pharmaceutical sales aid

3
Life has its ups and downs. Ig levels don’t have to. A On the roller coaster of Ig therapy, Do you know what to expect?

Upload: brian-blank

Post on 11-Mar-2016

227 views

Category:

Documents


1 download

DESCRIPTION

Sales Aid for blood imune disorder treatment to inform physicians.

TRANSCRIPT

Page 1: Pharmaceutical Sales Aid

Life has its ups and downs.Ig levels don’t have to.

A

On the roller coaster of Ig therapy,

Do you know what to expect?

Page 2: Pharmaceutical Sales Aid

Only Vivaglobin® is proven to maintain serum Ig at stable, steady levels

Immune Globulin Subcutaneous (Human), Vivaglobin®, is indicated for the treatment of patients with primary immunodeficiency (PI).

As with all immune globulin products, Vivaglobin® is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations and in persons with selective immunoglobulin A deficiency

who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Vivaglobin® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.

As with all immune globulin (Ig) products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella.

In clinical studies, administration of Vivaglobin® has been shown to be safe and well tolerated in both adult and pediatric subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy were not studied in pediatric subjects under two years of age.

Please see accompanying full Prescribing Information.

Important Safety Information:

Vivaglobin® avoids the high peaks and low troughs associated with IVIg therapy1-3

Only Vivaglobin® can deliver this level of proven efficacy and safety in Sub-Q therapy

Life has its ups and downs.Ig levels don’t have to.

Expect safe, efficacious, and well-tolerated administration in both adult and pediatric patients

• Vivaglobin® is the only 16% solution specifically formulated for Sub-Q in the US

• Vivaglobin® is the only Ig exclusively studied for Sub-Q in the US that has been used worldwide for more than 10 years

With IVIg therapy expect:Serum Ig levels to rise sharply, then decline — tailing off and wearing off as 3 to 4 weeks elapse1-3

With Vivaglobin® expect: Serum Ig levels to remain relatively stable and represent those seen in the general population1-5

Annual Acute Serious Bacterial Infections*

No

. An

nu

ally

1.0

0.8

0.6

0.4

0.2

0

Steady-state Ig levels help

protect against infections

0.04

• The most commonly reported AE is local injection-site reaction — typically mild to moderate and decreasing substantially over time

16

14

12

10

8

6

Days

Seru

m Ig

Lev

els

(g/L

)

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

16

14

12

10

8

6

Days

Seru

m Ig

Lev

els

(g/L

)

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

*Defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses.

1.6%0.2% 0.2%

10%

8%

6%

4%

2%

0

No serious systemic adverse events in more than 3600 infusions

in clinical trials

Perc

ent

of

Infu

sio

ns

Headache Rash Nausea

Systemic Adverse Events Occurring in >– 0.2% of infusions

Page 3: Pharmaceutical Sales Aid

Vivaglobin® is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

Vivaglobin® is a registered trademark of CSL Behring GmbH.

©2008 CSL Behring LLC1020 First Avenue • PO Box 61501

King of Prussia, PA 19406-0901 • USAwww.cslbehring-us.com IO#8B374 6/2008

Immune Globulin Subcutaneous (Human), Vivaglobin®, is indicated for the treatment of patients with primary immunodeficiency (PI). Please see accompanying full Prescribing Information.References1. Data on file, CSL Behring 2008.2. Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M, and the Subcutaneous IgG Study Group. Safety and efficacy of self-administered

subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265-273.3. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112:1-7.4. Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults

with primary immunodeficiencies—a prospective, multi-national study. J Clin Immunol. 2006;26:177-185. 5. Waniewski J, Gardulf A, Hammarström L. Bioavailability of gamma-globulin after subcutaneous infusions in patients with

common variable immunodeficiency. J Clin Immunol. 1994;14:90-97.

Call the VRC at:

1-877-VIVAGLOBIN (848-2456)Monday – Friday, 8 am – 8 pm (ET)

www.vivaglobin.com

Start Vivaglobin® and expect a new level of support network servicesHere are 3 steps to initiating Vivaglobin® therapy

Life has its ups and downs.Ig levels don’t have to.

1 Identify a Vivaglobin® patient

Fax a referral form to the VRC

Rely on the Vivaglobin® Network to do the rest

2

3

• Insurance verification

• Billing assistance

• CSL Behring therapy assistance and assurance programs

nurse training

• Reimbursement hotline

• Full suite of patient education materials