Amaranthus Hybridus Leaf

Dosage for Amaranthus Hybridus Leaf extract is highly individualized and must be determined by a board-certified allergist based on the patient's sensitivity level (determined via skin testing) and clinical history.

Diagnostic Dosing

• Skin Prick Test: Usually a concentration of 1:10 or 1:20 w/v in a glycerinated solution. A single drop is applied to the skin, followed by a prick.
• Intradermal Test: If the prick test is negative, an intradermal injection of 0.02 mL to 0.05 mL of a much more dilute solution (e.g., 1:1000 w/v) may be administered.

Therapeutic Dosing (Immunotherapy)

Therapy is divided into two phases:

1. 1Build-up Phase: Weekly or bi-weekly injections starting at a very low dose (e.g., 0.05 mL of a 1:100,000 w/v dilution). The dose is gradually increased until the maintenance dose is reached.
2. 2Maintenance Phase: Once the effective dose is reached (often 0.5 mL of a 1:100 or 1:20 w/v solution), injections are given every 2 to 4 weeks for a period of 3 to 5 years.

Amaranthus Hybridus Leaf extract is used in children, but dosing must be approached with extreme caution. Children are generally more prone to rapid systemic reactions. The dosing schedule is similar to adults but often starts at even more conservative dilutions. Safety and efficacy have not been established for children under the age of 5.

Renal Impairment

No specific dose adjustments are required for renal impairment, as the extract is not cleared renally. However, patients with severe renal disease may have a higher risk if emergency medications (like epinephrine) are required during a reaction.

Hepatic Impairment

No dosage adjustments are necessary for patients with liver disease.

Elderly Patients

Elderly patients (over 65) should be evaluated for cardiovascular stability. If an elderly patient is taking beta-blockers for hypertension, the use of allergenic extracts is generally discouraged due to the risk of epinephrine-resistant anaphylaxis.

• Administration: This medication is administered strictly via subcutaneous injection (under the skin) in the upper arm. It must NEVER be given intravenously.
• Observation: Patients MUST remain in the doctor's office for at least 30 minutes following every injection to monitor for signs of a systemic reaction.
• Storage: Vials must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Discard if the solution becomes turbid or changes color.
• Timing: Injections should be postponed if the patient has an active fever, acute asthma exacerbation, or a large local reaction from the previous dose.

If a dose is missed during the build-up phase, the next dose may need to be reduced or the previous dose repeated, depending on how much time has passed. If more than 4 weeks have passed since the last dose, the allergist will typically revert to a lower concentration to ensure safety.

An overdose in the context of allergenic extracts refers to receiving a dose higher than the patient's current tolerance level. This can lead to:

• Large Local Reactions: Swelling greater than 10cm at the injection site.
• Systemic Reactions: Hives, angioedema (swelling of the face/throat), wheezing, and hypotension (low blood pressure).
• Emergency Measure: Immediate administration of epinephrine (1:1000) and activation of emergency medical services.

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

Most patients undergoing immunotherapy with Amaranthus Hybridus Leaf will experience local reactions. These are generally not dangerous but can be uncomfortable.

• Injection Site Erythema: Redness at the site of the shot, typically appearing within minutes and resolving within 24 hours.
• Local Swelling (Wheal): A small, raised bump at the injection site. If the swelling is smaller than the size of a half-dollar, it is considered a normal response.
• Pruritus: Itching at the injection site or occasionally a mild 'itchy throat' shortly after the injection.

• Large Local Reactions: Swelling that exceeds 5-10 cm in diameter. This may require an adjustment of the next dose.
• Fatigue: Some patients report feeling unusually tired for a few hours after their injection.
• Mild Rhinitis: Sneezing or a runny nose shortly after the administration, reflecting a minor systemic immune activation.

• Urticaria (Hives): Generalized itching and red, raised welts appearing on parts of the body other than the injection site.
• Mild Wheezing: A slight tightening of the chest or shortness of breath.
• Gastrointestinal Distress: Nausea or abdominal cramping, which can be an early sign of a systemic reaction.

