Octagam 5%/Octagam 10%

Octagam 5%/Octagam 10%

human normal immunoglobulin

Manufacturer:

Octapharma

Distributor:

Medlink Marketing
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
Adult, childn & adolescents (0-18 yr): Replacement therapy in primary immunodeficiency syndromes w/ impaired antibody production; hypogammaglobulinaemia & recurrent bacterial infections in patients w/ chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed & in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunization; hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT); congenital AIDS w/ recurrent bacterial infections. Immunomodulation in primary immune thrombocytopenia (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barré syndrome; Kawasaki disease.
Dosage/Direction for Use
IV Individualized dosage. Initial rate: Octagam 5%: Infuse 1 mL/kg/hr for 30 min. May gradually increase to max of 5 mL/kg/hr. Octagam 10%: Infuse 0.01 mL/kg/min for 30 min. May gradually increase to max of 0.12 mL/kg/min. Replacement therapy in primary immunodeficiency syndrome Starting dose: 0.4-0.8 g/kg every 3-4 wk to obtain IgG trough levels of at least 5-6 g/L. Thereafter: 0.2-0.8 g/kg. To be taken every 3-4 wk to obtain IgG trough level of at least 5-6 g/L. Replacement therapy in secondary immunodeficiency 0.2-0.4 g/kg every 3-4 wk to obtain IgG trough level of at least 5-6 g/L. Congenital AIDS 0.2-0.4 g/kg every 3-4 wk. Hypogammaglobulinaemia (<4 g/L) in patients after allogeneic HSCT 0.2-0.4 g/kg every 3-4 wk to obtain IgG trough level >5g/L. Immunomodulation: Primary ITP 0.8-1 g/kg on day 1, possibly repeated once w/in 3 days or 0.4 g/kg/day for 2-5 days. Guillain-Barré syndrome 0.4 g/kg/day for 5 days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days in association w/ acetylsalicylic acid or 2 g/kg in 1 dose in association w/ acetylsalicylic acid.
Contraindications
Hypersensitivity to human normal Ig, human Ig & patients w/ antibodies against IgA.
Special Precautions
Hypersensitivity. Not indicated in patients w/ selective IgA deficiency. Obese patients & patients w/ preexisting risk factors for thrombotic events. Acute renal failure, aseptic meningitis syndrome, haemolytic anaemia. Patients on a controlled Na diet. High rate infusion & patients receiving the therapy for the 1st time. Concomitant use of loop diuretics. Adequate hydration prior to the initiation of therapy. Monitor the urine output & serum creatinine levels; clinical symptoms of haemolysis. May cause +ve direct antiglobulin reaction (Coombs' test); misleading +ve results in serological testing; falsely elevated glucose readings. Perform standard measures to prevent infections. May impair ability to drive & operate machinery. Renal impairment. Pregnancy & lactation.
Adverse Reactions
Hypersensitivity; headache; nausea; fever, fatigue, inj site reaction.
Drug Interactions
May impair efficacy (for at least 6 wk up to 3 mth) of live attenuated virus vaccines (3 mth interval should elapse before vaccination).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA - Immunoglobulins, normal human ; Used in passive immunizations.
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Octagam 10% soln for infusion 100 mg/mL
Packing/Price
(in 100 mL) 10 g x 1's (P56,000/bottle); (in 20 mL) 2 g x 1's (P11,200/bottle); (in 200 mL) 20 g x 1's (P112,000/box); (in 50 mL) 5 g x 1's (P28,000/bottle)
/philippines/image/info/octagam 10percent soln for infusion 100 mg-ml/2 g-20 ml?id=c0602813-2a86-4b26-86ac-ab970083120e
/philippines/image/info/octagam 10percent soln for infusion 100 mg-ml/5 g-50 ml?id=9ed0f834-819a-4080-833c-ab970083120e
/philippines/image/info/octagam 10percent soln for infusion 100 mg-ml/10 g-100 ml?id=a0cd96e7-9239-4250-8146-abc70089a9ed
/philippines/image/info/octagam 10percent soln for infusion 100 mg-ml/20 g-200 ml?id=9d58345a-aaa2-4dd0-b9d9-ab970083120e
Form
Octagam 5% soln for infusion 50 mg/mL
Packing/Price
50 mL x 1's (P14,000/box)
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