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Monday, August 15, 2022
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HHS Creates New Campaign to Increase Blood and Plasma Donations

eBST Newsletter Main Article
 

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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The U.S. Department of Health and Human Services (HHS) has launched a new campaign titled “Giving = Living” to increase awareness of the importance of donating blood and plasma and to encourage Americans to create new, regular donation habits. read more ]

 

U.S. and WHO Declare Monkeypox a Global Health Emergency

The U.S. and World Health Organization (WHO) have declared the monkeypox virus a global health emergency. In the U.S., a public health emergency can trigger grant funding and open up more resources for various aspects of a federal response. It also allows HHS Secretary Xavier Becerra to enter into contracts for treatments and other necessary medical supplies and equipment, as well as support emergency hospital services, among other things. read more ] read more ]

New Test Detects Immunity to COVID-19

Scientists at Enable Biosciences have developed a novel method to easily, rapidly and accurately detect neutralizing antibodies against SARS-CoV-2 from dried blood spots, named “SONIA” (Split-Oligonucleotide Neighboring Inhibition Assay). SONIA improves upon the existing gold-standard assay for neutralizing antibodies, the Plaque Reduction Neutralization Test, by eliminating the need for dangerous live viruses. read more ]

Industry News

Industry News Image

From Novavax

An emergency use authorization has been issued by the U.S. Food and Drug Administration for Novavax’s COVID-19 vaccine, adjuvanted for the prevention of COVID-19 caused by the SARS-CoV-2 virus in individuals 18 years of age and older. read more ]

From Incyte

The U.S. Food and Drug Administration has approved ruxolitinib (Opzelura) cream 1.5 percent as a treatment for nonsegmental vitiligo, the most common form of vitiligo, in adults and children ages 12 years and older. It is the first medication that can restore pigment in patients. read more ]

From Roche

Breakthrough device designation has been granted by the U.S. Food and Drug Administration for the Elecsys Amyloid Plasma Panel, an innovative new solution to enable Alzheimer’s disease to be detected earlier. The test detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing. read more ]

From Janssen

The U.S. Food and Drug Administration has expanded the use of ustekinumab injection (Stelara) for subcutaneous use to treat pediatric patients 6 years and older with psoriatic arthritis. Ustekinumab was approved for the same indication for adults in 2013. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     
Albutein Flex Bag - Grifols

What's New at FFF

CEFAZOLIN (APOTEX CORP.)

CEFAZOLIN for injection is a semi-synthetic cephalosporin for parenteral administration to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Each vial contains cefazolin sodium equivalent to 1 gram or 2 grams supplied in cartons of 25.

For more information about CEFAZOLIN, log in to biosupply.fffenterprises.com

FENTANYL CITRATE (FRESENIUS KABI)

FENTANYL CITRATE for injection is indicated for analgesic action of short duration during anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as needed; as an opioid analgesic supplement in general or regional anasthesia; for administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia; and as an anesthetic agent with oxygen in selected high-risk patients such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. The preservative-free solution is supplied in units of 10 1 mL single-dose prefilled syringes and 2 mL single-dose prefilled syringes.

For more information about FENTANYL CITRATE, log in to biosupply.fffenterprises.com

ADRENALIN (PAR PHARMACEUTICAL)

ADRENALIN (epinephrine injection) is a non-selective alpha and beta adrenergic agonist indicated for emergency treatment of allergic reactions (type 1), including anaphylaxis; and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. It is supplied in a carton containing 25 3 mL single-dose vials containing 1 mg/mL Adrenalin solution.

For more information about ADRENALIN, log in to biosupply.fffenterprises.com

EPSOLAY (DERMAVANT SCIENCES)

EPSOLAY (benzoyl peroxide cream) is indicated for the treatment of inflammatory lesions of rosacea in adults. It is supplied in an airless 30 gram pump.

For more information about EPSOLAY, log in to biosupply.fffenterprises.com

VTAMA (GALDERMA LABORATORIES)

VTAMA (tapinarof) cream 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. It is supplied in 60 gram laminated tubes.

