Vivaglobin

DRUG DESCRIPTION

Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured from large pools of human plasma by cold alcohol fractionation and is not chemically altered or enzymatically degraded.

Vivaglobin® (immune globulin subcutaneous human) is supplied as a sterile liquid to be administered by the subcutaneous route. Vivaglobin® (immune globulin subcutaneous human) is a 16% (160 mg/mL) protein solution, with a content of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is similar to that present in normal human plasma. Vivaglobin® (immune globulin subcutaneous human) contains 2.25% glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin® (immune globulin subcutaneous human) is 6.4 to 7.2. Vivaglobin® (immune globulin subcutaneous human) contains no preservative.

All plasma used in the manufacture of Vivaglobin® (immune globulin subcutaneous human) is tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT procedure is used and the plasma found to be negative. However, the significance of a negative result has not been established. In addition, the plasma has been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma that passed virus-screening is used for production and the limit for B19 in the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.

The manufacturing procedure for Vivaglobin® (immune globulin subcutaneous human) includes multiple processing steps that reduce the risk of virus transmission. The virus reduction capacity of two steps was evaluated in a series of in vitro spiking experiments; the steps were ethanol - fatty alcohol / pH precipitation and pasteurization in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions ranged from 9.0 to ? 14.1 log10 as shown in Table 1.

Table 1: Mean Virus Reduction Factors CSL Behring

Virus Studied: Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]
Enveloped Viruses
HIV-1 ? 6.2 ? 6.5 ? 12.7
BVDV ? 5.3 ? 8.7 ? 14.0
WNV ? 4.4 ? 9.3 ? 13.7
PRV ? 6.2 ? 7.9 ? 14.1
Non-enveloped Viruses
PEV ? 6.7 3.7 ? 10.4
CPV 6.7 2.3* 9.0
HIV-1: Human immunodeficiency virus type 1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g., herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization was ? 3.5 log10.

What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, shaking, nausea, vomiting;
  • fast heartbeat; or
  • nervousness.

Less serious side effects may include:

  • redness, itching, and swelling of skin where the shots are given;
  • headache;
  • mild itching or skin...

Read All Potential Side Effects and See Pictures of Vivaglobin »

What are the precautions when taking immune globulin subcutaneous (human) (Vivaglobin)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of immune system deficiency (selective IgA deficiency with known antibody against IgA).

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and...

Read All Potential Precautions of Vivaglobin »


Vivaglobin Consumer (continued)

SIDE EFFECTS: Mild swelling, redness, or itching at the injection site may occur and usually lessen as your body adjusts to the medication. Headache, upset stomach, fever, nausea, diarrhea, sore throat, cough, or pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are severely dehydrated, 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, if you have any of these conditions report them to your doctor or pharmacist. 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 groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes, confusion.

Though very unlikely to occur, this product may contain substances such as viruses that could cause infections because it is made from human blood (plasma). Careful screening of blood donors, special manufacturing methods, and tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of an infection such as: persistent fever, persistent sore throat, unusual tiredness, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 Side Effects section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of immune system deficiency (selective IgA deficiency with known antibody against IgA).

Before using this medication, tell your doctor or pharmacist your medical history.

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.


Vivaglobin Patient Information Including Side Effects

Brand Names: Vivaglobin

Generic Name: immune globulin (subcutaneous) (Pronunciation: im MYOON GLOB yoo lin)

  • What is immune globulin (Vivaglobin)?
  • What are the possible side effects of immune globulin (Vivaglobin)?
  • What is the most important information I should know about immune globulin (Vivaglobin)?
  • What should I discuss with my health care provider before using immune globulin (Vivaglobin)?
  • How is immune globulin given (Vivaglobin)?
  • What happens if I miss a dose (Vivaglobin)?
  • What happens if I overdose (Vivaglobin)?
  • What should I avoid while using immune globulin (Vivaglobin)?
  • What other drugs will affect immune globulin (Vivaglobin)?
  • Where can I get more information?

What is immune globulin (Vivaglobin)?

Immune globulin subcutaneous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency.

Immune globulin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, shaking, nausea, vomiting;
  • fast heartbeat; or
  • nervousness.

Less serious side effects may include:

  • redness, itching, and swelling of skin where the shots are given;
  • headache;
  • mild itching or skin rash;
  • upset stomach;
  • sore throat; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about immune globulin (Vivaglobin)?

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can interact with immune globulin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although immune globulin is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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