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.

• Use of Globucel injection is restricted in all those who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
• Use of this medicine is restricted in IgA deficient patients with antibodies against IgA and any known and previous history of hypersensitivity.
• Severe hypersensitivity reactions may emerge with IGIV products, including Globucel. In case of hypersensitivity, interrupt infusion immediately and institute appropriate treatment.
• Acute renal failure, acute tubular necrosis, osmotic nephrosis, proximal tubular nephropathy and death may occur upon use of IGIV products, mainly those containing sucrose. Periodic monitoring of renal function and urine output is required.
• Hyperproteinemia, hyponatremia and increased serum viscosity may occur in patients receiving IGIV treatment, including Globucel 10gm/100mL injection.
• AMS may emerge infrequently with IGIV therapy, including Globucel. Discontinuation of IGIV therapy has resulted in remission of AMS within a few days without sequelae.
• IGIV products, including Globucel, may contain blood group antibodies which may act as hemolysins and induce in vivo coating of RBCs with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Assess patients for clinical signs/symptoms of hemolysis.

Globucel may be stored for 36 months at 2 to 8°C (36 to 46°F) from the date of manufacture, AND medicinal product may be stored at temperatures not beyond 25°C (77°F) for up to six months anytime during the 36 month shelf life, after which the medicinal product must be promptly used or discarded. Avoid using this medicinal product after the expiration date.

Avoid simultaneous use of Globucel and Heparin through a single lumen delivery device due to Globucel, Heparin incompatibilities. Flush Hep-Lock through which Globucel was given with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection, and do not flush with Heparin.