For more information about VTAMA, log in to biosupply.fffenterprises.com

SEVENFACT (HEMA BIOLOGICS)

SEVENFACT (coagulation factor VIIa [recombinant]-jncw) is a concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. It is supplied as a room-temperature stable, white to off-white, lyophilized powder in single-use 1 mg or 5 mg vials, one vial per carton. The 1 mg vial is packaged with a pre-filled syringe containing 1.1 mL of sterile water for injection to reconstitute the diluent and one 13 mm vial adapter with a 5 micron filter. The 5 mg vial is packaged with a pre-filled syringe containing 5.2 mL of sterile water for injection to reconstitute the diluent and one 20 mm vial adapter with a 5 micron filter.

For more information about SEVENFACT, log in to biosupply.fffenterprises.com

PACLITAXEL (TWI PHARMACEUTICALS)

PACLITAXEL protein-bound particles for injectable suspension (albumin bound) is a microtubule inhibitor indicated for the treatment of: 1) metastatic disease or relapse within six months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated), 2) locally advanced or metastatic non-small cell lung cancer, as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy and 3) metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. It is supplied in a 100 mg single-dose vial individually packaged in a carton.

For more information about PACLITAXEL, log in to biosupply.fffenterprises.com

PREHEVBRIO (VBI VACCINES)

PREHEVBRIO (hepatitis B vaccine [recombinant]) is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. It is supplied in a 1.0 mL single-dose vial, or in a package of 10 single dose-vials.

For more information about PREHEVBRIO, log in to biosupply.fffenterprises.com

TWYNEO CREAM (GALDERMA)

TWYNEO CREAM (tretinoin and benzoyl peroxide) is a combination of tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. It is supplied in a 30-gram bottle with a pump.

For more information about TWYNEO CREAM, log in to biosupply.fffenterprises.com

CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL (PRASCO LABORATORIES)

CLINDAMYCIN PHOSPHATE AND TRETINOIN Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. It is supplied in 30 g and 60 g aluminum tubes.

For more information about CLINDAMYCIN PHOSPHATE/TRETINOIN GEL, log in to biosupply.fffenterprises.com

ACTHAR GEL (MALLINCKRODT PHARMACEUTICALS)

ACTHAR GEL (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age; for the treatment of exacerbations of multiple sclerosis in adults; and may be used for the following disorders and diseases: rheumatic, collagen, dermatologic, allergic states, ophthalmic, respiratory and edematous state. It is supplied in a 5 mL multi-dose vial containing 80 USP units per mL.

For more information about ACTHAR GEL, log in to biosupply.fffenterprises.com

VAZCULEP (EXELA PHARMA SCIENCES)

VAZCULEP (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. It is supplied in a strength of 10 mg/mL in a 1 mL single-use vial in packages of 10, a 5 mL vial in packages of 10 and a 10 mL vial as a single unit.

For more information about VAZCULEP, log in to biosupply.fffenterprises.com

TRANEXAMIC ACID (EXELA PHARMA SCIENCES)

TRANEXAMIC ACID in sodium chloride injection is indicated in patients with hemophilia for short-term use (i.e., 2-8 days) to reduce/prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. It is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 1,000 mg tranexamic acid in 100 mL of solution (10 mg/mL) sealed with a twist-off port and oversealed in an aluminum pouch.

For more information about TRANEXAMIC ACID, log in to biosupply.fffenterprises.com

GLYRX-PF (EXELA PHARMA SCIENCES)

GLYRX-PF is an anticholinergic indicated in 1) anesthesia (adult and pediatric patients) for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation; intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias; and for protection against peripheral muscarinic effects of cholinergic agents; and 2) in peptic ulcer (adults) as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated. It is supplied in 1 mL single-dose (0.2 mg/mL) vials packaged in 25s and 2 mL single-dose (0.4 mg/2 mL) vials packaged in 25s.

For more information about GLYRX-PF, log in to biosupply.fffenterprises.com

CAFFEINE CITRATE ORAL SOLUTION (EXELA PHARMA SCIENCES)

CAFFEINE CITRATE ORAL SOLUTION is indicated for the short-term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. It is supplied as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 5 mL colorless glass vials containing 3 mL solution at a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial).

