Globucel Injection

Primary Humoral Immunodeficiency (PI): The dose of Human Normal Immunoglobulin for patients with PI is 300-600 mg per kg body weight (3-6 mL/kg) administered every 3-4 weeks. The dosage may be adjusted over time in order to achieve the desired trough levels and clinical responses.

The proposed initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). In case of well-tolerated infusion, the rate may be gradually enhanced to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For those judged to be at risk for thrombosis or renal dysfunction, administer this medicine at the minimum infusion rate practicable.

If a patient routinely receives a dose of less than 400 mg per kg every 3-4 weeks (less than 4 mL/kg), and is at risk of measles exposure (i.e., traveling to a measles endemic area), administer a dose of at least 400 mg per kg (4 mL per kg) just before expected measles exposure. In case a patient is exposed to measles, a dose of 400 mg per kg (4 mL per kg) needs to be given as soon as quickly after exposure.

Idiopathic Thrombocytopenic Purpura (ITP): Human Normal Immunoglobulin for IV may be given at a total dose of 2 g/kg, splitted in 2 doses of 1 g/kg (10 mL per kg) given on 2 consecutive days or into 5 doses of 0.4 gram per kg (4 mL/kg) given on 5 consecutive days. If after administration of the first of two daily 1 g/kg (10 mL per kg) doses, an appropriate increase in the platelet count is noted at 24 hours, the 2’nd dose of 1 gram per kg (10 mL/kg) body weight may be withheld.

High dose regimen (1 g/kg × 1 to 2 days) is not required for those with expanded fluid volumes or where the fluid volume may be a concern.

The proposed initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). In case of well-tolerated infusion, the rate may be enhanced to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For those judged to be at increased risk for renal dysfunction or thrombosis, administer this medicine at the minimum infusion rate practicable.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Human Normal Immunoglobulin may be initially given as a total loading dose of 2 gram per kg (20 mL/kg) given in splitted doses over 2 to 4 consecutive days. The medicine may be given as a maintenance infusion of 1 gram per kg (10 mL/kg) given over 1 day or splitted into a couple of doses of 0.5 gram per kg (5 mL/kg) given on 2 consecutive days, every three weeks.

The proposed initial infusion rate is 2 mg/kg/min (0.02 mL/kg/min). In case of well tolerated infusion, the rate may be enhanced to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For those judged to be at increased risk for thrombosis or renal dysfunction, administer this medicine at the minimum infusion rate practicable.

The most commonly reported side effects with Globucel include:

• Primary Humoral immunodeficiency PI: Headache, nausea, cough, injection site reaction, pharyngitis, and urticaria.
• Immune Thrombocytopenic Purpura (ITP): Headache, fever, vomiting, nausea, back pain, and rash.
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Headache, chills, hypertension, fever, rash, nausea and asthenia.