igg therapy for the home-based patient: administration and ... · pdf fileigg therapy for the...

IgG Therapy for the Home-Based Patient: Administration and Delivery Method ConsiderationsBy Hetty Lima, R.Ph., FASHP, and Amy Clarke, R.N.

Adapted from the original April 26 presentation at the 2012 NHIA Annual Conference & Exposition

Supported by an educational grant from CSL Behring

IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations

CE Information:Pharmacist

This INFUSION article is cosponsored by Educational Review Systems (ERS), which is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. ERS has assigned1 contact hour (0.1 CEU) of continuing education credits to this article. Eligibility to receive continuing educationcredits for this article begins December 1, 2012 and expires November 20, 2015. The universal activity number

for this program is 0761999912176H01P. Activity Type: KnowledgeBased.

DietitianEducational Review Systems (Provider number ED002) is a Continuing Professional Education (CPE)Accredited Provider with the Commission on Dietetic Registration (CDR). Registered dietitians (RDs) anddietetic technicians, registered (DTRs) will receive 1 hour or 1 continuing professional education unit (CPEU)for completion of this program/material. Eligibility to receive continuing education credits for this articlebegins December 1, 2012 and expires November 30, 2014.

NurseEducational Review Systems is an approved provider of continuing nursing education by Alabama StateNurses Association (ASNA), an accredited approver of continuing nursing education by the AmericanNurses Credentialing Center, Commission on Accreditation. Program # 0511512002.

This program is approved for 1 hour of continuing nursing education. Eligibility to receive continuing education credits for thisarticle begins December 1, 2012 and expires November 30, 2014. Educational Review Systems is also approved for nursing continuingeducation by the state of California, the state of Florida, and the District of Columbia.

This continuing education article is intended for pharmacists, nurses, dietitians, and other alternatesite infusion professionals. Inorder to receive credit for this program activity, participants must complete the online posttest and subsequent evaluation questions available at this link: www.nhia.org/CE_Infusion. Participants are allowed two attempts to receive a minimum passing scoreof 70%.

Approval as a provider refers to recognition of educational activities only and does not imply Accreditation Council for Pharmacy Education, ERS, ANCC Commission on Accreditation, or Commission on Dietetic Registration approval or endorsementof any product.

Educational Learning Objectives:After reading this article, the participant should be able to:1. Distinguish between the advantages and disadvantages of SCIG for homebased patients. 2. Explain the differences in bioavailability and dosing strategy for IVIG versus SCIG.3. Describe the role of monitoring outcomes such as disease progression, frequency of infection, and days of school/work

missed in clinical decision making.4. Enumerate the core elements of patient and caregiver education when transitioning a patient to self administration of

SCIG therapy.

CPEAccreditedProvider

IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations 1

Author Bios:Hetty Lima, R.Ph., FASHP, is the Vice President of Specialty Infusion and Rare Diseases at Diplomat Specialty Pharmacy in Flint,Michigan. An accomplished health care executive with morethan 27 years of home infusion/specialty pharmacy experience,she has held executive leadership positions at providers such asBaxter Healthcare, CVS/Caremark’s Specialty Pharmacy division,and Coram’s Hemophilia Services division. A graduate of the University of Rhode Island, Lima is also the past President of theAmerican Society of HealthSystem Pharmacists’ (ASHP’s) Section of Home Care Practitioners. She has lectured at national andinternational pharmacy and nursing meetings and has publishedextensively on the clinical and practical aspects of home infusionand specialty pharmacy. Her work has appeared in numerouspharmacy and nursing journals and pharmaceutical texts.

Amy Clarke, R.N., is a registered nurse and has practiced in thehome infusion arena since 1994, as Director of Nursing for theChicago locations of Chartwell Diversified Services and OptionCare’s Home Infusion Therapy Pharmacies. Clarke has provided clinical education on infusion therapy and specialty medications tonursing staff (internal and external), pharmacists, physicians, andsocial workers. She has presented continuing education presenta

tions to some of the nation’s top payers including various BlueCross Blue Shield plans, Humana, Aetna and United Healthcare.

