Equine Gamma Globulin

Registered South African indications: 

• Renal transplantation
• Aplastic anaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Elderly
• Haematologic disorders

Forms avail. in SA and covered in this monograph: sol

Renal transplantation
- In combination with concomitant immunosuppressive therapy for the management of allograft rejection in renal patients

- Delaying the onset of allograft rejection

• IV: 15mg/kg/day, as an infusion, for 14 days; THEN every alternate day for 14 days

Administer the first dose within 24hrs of transplant

- Transplant rejection

• IV: 10-15mg/kg/day, as an infusion for 14 days; Additional alternate day therapy can be given up to 21 doses

The first dose can be delayed until the diagnosis of the first rejection episode

Aplastic anaemia
- Moderate to severe aplastic anaemia in patients who are unsuitable for bone marrow transplantation

• IV: 10-20mg/kg/day, as an infusion for 8-14 days; Additional alternate day therapy can be given up to 21 doses

It is strongly recommended to perform a skin prick test prior to administration of the first dose

See additional prescribing points

Not established for use in children

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Caution; not recommended

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Chills
• Headache
• Agitation
• Brain disease
• Burning sensation
• Dizziness
• Encephalitis
• Generalized ache
• Lethargy
• Seizures

Cardiovascular Disorders

• Bradycardia
• Cardiac disease
• Cardiac failure
• Chest pain
• Oedema
• Hypertension
• Hypotension
• Myocarditis
• Phlebitis
• Thrombophlebitis
• Clotted atrioventricular fistula

Respiratory Disorders

• Dyspnoea
• Pleural effusion
• Respiratory distress

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Stomatitis

Hepatobiliary Disorders

• Abnormal hepatic function tests
• Hepatosplenomegally

Genitourinary Disorders

• Proteinuria
• Abnormal renal function test

Musculoskeletal Disorders

• Arthralgia
• Back pain
• Joint stiffness
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Pruritis
• Skin rash
• Diaphoresis
• Night sweats
• Urticaria
• Wheal and flare
• Injection site reaction

Immune, Blood and Lymphatic System Disorders

• Leukopenia
• Thrombocytopenia
• Fever
• Lymphadenopathy
• Anaphylaxis
• Serum sickness
• Viral infection

Sensory Disorders

• Periorbital oedema

• Bacille Calmette-Guerin vaccine
• Echinacea
• Fingolimod
• Leflunomide
• Natalizumab
• Nivolumab
• Pimecrolimus
• Roflumilast
• Tacrolimus 
• Tofacitinib
• Vaccines 

• Full blood count with differential
• Vital signs

Specific cases may require

• Absolute CD3 count

Skin test

• First employ epicutaneous (prick) testing with undiluted equine gamma globulin
• If the patient does not show a wheal 10 minutes after pricking, proceed to intradermal injection of 0.02ml of a 1:1000 v/v dilution of equine gamma globulinin saline and a separate saline control injection of similar volume. Use only freshly diluted equine gamma globulin for skin testing
• Read the result at 10 minutes: A wheal of 3mm or greater than that of the saline control site, with erythema or both with or without pseudopod formation and itching or a marked local swelling, should be considered a positive test, and an increased possibility of a systemic allergic reaction should the drug be dosed intravenously
• A systemic reaction such as a generalized rash, tachycardia, dyspnea, hypotension, oranaphylaxis precludes any additional administration of equine gamma globulin

Administration

• The administered concentration should not exceed 4mg/ml
• The diluted equine gamma globulin should be allowed to reach room temperature before infusion. Equine gamma globulin is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein through an in-line filter with a pore size of 0.2-1.0micron
• The in-line filter should be used with all infusions of equine gamma globulin  to prevent the administration of any insoluble material that may develop in the product during storage
• The use of high-flow veins will minimize the occurrence of phlebitis and thrombosis
• Do not infuse a dose of equine gamma globulin in less than 4 hours
• Always keep appropriate resuscitation equipment at the patient's bedside while administering

Equine gamma globulin is a lymphocyte-selective immunosuppressant as is demonstrated by its ability to reduce the number of circulating, thymus-dependent lymphocytes that form rosettes with sheep erythrocytes. This anti-lymphocytic effect is believed to reflect an alteration of the function of the T-lymphocytes, which are responsible in part for cell-mediated immunity and are involved in humoral immunity. In addition to its anti-lymphocytic activity, Equine gamma globulin contains low concentrations of antibodies against other formed elements of the blood. In rhesus and cynomolgus monkeys, Equine gamma globulin reduces lymphocytes in the thymus-dependent areas of the spleen and lymph nodes. It also decreases the circulating sheep-erythrocyte-rosetting lymphocytes that can be detected.

Injection (per ml) 50mg

• Atgam (Pfizer) originator