> Warning: Stop taking Amaranthus Hybridus Leaf and call your doctor immediately or seek emergency care if you experience any of these symptoms of anaphylaxis:

• Laryngeal Edema: Swelling of the throat, a feeling of a 'lump' in the throat, or difficulty swallowing.
• Bronchospasm: Severe wheezing or inability to breathe.
• Hypotension: A sudden drop in blood pressure, which may feel like dizziness, fainting, or 'seeing stars.'
• Cyanosis: A bluish tint to the lips or fingernails, indicating lack of oxygen.
• Anaphylactic Shock: A life-threatening systemic collapse requiring immediate epinephrine.

There are no known long-term 'toxic' side effects of Amaranthus Hybridus Leaf extract. The long-term goal and effect of the treatment is the permanent or semi-permanent reduction of allergic symptoms. However, if injections are poorly managed, patients may develop chronic 'large local reactions' which can lead to localized skin thickening (induration).

Allergenic extracts, including Amaranthus Hybridus Leaf, carry an FDA-mandated warning regarding the risk of severe systemic reactions.

Summary of Warning:

• This product can cause severe life-threatening systemic reactions, including anaphylaxis.
• It should only be administered by physicians experienced in the treatment of allergic diseases and the management of anaphylaxis.
• Patients with unstable or severe asthma are at increased risk for fatal reactions.
• Patients must be observed for at least 30 minutes in the office after injection.
• Certain medications (like beta-blockers) may make a patient more resistant to the effects of epinephrine used to treat a reaction.

Report any unusual symptoms, especially those occurring after you leave the clinic, to your healthcare provider immediately.

Amaranthus Hybridus Leaf extract is a potent biological product. It is not a standard medication and must be handled with specialized clinical care. The most critical safety factor is the prevention and management of anaphylaxis (a severe, whole-body allergic reaction).

No FDA black box warnings are specifically unique to Amaranthus Hybridus Leaf beyond the general class warning for all non-standardized allergenic extracts. The class warning emphasizes that these products can cause severe, life-threatening systemic reactions. Immunotherapy should be discontinued if a patient experiences a severe systemic reaction and should only be restarted with extreme caution.

• Allergic Reactions / Anaphylaxis Risk: This is the primary risk. Patients must be screened for 'high-risk' days (e.g., peak allergy season, high exercise levels before/after shots) which can lower the threshold for a reaction.
• Asthma Status: Patients with uncontrolled asthma (FEV1 < 70% of predicted) should not receive Amaranthus Hybridus Leaf injections. A peak flow meter check may be required before each dose.
• Acute Illness: If a patient has a fever or respiratory infection, the injection should be deferred to avoid compounding the immune system's stress.
• Cardiovascular Health: Patients with pre-existing heart disease are at higher risk if they experience a systemic reaction, as their heart may not tolerate the stress of anaphylaxis or the high doses of epinephrine required to treat it.

• Pre-Injection Assessment: The clinician must check the injection site from the previous visit for any lingering swelling. The patient's current asthma symptoms must be assessed.
• Post-Injection Observation: A mandatory 30-minute wait time in the medical facility is required.
• Lung Function: Periodic spirometry or peak flow monitoring is recommended for patients with a history of asthma.

While the extract itself does not cause sedation, a systemic reaction can cause dizziness or loss of consciousness. Patients should not drive or operate heavy machinery for at least 30-60 minutes after an injection to ensure they are not experiencing a delayed reaction.

Alcohol consumption should be avoided on the day of an injection. Alcohol causes vasodilation (widening of blood vessels), which can increase the rate of allergen absorption from the injection site and potentially increase the risk or severity of a systemic reaction.

If a patient misses several months of therapy, the treatment must be restarted from the beginning or a significantly lower dose. There is no 'withdrawal' syndrome, but the clinical benefits (allergy protection) will gradually fade if the maintenance phase is not completed (usually 3-5 years).

> Important: Discuss all your medical conditions, especially asthma and heart problems, with your healthcare provider before starting Amaranthus Hybridus Leaf.