For more information about CAFFEINE CITRATE ORAL SOLUTION, log in to biosupply.fffenterprises.com

VERAPAMIL (EXELA PHARMA SCIENCES)

VERAPAMIL is indicated for the treatment of supraventricular tachyarrhythmias, including 1) Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes); and 2) temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (WPW and LGL syndromes). It is supplied in 5 mg (2 mL) vials in a carton of five; 5 mg (2 mL) vials in a carton of 25; and 10 mg (4 mL) vials in a carton of five.

For more information about VERAPAMIL, log in to biosupply.fffenterprises.com

NIPRIDE RTU (EXELA PHARMA SCIENCES)

NIPRIDE RTU sodium nitroprusside injection is a direct acting vasodilator indicated for immediate reduction of blood pressure; producing controlled hypotension to reduce bleeding during surgery; and treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. It is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) fliptop vials, 20 mg/100 mL (0.2 mg/mL) fliptop vials and 10 mg/50 mL (0.2 mg/mL) fliptop vials.

For more information about NIPRIDE RTU, log in to biosupply.fffenterprises.com

METHYLENE BLUE (BPI LABS)

METHYLENE BLUE injection is used to treat methemoglobinemia (a blood disorder in which an abnormal amount of methemoglobin is produced). It is supplied in 10 mL single-dose vials.

For more information about METHYLENE BLUE, log in to biosupply.fffenterprises.com

LANREOTIDE (CIPLA USA)

LANREOTIDE injection is a somatostatin analog indicated for 1) the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; and 2) the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival. It is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL in single-dose prefilled syringes.

For more information about LANREOTIDE, log in to biosupply.fffenterprises.com

SENSORCAINE (FRESENIUS KABI)

SENSORCAINE (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. It is supplied in 10 mL (2.5 mg/mL, 5 mg/mL and 7.5 mg/mL) and 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials in trays of 25, as well as 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials packaged in 5.

For more information about SENSORCAINE, log in to biosupply.fffenterprises.com

ALBUTEIN FLEXBAG 5% (GRIFOLS)

ALBUTEIN 5% (human) is an albumin solution indicated for hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia and plasma exchange. It is supplied in an easy-to-use, flexible container.

For more information about ALBUTEIN FLEXBAG 5%, log in to biosupply.fffenterprises.com

PYRIMETHAMINE TABLETS (ALVOGEN)

PYRIMETHAMINE TABLETS 25 mg are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. They are supplied as tablets, each containing 25 mg pyrimethamine in bottles of 100 (NDC 47781-925-01) and 30 (NDC 47781-925-30) and in 30-count unit-dose blister cartons (NDC 47781-925-31).

For more information about PYRIMETHAMINE TABLETS, log in to biosupply.fffenterprises.com

VAXELIS (SANOFI PASTEUR)

VAXELIS is a three-dose vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years old. It is supplied in a single-dose vial in packages of 10 and a 0.5 mL single-dose prefilled syringe with a Luer lock connection and a tip cap without a needle in packages of 10.

For more information about VAXELIS, log in to biosupply.fffenterprises.com

These products can be ordered from FFF Enterprises' BioSupply Online Ordering System or by calling
Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective July 1, 2022, through September 30, 2022.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
 
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA DIF J1572 $81.04 $79.74
GAMMAGARD SD J1566 $146.35 $144.00
GAMMAPLEX J1557 $96.68 $95.13
OCTAGAM J1568 $84.04 $82.69
PANZYGA 90283 / J1599 $138.70 $136.48
PRIVIGEN J1459 $93.87 $92.36
 
CUTAQUIG J1551 $120.28 $118.35
CUVITRU J1555 $149.71 $147.31
HIZENTRA J1559 $123.47 $121.49
HYQVIA J1575 $158.94 $156.39
XEMBIFY J1558 $135.69 $133.51
 
GAMMAGARD LIQUID J1569 $89.99 $88.55
GAMMAKED J1561 $86.78 $85.39
GAMUNEX-C J1561 $86.78 $85.39

*ASP + 4.3% applies only after July 1, 2022. On April 1, 2022, a 1% reduction in payment will apply until July 1, 2022, unless further Congressional action is taken to extend the moratorium.

 

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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BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace.

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