Clarke has a particular passion for immunoglobulin therapy, having personally performed over 1,500 IV and SC infusions to date.Working with home infusion pharmacy in the 1990s she observedthat IVIG was not well understood by nursing staff, pharmacies,payers, and in many instances the physicians themselves. She hasdeveloped multiple presentations on IVIG administrationspecifics, as well as the “ins and outs” of subcutaneous IG therapy. Clarke has developed a successful national IgG program asProgram Manager for Diplomat Specialty Pharmacy.

AUTHOR DISCLOSURE STATEMENT:The authors declare no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stockholdings, and honoraria. This article may include discussion of offlabel/investigational drug use but in a fair andunbiased manner. Hetty Lima and her sons use medications from the sponsoring organization (CSL Behring) totreat Von Willebrand’s Disease.

IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations2

IgG Market Overview and UsesThe IgG market has grown steadily over the past severalyears. In 2010, sales of intravenous IgG (IVIG) and subcutaneous IgG (SCIG) combined exceeded $2.8 billion. Approximately 42.3 million grams of product was sold in 2010—an8% increase over the previous year.1 Although IgG is by nomeans a major therapeutic class in terms of payer drugspend, like chemotherapy or rheumatology therapies, it isgradually becoming a notable category. For a health planwith 1 million covered lives, approximately $16 million orabout 6% of all claims will be for IVIG.2

Of the IgG that is used for FDAapproved indications, 36%is for the treatment of primary immunodeficiencies, 26% inhematology and oncology, 25% for neurological disorders,and 13% for miscellaneous indications.1 However, it’s difficult to ascertain the true breakdown of the IgG market because a great deal of immune globulin is used for offlabelindications. In 2009 the offlabel usages for IVIG represented approximately 55% of prescribed product.1 It’s important to note that although these indications are not yetapproved by the U.S. Food and Drug Administration (FDA),many indications are supported by peerreviewed literatureand are generally accepted for reimbursement by payers.See Exhibit 1 for a list of FDAapproved indications and offlabel uses.

With more than 150 specific disease states falling underthe umbrella of primary deficiency disorders, clinicians and

payers alike encounter challenges determining when andfor which patients IgG is most appropriate. A history ofproduct shortages and growing demand only serve to increase the pressures surrounding these decisions. In 2006,the American Academy of Allergy, Asthma, and Immunology(AAAAI) conducted a literature review and issued evidencebased recommendations for efficient use of IgG, categorizing them by the degree to which the therapy was beneficialand the strength of the recommendation based on the available evidence.3 This paper and other resources for cliniciansare available in an online toolkit available at:http://www.aaaai.org/practiceresources/managementtoolsandtechnology/ivigtoolkit.aspx.

The Emergence of SCIGThe subcutaneous method of IgG (SCIG) administration hasbeen an accepted practice in Scandinavia and the UnitedKingdom for some time. Literature dating back 60 years, including the research of pioneering American physicianOgden Bruton, a pediatrician at Walter Reed Army Hospital,documents the safe and effective use of SCIG in a case ofprimary immune deficiency (PID) in an eight year old boywith Xlined agammaglobulinemia which is also known as“Bruton’s syndrome.”4 In 1980, Berger and colleagues at theNational Institutes of Health reported using a portable syringe driver to administer IgG to three adult patients, concluding that the slow subcutaneous infusions were well

Exhibit 1Uses for IgG

* Only GamunexC® and GammaKed® are approved at this time

Source: Huber, A. Advanced Considerations for Home Administration of Immunoglobulin Therapy. NHIA Annual Conference & Exposition, April 2011, Orlando, Florida.

FDAApproved Indications(as of November 2012)

OffLabel Uses—Neurological OffLabel Uses—Other

• Primary immunodeficiencies• Allogenic bone marrow/stem cell

transplant• Chronic lymphocytic leukemia• Idiopathic thrombocytopenic

purpura• Pediatric HIV• Kawasaki disease• Chronic inflammatory

demyelinating polyneuropathy(CIDP)*

• Kidney transplant, with a highantibody recipient or anABOincompatible donor

• GuillainBarre syndrome • Multifocal Motor Neuropathy• Multiple Sclerosis • Myasthenia Gravis (w/exacerbation)• Neuromyelitis Optica (Devic’s

disease)• Stiff Person’s syndrome

• Dermatomyositis• Infertility• Pediatric autoimmune

neuropsychiatric disordersassociated with Streptococcalinfections (PANDAS)

