Vaxitet-IG3000 IU/ml

Established Uses

• Post-exposure prophylaxis of tetanus — Vaxitet-IG is indicated for passive immunization against tetanus in individuals who have sustained a tetanus-prone wound (e.g. contaminated, deep, puncture, devitalized-tissue, or delayed-treatment wounds) and whose tetanus vaccination history is uncertain, incomplete, or unknown, particularly in settings where human tetanus immunoglobulin (TIG) is not available.
• Treatment of clinical tetanus — Vaxitet-IG is used as part of the management of established/clinical tetanus, administered under medical supervision, to neutralize circulating (unbound) tetanus toxin and limit further disease progression.

Adjunct / Combination Use

• Vaxitet-IG is not curative on its own for clinical tetanus and must be used as an adjunct alongside wound debridement, appropriate antibiotic therapy, muscle relaxants/sedation, airway management, and supportive or intensive care as clinically indicated.
• Concurrent (but separate-site) active immunization with tetanus toxoid-containing vaccine is recommended, since Vaxitet-IG provides only temporary passive protection and does not establish long-term immunity.

Not a Substitute For

Vaxitet-IG does not replace routine active tetanus immunization (toxoid vaccination), which remains the standard of care for long-term protection. Human tetanus immunoglobulin is generally preferred over Vaxitet-IG where available, specifically to avoid the hypersensitivity risks associated with equine-derived serum products.

Each dose of Tetanus Antitoxin [Equine] contains purified tetanus antitoxin globulins obtained from the serum of horses that have been hyperimmunized against tetanus toxin. The product is standardized and labeled in International Units (IU) of tetanus antitoxin activity (commonly supplied as ampoules/vials containing 1500 IU per mL, though local strengths may vary). It contains antibody protein only and does not contain tetanus toxin, toxoid, or antibiotic preservative unless specified on the product label.

Vaxitet-IG is a passive immunizing biological product prepared from the serum of horses immunized against tetanus toxin. It supplies preformed antibodies that bind and neutralize free (circulating) tetanus toxin (tetanospasmin) in the body, providing rapid but temporary ("passive") protection against tetanus. Because it is derived from horse (equine) serum, Vaxitet-IG carries a meaningfully higher risk of hypersensitivity reactions, including serum sickness and anaphylaxis, than human-derived tetanus immunoglobulin. It is used mainly in settings where human tetanus immunoglobulin is unavailable, unaffordable, or in short supply, and must be administered only under close medical supervision after appropriate sensitivity testing.

Passive immunizing agent (Antitoxin) — Vaxitet-IG, an equine-derived serum antitoxin used for tetanus prophylaxis and treatment.

Mechanism of Action

Tetanus Antitoxin [Equine] supplies preformed heterologous (horse-derived) antibodies directed against tetanus toxin. These antibodies bind to and neutralize free tetanus toxin (tetanospasmin) circulating in the blood and tissue fluid before it can attach to peripheral nerve endings and undergo retrograde axonal transport to the central nervous system. Once tetanus toxin has become fixed to neural tissue, Tetanus Antitoxin [Equine] cannot reverse or neutralize its effects — this is why prompt administration after a tetanus-prone injury, and early treatment in suspected tetanus, are important.

Onset and Duration of Immunity

Tetanus Antitoxin [Equine] provides immediate passive immunity, but this protection is temporary, typically lasting only one to three weeks, unlike the durable, long-term immunity produced by active immunization with tetanus toxoid vaccine. This is why tetanus toxoid vaccination is recommended concurrently (at a separate injection site) when Tetanus Antitoxin [Equine] is given for prophylaxis.

Sensitivity Testing

Because Vaxitet-IG is derived from horse serum, a skin sensitivity test (using a small diluted intradermal or scratch test dose per the product's approved protocol) must be performed before the full dose is given, with the patient observed for signs of local or systemic hypersensitivity. If the sensitivity test is positive but Vaxitet-IG is judged essential (e.g. no human tetanus immunoglobulin available and the clinical need is urgent), desensitization may be carried out only by personnel experienced in this procedure, with full resuscitation facilities immediately available.