• Beta-Blockers (e.g., Propranolol, Atenolol, Metoprolol): These are strictly contraindicated in most immunotherapy protocols. Beta-blockers can make a person resistant to the effects of epinephrine. If a patient on a beta-blocker has anaphylaxis from an Amaranthus injection, the standard treatment (epinephrine) may fail to work, leading to a potentially fatal outcome.

• MAO Inhibitors (MAOIs): Drugs like phenelzine or selegiline can potentiate the effect of epinephrine, potentially causing a hypertensive crisis if epinephrine is needed to treat an allergic reaction.
• Tricyclic Antidepressants (TCAs): Similar to MAOIs, TCAs can increase the cardiovascular sensitivity to epinephrine.
• Other Immunotherapy: If a patient is receiving multiple allergenic extracts (e.g., Grass, Mold, and Amaranthus), the cumulative 'allergic load' increases the risk of a systemic reaction.

• Antihistamines: While not dangerous, antihistamines (like Loratadine or Cetirizine) can mask early 'warning signs' of a systemic reaction, such as itching or sneezing, and will interfere with the accuracy of diagnostic skin testing. Antihistamines should be stopped 3-7 days before skin testing.
• Systemic Corticosteroids: Long-term use of prednisone may suppress the immune response to the extract, potentially reducing its efficacy, although it does not usually increase the risk of a reaction.

• Alcohol: As noted, alcohol increases vasodilation and may speed up allergen absorption, increasing the risk of anaphylaxis.
• Spicy Foods: In some individuals, very spicy foods can trigger 'gustatory rhinitis,' which might be confused with a mild systemic reaction to the injection.

• St. John's Wort: May affect the metabolism of other medications used to treat reactions, though data is limited.
• Astragalus / Echinacea: These 'immune-boosting' herbs could theoretically interfere with the desensitization process, though clinical evidence is lacking.

• Skin Tests: Amaranthus Hybridus Leaf extract will cause a positive result on skin tests for Smooth Pigweed.
• Serum IgE: Total IgE levels may rise temporarily during the build-up phase of immunotherapy before eventually stabilizing or decreasing.
• Specific IgG4: Clinical labs may show an increase in Amaranthus-specific IgG4, which is a marker of successful immunotherapy.

> 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 persistently below 70% of predicted values are at an unacceptably high risk for fatal bronchospasm during a reaction.
• Recent Myocardial Infarction (Heart Attack): Within the last 3-6 months. The cardiovascular system must be stable enough to handle potential anaphylaxis.
• Hypersensitivity to Diluents: Patients with a known severe allergy to phenol (used as a preservative in many extracts) or glycerin (used for stability).
• Beta-Blocker Therapy: Due to the inability to effectively treat anaphylaxis with epinephrine.

• Autoimmune Disorders: Patients with active systemic lupus erythematosus (SLE) or rheumatoid arthritis may have unpredictable immune responses to allergenic extracts.
• Malignancy: Patients undergoing active chemotherapy or radiation.
• Pregnancy (Initiation): Immunotherapy should generally not be started during pregnancy due to the risk of anaphylaxis-induced fetal hypoxia. However, it can often be maintained if the patient is already at a stable maintenance dose.
• Significant Emotional or Mental Instability: Because the patient must be able to report symptoms accurately and comply with the 30-minute observation rule.

Patients allergic to Amaranthus Hybridus Leaf often show cross-sensitivity to other members of the Amaranthaceae family and the Chenopodiaceae family. This includes:

• Russian Thistle (Salsola kali)
• Lamb’s Quarter (Chenopodium album)
• Rough Pigweed (Amaranthus retroflexus)
• Burning Bush / Kochia (Kochia scoparia)

Healthcare providers must be aware that testing or treating for one of these may trigger reactions in a patient sensitized to another in the group.

> Important: Your healthcare provider will evaluate your complete medical history, including your lung function and current medications, before prescribing Amaranthus Hybridus Leaf.

