CytoGam

cytomegalovirus immune globulin

(site-oh-meg-a-loe-vye-rus) ,

CMVIG

(trade name),

CytoGam

(trade name)

Classification

Therapeutic: vaccines immunizing agents
Pharmacologic: immune globulins
Pregnancy Category: C

Indications

Prevention of cytomegalovirus (CMV) disease associated with transplantation of kidney, lung, liver, pancreas, or heart (if transplant is other than kidney from CMV-positive donors to CMV-negative recipient, then concurrent ganciclovir should be considered).

Action

Consists of IgG antibodies capable of providing passive immunity against CMV disease.

Therapeutic effects

Prevention of serious sequelae of CMV disease in transplant patients.

Pharmacokinetics

Absorption: Administered IV only, resulting in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 7 days.

Time/action profile (CMV antibody titers)

ROUTEONSETPEAKDURATION
IVrapidunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to immune globulins or albumin; Selective IgA deficiency.
Use Cautiously in: Obstetric / Lactation: Pregnancy or lactation (safety not established); Renal insufficiency or predisposition to acute renal failure.

Adverse Reactions/Side Effects

Central nervous system

  • headache
  • tremor
  • anxiety
  • seizures

Hematologic

  • pancytopenia
  • hemolysis
  • leukopenia

Respiratory

  • wheezing
  • dyspnea
  • pulmonary edema

Cardiovascular

  • hypotension
  • thromboembolism

Gastrointestinal

  • nausea
  • vomiting
  • hepatic dysfunction

Dermatologic

  • flushing
  • rash

Genitourinary

  • oliguria
  • anuria
  • acute renal failure

Musculoskeletal

  • back pain
  • muscle cramps

Miscellaneous

  • allergic reactions including chills
  • fever
  • anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

May interfere with immune response to some live-virus vaccines including measles, mumps, and rubella (MMR ; do not administer within 3 mo of immune globulin).

Route/Dosage

Kidney Transplant
Intravenous (Adults) 150 mg/kg within 72 hr of transplantation, followed by 100 mg/kg at 2, 4, 6, and 8 wk, then 50 mg/kg at 12 and 16 wk post-transplantation.
Liver, Pancreas, Lung, or Heart Transplant
Intravenous (Adults) 150 mg/kg within 72 hr of transplantation, and at 2, 4, 6, and 8 wk, then 100 mg/kg after at 12 and 16 wk post-transplantation.
Intravenous (Children) Safety and efficacy has not been established in pediatrics, however adult doses have been used in children.

Availability

Powder for injection: 1000-mg vial, 2500-mg vial

Nursing implications

Nursing assessment

  • Monitor vital signs prior to, during, and following infusion and before any increases in infusion rate.
  • Monitor patient for adverse reactions throughout therapy. If patient develops minor side effects (nausea, vomiting, muscle cramps, back pain, fever, flushing, chills), slow infusion rate or stop infusion temporarily. If hypotension or anaphylaxis occurs, stop infusion and administer treatment (epinephrine and diphenhydramine).

Potential Nursing Diagnoses

Risk for infection (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Intravenous Administration
  • Intermittent Infusion: Reconstitute with 50 mL of sterile water for injection with a double-ended needle or large syringe. To avoid foaming, do not shake vial. If using a double-ended needle, insert into water first, as powder is supplied in an evacuated vial and water will transfer by suction. After sterile water is transferred, release residual vacuum to speed dissolution. Rotate gently to wet undissolved powder. Allow 30 min for powder to dissolve. Solution should be clear, colorless, and free of particulate matter. Infusion should be started within 6 hr and completed within 12 hr of reconstitution.
    • Administer via infusion pump through a separate IV line. If not possible, solution may be piggybacked in an IV line containing 0.9% NaCl, D5W, D10W, D20W, or combinations of dextrose and saline, but do not dilute to more than 1:2. Do not use filters.
  • Rate: Administer initial dose at 15 mg/kg/hr for first 30 min. If no adverse reactions occur, rate may be increased to 30 mg/kg/hr; if no adverse reactions occur in subsequent 30 min, rate may be increased to 60 mg/kg/hr. Do not exceed 75 mL/hr volume or 60 mg/kg/hr rate. Monitor patient closely during rate changes. May cause pain at injection site.
    • During subsequent doses, rate may be increased in same increments every 15 min if no adverse reactions occur, until 60 mg/kg/hr maximum is reached.

Patient/Family Teaching

  • Instruct patient to notify health care professional if any adverse reactions occur.
  • If live virus vaccines were administered within 14 days of immune globulin, vaccination should be repeated 3 mo after the last dose of immune globulin.

Evaluation/Desired Outcomes

  • Prevention of serious sequelae of CMV disease, including blindness, associated with transplantation of kidney, lung, liver, pancreas, or heart.

CytoGam®

Cytomegalovirus immune globulin, intravenous, CMV-IGIV Virology An Ig concentrate used as prophylaxis against CMV disease associated with kidney, lung, liver, pancreas, and heart transplants
References in periodicals archive ?
CytoGam is made from human plasma and, like other plasma products, carries the possibility for transmission of blood-borne viral agents.
launch of MedImmune's first commercial product, CytoGam, and was on the launch teams for its other products including the international launch of Synagis.
UMass Medical School has had recent success bringing other ideas to market, most notably cytogam, a drug licensed to CSL Behring that blocks cytomegalovirus disease associated with organ transplantation; Clarinex, that ubiquitous allergy medicine; and through the medical device company Reflectance Medical Inc.
MedImmune actively markets three products, Synagis (palivizumab), Ethyol (amifostine) and CytoGam (cytomegalovirus immune globulin intravenous (human)), and has 11 products in clinical testing.
Gaithersburg, MD, announced the FDA has approved marketing of an expanded indication for CytoGam (Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV).
In the first six months of 2004, worldwide sales of Synagis were $478 million; sales of Ethyol were $49 million; CytoGam sales were $18 million; and FluMist revenues (including product sales, royalties and reimbursements) totalled $33 million.
Kishbauch's leadership as President and COO, MedImmune re-launched its first product, CytoGam, for the organ transplant market.
In the first six months of 2005, sales of Ethyol were $45 million and sales of CytoGam were $22 million.
from 1995 to 2001, where he was responsible for the launch of both RespiGam and Synagis for the prevention of respiratory disease in premature infants, as well as new indications for CytoGam in the transplantation field.
The estimated 2006 financial impact of the CytoGam transaction is an increase in diluted earnings per share of $0.
In the 2004 third quarter, sales of CytoGam were $11 million, while last season's shipments of FluMist did not begin until the fourth quarter.
The acquisition includes CytoGam and related assets, including patents and trademarks, manufacturing contracts and government authorizations associated with the product.