• Pemphigus• Polymyositis• Renal transplant• Scleroderma• Sjogren’s syndrome• Susac’s syndrome


tolerated and noticeably free of adverse reactions.5 Thisstudy paved the way for additional research in both adultand pediatric patients—largely with positive results. By1981, the safe and effective home administration of SCIGwas first reported.6 Subsequent studies reported similar success with varying rates of administration.7,8,9

Despite these innovations, the subcutaneous (SC) methodof IgG administration did not take hold in the U.S., largely dueto the availability of IVIG and the fact that there was no commercial product specifically formulated for SC delivery. Thatchanged in 2006, when the FDA approved the first IgG formulation designed exclusively for subcutaneous administration.10

Since then, three additional SCIG formulations have been FDAapproved for primary immunodeficiency—with others currently in clinical trials. The subcutaneous administration of IVIGformulations has also become more widespread.

To date, few studies have been conducted to directlycompare IVIG and SCIG. However, sufficient available research has shown that, due to its relatively stable bioavailability, SCIG is associated with fewer systemic adverseevents.11 In addition, this administration route offers a variety of advantages to patients who are willing to committo selfadministration.

SCIG Patient SelectionSCIG offers several advantages over intravenous administration. Chief among them is a viable treatment alternative for

patients with limited vascular access or those who cannot tolerate the side effects commonly associated with IV administration. The slower administration and gradual absorption of SCIGeliminates rapid, large variances in serum IgG levels, which reduces adverse affects, such as migraines, and the need to premedicate prior to infusion. In addition, consistent serum levelsachieved through this therapy modality eliminate low troughlevels, thereby reducing associated symptoms, such as extreme fatigue, joint pain, swelling, and malaise.11

SCIG also offers greater flexibility and patient autonomy. Although the fractionated doses require weekly—or more frequent—infusions, patients often enjoy the flexibility of being

SCIG at a Glance

Advantages • No IV access necessary• Fewer systemic side effects, no need to pre

medicate• Fewer systemic effects resulting from peak and

trough variability• Patient flexibility/autonomy

Disadvantages of SCIG• Requires commitment and compliance• Not appropriate for large volume therapies or very

lean patients• Requires more frequent infusions• Local infusion reactions can occur


of the AAAAI issued a report in which it asserted that thedose of IgG should be titrated to achieve a trough levelgreater than 500 mg/dL in agammaglobulinemic patients andthat trough levels greater than 800 mg/dL have the potentialto improve pulmonary outcomes.3 This was further demonstrated in a 2010 metaanalysis of PIDD patients on IVIG therapy and experiencing pneumonia, whose rates of infectionwere reduced by increasing the IgG trough levels to midnormal range (1,000 mg/dL).17 A subsequent study, published in2012, examined a broader set of outcomes and also favoredhigher doses of IgG. Researchers comparing results from twoparallel clinical studies found that PIDD patients who maintained a higher mean IgG dose (1.5 times higher) had significantly lower rates of nonserious infections, hospitalization,antibiotic use, and missed work/school activity. In addition,the higherdose group experienced lower health care utiliza

Exhibit 2Subcutaneous Versus IntravenousSerum Ig levels

Source: P&T Product Profiler – Hizentra Vol. 35, Issue 8 /August 2010 Section 2 / adapted from Berger 2004. Available at http://www.ptcommunity.com/ptjournal/fulltext/Profiler_Hizentra/Profiler_Hizentra.pdf

1600

1400

1200

1000

800

600

4000 2 4 6 8 10 12 14 16 18 20 22

Days

Intravenous Ig

Subcutanenous Ig

Tota

l IgG

Exhibit 3FDA-Recommended Dose Conversionfor SCIG• 20% products = IVIG dose (g) x 1.53 / number of

weeks between doses• 10% products = IVIG dose (g) x 1.37 / number of

weeks between doses

able to perform their own infusions, at home when it’s convenient, without having to travel to and from a treatment center.A 2010 study showed that patients preferred SCIG over IVIGtherapy (92%) and home therapy over therapy at theclinic/physician (83%).12

Unfortunately, patients requiring higher IgG doses, such asthose with autoimmune diseases, may not be appropriatecandidates for SCIG therapy due to the large volume of fluidthat would need to be delivered. This is especially true for patients on formulations with comparatively lowerconcentration IgG (i.e. 10% vs 16% or 20%). Similarly, patients who arevery lean may not be suitable candidates for SCIG becausethey often have limited appropriate sites for SC access.

