Product image of Hexacima (Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta) supplied by GNH India

Hexacima

Active Ingredient:
Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta
Origin:
EU

Hexacima (Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta)

Hexacima is a vaccine that combines Haemophilus influenzae type b polysaccharide (PRP), diphtheria toxoid, and tetanus toxoid. It is supplied as a liquid for intramuscular injection. Marketed in the European Union, Hexacima is classified under ATC code J07AG and is intended to stimulate active immunity against Hib, diphtheria, and tetanus. The formulation follows EU regulatory standards and is administered by a healthcare professional as part of routine immunization schedules.

Manufacturer / TM Owner

Sanofi Winthrop Industrie

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Indications & Clinical Uses

Hexacima is indicated for active immunization against three bacterial diseases and is incorporated into standard vaccination programs for children and adolescents. The vaccine can be administered as a primary series or as a booster dose, depending on the patient’s age and previous immunization history.

  • Prevention of invasive Haemophilus influenzae type b disease.
  • Protection against diphtheria caused by Corynebacterium diphtheriae.
  • Protection against tetanus caused by Clostridium tetani toxin.
  • Inclusion in routine infant and toddler immunization schedules.
  • Use as a booster dose in older children, adolescents, or adults who have completed the primary series.

How It Works

  • Hexacima induces active immunity by presenting three antigenic components to the immune system. The Hib polysaccharide (polyribosylribitol phosphate) is conjugated to a carrier protein, enabling T‑cell dependent antibody production against the bacterial capsule. Diphtheria and tetanus toxoids are chemically inactivated toxins that stimulate the formation of neutralizing antibodies. Together, these antigens trigger B‑cell activation and memory cell development, providing long‑lasting protection.

Side Effects

Hexacima, like other injectable vaccines, may be associated with local and systemic reactions. Most reactions are mild and resolve without intervention.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (≤38.5 °C) within 24 hours.
  • Mild fatigue or irritability, especially in children.
  • Headache or mild muscle aches.
  • Mild redness or warmth around the injection site lasting 1–2 days.

Serious

  • Severe allergic reaction (anaphylaxis) with hives, airway swelling, or hypotension.
  • High fever (>40 °C) persisting more than 48 hours.
  • Neurological signs such as seizures or prolonged crying.
  • Signs of Guillain‑Barré syndrome (weakness, tingling).
  • Severe local reaction with extensive swelling or necrosis.
  • Unexplained bleeding or bruising at the injection site.

Precautions & Warnings

Healthcare providers should evaluate patient history before administering Hexacima to minimize risk and ensure appropriate use.

  • Defer vaccination in individuals with a known severe allergy to any vaccine component.
  • Postpone if the patient has an acute moderate or severe illness with fever.
  • Observe for at least 15 minutes after injection for immediate hypersensitivity reactions.
  • Use caution in persons with a history of Guillain‑Barré syndrome.
  • Pregnant or breastfeeding women should discuss risks and benefits with a clinician.
  • Do not administer intravascularly; ensure proper intramuscular technique.
  • Report any unexpected adverse events to pharmacovigilance authorities.

Avoid Interactions

Vaccines may interact with other medical products or conditions that affect immune response. Consider the following when planning administration of Hexacima.

Avoid

  • Concurrent administration with live viral vaccines (e.g., measles, mumps, rubella) unless recommended by guidelines.
  • Use in individuals receiving immunosuppressive therapy that markedly reduces antibody production.

Use with caution

  • Simultaneous receipt of other inactivated vaccines; monitor for increased local reactions.
  • Patients on high‑dose corticosteroids may have reduced immunogenicity.
  • Individuals with a history of severe allergic reactions to previous vaccines.
  • Administration during acute febrile illness may obscure vaccine‑related fever.
  • Patients receiving blood products or immunoglobulins within 3 months should be evaluated for possible interference with vaccine response.

Frequently Asked Questions

Hexacima provides immunization against Haemophilus influenzae type b infection, diphtheria, and tetanus.

The recommended schedule typically includes a primary series of two or three doses, followed by a booster dose, but the exact number depends on age and prior vaccination history.

Yes, Hexacima can be administered concomitantly with other inactivated vaccines, though injection sites should be separate and patients monitored for increased local reactions.

Common reactions include pain, redness or swelling at the injection site, low‑grade fever, mild fatigue, irritability, headache, and mild muscle aches.

The pregnancy safety category is listed as unknown; pregnant or breastfeeding women should discuss potential risks and benefits with their healthcare provider.

If anaphylaxis is suspected, immediate medical attention is required, including administration of epinephrine and emergency care.

The Hib polysaccharide is conjugated to a protein carrier, enabling a T‑cell dependent immune response that produces protective antibodies against the bacterial capsule.

Previous receipt of individual Hib, diphtheria, or tetanus vaccines does not contraindicate Hexacima, but timing should follow local immunization guidelines to avoid unnecessary duplication.

Hexacima should be stored in a refrigerator between 2 °C and 8 °C, protected from light, and not frozen.

Individuals with a known severe allergy to any component of the vaccine, or those with a history of severe allergic reactions to previous vaccines, should avoid Hexacima.

Hexacima is an inactivated vaccine and can be administered to immunocompromised individuals, but immune response may be reduced; clinicians should assess each case individually.

Hexacima is administered by intramuscular injection, typically into the deltoid muscle for adults or the anterolateral thigh for infants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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