Respiratory Syncytial Virus Immune Globulin, Human (Intravenous)

As an immunization agent, Respiratory Syncytial Virus Immune Globulin provides your body with the antibodies required to protect itself from RSV infection.

Overview

Respiratory Syncytial Virus Immune Globulin intravenous (RSV-IGIV) helps your body fight off infection from the respiratory syncytial virus (RSV) by providing the antibodies it needs.

RSV is a serious respiratory tract infection which affects the lungs and can lead to bronchitis and pneumonia. In very severe cases it can cause death. RSV is more likely to occur in vulnerable people such as infants and young children less than six months old. Those born with underlying heart or lung problems as well as premature babies are those most at risk of developing RSV.

RSV is a seasonal virus which starts appearing in November and lasts through April and May. January to February are the peak months for infection. The risk of infection is greatly reduced if the patient is immunized with Respiratory Syncytial Virus Immune Globulin before the start of the RSV season in November.

Conditions Treated

  • Used to prevent infection by the respiratory syncytial virus (RSV).

Type of Medicine

  • Immunization agent

Side effects

In rare circumstances, children taking RSV-IGIV may experience adverse side effects. You should tell the administering physician immediately if you start to experience any of the following symptoms:

  • Difficulty breathing
  • Fever of 39.2 °C (102.6 °F) or higher
  • Hives (skin rashes)
  • Increased heart rate
  • Itching (especially of the hands and feet)
  • Reddening of the skin (especially around ears)
  • Swelling of eyes, face and nose
  • Sudden and severe tiredness or weakness
  • Vomiting

There is a possibility that patients may experience side effects which are not listed here. Patients should notify their administering physician as soon as they start to feel unwell. Any adverse reactions should also be reported to the Food & Drug Administration (FDA) at 1-800-FDA-1088.

Treatment for adverse effects:

If the patient suffers a hypersensitivity reaction - administer antihistamines and corticosteroids if necessary.

If the patient suffers a severe hypersensitivity or anaphylactic reaction - administer epinephrine, antihistamines or corticosteroids as required.

Dosage

RSV-IGIV should only be administered by a health professional to Children under the age of 24 months. The dosage amount will vary according to the patient's weight and medical history. General dosage guidelines stipulate that 750 mg/kg (about 15 mL/kg volume) should be administered once a month for five months throughout RSV season. Initiation of RSV-IGIV should start before the RSV season has started and finish at the end.

Note: The RSV season in Canada usually starts in October and can last until the following March-May.

During administration the rate of infusion should be increased gradually, starting with 1.5 mL/kg/hr for 15 minutes followed by 3.6 mL/kg/hr for the remainder of the infusion. The maximum rate of infusion should not exceed 3.6 mL/kg/hr. It may be necessary to slow the infusion rate on children who are particularly ill, such as those with bronchopulmonary dysplasia (BPD).

There have been instances of renal dysfunction in some patients during intravenous administration of RSV-IGIV. Sufficient data does not exist to establish the exact cause, incidence may be related to the rate of infusion, the presence of sucrose as a stabilizer, product concentration, or a pre-existing condition. Therefore no dosage adjustments are available for patients with renal dysfunction.

Note: Medical tests (heart/respiratory rate, kidney function) should be carried out periodically to monitor the patient's progress and check for possible side effects. Parents should consult the administering physician for more information.

Interactions

Respiratory Syncytial Virus Immune Globulin (RSV-IGIV) is known to have 152 major drug interactions. These interactions may increase the patient's risk of serious side effects or reduce the effectiveness of existing medication. Major interactions with Respiratory Syncytial Virus Immune Globulin may also cause kidney damage.

Parents should, therefore, keep a list of medications, both prescribed and over the counter, which the child has taken and share it with the administering physician. DO NOT stop, start or change the dosage of any medication without first consulting a doctor.

The following is a partial list of drugs which are known to have major interactions with RSV-IGIV:

  • Amphotericin b
  • Aspirin low strength
  • Bacitracin
  • Bromfenac
  • Celcoxiib
  • Children's Motrin (Ibuprofen)
  • Etodolac
  • Gentamicin
  • Ibuprofen
  • Naproxen
  • Rapamune
  • Sodium salicylate
  • Trexall (methotrexate)

You can find a full list of affected drugs here.