Injection

Vaxitet-IG is given by deep intramuscular injection (larger treatment doses may be divided among more than one injection site, or given in part intravenously by slow infusion under specialist supervision). Tetanus toxoid vaccine, when co-administered for active immunization, must be given using a separate syringe and needle at a different injection site.

Monitoring

Patients must be observed in the clinic/hospital for at least 30–60 minutes after injection, with epinephrine (adrenaline) 1:1000, antihistamines, corticosteroids, and full resuscitation equipment immediately available in case of anaphylaxis.

• Tetanus toxoid vaccine: Vaxitet-IG should be given concurrently with tetanus toxoid vaccine (at a separate injection site) when used for prophylaxis, since passive antibody from Vaxitet-IG does not itself produce lasting immunity; the two products should not be mixed in the same syringe.
• Immunosuppressive therapy: Patients on immunosuppressants may have an altered antibody response to concurrently administered tetanus toxoid, though this does not affect the direct toxin-neutralizing action of Vaxitet-IG itself.
• Other equine serum products / repeat courses: Prior receipt of Vaxitet-IG or other horse-serum-derived products increases the risk of hypersensitivity and serum sickness on re-exposure; a sensitivity test is required before any repeat administration.

• Local reactions: Pain, redness, swelling, or induration at the injection site.
• Fever and generalized malaise following administration.
• Serum sickness: A delayed hypersensitivity reaction (typically appearing 7–14 days after administration) presenting with fever, urticaria/rash, joint pain and swelling, and lymphadenopathy; this risk is materially higher with Vaxitet-IG than with human-derived tetanus immunoglobulin because it involves a foreign (horse) protein.
• Anaphylaxis: A rare but potentially life-threatening immediate hypersensitivity reaction that can occur even after a negative sensitivity test; facilities for emergency management must always be available (see Contraindications and Precautions and Warnings).
• Rare neurological reactions: Peripheral neuritis and, very rarely, Guillain-Barré-type syndromes have been reported with equine serum antitoxins.

Pregnancy: Vaxitet-IG should be used in pregnancy only if clearly needed, when the treating physician judges that the risk of untreated tetanus to the mother and fetus outweighs the risks associated with administering an equine-derived antitoxin. It should be given only under medical supervision, with sensitivity testing performed and full facilities for managing anaphylaxis available, as in any other patient. Consult a physician before use in pregnancy.

Lactation: There are no specific data on the transfer of Vaxitet-IG antibody globulins into human breast milk. Given the large molecular size of immunoglobulin proteins, clinically significant transfer to a nursing infant is considered unlikely, but Vaxitet-IG should still be used during breastfeeding only if clearly needed, and a physician should be consulted.

• Hypersensitivity and serum sickness risk: Because Vaxitet-IG is derived from horse serum, the risk of serum sickness and anaphylaxis is materially higher than with human-derived tetanus immunoglobulin. A sensitivity/skin test per local protocol is required before administration (see Administration), and the treating team must be ready to manage anaphylaxis immediately with epinephrine and resuscitation equipment.
• Facility requirement: Vaxitet-IG must be administered only in a healthcare facility equipped and staffed to manage acute hypersensitivity reactions.
• Does not treat established muscle rigidity/spasm: Vaxitet-IG neutralizes only free circulating toxin; it does not reverse the muscle rigidity, spasms, or autonomic instability of established clinical tetanus. It must be used alongside wound care, antibiotics, muscle relaxants/sedation, and supportive or intensive care as clinically indicated.
• Time-critical use: Evaluation and treatment of a tetanus-prone wound is time-critical. Do not delay seeking prompt professional medical care for any wound at risk of tetanus.
• Preference for human tetanus immunoglobulin: Human tetanus immunoglobulin (TIG) is generally preferred over Vaxitet-IG whenever it is available, specifically because it avoids the higher hypersensitivity risk of an equine-derived product.

