need to be permanently discontinued.

> Important: Discuss all your medical conditions, especially heart or lung issues, with your healthcare provider before starting Astragalus Mongholicus Root.

• Beta-Blockers (e.g., Propranolol, Atenolol): These medications are strictly contraindicated or used with extreme caution. Beta-blockers can make an allergic reaction more severe and, more importantly, they block the effects of epinephrine (adrenaline), making it difficult or impossible to treat anaphylaxis if it occurs.

• ACE Inhibitors (e.g., Lisinopril): These drugs may increase the risk of systemic reactions or more severe airway swelling (angioedema) during immunotherapy.
• MAO Inhibitors (e.g., Phenelzine): These can interfere with the body's ability to process emergency medications like epinephrine, potentially leading to a hypertensive crisis if an allergic reaction is treated.
• Tricyclic Antidepressants (e.g., Amitriptyline): Similar to MAOIs, these can potentiate the effects of epinephrine, requiring careful dose management in emergencies.

• Other Allergenic Extracts: If a patient is receiving multiple types of allergy shots (e.g., grass, mold, and Astragalus), the cumulative 'allergic load' is higher, increasing the risk of a systemic reaction. These should often be administered in different arms.
• Immunosuppressants (e.g., Prednisone, Cyclosporine): These medications may reduce the effectiveness of the immunotherapy by preventing the immune system from mounting the desired 'protective' response.

There are no direct food-drug interactions. However, patients with 'Oral Allergy Syndrome' (OAS) may find that eating certain legumes or related vegetables (like peas or beans) shortly before or after an injection could worsen their symptoms due to cross-reactivity between the root proteins and the food proteins.

• Astragalus Supplements: Patients should avoid taking oral Astragalus supplements while undergoing immunotherapy with the root extract. The oral supplement may introduce unknown quantities of the allergen, making the clinical dosing of the extract unpredictable and potentially dangerous.
• St. John's Wort: May theoretically affect the metabolism of other medications used to treat allergic reactions, though the clinical significance is low.

• Skin Prick Tests: Taking antihistamines (like Claritin, Zyrtec, or Benadryl) will suppress the skin's reaction to the extract, leading to a false-negative result. These must be stopped 3 to 7 days before testing.
• Specific IgE Blood Tests (ImmunoCAP): The extract itself does not interfere with the blood test, but the immunotherapy treatment will eventually cause IgE levels to drop and IgG4 levels to rise, which is the intended clinical outcome.

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

• Severe, Uncontrolled Asthma: Patients with an FEV1 consistently below 70% of predicted value or those with frequent exacerbations are at an unacceptable risk for fatal bronchospasm during treatment.
• Previous Severe Reaction: A history of near-fatal anaphylaxis to Astragalus Mongholicus Root where the cause could not be mitigated by dose adjustment.
• Beta-Blocker Therapy: As noted previously, the inability to respond to epinephrine makes immunotherapy significantly more dangerous.
• Acute Infection: Treatment should never be initiated or continued during an active febrile illness.

• Pregnancy: While maintenance immunotherapy is often continued during pregnancy, it is generally NOT recommended to start a new build-up phase due to the risk of anaphylaxis-induced fetal hypoxia (lack of oxygen to the baby).
• Autoimmune Disorders: Patients with active systemic lupus erythematosus (SLE) or rheumatoid arthritis may experience a flare-up of their condition as the immune system is stimulated.
• Malignancy: Patients undergoing active chemotherapy or those with certain cancers may have compromised immune systems that cannot properly process the immunotherapy.

Patients who are highly allergic to other members of the Fabaceae (Leguminosae) family—such as peanuts, soy, lentils, or alfalfa—may exhibit cross-sensitivity to Astragalus Mongholicus Root. This means they may react more strongly to the extract even if they have never been directly exposed to the Astragalus plant before. Clinicians should perform initial testing with highly diluted concentrations in these patients.

> Important: Your healthcare provider will evaluate your complete medical history, including your lung function and current medications, before prescribing Astragalus Mongholicus Root.

