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Wednesday, September 23, 2015
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Serious Flu Risk Could Be Identified with Genetic Test

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In this Issue

•  IVIG/Albumin Supply Index
•  Open Market Pricing
•  New Products from FFF
•  Current Medicare
IVIG / SCIG Rates
•  Resources
•  Subscribe to IG Living and BioSupply Trends Quarterly
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In August, a U.S.-Chinese research team pooled the results of four published studies, which show that among 445 people infected with either swine flu or H5N1 bird flu, those with a variant of a gene called IFITM3 were 24 percent more likely to have suffered a severe infection. [ read more ]

Experimental Blood Test Can Reveal Virus Exposure

A $25 experimental blood test called VirScan can detect the remains of more than 1,000 strains of 206 viruses that are infecting or have ever infected a person. While individuals could be previously tested only for antibodies one virus at a time, VirScan can search for hundreds of antibody reactions simultaneously. Developed by researchers at Howard Hughes Medical Institute, the test can identify traces of antibodies that remain in the immune system to fight the viruses should they return.
[ read more ]

ProMetic Completes First Dosing in Plasminogen Deficiency Patients

In its Phase 1 clinical trial, ProMetic Life Sciences successfully completed its first round of intravenous plasminogen dosing in plasminogen deficiency patients, which was found to be safe and very well tolerated with no drug-related adverse events. The company will now proceed with the administration of a higher dose in order to complete the pharmacokinetic profile of the drug before year-end as planned.
[ read more ]

Industry News

blue molecules

From Novartis

The U.S. Food and Drug Administration has approved an expanded use for Promacta (eltrombopag) to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immune globulin or splenectomy.
[ read more ]

From Bio Products Laboratory

Bio Products Laboratory has launched a clinical trial evaluating the safety and pharmacokinetics of Subgam-VF 16% liquid subcutaneous immune globulin for the treatment of primary immunodeficiency diseases.
[ read more ]

From Baxalta

Results of a Phase 3 study show that BAX 111, a highly purified investigational recombinant von Willebrand factor analog, appeared safe and effective for treatment of bleeding episodes in patients with severe von Willebrand disease.
[ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Supply Index from February - August 2015
 
Log in to BioSupply for IVIG and Albumin Product Pricing
 

Featured Product Of The Month

Bivigam (BioTest)

BIVIGAM (immune globulin intravenous (human) 10% liquid) is indicated for the treatment of primary humoral immunodeficiency, including but not limited to the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. The product has a median half-life of 30 days, contains no sucrose/glucose/maltose, is stabilized with glycine, has trace amounts of IgA, contains a latex-free stopper, features tamper-evident seals and can be stored for up to 24 months (until expiration date on vial packaging) at 2 degrees to 8 degrees Centigrade.

For more information about Bivigam, go to biosupply.fffenterprises.com

 

New Products From FFF

Miacalcin (Mylan Institutional)

Miacalcin (calcitonin-salmon) synthetic injection is a calcitonin, indicated for the following conditions:

  1. Symptomatic Paget’s disease of bone when alternative treatments are not suitable.
  2. Hypercalcemia
  3. Postmenopausal osteoporosis when alternative treatments are not suitable.

Zarxio (Sandoz)

A biosimilar to Neupogen, Zarxio is approved for the same indications as Neupogen, and is prescribed to:

  1. Patients with cancer receiving myelosuppressive chemotherapy.
  2. Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
  3. Patients with cancer undergoing bone marrow transplantation.
  4. Patients undergoing autologous peripheral blood progenitor cell collection and therapy
  5. Patients with severe chronic neutropenia.

Doxorubicin (Sun Pharma)

Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for:

  1. Treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
  2. Treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy

VariZIG Liquid Formulation (Emergent BioSolutions)

Varicella zoster immune globulin (human) is indicated for post-exposure prophylaxis in high-risk individuals, including immunocompromised children and adults; newborns of mothers with varicella shortly before or after delivery; premature infants; infants less than 1 year old; adults without evidence of immunity; and pregnant women

Zerbaxa (ceftolozane/tazobactam) 1.5 g vial/10 pack (Merck)

Combination cephalosporin-class antibacterial drug and a beta-lactamase inhibitor indicated for the treatment of the following infections caused by designated susceptible microorganisms:

  1. Complicated intra-abdominal infections, used in combination with metronidazole
  2. Complicated urinary tract infections, including pyelonephritis

Stratis Needle-Free Injection System 0.5 mL (PharmaJet)

Needle-free injection system that delivers vaccines either intramuscularly or subcutaneously via a narrow, precise fluid stream syringe that delivers the medicine or vaccine through the skin (only approved for use with AFLURIA 5 mL 10 DS vial)

Novoeight 250 IU vial, 500 IU vial, 1000 IU vial, 1500 IU vial, 2000 IU vial, 3000 IU vial (Novo Nordisk)

Antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A for

  1. Control and prevention of bleeding.
  2. Perioperative management.
  3. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Sivextro Tedizolid Phosphate 200 mg tablet-6 pk, 200 mg tablet-30 pk, 200 mg IV vial-10pk (Merck)

Antibacterial drug for the treatment of adults with skin infections and to reduce the development of drug-resistant bacteria

Tice BCG 50 mg SDV (Merck)

Intravesical vaccine for the treatment and prophylaxis of carcinoma in situ of the urinary bladder, and prophylaxis of stage Ta and/or T1 papillary tumor of the urinary bladder

Gardasil 9 0.5 ml PFS (Merck)

Human papillomavirus 9-valent vaccine approved for females ages 9 years through 26 years

FFF Enterprises offers a wide portfolio of plasma products, vaccines and critical-care biopharmaceuticals, to view our complete list of products visit our website – Product Catalog. These products can be ordered by calling Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective October 1, 2015, through December 31, 2015.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
Bivigam J1556 $76.98 $75.75
Carimune NF J1566 $66.21 $65.15
Flebogamma J1572 $71.31 $70.17
Gammagard S/D J1566 $66.21 $65.15
Gammaplex J1557 $74.56 $73.37
Octagam J1568 $85.60 $84.23
Privigen J1459 $76.10 $74.88
SCIG
Hizentra J1559 $84.69 $83.33
HyQvia J3490 or J3590 ** **
IVIG / SCIG
Gammagard Liquid J1569 $77.13 $75.89
Gammaked J1561 $80.59 $79.30
Gamunex-C J1561 $80.59 $79.30

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
**Pricing not yet available.

Resources

FFF customers may order the following complementary resources to help you with your practice:

Seasonal Flu Poster flu myths and facts brochure
immune globulin reference charts
•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

Subscribe to IG Living

IG Living is the only magazine for the immune globulin (IG) community for patients who suffer from chronic illness and their caregivers.

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