For SCIG to be successful, patients and caregivers mustbe committed to learning and adapting to selfcare. Theyshould also have a demonstrated history of therapy compliance. Independence is typically achieved after two to fournurse teaching visits with continued clinical monitoring andpatient followup.

Dosing and Conversion to SCIG Several studies demonstrate favorable improvement in infection rates, hospital admissions, and overall morbidity for patients on SCIG.7,1316 But, how much IgG is needed to achievethese results, and what is the best dosing strategy for patients just starting SCIG therapy and/or converting from IVIG?Not all patients respond the same way to the many IgG formulations on the market. Differences in pH, osmolarity,amount of sucrose, and amount of IgA, make product selection very individualized. Similarly, there is no cookie cutterformula for dosing—although higher doses are beginning tobe supported in the literature as offering improved clinicalbenefits and quality of life for patients.17

Unlike IVIG, SCIG doesn’t immediately enter the circulatory system during administration. For this reason, it has alower systemic bioavailability and more stable serum levelsfollowing administration. Weekly administration of SCIGleads to stable steadystate serum IgG levels with lowerpeak levels and higher trough levels compared to monthlyIVIG treatment (see Exhibit 2). The FDA recognized this difference and adjusted dosing to achieve a similar “area underthe curve” (AUC) by using a productspecific multiplier forcalculating dosages. Formulas for converting IVIG doses areprovided in package inserts and available from IgG manufacturers online (see Exhibit 3).

The optimal dose of IgG for primary immune deficiency wasconsidered to be 400800 mg/kg/month (100200mg/kg/week for SCIG) with the goal of achieving serum levelsof 500 mg/dL or greater.18,19 But, in 2006, the PID Committee


tion and improved indices of wellbeing compared to thegroup treated with traditional IgG doses.18

Many clinicians now believe that the mean dose adjustment coefficient and the mean trough level ratio should onlybe used as rough guides in dosing. As additional outcomes,such as slowing of disease progression, frequency of infection, days of work/school missed, etc., are considered, experienced clinicians are tending toward higher doses whilerelying on patient monitoring to adjust therapeutic levels ofIgG. In a survey of immunologists, those with more indepthexperience—more than 10% of their practice was devotedto PID patients—were significantly more likely to targethigher serum levels (above 750 mg/dL); whereas those withfewer than 10% PID patients usually targeted lower serumlevels (500750 mg/dL).20

Home infusion and specialty pharmacy providers can play acritical role in patient monitoring by collecting supporting documentation on the therapeutic effectiveness of IgG regimensfrom a variety of perspectives, including: response to therapy,abatement of symptoms, and quality of life. This data providesmeaningful feedback for physicians working to find each patient’s dosing “sweet spot,” and also aids in building a case forreimbursement, especially if the patient’s recommendeddosage falls outside the “normal” payer guidelines.

SCIG AdministrationSCIG administration presents some unique challenges froma clinical perspective. With the medication itself, volume andviscosity are key factors in care planning. The therapy alsoinvolves a different—but similar—set of supplies than thoseused to administer IVIG.

For example, the home infusion/specialty pharmacy careteam should map out a regimen based on the prescribed dosing parameters. They need to consider the individual patientand total volume of therapy to determine the number of fractionations and sites to be infused with each administration.As a rule of thumb, infusions should last 4550 minutes, andshould not be longer than 90 minutes. Generally, no morethan 15 mL should be administered in any one site. In orderto limit swelling, a rate of 20 mL/hour is suggested for rapidinfusions; 4 mL/hour is suggested for longer infusions.11

SCIG is viscous—much more so than the sterile water usedto calibrate typical IV administration rates—so tubing setsneed to be adjusted to achieve the desired rate. For example,pumps and tubing may need to be set at 600 mL/hr to deliver20 mL/hr to the patient. There are several infusion pumpsand needles specifically designed for SC administration—some pumps use only proprietary sets. Many pump manufacturers offer sample supply lists online to prompt pharmacy


ordering. It should also be noted that a growing number ofprescribers prefer IV push administration, which is lowertechbut also reduces supply costs.

