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Allergen Immunotherapy

The dosage for Saccharomyces Cerevisiae allergenic extract is highly individualized. It typically follows a 'build-up' phase and a 'maintenance' phase.

• Build-up Phase: Starts with a very low dose (e.g., 0.05 mL of a 1:100,000 w/v dilution). Doses are increased weekly or bi-weekly depending on the patient's local reaction.
• Maintenance Phase: Once the target dose is reached (often 0.5 mL of a 1:100 or 1:10 w/v dilution), the interval between injections is increased to every 2 to 4 weeks.

Oral Probiotic Use

For the prevention of antibiotic-associated diarrhea, the typical adult dose is 250 mg to 500 mg (approx. 5-10 billion CFUs) taken once or twice daily. For the treatment of C. difficile, doses may be higher, as directed by a healthcare provider.

Allergen Immunotherapy

Pediatric dosing follows the same principles as adult dosing but requires even more cautious escalation. It is generally not recommended for children under the age of 5 unless the allergic burden is severe and other treatments have failed.

Oral Probiotic Use

For children, the standard dose for diarrhea management is 250 mg twice daily. It is important to consult a pediatrician before administering yeast-based supplements to infants under 12 months of age.

Renal Impairment

No specific dosage adjustments are provided in the manufacturer's labeling for patients with renal impairment, as the yeast (oral) is not systemically absorbed and the extract (injected) is used in minute quantities. However, clinical monitoring is advised.

Hepatic Impairment

No dosage adjustments are required for hepatic impairment. The clearance of Saccharomyces does not rely on hepatic metabolic pathways.

Elderly Patients

Elderly patients should be started at the lower end of the dosing range for immunotherapy due to a higher prevalence of underlying cardiovascular disease, which could complicate the management of a systemic allergic reaction (anaphylaxis).

• Injections: These must be administered by a healthcare professional in a clinical setting equipped to handle anaphylaxis. Patients must remain in the office for at least 30 minutes following the injection.
• Oral Capsules: Should be swallowed whole with a glass of water. They can be taken with or without food. However, if taking for antibiotic-associated diarrhea, they can be taken simultaneously with the antibiotic, as yeast is naturally resistant to antibacterial agents.
• Storage: Most oral forms should be stored in a cool, dry place. Some specific formulations may require refrigeration to maintain the viability of the yeast cells. Always check the product label.

• Immunotherapy: If an injection is missed, the next dose may need to be reduced depending on how much time has passed. Contact your allergist immediately for instructions.
• Oral Supplement: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.

• Injected: An overdose of allergenic extract can lead to severe systemic reactions, including hives, angioedema (swelling), bronchospasm, and anaphylactic shock. Emergency administration of epinephrine is required.
• Oral: Overdose of oral Saccharomyces is rare but may result in significant gastrointestinal distress, such as severe bloating or constipation. If an accidental large ingestion occurs, contact a Poison Control Center.

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

For the Allergenic Extract:

• Local Injection Site Reactions: This is the most common side effect. It includes redness (erythema), itching (pruritus), and a raised bump (wheal) at the site of the injection. These typically resolve within 24 to 48 hours.
• Swelling: Mild swelling of the arm where the injection was given.

For the Oral Probiotic:

• Flatulence (Gas): Many patients experience an increase in intestinal gas as the yeast interacts with gut flora.
• Abdominal Bloating: A feeling of fullness or pressure in the abdomen.
• Constipation: Some individuals may notice a slowing of bowel movements initially.

• Headache: Some patients report mild headaches following immunotherapy sessions.
• Nausea: Mild stomach upset, particularly if the oral form is taken on an empty stomach.
• Thirst: An increased sensation of thirst has been noted in some clinical trials.

• Fungemia (Saccharomyces Sepsis): This is a very rare but critical side effect where the yeast enters the bloodstream. This occurs almost exclusively in patients with central venous catheters or those who are severely immunocompromised.
• Severe Migraine: Occasionally reported following high-dose immunotherapy.
• Urticaria (Hives): Generalized hives away from the injection site, indicating a mild systemic allergic reaction.

> Warning: Stop taking Saccharomyces Cerevisiae and call your doctor immediately if you experience any of these.

• Anaphylaxis: A life-threatening allergic reaction. Symptoms include a sudden drop in blood pressure, difficulty breathing, swelling of the throat or tongue, and loss of consciousness.
• Angioedema: Deep swelling under the skin, particularly around the eyes, lips, or extremities.
• High Fever and Chills: These may be signs of fungemia (yeast in the blood), especially if you have a weakened immune system.
• Chest Tightness or Wheezing: Signs of an acute asthma-like reaction following exposure to the extract.

Long-term use of Saccharomyces as a probiotic is generally considered safe for healthy individuals. However, the long-term effects of allergen immunotherapy can include a permanent change in the immune system's response to the fungus, which is the intended therapeutic goal. There is no evidence that long-term oral use leads to dependency or permanent alteration of the native microbiome in a negative way.

