Immune Globulin and Hyaluronidase (Subcutaneous)

Overview

When patients are healthy, their immune system helps to fight infection and illness. As well as helping to prevent patients becoming unwell, their immune system fights any viruses or infections that are established in the body and ensures the patient recovers well. If patients have primary immunodeficiency, however, their immune system does not function properly and this can leave them prone to serious health complications.

Primary immunodeficiency can be caused by one of over three hundred conditions and is generally caused by a genetic or hereditary defect. In all cases, the patient's immune system is compromised, but the exact problem with the immune system depends on the specific cause of the patient's primary immunodeficiency.

Some patients with primary immunodeficiency may have a small part of their immune system missing, while others can have numerous components of their immune system absent. Alternatively, rather than missing crucial parts of the immune system, patients with primary immunodeficiency may have a complete immune system, but it may not function correctly.

As a result, patients with primary immunodeficiency are prone to infections in every part of their body. Often, these infections are difficult to treat, as the patient's immune system is unable to rid their body of infection in the normal way. When infections are able to spread, the patient may be placed in a life-threatening situation.

By administering Immune Globulin and Hyaluronidase, doctors can help to increase the effectiveness of the body's immune system. Containing antibodies from human blood, Immune Globulin increases the body's defenses and can help to reduce the frequency of infections in patients with primary immunodeficiency. In addition to this, Immune Globulin helps patients to fight infections when they are contracted and can, therefore, reduce the severity of illnesses. As Hyaluronidase helps the patient's body to absorb Immune Globulin, it is generally administered in conjunction with this medication.

Whilst Immune Globulin and Hyaluronidase does not reverse or cure primary immunodeficiency, it does increase the efficacy of the patient's immune system. Regardless of which genetic condition is causing the patient's primary immunodeficiency, Immune Globulin and Hyaluronidase can be used to strengthen their immune system and prevent them from contracting frequent or severe infections.

Conditions Treated

Type Of Medicine

  • Immunizing agent

Side Effects

When patients are treated with medication, they may experience some adverse effects. Before treatment is administered, patients may be warned about the possible side effects associated with the medication and given advice regarding symptom management.

If patients are treated with Immune Globulin and Hyaluronidase, they may notice the following side effects:

  • Red streaks on the skin
  • Nausea
  • Headache
  • Vomiting
  • Unusual weakness or tiredness
  • Tenderness, pain or swelling at the site of the injection
  • Swelling, redness, pain, discomfort or itching and the infusion site

Often, the above side effects are most prominent after Immune Globulin and Hyaluronidase has been administered, but they tend to decrease over time. If they are fairly mild and are not bothersome to the patient, they may not require medical attention. However, if the patient's side effects are severe or do not decrease over time, they should obtain medical help.

In addition to this, patients should obtain immediate medical attention if they experience the following side effect after being treated with Immune Globulin and Hyaluronidase:

Patients should also obtain medical assistance if they experience any other side effects during or following treatment with Immune Globulin and Hyaluronidase.

Dosage

When patients are first treated with Immune Globulin and Hyaluronidase, they may be given a course of treatment over a seven week period. During this time, patients will be given increasing amounts of Immune Globulin and Hyaluronidase in week one, two, four and seven. Typically, the patient's dose will increase from 7.5g to 30g over this time.

Following the initial course of treatment, patients are usually given Immune Globulin and Hyaluronidase on a regular basis, with treatments occurring up to every four weeks. The patient's physician will determine what dose is appropriate for them, based on their clinical presentation and previous response to the medication.

As Immune Globulin and Hyaluronidase is administered subcutaneously, patients may be required to attend a clinic or hospital for their initial dose of treatment. Subsequently, patients may be able to self-inject the medication at home, if they choose to do so.

Prior to administering Immune Globulin and Hyaluronidase themselves, patients should place the necessary equipment and medication on a hard, flat surface, in a well-lit area. Before using the equipment, patients should wash their hands thoroughly.

When patients are ready to administer the medication, they should choose a suitable infusion site. This is usually in the stomach area, thighs or abdomen. However, patients should not administer Immune Globulin and Hyaluronidase into the same area each time and should not choose an area which is inflamed, swollen or has broken skin.

Patients will need to check the vials of medication before they are administered. Immune Globulin solution should present as a slightly yellow and clear solution, whilst Hyaluronidase should be colorless and clear. The vials should not contain any particles or be cloudy or discolored. If necessary, patients should select an alternative vial to use.