While rotating injection sites is a standard best practice formost therapies, this is not the case for SCIG. After a few administrations, subcutaneous pockets can accept the IgG morereadily without triggering an antibody reaction. Most SCIGpatients use the same sites repeatedly, or alternate everyother use. It’s also important to note that inadvertent intradermal injection of IgG could cause the release of mediatorsresulting in an adverse reaction via complement activation.11

The best way to avoid this is to be sure that the needle lengthis appropriate for the individual patient and injection site.

Hot packs, which cause vasodilatation, can trigger a similar reaction, and should be avoided. However, cold is an effective tool in preventing site reactions and slightly numbingthe area prior to needle insertion. Many providers advisepatients to use freezer packs or even place flat rocks in thefreezer for chilling an injection site prior to administration.Topical steroids and histamine blockers are also effective inreducing minor site reactions.

Regardless of the route of administration, IgG therapyis the inoculation of a proteinbased substance into thebody. Therefore, adverse reactions similar to those reported with other IgG administration methods may alsooccur. While the most frequent adverse reaction is alocal reaction at the injection site, Exhibit 4 lists otheradverse reactions reported in clinical studies as a percentage of subcutaneous administrations for one formulation of SCIG.21

Preparing the Patient for SCIG TherapyAs mentioned previously, patients who take on selfadministration must be willing to undergo appropriate training.Patients and caregivers are taught administration techniques via handson instruction from a nurse, and asked toreturn demonstrate successfully before independently performing selfinfusion.

Exhibit 4Adverse Reactions for SCIG

Source: ZLB Behring. Immune Globulin Subcutaneous(Human) Vivaglobin Prescribing information, January2006.

Adverse Reaction (n=3,656 infusions)

Frequency

Injection site reactions 49%

Noninjection site reactions

• Headache 1.6%

• Rash 0.2%

• Nausea 0.2%

• Nervousness 0.1%

• Asthenia 0.1%

• Skin disorder 0.1%

• Urine abnormality 0.1%

• Fever 0.1%

• Dyspnea 0.1%

• Gastrointestinal pain 0.1%

• Tachycardia 0.1%


The primary driver in the success of that educational effort isbeing sure that the patient knows what to expect. The homeinfusion care team should create a care plan that details thenumber of infusions per week/month the patient will have, anestimated time for each infusion, the volume being infused, andthe number of sites accessed. This information—along with aset of supplies, written instructions, and pharmacy contact information—should be supplied prior to the teaching visit.

Typically, patients and/or caregivers can become independent in as few as two or three teaching visits (see Exhibit5). During the first visit, the nurse performs the entire administration, explaining each step as the patient observes.There should be time for the patient to ask questions andget acquainted with the many various supplies. The secondvisit is a tandem administration with the patient performingthe majority of the tasks with verbal cues from the nurse.The nurse may perform certain tasks, such as the needlestick. By the third visit, the patient should be able to performall of the tasks with only minimal cuing from the nurse. Ifthe patient or caregiver is not fully independent, more visitsmay be offered. Additional support, such as phone assis

tance and access to manufacturer teaching materials, mayalso be offered.

Another critical element for success is regular followup.Phone calls to check on patient progress and answer questions aid in compliance and help patients avoid complications that can sometimes arise from lapses in technique.

Patients should be made aware of what to expect duringSCIG administration. Typically, the first several infusions resultin a stretching, burning, tingling feeling at the injection site.This sensation usually disappears after the tissue in and aroundsubcutaneous space becomes sensitized. Patients may continue to experience sunburnlike redness and swelling at theinjection site and a “goose egg” reservoir of fluid in the subcutaneous space, due to the volume of infusion. These fluid pockets generally disappear within 6 24 hours as the fluid isabsorbed into the body. It’s common for patients to feel tenderness and/or discomfort at the infusion site 12 24 hours following administration; counsel them to choose activities andeven clothing appropriately. Patients may also experiencebruising 5 10 days after an infusion, and should know not tobe alarmed by the delayed appearance of bruising.

Exhibit 5Core Elements of Patient Education

• Therapy regimen. The patient’s lifestyle must accommodate more frequent (weekly vs. monthly) administrations.Patients must also understand that compliance with an independent self administration schedule is essential togood outcomes.

