GamaSTAN®

05/22/2024
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Product Information

  • Name: GamaSTAN® S/D
  • Type: Immune Globulin (Human), Solvent/Detergent Treated
  • Form: Injectable Solution, 15-18% Protein
  • Manufacturer: Grifols Therapeutics Inc.
  • Distributor: Grifols Canada Ltd.

Indications and Clinical Use

  • Hepatitis A: Prophylaxis is most effective when administered before or shortly after exposure.
  • Measles (Rubeola): Effective in preventing or modifying measles if given within 6 days of exposure. Recommended for susceptible individuals, particularly household contacts and immunocompromised persons.
  • Varicella: Used when Varicella-Zoster Immune Globulin (VZIG) is unavailable.
  • Rubella: Not routinely recommended but may lessen infection likelihood in exposed, susceptible pregnant women.

Contraindications

  • Hypersensitivity to the product or its components.
  • Individuals with isolated IgA deficiency.
  • Patients with severe thrombocytopenia or coagulation disorders.

Warnings and Precautions

  • For intramuscular injection only; not for intravenous or subcutaneous use.
  • Products made from human plasma may contain infectious agents; caution is advised.
  • Association with thromboembolic events; caution in patients with risk factors like obesity, hypertension, diabetes, etc.
  • Epinephrine should be available for managing acute allergic reactions.

Adverse Reactions

  • Common: Pain and tenderness at the injection site.
  • Severe: Anaphylaxis, angioedema, and urticaria are rare but possible.

Drug Interactions

  • Interference with live viral vaccines (e.g., measles, mumps, rubella); vaccination should be deferred for about 5 months post-administration.

Dosage and Administration

  • Hepatitis A: 0.1 mL/kg for contacts; higher doses for longer travel durations.
  • Measles: 0.25 mL/kg within 6 days of exposure.
  • Varicella: 0.6-1.2 mL/kg if VZIG is unavailable.
  • Rubella: 0.55 mL/kg for exposed, susceptible pregnant women.
  • Administer intramuscularly, preferably in the upper thigh or deltoid muscle; avoid gluteal region to prevent sciatic nerve injury.

Storage and Stability

  • Store at 2-8°C, do not freeze. Single-use vials must be discarded after opening.

Special Populations

  • Pregnant Women: Use only if clearly needed.
  • Nursing Women: Decision to use should consider potential risks to the infant.
  • Pediatrics: Safety and effectiveness not established.

Consumer Information

  • Provides antibodies to prevent or reduce the severity of infections like hepatitis A, measles, chickenpox, and rubella.
  • Discuss risks and benefits with a healthcare provider before use.
  • Potential side effects include injection site pain, allergic reactions, and, rarely, anaphylaxis.
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Written By Paul Kim

Medical Director - APN, NSWOC, RNP

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