There are no specific FDA Black Box Warnings for Saccharomyces Cerevisiae as an ingredient. However, all Allergenic Extracts carry a general warning regarding the risk of severe non-fatal and fatal systemic allergic reactions. These products must only be administered by physicians who are exceptionally experienced in the treatment of anaphylaxis and in facilities where emergency equipment is immediately available.

Report any unusual symptoms to your healthcare provider.

Saccharomyces Cerevisiae, while naturally occurring, must be used with caution in clinical settings. The primary safety concern with the injectable extract is the risk of systemic allergic reactions. For the oral probiotic form, the primary concern is the risk of systemic infection in vulnerable populations. Patients should always inform their healthcare provider of any history of yeast allergy before starting treatment.

No FDA black box warnings for Saccharomyces Cerevisiae specifically. However, the class-wide warning for allergenic extracts applies: "This product can cause severe systemic reactions, including anaphylaxis, which may be fatal. Patients should be observed for at least 30 minutes after injection."

• Allergic Reactions / Anaphylaxis Risk: Patients with a known high sensitivity to yeast are at an increased risk. Immunotherapy should be delayed if a patient is experiencing an acute asthma exacerbation or is feeling generally unwell.
• Fungemia Risk: There have been documented cases of Saccharomyces fungemia in patients with central venous catheters. The yeast can be inadvertently introduced into the catheter during the handling of probiotic capsules or through translocation from the gut in critically ill patients.
• Immunocompromised Patients: Those with HIV/AIDS, patients undergoing chemotherapy, or those on long-term immunosuppressants (like prednisone or cyclosporine) should avoid oral Saccharomyces unless specifically directed by a specialist.
• Beta-Blocker Use: Patients taking beta-blockers (e.g., metoprolol, propranolol) may be resistant to the effects of epinephrine, which is the standard treatment for anaphylaxis. This makes immunotherapy significantly more dangerous for these individuals.

• Observation: A 30-minute post-injection observation period is mandatory for all patients receiving the allergenic extract.
• Skin Testing: Periodic re-evaluation of skin sensitivity may be needed to assess the progress of immunotherapy.
• Clinical Signs: Patients taking the probiotic should be monitored for signs of systemic infection, such as unexplained fever or malaise.

Saccharomyces Cerevisiae generally does not affect the ability to drive or operate machinery. However, if a patient experiences a systemic reaction or feels lightheaded following an injection, they should avoid these activities until symptoms fully resolve.

There is no direct interaction between Saccharomyces and alcohol. However, alcohol can sometimes exacerbate the symptoms of an allergic reaction or GI distress, so moderation is advised during the initial phases of treatment.

• Immunotherapy: If discontinued, the patient's sensitivity to the allergen will likely return over time. Tapering is not usually required, but a restart of the 'build-up' phase is necessary if the patient wishes to resume after a long break.
• Probiotic: Can be stopped abruptly without withdrawal symptoms. The yeast will be cleared from the system within a few days.

> Important: Discuss all your medical conditions with your healthcare provider before starting Saccharomyces Cerevisiae.

• Systemic Antifungal Medications: Drugs such as fluconazole (Diflucan), itraconazole (Sporanox), and amphotericin B will kill the live yeast cells in oral Saccharomyces products, rendering the probiotic ineffective. If both are needed, they should be spaced by at least 4 to 6 hours, though even then, efficacy is significantly reduced.

• Monoamine Oxidase Inhibitors (MAOIs): Some yeast-derived products, particularly 'aged' or 'nutritional' yeasts, contain tyramine. When taken with MAOIs (e.g., phenelzine, selegiline), this can lead to a dangerous increase in blood pressure (hypertensive crisis). While most modern probiotic capsules have low tyramine, caution is warranted.
• Immunosuppressants: Drugs like azathioprine, tacrolimus, or high-dose corticosteroids increase the risk of the yeast crossing the intestinal barrier and causing a systemic infection (fungemia).

• Antibiotics: While Saccharomyces is a yeast and not killed by antibiotics, the antibiotics will change the gut environment. Taking them together is often the goal (to prevent diarrhea), but the clinical response should be monitored.

• High-Sugar Foods: Some evidence suggests that a diet very high in refined sugars may promote the overgrowth of various yeast species, potentially altering the balance the probiotic is trying to achieve.
• Alcohol: As mentioned, alcohol may increase the permeability of the gut or exacerbate allergic symptoms.

• Antifungal Herbs: Supplements with known antifungal properties, such as oil of oregano, caprylic acid, or high doses of garlic (allicin), may reduce the viability of the Saccharomyces yeast if taken simultaneously.

• Skin Prick Tests: If a patient is taking antihistamines (e.g., loratadine, cetirizine), the results of a skin test using Saccharomyces extract will be falsely negative. Antihistamines must be discontinued for 3 to 7 days prior to testing.
• Stool Cultures: The presence of Saccharomyces in a stool sample is normal during and shortly after treatment and should not be confused with a pathogenic fungal infection.

