1. Should IgG only be administered in a controlled setting? Is the patient's home safe for the administration of IgG therapy?
IgG America has administered thousands of IgG treatments to patients in the comfort and convenience of their homes. All patients are carefully screened to determine if home administration is safe and appropriate for their individual needs. A registered nurse monitors all home treatments continuously.
If the physician requires that the first dose be given in a controlled setting, IgG America can provide all subsequent doses at home.
2. Although there are many different brands of IgG available, aren't they really the same?
IgG brands are considered therapeutically equivalent but they are not chemically identical. Brands differ according to sugar content, pH, osmolality, IgA content as well as many other factors. Experts believe that these subtle chemical differences explain why a patient may be better able to tolerate one brand over another. You can learn more about the chemical composition of IgG brands by reviewing the IgG America Product Profile Chart (see Brand Selection) or by asking an IgG America pharmacist.
3. What are the expected outcomes of IgG therapy?
The outcome of therapy depends on the diagnosis. For patients with immune deficiency, the replacement of IgG helps the body resist infection and remain healthy. For other diagnoses, IgG is used to help control or manage symptoms. These symptoms vary according to the specific disease. It is important to remember that IgG is not a cure for any disease.
4. How long will the patient need to remain on IgG therapy?
Patients with an immune deficiency often need replacement therapy throughout their lifetime. For all others, the need for continued treatment depends on the patient's ability to tolerate and respond to IgG therapy.
5. How can the costs of IgG therapy be managed? Are the cost savings significant?
Costs are managed by simultaneously matching the brand of IgG clinically indicated by the patient's medical history and risk profile to the most cost-effective product. Since there are variations in the costs of IgG products, the savings that result from this selection process can be substantial.
6. Isn't IgG treatment at home more expensive that treatment provided by an infusion center or physician's office?
Home infusion is not as costly an option as many case managers may have been told. The actual cost depends on many factors. Most of the time, it is less expensive to provide IgG therapy at home.
Every case must be analyzed individually. IgG America will help you determine if home infusion is a cost effective option for your patient.
7. IVIG seems difficult to get. Is there a national shortage?
Although the FDA has stated that there is not a national shortage, ongoing changes within the plasma industry, brand changes by manufacturers and national reimbursement trends have made it much more difficult for all healthcare providers to obtain product. This is true of all FDA-approved brands of IVIG.
Read what the FDA says about the availability of IVIG at www.fda.gov. Fortunately, IgG America continues to access to all product brands and works diligently to keep physicians and patients informed regarding any anticipated changes in availability.
8. Is IgG therapy safe?
Since 1985, the federal government has required that all blood products undergo viral inactivation during the manufacturing process to protect patients against disease. Since that time, many safety processes have been developed and all have been successful in reducing the risks associated with the use of immunoglobulins, which are derived from blood plasma. There have been no reported cases of any disease transmission from IgG for the past 12 years. New diseases such as West Nile Virus and SARS are also strictly monitored. There have been no cases of West Nile Virus or SARS spread by the use of any brand of IgG. New tests and safety technology continue to be developed by IgG manufacturers.
9. What is subcutaneous (SCIG) treatment? When is it used?
For individuals with immune deficiencies, IgG may be infused just under the skin rather than into a vein. There are several advantages to subcutaneous administration. Individuals often report that it is less painful, experience fewer side effects and avoid frequent trips to the infusion center or physician office.
Patients are taught to do subcutaneous infusion independently at home. Unlike IVIG, subcutaneous administration is usually done weekly. Subcutaneous administration is a popular treatment option in pediatrics, in adults who prefer self management of their infusions, for those who prefer to reduce time away from school or office to infuse in a treatment center and for those who have experienced difficulty tolerating immunoglobulins given intravenously.
10. In addition to cost, what other factors should a case manager consider when arranging IgG therapy?
Is this the patient's first dose of IgG? If so, the physician may require the first dose be administered in a controlled setting.
How carefully should the patient be monitored during the infusion? IgG America requires that the nurse remain with the patient throughout the infusion. Since it is clinically impossible to predict an adverse event, the presence of the nurse throughout the treatment maximizes patient safety during the treatment.
What type of vascular access will the patient need? Case management will be more complex if the patient requires a centrally placed device.
What is the patient's home environment? Adequate utilities, general safety and the presence of a responsible caregiver or family member are important considerations if IgG infusion will be done in the home.
Does the patient have a history of non-compliance or non-adherence to treatment? Reducing and controlling common side effects of IgG therapy require that the patient follow pre treatment instructions carefully. Non-compliance can affect the clinical outcome of IgG treatment.
11. Why are there so few clinical trials in progress to support the use of IgG for what are classified as off-label (i.e. not approved by the FDA) uses?
Most-off label uses focus on rare disorders that affect only a very limited number of individuals. For this reason, the technical complexity of conducting a clinical trial is too expensive relative to the potential financial benefit for the manufacturer. In these cases, physicians rely on smaller research studies to validate IgG use in rare diseases.
12. If a patient reacts to IgG, can he or she receive further treatment?
Unless the patient experiences a very serious reaction (and these are extremely rare), the physician may "rechallenge" the patient with the same brand of IgG for one or even two more treatments. The physician can also evaluate changing the dose and/or the rate, as well as changing brands, as alternatives to discontinuing treatment.
13. What are the advantages to the case manager of using a specialty infusion pharmacy to provide IgG services?
A specialty infusion pharmacy such as IgG America has the benefit of tremendous therapy-specific experience. IgG America has successfully provided thousands of IgG treatments. Because this is our only therapy, we have developed a clinical care model that is designed around the needs and preferences of each IgG patient. |
