Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 50±10mg/mL (50mL)
Cytomegalovirus Prophylaxis
Monitor vital signs preinfusion, during infusion & postinfusion, renal function
Kidney Transplant
- 150 mg/kg IV infusion within 72 hours of transplant, THEN 100 mg/kg 2, 4, 6, 8 weeks posttransplant, THEN 50 mg/kg 12 & 16 weeks posttransplant
Liver, Pancreas, Heart, Lung Transplant
- 150 mg/kg IV infusion within 72 hours of transplant & 2, 4, 6, 8 weeks posttransplant, THEN 100 mg/kg 12 & 16 weeks posttransplant
CMV Pneumonia (Orphan)
For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients
Orphan indication sponsor
- Bayer Corporation, Pharmaceutical Division, Biological Products; 400 Morgan Lane; New Haven, CT 06516
Renal Impairment
Use caution; may use minimum infusion rate ≤ 180 mg/kg/hr
Dosage Forms & Strengths
injectable solution
- 50±10mg/mL (50mL)
Congenital CMV (Orphan)
Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women
Orphan indication sponsor
- Biotest Pharmaceuticals Corporation; 5800 Park of Commerce Blvd, NW; Boca Raton, FL 33487
Use caution; elderly >65 years may experience renal insufficiency
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
cytomegalovirus immune globulin (CMV IG), axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
cytomegalovirus immune globulin (CMV IG), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
cytomegalovirus immune globulin (CMV IG), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
cytomegalovirus immune globulin (CMV IG), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
cytomegalovirus immune globulin (CMV IG), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
cytomegalovirus immune globulin (CMV IG), tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (10)
- BCG vaccine live
cytomegalovirus immune globulin (CMV IG) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of cytomegalovirus immune globulin (CMV IG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of cytomegalovirus immune globulin (CMV IG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- measles (rubeola) vaccine
cytomegalovirus immune globulin (CMV IG) decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles mumps and rubella vaccine, live
cytomegalovirus immune globulin (CMV IG) decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- measles, mumps, rubella and varicella vaccine, live
cytomegalovirus immune globulin (CMV IG) decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of cytomegalovirus immune globulin (CMV IG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- rubella vaccine
cytomegalovirus immune globulin (CMV IG) decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- smallpox (vaccinia) vaccine, live
cytomegalovirus immune globulin (CMV IG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- varicella virus vaccine live
cytomegalovirus immune globulin (CMV IG) decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
Minor (0)
Adverse Effects
1-10%
Diaphoresis
Flushing, Facial
Fever
Shivering
Nausea, Vomiting
Arthralgia
Backache
Muscle cramps
Wheezing
<1%
Anaphylaxis (rare)
Aseptic meningitis (Rare)
Acute renal failure, acute tubular necrosis, angioneurotic edema reported
Warnings
Contraindications
History of severe reaction to immune globulins
Cautions
Made from human donors, so theoretical risk of pathogen transmission
Contains sucrose as stabilizer, associated with higher risk of IV immune globulin-related renal dysfunction
Possibility of other adverse reactions associated with IV immune globulins, eg, aseptic meningitis syndrome, transfusion-related acute lung injury
Renal impairment
Pregnancy & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
IgG antibodies to CMV pooled from human donors; provides passive immunity against cytomegalovirus
Administration
IV Administration
Does not contain preservatives so begin infusion within 6 hr of entering into vial & complete within 12 hr
Do not dilute
Do not shake vial: avoid foaming
Do not use if discoloration/particulate matter/turbidity
Administer thru IV line with in-line filter (15 micron) & infusion pump. Separate IV line preferred but may be given IVPB into preexisting line with NS or D20W, D10W, D5W & D2.5W with or without NaCl. If preexisiting line must be used, do not dilute CytoGam more than 1:2
Administer initial dose at 15 mg/kg/hr, after 30 min incr to 30 mg/kg/hr x 30 min, then to 60 mg/kg/hr provided no adverse reactions occur at either step. NMT 75 mL/hr Subsequent doses start 15 mg/kg/hr x15 min, then 30 mg/kg/hr x15 min, then 60 mg/kg/hr provided no adverse rxns; NMT 75 mL/hr
Adverse reactions may require slowing/interrupting infusion
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| CytoGam intravenous - | 50 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cytomegalovirus immune globulin intravenous
CMV IMMUNE GLOBULIN - INTRAVENOUS
(CMV ih-MYOON GLOB-you-lin)
COMMON BRAND NAME(S): Cytogam
WARNING: This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.The risk of blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce this risk.Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
USES: This medication is used to prevent a certain serious viral infection (cytomegalovirus-CMV) in persons having an organ transplant (kidney, heart, liver, lung, pancreas). During the transplant process, the body's defense system (immune system) is weakened to prevent the body from attacking (rejecting) the new organ. A weakened immune system increases the risk of a serious, possibly fatal infection with CMV. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies) that help fight CMV. This medication is often used with the antiviral medication ganciclovir.
HOW TO USE: This medication is given by slow infusion into a vein. It is given as directed by your doctor, usually every 2 to 4 weeks, with the first dose given within 3 days of the transplant. The dosage and frequency depends on your medical condition, weight, and response to treatment.Your health care professional will start the medication slowly while monitoring you closely. If you have few or no side effects, the medication will be given faster. Tell your health care professional right away if you experience any side effects such as flushing, chills, muscle cramps, back/joint pain, fever, nausea, vomiting, or shortness of breath. The infusion may need to be stopped or given more slowly.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.
SIDE EFFECTS: See also Warning section.Flushing, chills, muscle cramps, back/joint pain, fever, nausea/vomiting may occur. Tell your doctor or health care professional right away if any of these effects occur, last, or get worse. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fast/irregular heartbeat, unusual tiredness, signs of kidney problems (such as change in the amount of urine, pink/bloody/frothy urine), sudden weight gain.Treatment with this medication may rarely cause an inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.Lung problems may occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: drugs that may harm the kidney (for example, aminoglycosides such as gentamicin), "water pills" (diuretics such as furosemide).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as kidney function, urine volume) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. Use opened vials within 6 hours. Discard any unused portion. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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