Patients should then follow their physician's instructions in order to prepare the medication for infusion. Following this, patients should use an alcohol wipe to clean the intended infusion site. Following this, patients should pinch the skin in the relevant area with two fingers and insert the needle and tube under the skin. Sterile tape and gauze can then be placed over the site of the injection to prevent the needle from coming out.

Before Immune Globulin and Hyaluronidase is infused, patients should ensure that there is no blood flowing into the infusion tube. If there is, patients should remove the needle and tube and throw them away. New equipment should then be used.

Patients can then use the infusion pump to administer Immune Globulin and Hyaluronidase via the needle and tube. When the full amount of medicine has been infused, patients can turn the pump off and remove the gauze, tape, needle and tube.

Patients should discard the needle and tube in an appropriate medical disposal waste box and ensure it is placed in a safe location. In order to keep a log of their treatment, patients should remove the peel off label from the vial of medicine and place it in their treatment diary. Patients should also write down the date the medication was administered, the time of the treatment and how much medicine was used.

Following this, patients should clean the infusion pump and store it in a safe location, ready for their next treatment.

If patients will be administering Immune Globulin and Hyaluronidase at home, they will be given thorough instructions and demonstrations prior to doing so. If patients are unsure how to administer the medicine, they should seek advice from their physician or pharmacist.

In order to be effective, Immune Globulin and Hyaluronidase must be administered in accordance with the treatment schedule set out by the patient's doctor. If the patient forgets to administer a dose of Immune Globulin and Hyaluronidase, they should contact their physician or pharmacist straight away.

Potential Drug Interactions:

If patients are using more than one medication at a time, it may be possible for an interaction to occur. As this could be harmful to the patient, they may be advised not to use certain medications whilst they are being treated with Immune Globulin and Hyaluronidase. Patients should not have any immunizations without their doctor's express approval during treatment with Immune Globulin and Hyaluronidase or for one year following the cessation of treatment.

In addition to this, patients are not usually given the following medications if they are receiving treatment with Immune Globulin and Hyaluronidase:

  • Benzocaine
  • Prilocaine
  • Bupivacaine
  • Proparacaine
  • Bupivacaine Liposome
  • Ropivacaine
  • Butacaine
  • Mepivacaine
  • Chloroprocaine
  • Lidocaine
  • Cocaine
  • Propoxycaine
  • Dibucaine
  • Procaine
  • Etidocaine
  • Tetracaine

Although the above medications are not usually recommended for use alongside Immune Globulin and Hyaluronidase, doctors may feel it's appropriate for some patients. If so, the patient may be advised to take their medicine at a specific time or be given a modified dose so that an interaction is less likely to occur.

As interactions can also occur between over the counter medicines, supplements and vitamins, patients should tell their doctor if they are using any of these substances before they are treated with Immune Globulin and Hyaluronidase. Similarly, patients should obtain medical advice before using any new medicines, vitamins or supplements once they have started treatment with Immune Globulin and Hyaluronidase.

Warnings

If patients with primary immunodeficiency have any other medical conditions, it may affect their treatment with Immune Globulin and Hyaluronidase. Patients should notify their doctor of any existing health problems prior to beginning treatment. The following conditions can be particularly relevant if treatment with Immune Globulin and Hyaluronidase is being used:

  • Heart attack
  • Blood vessel or heart disease
  • Diabetes
  • Atherosclerosis
  • Thick blood (Hyperviscosity)
  • Blood clotting problems
  • Paraproteins in the blood (Paraproteinemia)
  • Bleeding problems
  • Sepsis
  • IgA (Immunoglobulin A) deficiency with antibodies against IgA
  • IgA (Immunoglobulin A) deficiency with antibodies against IgA and historical hypersensitivity
  • Kidney problems
  • Major loss of body fluids or low blood volume (Hypovolemia)

To date, the use of Immune Globulin and Hyaluronidase in pediatric patients has not been studied. It is not known whether this medicine will react differently or pose significant risks if administered to pediatric patients.

Although Immune Globulin and Hyaluronidase can be used to treat geriatric patients, these patients may have age-related kidney, heart, liver or blood clotting problems that may require modification of the treatment.