Warnings

Aside from the aforementioned drug interactions, administering physicians need to carry out a thorough investigation into the patient's medical history. RSV-IGIV contains active ingredients which can cause complications to children with underlying medical conditions. Caution is advised if the patient has a history of, or is suffering from any of the following medical conditions:

  • Blood infection (sepsis)
  • Diabetes
  • Congenital heart disease
  • Kidney disease
  • IgA deficiency
  • Too much/little body weight
  • Paraproteinemia

Other medical problems:

Administering health care professionals should only use RSV-IGIV in special circumstances if one of the following medical problems exist:

An allergic reaction to human immunoglobulins

Immunoglobulin A (IgA) deficiency - (RSV-IGIV may cause severe allergic reaction)

Additionally, if your child is suffering from any other medical problem which is not listed above, make sure you tell your doctor before infusion.

Patients most at risk

RSV-IGIV is not approved for patients who have congenital heart disease (CHD). During trials, a number of children with CHD developed severe or life-threatening adverse reactions to the drug. Although this may have been down to the drug being administered post heart surgery. Further trials have not been carried out.

Children with an underlying pulmonary disease such as bronchopulmonary dysplasia (BPD) may be sensitive to developing fluid overload and at risk of developing hypotension, anaphylaxis or a severe allergic reaction. Administering physicians should, therefore, proceed with extreme caution when administering RSV-IGIV to patients with an underlying pulmonary disease. The patient's vital signs should be monitored and the patient observed carefully throughout the infusion.

Vaccinations

Parents should also notify the administering physician about any recent or planned immunizations/vaccinations. Respiratory Syncytial Virus Immune Globulin may prevent certain live viral vaccines (such as measles, mumps and rubella) from having a response.

If your child has recently received any such vaccine your doctor may test for a response or opt to have the child revaccinated later. If a vaccination is due, advise your doctor who will decide the best time to receive them in order to get an adequate response.

Geriatrics

RSV-IGIV is only approved for use on children and infants younger than 24 months. No testing has been carried out for older patients.

Storage

This product should be stored at room temperature between 2 and 8ºC (36 and 46 ºF) unless the manufacturer specifies otherwise. Always read the manufacturer's storage instructions. All medicines should be kept in a locked medical cabinet where they are protected from direct sunlight and secured from children and pets. Always ensure unspent medicine is returned there after use.

When expired Respiratory Syncytial Virus Immune Globulin should be disposed of properly. DO NOT pour this medicine down the drain or flush it down the toilet. If in doubt consult the manufacturer direct or your waste disposal company for the appropriate method or disposal.

Note: DO NOT freeze.

Summary

Syncytial Virus Immune Globulin intravenous (RSV-IGIV) is used to immunize at-risk patients from the RSV virus which is a major cause of mortality in both the developed and developing world. In the United States alone RSV is responsible for up to 90,000 hospitalizations and nearly 4,500 deaths each year.

RSV affects patients of any age but it can prove fatal in infants (< 24 months), where it causes bronchiolitis and pneumonia. Because of the age of such patients, RSV can be difficult to detect, with early warning signs include; lethargy, irritability and poor feeding, which can sometimes be accompanied by apneic episodes often attributed to other causes. Because of this immunization against the virus is recommended in high-risk patients.

RSV-IGIV is administered intravenously by a trained healthcare professional. Usual dosage consists of five injections. One each month for the duration of the the RSV season, which runs from early November to March in the United States (Regional variations may apply). The full set of five injections should be carried out to ensure the patient is properly protected.

While the risk of side effects is rare, care should be taken by the administering healthcare professional to ensure that the child does not have any underlying health problems such as congenital heart disease, kidney problems or sepsis. Other medical problems to look out for include a history of allergic reactions to human immunoglobulins or selective IgA deficiencies.

RSV is a common infection, but with the right treatment is preventable. So long as proper consideration is given to the risks involved, RSV-IGIV provides safe protection from the RSV virus. Healthcare providers should therefore consider immunization for all at-risk patients during the RSV season to reduce the risk of acquired community infection and breakouts.

 

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Last Reviewed:
January 31, 2018
Last Updated:
April 26, 2018
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