• Anaphylaxis procedures. Review epinephrine autoinjector use and storage procedures in the event of an anaphylactic reaction.

• Hand hygiene. Proper hand hygiene is a core element in all effective infection control programs, including in the patient’s home.

• Site selection and preparation. Patients should be involved in determining which site(s) to use for infusion basedon comfort, body mass, convenience, etc. They should also be counseled on how to recognize improper needlelength for the site used (i.e. A needle that is too long may brush muscle wall causing bruising and discomfort, or aneedle that is too short can infuse intradermally, increasing the severity of local infusion site reactions.)

• Supplies. Patients should receive a list with all the supplies needed for their care along with storage/handling instructions. Inventory awareness and appropriateness should also be stressed with patients during the trainingphase, as they will be expected to assist their pharmacy with their supply needs and should know how to communicate supply and usage needs.

• Priming needles. Patients should be instructed that all effort should be taken to insert a dry needle so that IgG isnot being tracked through the dermis, triggering a possible histamine release and increasing the probability of alocal site reaction.

• Needlestick procedure. Teach patients to insert the needle into the subcutaneous space and how to avoid intradermal injection. Proper placement of the needles limits leaking, discomfort, and localized site reactions. Also teach90degree angle insertion, avoiding scars, skin folds, or keloids.

• Needle Securement: Apply tape over the needle in a chevron pattern to hold it securely in place during the infusion,minimizing the risk of dislodgement and subsequent intradermal infusion.

• Disposal of trash and medical waste. Instruct patients on state and local regulations and to have appropriategarbage receptacle ready before the administration procedure begins.

• Adverse reactions. While local site reactions are the most common, patients should also be educated regarding therare risks of aseptic meningitis, renal compromise, and cardiac compromise – particularly if there is comorbidity.

• Troubleshooting. Caution patients that the use of heating pads may increase a histamine response. Icing with acold water bottle before needle placement minimizes pain and can enhance comfort. Chronic leaking or redness atthe site should be a sign for the patient to discuss the needle length and/or pretreatment with their clinician.


It’s important that patients are educated about thetypes of adverse reactions associated with SCIG and howto recognize them. Symptoms, such as warmth, redness,and itching may be associated with a lessserious site reaction and may be resolved by working with their clinical

team to strategize a pretreatment plan or reexamineneedle length, administration procedure, or other variables. See the “SCIG Administration” section on page 5for more information.

Case StudyConverting IVIG patient to SCIG

Mr. D was a 46yearold male with CIPD. Hewas experiencing pain and decreasedstrength in his lower extremities. For fouryears, he had been receiving the same IVIGformulation (offlabel) at an infusion center.To be treated, he needed to travel 60 minutes (each way) monthly, in addition to waitand infusion time at the hospitalbased infusion clinic.

Following his infusions, he experiencedsevere chronic reactions, including migraine, vomiting, and flulike symptomsand was bedridden for up to three dayspostinfusion. Overall, his disease statewas poorly controlled and his quality of lifewas greatly diminished.

The specialty infusion team worked withMr. D’s physician to find an alternative IVIGformulation that might reduce the side effectshe was experiencing. The team educated thephysician on recognizing patientspecific product intolerances as well as raterelated side ef

fects that can be abated by using a standard IVIG infusion rate (which the center was not doing). Mr. D successfully switched to a different IVIG product without incident and received his infusions at home. His infusion

reactions resolved—he was no longer bedbound for three days with flulike symptoms each month—and his trips to theinfusion center were also eliminated which conservatively saved his payer $20,000 per year in infusion suite costs. Mr. Dalso reported decreased pain in his limbs and neck.

Mr. D then expressed his desire to move to SCIG in order to become even more autonomous. He converted successfullyafter three nurseteaching visits, and reports having improved energy levels and quality of life. He has regular monthlyassessments with his physician, and the specialty pharmacy infusion team follows his progress.

Subcutaneous immune globulin therapy offers a safe, less invasive alternative to intravenous IG therapy to those patientsand caregivers willing to selfadminister in the home setting.