• FDA Category C: Animal reproduction studies have not been conducted with Amaranthus Hybridus Leaf extract.
• Risk Summary: The primary risk during pregnancy is maternal anaphylaxis, which can lead to uterine contractions, placental abruption, and fetal hypoxia (lack of oxygen to the baby).
• Clinical Guidance: Most allergists will not start a 'build-up' phase during pregnancy. If a patient is already on a stable maintenance dose and is tolerating it well, the injections are usually continued at that dose (or reduced slightly) but not increased.

• Lactation Risk: It is not known if the allergenic proteins or the IgG4 antibodies produced during therapy pass into breast milk. However, since these are large proteins that would likely be digested in the infant's gut, the risk to a nursing infant is considered negligible. Immunotherapy is generally considered safe for breastfeeding mothers.

• Approved Use: Immunotherapy is effective in children as young as 5 years old for the treatment of allergic rhinitis and asthma.
• Special Considerations: Children may have difficulty communicating the early symptoms of a systemic reaction (e.g., 'my throat feels funny'). Close observation by nursing staff is paramount. Dosing should be conservative, and the 'build-up' phase may be slower than in adults.
• Growth Effects: There is no evidence that allergenic extracts affect growth or development in children.

• Risk Assessment: Patients over 65 are more likely to have co-morbidities like coronary artery disease or COPD, which increase the risk of a fatal outcome from an allergic reaction.
• Polypharmacy: Careful review of medications is required to ensure the patient is not taking beta-blockers or other interfering drugs.
• Renal/Hepatic: No specific changes in the extract's action occur with age, but the body's ability to recover from a systemic reaction may be diminished.

• Adjustment: No dose adjustment is needed. However, clinicians should ensure the patient is stable enough to receive emergency medications if necessary.

• Adjustment: No dose adjustment is needed. The liver is not primarily involved in the processing of injected allergenic proteins.

> Important: Special populations require individualized medical assessment. Always inform your allergist if you become pregnant or develop new health conditions during treatment.

Amaranthus Hybridus Leaf extract acts as an immunomodulator. The primary allergens in the leaf and pollen are proteins (often in the 10-70 kDa range) that are recognized by the immune system. In the diagnostic phase, these proteins cause immediate mast cell degranulation in sensitized skin. In the therapeutic phase, repeated exposure to sub-threshold doses of these proteins induces a state of desensitization. This is characterized by the induction of IL-10 producing Regulatory T-cells and the production of allergen-specific IgG4, which acts as a 'decoy' antibody, intercepting the allergen before it can bind to IgE on mast cells.

• Onset of Action: Diagnostic skin reactions occur within 15-20 minutes. Therapeutic effects (symptom reduction) typically take 3 to 6 months to become noticeable and 12 to 18 months to reach peak efficacy.
• Duration of Effect: A completed 3-to-5-year course of immunotherapy can provide symptom relief for many years, and in some cases, permanently, by fundamentally altering the immune system's memory.

| Parameter | Value |

|---|---|

| Bioavailability | N/A (Subcutaneous) |

| Protein Binding | N/A (Local immune interaction) |

| Half-life | Variable (Proteins degraded within hours/days) |

| Tmax | 15-30 minutes (Systemic absorption peak) |

| Metabolism | Local Proteolysis |

| Excretion | Cellular metabolic pathways |

• Composition: A complex mixture of water-soluble proteins, glycoproteins, and polysaccharides derived from Amaranthus hybridus.
• Molecular Weight: Ranges from 10,000 to 70,000 Daltons for the primary allergenic fractions.
• Solubility: Highly soluble in aqueous buffered solutions or 50% glycerin.
• Stability: Sensitive to heat and light; requires refrigeration to prevent protein denaturation.

Amaranthus Hybridus Leaf is classified as a Non-Standardized Plant Allergenic Extract. It belongs to the broader therapeutic category of Allergen Immunotherapy (AIT) or 'Allergy Shots.' It is distinct from pharmacological agents like antihistamines or corticosteroids because it treats the underlying cause of the allergy rather than just the symptoms.