Using Immune Globulin and Hyaluronidase may cause the patient to suffer from blood clots. This may be more likely if the patient has previously had blood clotting problems, hardening of the arteries (atherosclerosis) or heart disease. Blood clots can also be more likely if the patient is taking medicines containing estrogen, obese or if they are required to spend a lot of time immobile because of illness or surgery. If patients experience the following symptoms, they must seek immediate medical help:

  • Shortness of breath
  • Chest pain
  • Problems with walking, vision or speech
  • Leg pain
  • Severe headache

Patients may experience a serious condition known as aseptic meningitis syndrome (AMS) and should obtain immediate medical help if they experience the following symptoms:

  • Painful eye movements
  • Eye sensitivity to light
  • Nausea or vomiting
  • Stiff neck
  • Fever
  • Drowsiness
  • Severe headache

In some patients, Immune Globulin and Hyaluronidase may cause hemolysis (bleeding). If patients experience the following symptoms, they will need immediate medical treatment:

  • Dark urine
  • Back or stomach pain
  • Difficulty breathing
  • Decreased urination
  • Yellowing of the skin or eyes
  • Tiredness
  • Increased heart rate

When patients are using Immune Globulin and Hyaluronidase, they may develop a serious kidney problem. Patients should obtain immediate medical help if they experience the following symptoms:

  • Decreased urine output
  • Any problem with urination
  • Dark brown or red urine
  • Pain in lower back or side
  • Swollen arms, face or legs
  • Sudden weight gain

Patients could also develop a serious lung problem while they are being treated with Immune Globulin and Hyaluronidase. They should obtain urgent medical assistance if they experience any of the following symptoms:

  • Noisy, fast or difficult breathing, sometimes with wheezing
  • Chest pain
  • Blue fingernails or lips
  • Pale skin
  • Fever
  • Coughing that sometimes produces a frothy, pink sputum
  • Increased sweating
  • Swelling of the ankles or legs
  • Shortness of breath

Immune Globulin and Hyaluronidase is produced from human blood which has been donated. Although donors are tested for viruses prior to donating blood and blood is tested following donation, there is a risk that a virus could be contracted from donated blood. Patients should discuss this with their physician if they have any concerns.

If the patient is due to be treated by any doctor or dentist, they should inform them that they have primary immunodeficiency and that they are being treated with Immune Globulin and Hyaluronidase.

Immune Globulin and Hyaluronidase may affect the results of some medical tests. Patients should notify the relevant healthcare practitioner that they are being treated with this medicine prior to any tests being carried out.

It is not known whether Immune Globulin and Hyaluronidase will cause a risk to an unborn fetus if it is administered to a pregnant patient. Due to this, Immune Globulin and Hyaluronidase should only be used to treat a pregnant patient if the benefits clearly outweigh the risks.

Some medications can be passed on to an infant via breastfeeding. It is not known if Immune Globulin and Hyaluronidase can be transferred in this way or if it would present a risk to the infant. Due to this, patients may be advised not to breastfeed while they are being treated with Immune Globulin and Hyaluronidase and should obtain medical advice before doing so.

When patients are being treated with Immune Globulin and Hyaluronidase, they may develop a serious allergic reaction, including anaphylaxis. If patients have a known allergy to any substances, they should inform their physician before starting treatment. Patients with an IgA deficiency, antibodies against IgA and a history of hypersensitivity to human immunoglobulin or Hyaluronidase should not be given this medicine.

If patients exhibit an allergic reaction, they will require emergency medical treatment. An allergic reaction may include the following symptoms:

  • Difficulty swallowing
  • Difficulty breathing
  • Lightheadedness or dizziness
  • Chest pain
  • Hives, itching or a rash on the skin
  • Swelling of the hands, face or mouth

Storage

When storing Immune Globulin and Hyaluronidase at home, patients should adhere to the manufacturer's instructions. Generally, Immune Globulin and Hyaluronidase can be stored in a refrigerator or at room temperature, but should be kept in its original container. If the medication has been stored at room temperature for any length of time, it should not then be returned to a refrigerator.

Patients should check the use by dates on the vials before using them. If the medicine is out of date or if the patient is advised to stop using Immune Globulin and Hyaluronidase, they will need to dispose of the medicine.

When storing Immune Globulin and Hyaluronidase and medical equipment at home, patients should place these items in a secure location and ensure that children and pets cannot gain access to them.

Patients should not throw medication or medical equipment, such as used needles and infusion tubes, out with regular household waste, as it may pose a risk to other people. Instead, patients should contact their physician's office or pharmacist and use a specialist medicine disposal service.

Summary

As patients with primary immunodeficiency are likely to contract frequent infections, it's necessary to increase the efficacy of their immune system. Without appropriate treatment, patients may experience serious and severe infections, which could put them in a life-threatening condition.

By administering Immune Globulin and Hyaluronidase on a regular basis, physicians can boost the patient's immune system and reduce the frequency and severity of subsequent infections.