Monday, January 18, 2021

Early High-Titer Convalescent Plasma Effective in Reducing COVID-19 Infection in Mildly Ill Seniors

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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
 

Results from a recent study showed early administration (within 72 hours) of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected seniors reduced COVID-19 progression. read more ]

CDC Issues COVID-19 Vaccine Guidelines for Individuals with Underlying Health Conditions

Because "adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19," the Centers for Disease Control and Prevention (CDC) has issued new guidance that states a COVID-19 vaccine may be administered to these individuals "provided they have not had a severe allergic reaction to any of the ingredients in the vaccine." This includes people with weakened immune systems due to other illnesses or medication, HIV and autoimmune conditions, but it should be known that limited safety data is available on the effects of the vaccines on these individuals. read more ]

Researchers Discover Possible Reason for COVID-19 Vaccine Allergic Reactions

Scientists have identified the compound polyethylene glycol (also known as PEG) as the potential culprit causing the allergic reactions to the COVID-19 vaccines. In both the Pfizer-BioNTech and Moderna vaccines, PEG is part of the fatty envelope that surrounds the messenger RNA, the main ingredient in the vaccine. PEG is found in other drugs and is known to trigger anaphylaxis on rare occasions. read more ]

Industry News

 
Industry News Image
 

From Novavax

Novavax has begun a Phase III study of its COVID-19 vaccine with a goal of enrolling 30,000 volunteers in the U.S. and Mexico. The vaccine is made from a stabilized form of the coronavirus spike protein using the company's recombinant protein nanoparticle technology.  [ read more ]

From Johnson & Johnson

Johnson & Johnson is testing a coronavirus vaccine known as JNJ-78436735 or Ad26.COV2.S. The vaccine is based on the virus's genetic instructions for building the SARS-CoV-2 spike protein. But unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Johnson & Johnson vaccine uses double-stranded DNA. Results from a clinical trial are expected in January. read more ]

From AstraZeneca

AstraZeneca and the University of Oxford have developed a COVID-19 vaccine using the same viral-vector technology as Johnson & Johnson, in which a modified virus triggers an immune response. The vaccine was approved in the United Kingdom at the end of December and began distribution the first week of January, and the company says it "should be effective" on the variant first discovered there. The vaccine is cheaper than others and does not need to be kept at ultra-low temperatures required by the Pfizer and Moderna vaccines. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

DOCETAXEL (HOSPIRA INC.)

DOCETAXEL injection is indicated for treatment of patients with 1) locally advanced or metastatic breast cancer after failure of prior chemotherapy, and in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node-positive breast cancer; 2) locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy, and in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition; 3) metastatic castration-resistant prostate cancer in combination with prednisone; 4) advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease; and 5) locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and fluorouracil. It is supplied in 20 mg/1 mL single-dose vials, and 80 mg/4 mL and 160 mg/8 mL multiple-dose vials as a sterile, pyrogen-free, non-aqueous pale-yellow to brownish yellow solution.

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

DIAZEPAM (HOSPIRA INC.)

DIAZEPAM injection is indicated for 1) relief of acute anxiety when rapid action is required; 2) acute alcohol withdrawal; 3) a useful adjunct in endoscopic procedures, skeletal muscle spasm associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome and tetanus, as well as status epilepticus and severe recurrent convulsive seizures; and 4) premedication in patients undergoing surgical procedures and cardioversion. It is supplied in 10 mL multiple-dose vials containing 50 mg (5 mg/mL).

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

LABETALOL HYDROCHLORIDE (HOSPIRA INC.)

LABETALOL HYDROCHLORIDE injection, UPS, is indicated for control of blood pressure in severe hypertension. It is supplied in a 4 mL (20 mg) Carpuject single-dose cartridge with a Luer Lock.

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

0.9% SODIUM CHLORIDE (HOSPIRA INC.)

0.9% SODIUM CHLORIDE, injection, USP, is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. It is supplied in tubs of 25 Carpuject single-dose cartridges with Luer Lock containing 3 mL or 5 mL; a tub of 50 Carpuject single-dose cartridges with Luer Lock containing 2 mL; in trays of 25 single-dose plastic fliptop vials containing 10 mL, 20 mL or 50 mL; and a tray of 25 single-dose LifeShield plastic fliptop vials containing 10 mL.

For more information about 0.9% SODIUM CHLORIDE, log in to biosupply.fffenterprises.com

ZILRETTA (FLEXION THERAPEUTICS)

ZILRETTA (triamcinolone acetonide injectable suspension) is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is supplied as 1) a 5 mL single-dose vial to deliver 32 mg of triamcinolone acetonide supplied as a sterile white to off-white powder in a clear vial, and 2) a 5 mL single-dose vial supplied as a sterile, clear liquid solution of 0.9% w/w sodium chloride (normal saline) containing 0.5% w/w sodium carboxymethylcellulose, and 0.1% w/w polysorbate-80 in a glass vial.