Actual patient not shown. Photo courtesy of Melvin Berger, M.D. and CSL Behring

IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations

References1. Marketing Research Bureau, Inc. The plasma proteins market

in the U.S. July 2011; 28(12):168. Available at http://www.marketingresearchbureau.com/IBPN_July2011.pdf (accessed on10/29/2012).

2. Icore Healthcare. Medical pharmacy and oncology trendreport, 2nd edition. 2011:38. Available at:http://www.icorehealthcare.com/icoreutil/trendreportdownload.aspx/ (accessed 10/29/2012).

3. Orange J, Hossny E, Weiler C, et al. Use of intravenousimmunoglobulin in human disease: A review of evidenceby members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma, andImmunology. J Allergy Clin Immunol.2006;117(4):S525553. Available at: www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/2006_ivig_evidence_review.pdf (accessed 10/29/2012).

4. Bruton OC. Agammaglobulinemia. Pediatrics.1952.Jun;9(6):7228.

5. Berger M, Cupps TR, Fauci AS. Immunoglobulin replacement therapy by slow subcutaneous infusion.Ann InternMed.1980;93(1):5556.

6. van der Meer JWN, van Furth R. Rood JJ. Subcutaneousadministration of gamaglobulin. In: Nydegger UE, ed.Immunotherapy: a guide to immunoglobulin prophylaxisand therapy. London:Academic Press, 1981:13342.

7. Gardulf A, Hammarstrom L, Smith C.I.E. Home treatment of hypogammaglobulinaemia with subcutaneousgammaglobulin by rapid infusion. Lancet.1991;338(8760):162166.

8. Gardulf A, Andersen V. Bjorkander J. et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet.1995;345:3659

9. Welch MJ, Stiehm ER. Slow subcutaneous immunoglobulin therapy in a patient with reactions to intramuscularimmunoglobulin. J Clin Immunol. 1983;3(3):285286.

10. FDA. Approval letter for Vivaglobin. January 9, 2006.Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm070367.htm (accessed 10/29/2012).

11. Berger, M. Subcutaneous immunoglobulin replacementin primary immune deficiencies.J Clin Immunol.2004;112:17.

12. Hoffmann F, Grimbacher B, Thiel J, et al. Homebased subcutaneous immunoglobulin G replacement therapy underreallife conditions in children and adults with antibody deficiency.Eur J Med Res.2010 Jun 28; 15(6) :23845.

13. Gasper, Gerritsen, Jones. Immunoglobulin treatment byrapid subcutaneous infusion, Arch Dis Child 79(1998);4851.

14. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM,Bjorkander J. The comparison of the efficacy and safetyof intravenous versus subcutaneous immunoglobulinreplacement therapy. J Clin Immunol.2000;20(2):94100.

15. Ugazio AG, Duse M, Re R, Mangili G, Burgio GR. Subcutaneous infusion of gammaglobulins in management ofagammaglobulinaemia. Lancet.1982;1(8265):226.

16. Gardulf A, Bjorvell H, Gustafson R, Hammarstrom L,Smith CI. Safety of rapid subcutaneous gammaglobulininfusions in patients with primary antibody deficiency.Immunodeficiency.1993;4(14):8184.

17. Orange JS, Grossman WJ, Navickis RJ, and Wilkes MM.Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A metaanalysis of clinical studies. Clinical Immunology.2010;137:21–30.

18. Haddad E, Berger M, Wang, E, et. al. Higher doses ofsubcutaneous IgG reduce resource utilization in patients with primary immunodeficiency. J Clin Immunol.2012. April;32(2):281289.

19. Speidel K. Subcutaneous administration of immunoglobulin replacement therapy in the home caresetting.INFUSION.2006.12(3):S1S8.

20. Yong PL, Boyle J, Ballow M, Boyle M, Berger M, BlessingJ, et al. Use of intravenous immunoglobulin and adjunctive therapies in the treatment of primary immunodeficiencies: a working group report of and study by thePrimary Immunodeficiency Committee of the AmericanAcademy of Allergy Asthma and Immunology.J Clin Immunol. 2010;135:255–263.

21. ZLB Behring. Immune Globulin Subcutaneous (Human)Vivaglobin Prescribing information, January 2006.

Supplement to INFUSION, November/December 2012 (Vol. 18, No. 6)

National Home Infusion Association • 703.549.3740 • www.nhia.org • [email protected]