Histoglob

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Histoglob

Property Description
Active ingredient Human Normal Immunoglobulin, Histamine Dihydrochloride, Sodium Thiosulphate
Form Sterile solution for injection (parenteral)
Pharmacological class Immunomodulator, Anti-allergic medicine
Common use Long-term modulation of allergic hypersensitivity
Origin Biologically-derived (Immunoglobulin component) and synthetic

Histoglob is a specialized combination medicine and immunotherapy product used for the long-term modulation of the immune system in chronic allergic states. This treatment is classified as an anti-allergic medicine and immunomodulator, designed to address underlying hypersensitivity rather than providing immediate, temporary symptom relief. The product is administered via the parenteral route as a subcutaneous injection, typically as a sterile solution prepared from a lyophilised product.


What Type of Drug is Histoglob? (Classification and Form)

Histoglob is classified as a type of non-allergen-specific immunotherapy, intended to modify the body's generalized immune response. Its high-level pharmacological classification places it within the broader group of Immune Globulin/Antisera and Immunoglobulins. Clinically, the concept involves the linking of Immunoglobulin with Histamine to produce specific antibodies via this type of complex. The drug is distinctively available only as an injection, confirming its parenteral route of administration, which is necessary for the systemic immune system engagement this treatment requires.


Core Composition and Origin (Active Ingredients)

The medicinal entity contains a complex combination of three primary active ingredients: Human Normal Immunoglobulin, Histamine Dihydrochloride, and Sodium Thiosulphate. The Human Normal Immunoglobulin (a Gammaglobulin) is a biologically-derived component sourced from pooled human plasma, reflecting its status as a therapeutic protein and blood product. The drug's therapeutic core is the resulting Gammaglobulin-histamine Dihydrochloride complex, where the Immunoglobulin is chemically bound to the synthetic Histamine derivative. The formulation represents an example of combined immunoglobulin and biogenic amine therapy.


General Purpose: What Histoglob is Designed to Achieve

Histoglob is designed to serve as a basic treatment aimed at achieving long-term stability in patients with persistent, recurring allergic conditions, such as chronic allergic rhinitis or urticaria. Its general purpose is achieved by stimulating the production of specialized antihistaminic antibodies, which circulate and neutralize excess histamine released by the body's immune cells. This action supports a reduction in overall tissue hypersensitivity, helping the body restore a more balanced immune state.

What side effects are possible with Histoglob?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety statements for Histoglob, as defined in regulatory labeling.


Adverse Reactions by Frequency

Side effects observed during clinical trials are classified by how often they occur:

Classification Examples of Adverse Reactions
Very Common (1/10) Injection site pain/redness, Headache
Common (1/100 to < 1/10) Fatigue, Nausea, Mild fever (pyrexia)
Rare (1/10,000 to < 1/1,000) Severe hypotension, Anaphylactoid reaction

Adverse reactions are also grouped by the System Organ Class (SOC) affected, including Nervous System Disorders, Gastrointestinal Disorders, and Immune System Disorders, among others.


Serious Adverse Reactions (SARs)

Rare but clinically significant reactions documented in regulatory sources include Anaphylactic/Anaphylactoid Reaction, Severe Hypotension, and Angioedema (swelling beneath the skin). Patients must be observed for at least 30 minutes following administration to monitor for immediate hypersensitivity reactions, which are most likely to occur within the first few treatment cycles.


Population-Specific Safety Notes

Official labeling contains specific notes regarding use in certain populations:

  • Renal Impairment: Caution is advised in patients with severe renal impairment, requiring close monitoring of kidney function.
  • Pregnancy/Lactation: Use is warranted only if the potential benefit justifies the potential risk, as human data are limited.

Safety Restrictions

Histoglob is absolutely contraindicated in individuals with a known severe, systemic hypersensitivity to the drug or any of its excipients. Use is also restricted in patients with severe, uncontrolled asthma.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation describes overdose manifestations based on the high-level effects of the active components, Human Normal Immunoglobulin and Histamine Dihydrochloride. Over-administration may manifest as Hypotension (low blood pressure), Flushing, Headache, Nausea, Vomiting, Fever, Chills, and changes in heart rhythm, including Tachycardia.

Overdose carries a documented risk of severe and life-threatening outcomes, primarily affecting the Cardiovascular system and Renal system. Serious outcomes include Acute Renal Failure and potentially Thromboembolic Events.

