cytomegalovirus immune globulin (CMV IG) (Rx)

Brand and Other Names:CytoGam, cmv ig
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

and cytomegalovirus immune globulin (CMV IG)

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (7)

                • BCG vaccine live

                  cytomegalovirus immune globulin (CMV IG) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

                • 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.

                • 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)

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                  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

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                  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

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                  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.

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                  Pharmacology

                  Mechanism of Action

                  IgG antibodies to CMV pooled from human donors; provides passive immunity against cytomegalovirus

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                  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

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  CytoGam intravenous
                  -
                  50 mg/mL vial

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  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 as directed by your doctor.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.The first dose is usually given within 3 days of the transplant, followed by more doses every 2 to 4 weeks or as directed by your doctor. The dosage and frequency depends on your medical condition, weight, and response to treatment.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, persist, or worsen. 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 if you experience any of these unlikely but serious side effects: 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.Rarely, this product may contain substances that could cause infections because it is made from human blood. Discuss the risks and benefits with your doctor. Tell your doctor right away if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.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.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 not known whether 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: Laboratory and/or medical tests (e.g., kidney function test, urine volume) should be performed periodically to monitor your progress or check for side effects. 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 between 36-46 degrees F (2-8 degrees C). 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 August 2021. Copyright(c) 2021 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.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.