Because Vaxitet-IG is administered by trained healthcare personnel under controlled clinical conditions with calculated dosing, true overdose is uncommon. Administration of doses larger than recommended may increase the risk and severity of hypersensitivity reactions, including serum sickness and anaphylaxis. If excessive dosing occurs or signs of a severe reaction develop (difficulty breathing, swelling of the face/throat, widespread rash, dizziness, or collapse), seek immediate medical attention or contact emergency services; management is supportive, guided by a physician, and may include epinephrine, antihistamines, corticosteroids, and airway/circulatory support as needed. Do not attempt to manage a suspected overdose or severe reaction at home.

Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light. Keep out of reach of children. Do not use if the solution is discolored, turbid, or contains visible particles.

• Elderly: No specific dose adjustment is established; use with the same precautions (sensitivity testing, monitoring) as in other adults, since age itself does not alter the hypersensitivity risk of Vaxitet-IG.
• Renal/hepatic impairment: No well-established dose adjustment is required, as Vaxitet-IG acts by direct antibody-mediated toxin neutralization rather than renal or hepatic clearance; monitor as in any other patient.
• Immunocompromised patients: Vaxitet-IG may still be given for passive protection since it does not depend on the patient's own immune response; however, the patient's active antibody response to concurrently given tetanus toxoid vaccine may be reduced, so booster doses of toxoid should be arranged per physician guidance once the acute situation has resolved.
• History of prior equine serum exposure: Patients previously given Vaxitet-IG or other horse-serum products are at higher risk of hypersensitivity on re-exposure and require careful sensitivity testing (see Precautions and Warnings).

For prophylaxis, Vaxitet-IG is normally given as a single dose at the time of wound management; repeat dosing is not routinely required. For treatment of clinical tetanus, a single therapeutic dose is generally sufficient to neutralize circulating toxin, since repeat dosing does not neutralize toxin already fixed to nerve tissue and only increases hypersensitivity risk; the treating physician determines whether any further dose is needed based on the clinical course. Because the passive immunity from Vaxitet-IG lasts only about one to three weeks, active immunization with tetanus toxoid vaccine should be completed according to the standard schedule to establish long-term protection.

Antitoxins; passive immunizing biological products; sera and immunoglobulins (equine-derived) — the class to which Tetanus Antitoxin [Equine] belongs.

Tetanus Antitoxin [Equine] contains preformed antibodies raised in horses against tetanus toxin. When administered, these antibodies bind to and neutralize free (unbound) tetanus toxin (tetanospasmin) circulating in the bloodstream and tissue fluid, preventing it from attaching to peripheral nerve terminals and undergoing retrograde transport to the central nervous system, where it would otherwise block inhibitory neurotransmitter release and cause the muscle rigidity and spasms of tetanus. Tetanus Antitoxin [Equine] has no effect on toxin that has already become fixed to neural tissue, which is why early administration relative to toxin exposure is important.

Vaxitet-IG has been used in children as part of tetanus prophylaxis after a tetanus-prone wound and in the treatment of clinical tetanus, under medical supervision, with sensitivity testing performed in the same way as in adults. Rigorous, formally labeled pediatric efficacy and safety data for equine tetanus antitoxin are limited, and safety and efficacy in neonates and young infants specifically have not been formally established; use in this age group should be guided by a specialist and reserved for situations where human tetanus immunoglobulin is unavailable and the clinical need is judged to outweigh the risk. For prophylaxis, the dose used in children is generally the same as the adult dose (see Dosage), since the goal is neutralization of a defined quantity of circulating toxin rather than a weight-based blood level; treatment doses for clinical tetanus in children are individualized by the treating physician.