Required Emergency Actions

Seek immediate medical attention for any severe symptoms or suspicion of over-administration. Regulator-mandated action requires that the product administration be discontinued immediately upon the onset of severe systemic symptoms. Urgent medical attention must be sought for signs of severe compromise, such as difficulty breathing, severe chest pain, or evidence of kidney dysfunction.

No specific antidote is known for this product. Therefore, management is strictly limited to symptomatic and supportive treatment, often requiring continuous cardiovascular monitoring and renal function monitoring in a supervised medical setting.

Population-specific considerations noted in labeling include an Increased risk of Acute Renal Failure in patients with pre-existing renal impairment, and an Increased risk of Thromboembolic Events in the elderly.

Therapeutic Uses of Histoglob

What Histoglob Treats: Main Uses and Benefits

Histoglob is a specialized immunotherapy product generally used as a basic, long-term treatment for patients with persistent allergic conditions. This approach supports the patient during difficult episodes by easing distress associated with severe allergic manifestations. This type of immunotherapy is considered relevant in the management of chronic allergic dermatoses.


Therapeutic Scope and Patient Benefit

This medication is commonly used to help with conditions characterized by periods of heightened symptoms such as Chronic Urticaria (hives), Eczema or Atopic Dermatitis, allergic rhinitis (including hay fever), and certain presentations of asthmatic bronchitis. It is applied in addressing symptom clusters that include persistent, intense itching (pruritus), the appearance of wheals, and severe nasal congestion. This therapy is commonly used in conditions where functional stability becomes affected, particularly where the symptomatic burden is significant.

The long-term approach contributes to easing the overall symptom load and may assist with functional stability by helping patients cope more steadily with symptom fluctuations. This therapeutic approach is relevant in contexts involving heightened systemic burden and provides supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Chronic Skin & Airway Symptoms

Quick Fact: Relief for Chronic Skin & Airway Symptoms This treatment is commonly used to help manage systemic hypersensitivity disorders, providing support for the most disruptive symptoms of persistent skin conditions and recurrent respiratory allergy. The treatment is used as a long-term therapeutic strategy rather than just immediate, temporary symptomatic relief.

Eligibility and Restrictions for Use

Who Can and Cannot Use Histoglob?

This section outlines the official eligibility and non-eligibility requirements for Histoglob, strictly based on authoritative regulatory documentation.

Contraindicated Populations

Use of Histoglob is contraindicated (must not be used) in individuals who meet the following criteria:

  • Known hypersensitivity or allergy to Histoglob or any of its components.
  • Experiencing an acute allergic attack (e.g., acute asthmatic attack). Treatment must be deferred until the acute symptoms have been alleviated.

Populations Requiring Caution or Special Consideration

Regulatory documents advise against use or recommend special medical supervision for the following groups:

  • Pregnancy and Menstruation: The medicine is not recommended for use during pregnancy or menstruation due to safety data limitations.
  • Existing Superinfection: Treatment should be deferred until any existing superinfection has been treated and cleared.
  • Children and Infants: Use is generally well-tolerated but must be prescribed by a physician, as general safety and efficacy are not fully established for all pediatric uses.
  • Kidney or Liver Impairment: Caution is advised, and a physician may need to adjust the dosage based on function.
  • IgA Deficiency: Use is cautioned in patients with known Immunoglobulin A (IgA) deficiency.

Eligibility-Related Restrictions

To maintain eligibility and effectiveness, live vaccines should not be administered for at least three months following Histoglob therapy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Histoglob is primarily defined by the properties of its Human Normal Immunoglobulin component, as documented in government regulatory monographs.


Interactions with Vaccines

This product can cause pharmacodynamic interference with certain other medicines, particularly live attenuated virus vaccines. The passive transfer of antibodies from Histoglob may reduce the effectiveness and impair the immune response to these vaccines, including Measles, Mumps, Rubella (MMR) vaccine and Varicella (Chickenpox) vaccine.

Interaction Type Interacting Medicines Restriction
Pharmacodynamic Interference Live Attenuated Virus Vaccines Administration must be separated.

To prevent the loss of vaccine efficacy, regulatory guidance requires a mandatory timing separation. Live attenuated virus vaccines should be administered no sooner than three months following the use of Histoglob. In specific cases, such as the measles vaccine, interference may persist longer.


Interference with Laboratory Tests

Histoglob may interfere with the interpretation of certain diagnostic procedures. The presence of passively transferred antibodies can lead to analytical interference in serological testing. This may result in false-positive results on antibody tests, such as the direct or indirect antiglobulin (Coombs') test.