Pregnancy Category C (General for extracts): There are no adequate and well-controlled studies of Astragalus Mongholicus Root extract in pregnant women.

• Risks: The primary risk is not the extract itself, but the potential for maternal anaphylaxis, which can lead to uterine contractions, placental abruption, and fetal death due to oxygen deprivation.
• Clinical Practice: Allergists typically do not start new immunotherapy during pregnancy. If a patient is already on a stable maintenance dose and is tolerating it well, the treatment may be continued, but the dose is usually not increased until after delivery.

It is generally considered safe to continue Astragalus Mongholicus Root immunotherapy while breastfeeding. The large allergenic proteins are unlikely to pass into breast milk in significant quantities, and there is no evidence of harm to the nursing infant. However, the mother should be monitored for systemic reactions as usual.

• Approved Age: Generally used in children 5 years and older.
• Considerations: Children may have difficulty communicating the early signs of a systemic reaction (e.g., 'itchy throat' or 'funny feeling'). Parents must be educated to recognize the signs of hives or wheezing.
• Benefits: Early immunotherapy in children with allergic rhinitis has been shown in some studies to reduce the risk of developing asthma later in life (the 'allergic march').

• Cardiovascular Risk: Patients over 65 are more likely to have underlying coronary artery disease, making them more vulnerable to the effects of both anaphylaxis and the epinephrine used to treat it.
• Skin Reactivity: Reduced skin turgor and histamine response may make diagnostic skin testing less accurate. Intradermal testing may be necessary for a definitive diagnosis.
• Polypharmacy: Older adults are more likely to be taking medications (like beta-blockers or ACE inhibitors) that interact with the extract.

There are no specific restrictions for patients with renal impairment. The proteins are naturally degraded by cellular processes and do not rely on renal filtration for clearance. However, patients on dialysis should have their immunotherapy scheduled on non-dialysis days to ensure they are at their cardiovascular baseline.

No dosage adjustments are required. The liver's cytochrome P450 system is not involved in the processing of allergenic proteins.

> Important: Special populations require individualized medical assessment and often a more cautious approach to dosing.

The pharmacology of Astragalus Mongholicus Root extract is centered on the modulation of the Type I Hypersensitivity response.

1. 1Diagnostic Phase: The extract's constituent proteins (allergens) bind to IgE antibodies on the surface of cutaneous mast cells. This cross-linking of IgE triggers the release of pre-formed mediators like histamine and newly synthesized mediators like leukotrienes, causing the 'wheal and flare' response.
2. 2Therapeutic Phase: Repeated subcutaneous exposure to the allergen induces 'immune tolerance.' This involves the induction of T-regulatory cells (Tregs) that produce IL-10 and TGF-beta, which suppress the Th2 allergic response. It also stimulates B-cells to produce IgG4, which acts as a 'decoy' or 'blocking' antibody.

• Onset of Action: Skin test results are visible within 15 to 20 minutes. For immunotherapy, clinical improvement in allergy symptoms typically takes 3 to 6 months of treatment, with maximum benefit seen after 1 to 2 years.
• Duration of Effect: A single skin test reaction lasts 2 to 4 hours. The effects of a full course of immunotherapy can last for several years after the treatment is stopped.

| Parameter | Value |

|---|---|

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

| Protein Binding | Primarily to IgE and IgG4 antibodies |

| Half-life | Minutes (proteins are rapidly degraded) |

| Tmax | 15-20 minutes (for skin reaction) |

| Metabolism | Proteolysis by antigen-presenting cells |

| Excretion | Not renally excreted as intact drug |

• Composition: A complex mixture of proteins, glycoproteins, and polysaccharides derived from the root of Astragalus mongholicus.
• Solubility: Highly soluble in aqueous buffered saline or 50% glycerin solutions.
• Molecular Weight: Varies; contains multiple protein fractions ranging from 10 kDa to over 100 kDa.

Astragalus Mongholicus Root belongs to the class of Non-Standardized Plant Allergenic Extracts. It is grouped with other botanical extracts such as Ragweed, Timothy Grass, and Oak extracts, though each is unique to the specific plant's proteome.