Cuvitru

Cuvitru

human normal immunoglobulin

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
Replacement therapy in adults, childn & adolescents (0-18 yr) in primary immunodeficiency syndromes w/ impaired Ab production; hypogammaglobulinaemia & recurrent bacterial infections in patients w/ chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed or are contraindicated; hypogammaglobulinaemia & recurrent bacterial infections in multiple myeloma patients; hypogammaglobulinaemia in patients pre- & post-allogeneic haematopoietic stem cell transplantation.
Dosage/Direction for Use
SC Individualised dose based on clinical response. Dose regimen should achieve IgG trough level of at least 5-6 g/L & aim to be w/in reference interval of serum IgG for age. Infusion rate: Initially 10 mL/hr/site, may be increased at 10-min intervals to max 20 mL/hr/site for the 1st 2 infusions if well tolerated. Each single dose may need to be injected at different anatomic sites. Infusion site may be changed every 5-15 mL in infants & childn. Doses >30 mL may be divided according to patient preference in adults. Loading dose: 0.2-0.5 g/kg (1-2.5 mL/kg), may be divided over several days to max 0.1-0.15 g/kg daily. Maintenance dose: Administer at repeated intervals after attaining steady state IgG levels to reach cumulative mthly dose of 0.3-1 g/kg.
Contraindications
Current or history of hypersensitivity to human Ig treatment. Severe IgA deficiency. Must not be given intravascularly or intramuscularly.
Special Precautions
Immediate discontinuation in case of severe hypersensitivity or anaphylactic-type reactions. Shock could develop if accidentally administered into a blood vessel. Risk of adverse reactions is more frequent when receiving human normal Ig for the 1st time or, in rare cases, when switching between human normal Ig products or when there has been long interval since previous infusion. Avoid potential complications by initially injecting the product slowly, then ensuring careful monitoring for any symptoms throughout infusion period. Patients w/ anti-IgA Ab should be treated only under close medical supervision. Patients at risk for thrombosis should receive Cuvitru at the slowest infusion rate practicable & be monitored for thrombotic complications. Reports of severe renal adverse reactions including acute renal failure, acute tubular necrosis, proximal tubular nephropathy, & osmotic nephrosis. Reports of aseptic meningitis syndrome, occurring more frequently in female patients. Monitor patients for hemolysis, particularly those at increased risk. Interference w/ serological testing (eg, misleading or false +ve results). Possible transmission of infectious agents. May impair ability to drive or operate machinery. Balance potential risk & only prescribe to pregnant & breastfeeding women if clearly needed.
Adverse Reactions
Headache; diarrhoea, nausea; fatigue, infusion site erythema, inj site pain. Dizziness, migraine, somnolence; hypotension; abdominal pain; pruritus, urticaria; myalgia; pain, inj site pruritus, infusion site swelling, urticaria, &/or bruising.
Drug Interactions
Impaired efficacy of live attenuated virus vaccines (eg, MMR & varicella) for a period of at least 6 wk & up to 3 mth; for measles, impairment may persist up to 1 yr.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Cuvitru soln for SC inj 4 g/20 mL
Packing/Price
20 mL x 1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in