Mechanism of Action

Histoglob is a preparation of histamine coupled to human normal immunoglobulin that acts as an immune modulator. Its mechanism involves adjusting the body's physiological response to the signaling chemical, histamine, across three core domains.


Adaptive Immune Response to Histamine Conjugate

This domain covers the primary mechanistic action where the drug complex stimulates the adaptive immune system to generate histamine-specific IgG antibodies. The subsequent binding of these self-produced antibodies to free histamine effectively neutralizes the mediator, limiting its availability to activate receptors that would otherwise drive physiological responses.


Modulation of Immune Signaling Cascades

This mechanism involves a long-term adjustment of systemic reactivity. By reducing the available concentration of active histamine and influencing the accumulation and activity of inflammatory cells such as eosinophils, Histoglob modifies the signaling cascade associated with chronic immune responses within affected tissues. This mechanism results in altered homeostatic signaling dynamics.


Effects on Vascular Permeability and Smooth Muscle Tone

The cumulative effect of neutralization and modulation results in predictable physiological adjustments, primarily focusing on tissue function. By reducing the over-stimulation caused by histamine, the mechanism reduces histamine-dependent increases in vascular permeability and decreases the stimulation of smooth muscle contraction, which modulates the physiological state of the tissues.

Dosage and Administration Information

How to Use Histoglob

Histoglob is a specialized combination product that is administered according to precise, cyclic dosing schedules. The medicine is intended solely for subcutaneous injection (SC) and is administered by a healthcare professional, such as a doctor or nurse. It is explicitly not approved for intravenous, intramuscular, or oral use.


Official Dosing Regimens

The treatment pattern for Histoglob is defined by an initial course and subsequent repetition or booster phases. The dosage volume per administration is consistently 1 ml of the sterile solution for injection.

Patient Population Initial Course Length Frequency Repetition/Booster
Adults 3 injections 4-day intervals Course may be repeated after one month, or boosters given at 3 and 6 months
Children 3 injections 8-day intervals Follows similar long-term repetition patterns for chronic cases

Administration Conditions and Timing

Administration of Histoglob involves specific procedural conditions to ensure proper use. Because the medicine is sensitive to heat (thermolabile), the injection is prepared and delivered using a cool syringe.

Crucially, the treatment is not an acute intervention. It is not initiated or continued during an acute allergic attack or a severe asthmatic exacerbation, as its use is restricted to periods of patient stability. This structured, intermittent use over time establishes Histoglob as a long-term therapeutic strategy.

Recent Clinical Evidence

Recent Clinical Evidence

Clinical research has focused on the potential use of the histamine-immunoglobulin compound, Histoglob, in the context of certain allergic and inflammatory conditions, primarily chronic urticaria.

Phase 3 Trial Data

Research evaluated the potential influence of this compound on symptoms in patients with moderate-to-severe X-syndrome. This investigation involved 450 participants over a one-year period. The primary endpoint was patient-reported symptom severity.

One study evaluated whether the compound was examined for a change in inflammation levels, which was examined alongside outcomes for pain and fatigue. Findings from this specific analysis were mixed regarding the secondary outcomes. While initial research is ongoing, current research does not describe this as a cure.

Observed Outcomes and Duration

In a 12-week trial, participants experienced a reported decrease in flare-ups. The study compared the outcomes to a placebo group. The drop-out rate due to side effects was reported at 4.5%.

Research has examined the compound's potential role alongside existing treatments. Another study examined whether combining this drug with standard therapy was examined for differences in the time-to-change in patient-reported outcomes, specifically mobility. The primary outcome was measured at the three-month mark.

The long-term effects are still being fully explored, and initial data is descriptive of findings related to the chronic condition. Evidence remains limited on effects beyond 12 months.

Key Studies & References

  1. Immunoglobulin/Histamine Complex in Allergic Diseases: A Systematic Review
  2. Histaglobulin: An Elixir for Treatment of Chronic Urticaria
  3. Histoglob Injectable Product Information (Manufacturer's Monograph)

Frequently Asked Questions (FAQ)

Common questions about Histoglob (FAQ)


Q: Is it common to have stomach upset when taking Histoglob?

Official product information lists gastrointestinal issues, such as nausea, among the common side effects that occur in 1/100 to < 1/10 of patients. Some people also report other common gastrointestinal reactions, including vomiting and diarrhea. If you have concerns about stomach upset, a discussion with a healthcare professional may be helpful.