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

FENTANYL CITRATE (HOSPIRA INC.)

FENTANYL CITRATE injection is indicated for 1) analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises; 2) use as an opioid analgesic supplement in regional anesthesia; 3) 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 4) use 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. It is supplied in single-dose glass containers as clamcells of (10) 2 mL and 5 mL single-dose ampules; trays containing (25) 2 mL, 5 mL, 10 mL, 20 mL and 50 mL single-dose fliptop vials; and cartons containing (5) 10 mL and 20 mL single-dose ampules.

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

XERAVA (ERAVACYCLINE) (TETRAPHASE PHARAMACEUTICALS)

XERAVA (ERAVACYCLINE) for injection is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. The yellow to orange sterile, preservative-free powder for reconstitution is supplied in single-dose 10 mL clear glass vials in 50 mg and 100 mg doses with a rubber stopper and an aluminum overseal.

For more information about XERAVA (ERAVACYCLINE), log in to biosupply.fffenterprises.com

PROTONIX I.V. (PFIZER)*

PROTONIX I.V. (pantoprazole sodium) for injection is indicated in adults for 1) short-term treatment (seven to 10 days) of gastroesophogeal reflex disease associated with a history of erosive esophagitis, and 2) pathological hypersecretion conditions, including Zollinger-Ellison syndrome. It is supplied as a single-dose vial as a white to off-white freeze-dried powder for reconstitution containing 40 mg of pantoprazole in packages of 10 and 25 vials.

For more information about PROTONOX I.V., log in to biosupply.fffenterprises.com
*Call for eligibility through your GPO affiliation.

SULFAMETHOXAZOLE AND TRIMETHOPRIM (SOMERSET THERAPEUTICS)

SULFAMETHOXAZOLE and TRIMETHOPRIM injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients 2 months of age and older for treatment of infections caused by designated, susceptible bacteria. It is supplied in 5 mL single-dose and 10 mL and 30 mL multiple-dose vials, with each 5 mL dose containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.

For more information about SULFAMETHOXAZOLE and TRIMETHOPRIM, log in to biosupply.fffenterprises.com

DEXMEDETOMIDINE HYDROCHLORIDE (BAXTER)

DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection is a relatively selective alpha2-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting, and sedation of nonintubated patients prior to and/or during surgical and other procedures. It is available as 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL GALAXY containers, respectively.

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

IXINITY (APTEVO BIOTHERAPEUTICS)

IXINITY (coagulation factor IX [recombinant]) is a human blood coagulation factor indicated for adults and children 12 years and older with hemophilia B for control and prevention of bleeding episodes and perioperative management. It is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). Kits include one single-use vial (containing nominally 250, 500, 1000, 1500, 2000 and 3000 IU per vial), a 10 mL syringe prefilled with 5 mL of sterile water for injection with plunger rod attached, and a vial adapter with filter.

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

HIZENTRA PRE-FILLED SYRINGES (CSL BEHRING)

HIZENTRA (immune globulin subcutaneous [human] 20% liquid) PRE-FILLED SYRINGES for primary immunodeficiency patients are ready to use, eliminating the need to transfer the drug from the vial to a syringe. The syringes come in 5 mL and 10 mL (fully assembled) and 20 mL (requiring the plunger rod to be screwed onto the syringe stopper prior to use).

For more information about HIZENTRA PRE-FILLED SYRINGES, log in to biosupply.fffenterprises.com

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

Current Medicare IVIG / SCIG Rates

Rates per gram are effective Jan. 1, 2021, through March 30, 2021.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV 90283 / J1599 ** **
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA J1572 $73.72 $72.54
GAMMAGARD SD J1566 $133.94 $131.80
GAMMAPLEX J1557 $99.62 $98.02
OCTAGAM J1568 $83.26 $81.93
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $84.85 $83.49
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $139.44 $137.20
HIZENTRA J1559 $110.94 $109.16
HYQVIA J1575 $143.36 $141.06
XEMBIFY J1558 $146.87 $144.51
IVIG / SCIG
GAMMAGARD LIQUID J1569 $87.25 $85.85
GAMMAKED J1561 $87.35 $85.95
GAMUNEX-C J1561 $87.35 $85.95

* Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
** ASP-based Medicare payment rate not yet available; payment rate assigned by your Medicare Administrative Contractor.

 

Resources

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

•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

Subscribe to IG Living

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Trends Quarterly

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

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