Vaccinia Immune Globulin Intravenous

Vaccinia Immune Globulin Intravenous is an immune globulin indicated for the treatment and/or modification of the following conditions:

• eczema vaccinatum
• progressive or severe generalized vaccinia
• vaccinia infections in individuals who have skin conditions, such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
• aberrant infections induced by the vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard

Vaccinia Immune Globulin Intravenous is available under the following different brand names: VIGIV

Common side effects of Vaccinia Immune Globulin Intravenous include:

• headache
• nausea
• dizziness
• feeling hot or cold
• shivering
• eye problems
• vomiting
• weakness
• fever
• back pain
• muscle cramps
• numbness and tingling
• tremor
• increased sweating
• pale skin (pallor)

Serious side effects of Vaccinia Immune Globulin Intravenous include:

• headache
• rigors
• nausea
• dizziness
• feeling cold
• sweating increased and feeling hot

Rare side effects of Vaccinia Immune Globulin Intravenous include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 5% (50 mg/mL) gamma globulin solution containing vaccinia virus antibodies of more than 50,000 Units/vial
• 20 mL single-dose vial

Vaccinia immunization complications

Adult dosage

• Dose
  • 6000 Units/kg IV as soon as symptoms appear and are judged to be due to severe vaccinia-related complication
  • Consider repeat dosing, depending on symptom severity and response to treatment; however, clinical data on repeat doses are lacking
  • Consider higher doses of 9000 Units/kg if the patient unresponsive to a lower dose
  • Up to 24,000 Units/kg administered to healthy volunteers were well tolerated in clinical trials

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Vaccinia Immune Globulin Intravenous has severe interactions with no other drugs
• Vaccinia Immune Globulin Intravenous has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Vaccinia Immune Globulin Intravenous has moderate interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • efgartigimod alfa
  • efgartigimod/hyaluronidase SC
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella, and varicella vaccine, live
  • rozanolixizumab
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • varicella virus vaccine live
• Vaccinia Immune Globulin Intravenous has minor interactions with the following drug:
  • protein a column

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to immunoglobulins
• Presence of isolated vaccinia keratitis
• IGA deficiency

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vaccinia Immune Globulin Intravenous?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vaccinia Immune Globulin Intravenous?”

Cautions

• Severe, immediate hypersensitivity reactions to plasma-derived products may occur; administer in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available; discontinue immediately if hypotension, allergic, or anaphylactic reaction occurs
• Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and death may occur with the use of IGIV products; caution with renal insufficiency (including, but not limited to those with diabetes mellitus, age more than 65 years, volume depletion, paraproteinemia, sepsis, coadministration of nephrotoxic drugs); contains 5% sucrose
• Some types of blood glucose testing systems (eg, tests based on glucose dehydrogenase pyrroloquinoline quinone [GDH-PQQ] or glucose-dye-oxidoreductase methods) could falsely interpret the maltose contained in VIGIV as glucose; and therefore, result in falsely elevated glucose readings and unnecessary administration of insulin
• Thrombotic events may occur; caution in patients at risk including history of cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheters, and/or known or suspected hyperviscosity
• May contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immune globulin, causing a positive direct antiglobulin reaction and hemolysis
• Aseptic meningitis syndrome (AMS) may occur; it usually begins within several hours to 2 days following IGIV treatment; discontinuation of treatment has resulted in remission of AMS within several days without sequelae
• Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur; TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever reported within 1 to 6 hours after transfusion
• Derived from human plasma, a small risk of viral transmission (eg, Creutzfeldt-Jakob disease) through administration
• Drug interaction overview
  • Defer immunization with live virus vaccine approximately 3 months after administration of VIGIV
  • Revaccinate people (after 3 months) who received VIGIV shortly after a live virus vaccine
  • Immune globulin may impair the efficacy of live attenuated vaccines (e.g., measles, rubella, mumps, and varicella)

Pregnancy and Lactation

• There are no data on drug use in pregnant women to inform on drug-associated risk
• Animal reproduction studies have not been conducted
• Lactation
  • Data are not available to assess the presence or absence of VIGIV in human milk, its effects on breastfed children, or milk production/excretion