Q: Is it safe to consume alcohol while I am using Histoglob?

Regulatory documents do not state a known interaction between Histoglob and alcohol. General practice involves patients discussing the consumption of alcohol with a healthcare professional while on any therapy.


Q: What were the results of the main clinical trials for Histoglob?

The clinical research, including trials that lasted up to 12 weeks, primarily focused on patient-reported symptom severity. Evidence indicates that participants who received the compound reported a decrease in flare-ups compared to the group that received a placebo.


Q: How long does it usually take to feel a difference after starting Histoglob?

Histoglob is classified as a long-term therapeutic strategy intended to modulate chronic conditions over time, not to provide immediate relief. Clinical evaluations of patient response typically focus on a period of weeks or months, with certain trials assessing outcomes at the 12-week mark.


Q: What foods or supplements should I avoid when using Histoglob?

Official interaction information does not list any specific food or significant supplement interactions for Histoglob. Official guidance suggests individuals inform their healthcare professional about all supplements and over-the-counter products being used.


Q: Is there an age limit for people who can use Histoglob?

Official product information includes separate dosing schedules for both adults and children. While use in children is generally tolerated, it must be prescribed by a physician because general safety and efficacy are not fully established for all pediatric uses. No specific upper age limit is noted in the available regulatory documents.


Q: Is Histoglob considered a controlled substance?

Histoglob is classified as an immunomodulator, not a pain medication or psychoactive drug. Available safety fact sheets describe the medicine as non-addictive, and it does not appear on official lists of controlled substances.


Q: What does the term 'off-label use' mean in relation to Histoglob?

The term off-label use is a regulatory concept defined as using a medicine for an indication, age group, dosage, or route of administration that has not been officially approved by the relevant primary regulatory agencies. This refers to usage outside the specific conditions listed on the official product label.


Q: What is the risk of developing an infection while on Histoglob?

Official labeling advises that treatment with Histoglob should be deferred if a patient has an existing infection, specifically a 'superinfection,' that has not been treated and cleared. Any concerns about new or worsening infections are typically discussed with a healthcare professional.


Q: Can Histoglob make other health problems worse?

Regulatory documents list certain pre-existing conditions as contraindications (meaning the drug must not be used) or requiring special medical supervision (caution). Examples include severe uncontrolled asthma, severe renal (kidney) impairment, and a known IgA (Immunoglobulin A) deficiency.


Q: Is it normal to feel a bit dizzy after the first few doses of Histoglob?

Official safety information includes dizziness among the commonly experienced side effects following administration. This is listed alongside other common reactions in the nervous system disorders classification.


Q: If I am allergic to other medicines, can I still take Histoglob?

Histoglob is strictly contraindicated only in individuals with a known severe, systemic hypersensitivity (allergy) to the drug itself or any of its components. Official documents do not list a general allergy to other medicines as a specific contraindication for Histoglob.


Q: Does Histoglob contain any ingredients from animals?

The product's main biologically-derived component is Human Normal Immunoglobulin (a Gammaglobulin). This component is sourced from pooled human plasma, confirming that the origin is human, not animal.


Q: Why do doctors often mention that Histoglob is a 'supportive' treatment?

Official sources classify Histoglob as a basic treatment and an immunomodulator for chronic allergic states. It is designed to achieve long-term stability by modifying the immune system, rather than providing the immediate, temporary symptom relief typically associated with non-prescription drugs.


Q: Are there specific symptoms that mean Histoglob is 'working'?

Clinical studies have primarily assessed the efficacy of the compound based on patient-reported symptom severity. The evidence found that participants experienced a reported decrease in flare-ups compared to placebo, which is the key measure of effect described in the research.

How should Histoglob be stored and disposed of?

Histoglob must be stored strictly under refrigerated conditions to maintain the stability of its components. The mandatory temperature range is 2 C to 8 C (36 F to 46 F).

Storage Constraint Requirement (Regulatory Basis)
Temperature Store in a refrigerator; Do not freeze
Protection Must be protected from light and heat
Safety Keep out of the sight and reach of children

Because the product is thermolabile, freezing it is strictly prohibited. Unused, expired product and associated injection supplies (sharps) must be disposed of according to local regulations for pharmaceutical waste. The medicine should not be disposed of in household trash or through wastewater systems.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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