For each major interaction, the mechanism is usually either pharmacodynamic (the drugs have opposing or synergistic biological effects) or physical (the antifungal drug directly destroys the probiotic organism). Management typically involves either avoiding the combination or careful timing of doses.

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

• Severe Yeast Allergy: Any patient with a history of anaphylaxis or severe systemic hives in response to yeast or yeast-containing products (like bread or beer) must never receive the allergenic extract or oral probiotic.
• Central Venous Catheter (CVC): Due to the high risk of 'catheter-related fungemia,' the use of Saccharomyces probiotics is strictly contraindicated in hospitalized patients with a CVC.
• Critically Ill Patients: Those in an ICU setting or with severe intestinal barrier compromise (e.g., severe inflammatory bowel disease flare) should not use the probiotic form due to the risk of translocation into the blood.

• Pregnancy: While not strictly contraindicated, the use of immunotherapy should not be initiated during pregnancy due to the risk of anaphylaxis-induced fetal hypoxia. Maintenance doses may be continued if well-tolerated.
• Severe Asthma: Patients with uncontrolled asthma are at a much higher risk of fatal reactions from allergenic extracts.
• Valvular Heart Disease: Those with prosthetic heart valves may be at a higher risk of endocarditis if fungemia occurs.

Patients allergic to Saccharomyces Cerevisiae may also show cross-reactivity with other fungi, such as Candida albicans or Aspergillus species. Caution is advised when performing multiple fungal skin tests simultaneously.

> Important: Your healthcare provider will evaluate your complete medical history before prescribing Saccharomyces Cerevisiae.

• FDA Pregnancy Category: Historically Category C.
• Risks: There is no evidence that Saccharomyces is teratogenic (causes birth defects). However, the primary risk during pregnancy is a systemic allergic reaction (anaphylaxis) to the injectable extract, which can cause a sudden drop in maternal blood pressure and oxygen delivery to the fetus.
• Guidance: Probiotic use is generally considered safe during pregnancy for GI health, but always consult an OB/GYN.

Saccharomyces Cerevisiae is not known to pass into breast milk in any significant quantity. It is generally considered compatible with breastfeeding. The yeast itself is a common part of the human diet and is not expected to cause adverse effects in the nursing infant.

• Approved Use: Probiotics are frequently used in children to treat diarrhea. Allergen immunotherapy is generally reserved for children 5 years and older.
• Special Dosing: Pediatric doses are often the same as adult doses for probiotics (250-500mg), but the clinical necessity should be confirmed by a pediatrician.
• Warnings: Use in premature infants or those with indwelling medical devices is strictly discouraged.

Elderly patients may have a higher risk of adverse outcomes from anaphylaxis due to pre-existing cardiovascular or pulmonary disease. Additionally, the risk of fungemia may be slightly higher in the elderly due to age-related immunosenescence (weakening of the immune system).

No dosage adjustments are required. The yeast is not systemically absorbed from the gut, and the metabolic products of the extract are not known to be nephrotoxic.

No dosage adjustments are required. Saccharomyces does not undergo significant hepatic metabolism.

> Important: Special populations require individualized medical assessment.

At the molecular level, Saccharomyces Cerevisiae contains a cell wall composed of beta-glucans, mannoproteins, and chitin. These components are potent immunomodulators.

• In Allergy: The mannoproteins act as the primary antigens that bind to IgE on mast cells.
• In Probiotics: The yeast acts as a 'decoy' for pathogens. For example, Vibrio cholerae and E. coli bind to the mannose receptors on the Saccharomyces cell wall instead of the intestinal epithelium, allowing them to be flushed out of the system.

• Onset of Action: For GI symptoms, improvement is often seen within 24 to 72 hours. For allergy testing, the reaction occurs within 15 to 20 minutes.
• Duration of Effect: The probiotic effect lasts only as long as the yeast is being consumed, plus the 3-5 days it takes to clear the gut. Immunotherapy effects can last for years after a 3- to 5-year course of treatment.

| Parameter | Value |

|---|---|

| Bioavailability | 0% (Oral); Systemic (Injected) |

| Protein Binding | N/A |

| Half-life | 3-6 hours (cellular components) |

| Tmax | N/A |

| Metabolism | Proteolytic degradation |

| Excretion | Fecal (Oral); Renal (Injected metabolites) |

• Classification: Fungi; Ascomycota; Saccharomycetes; Saccharomycetales; Saccharomycetaceae; Saccharomyces.
• Components: Rich in B-vitamins (Thiamine, Riboflavin, Niacin), proteins, and trace minerals.
• Solubility: The extract is a soluble protein fraction in aqueous buffered saline.

Saccharomyces Cerevisiae is a Non-Standardized Fungal Allergenic Extract. It shares this class with other fungal extracts like Alternaria, Cladosporium, and Penicillium. In its oral form, it is a Probiotic, related to other beneficial organisms like Lactobacillus and Bifidobacterium.