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Monday, July 17, 2023

Sanofi’s mRNA Influenza Vaccine Clinical Trial Unsuccessful

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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Current clinical trials of Sanofi's mRNA technology behind the most successful COVID-19 vaccines show they will not be effective against influenza; Sanofi is now working on a next generation of vaccines.read more ]

 
Heparin - Techdow Advertisement in eBST newsletter July 2023
 

mRNA Vaccine Plus Keytruda Reduces Spread of Melanoma

Adding an experimental mRNA-based vaccine developed by Moderna and Merck & Co to Keytruda reduced the risk that melanoma would spread by 65 percent over treatment with the immunotherapy drug alone, according to a mid-stage trial. read more ]

 

Genetic Variant Identified That Increases Disease Severity in MS

A new study has identified a genetic variant of multiple sclerosis (MS) that increases disease severity, an advance that researchers say offers a key step toward understanding and eventually fighting the progressive form of MS. read  more ]

Industry News

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From Moderna

Moderna has applied for U.S. Food and Drug Administration approval of its updated COVID vaccine, which targets omicron subvariant XBB.1.5, the dominant strain of the virus nationwide and the most immune-evasive strain to date. read more ]

From argenx

argenx's subcutaneous formulation Vyvgart has been approved by the U.S. Food and Drug Administration to treat generalized myasthenia gravis (gMG). Vyvgart (efgartigimod) was the first in a new class of medication approved by FDA in 2021 as a one-hour intravenous infusion for gMG patients positive for the anti-acetylcholine receptor antibody. The new subcutaneous formulation is a single injection for four weeks. read more ]

From Takeda Pharmaceuticals

The U.S. Food and Drug Administration has approved a supplemental biologics license application to expand the use of HYQVIA (immune globulin infusion 10% [human] with recombinant human hyaluronidase) to treat primary immunodeficiency in children 2 years to 16 years old. read more ]

From Novartis

Sandoz has announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection is now available in the United States as of July 1. Hyrimoz HCF (100 mg/mL) is approved to treat all indications no longer covered by the regulatory exclusivity for the reference medicine, Humira (adalimumab), as of July 1, 2023, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

Moderna COVID-19 Vaccine (MODERNA U.S. Inc.)

Moderna COVID-19 Vaccine is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is supplied in cartons of 10 5.5 mL multiple-dose vials and cartons of 10 7.5 mL multiple-dose vials.

For more information about Moderna COVID-19 Vaccine, log in to biosupply.fffenterprises.com

MENVEO ONE-VIAL (GLAXOSMITHKLINE)

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 months through 55 years of age. It is supplied in cartons containing five vials of MenCYW-135 liquid conjugate component and cartons containing five vials of MenA lyophilized conjugate component.

For more information about MENVEO ONE-VIAL, log in to biosupply.fffenterprises.com

CALCIPOTRIENE FOAM (MAYNE PHARMA)

CALCIPOTRIENE FOAM is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. It is supplied in a 60 gram aluminum can.

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

SORILUX FOAM (MAYNE PHARMA)

SORILUX FOAM is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. It is supplied in 60 gram and 120 gram aluminum cans.

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

REGADENOSON (PFIZER)

REGADENOSON injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It is supplied as a sterile, preservative-free, clear and colorless solution containing 0.08 mg/mL REGADENOSON in a bundle of 10 5 mL single-dose prefilled plastic Ansyr syringes with a luer-lock fitting.

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

REBINYN (NOVO NORDISK)

REBINYN (coagulation factor IX [recombinant], GlycoPEGylated) is a recombinant DNA-derived coagulation factor IX concentrate indicated for use in adults and children with hemophilia B (congenital factor IX deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes. It is supplied in packages comprised of a single-dose vial containing nominally 500, 1000, 2000 or 3000 IU of factor IX potency; a MixPro prefilled diluent syringe containing 10 mM histidine solution (1.6 mg/mL), and a sterile vial adapter with 25 micrometer filter, which serves as a needleless reconstitution device.

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

DICLOFENAC EPOLAMINE TOPICAL SYSTEM (YARAL PHARMA)

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug indicated for the topical treatment of acute pain due to minor strains, sprains and contusions in adults and pediatric patients 6 years and older. It is supplied in resealable envelopes, each containing five topical systems (10 cm x 14 cm) with six envelopes per box.

For more information about DICLOFENAC EPOLAMINE TOPICAL SYSTEM, log in to biosupply.fffenterprises.com

NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION (XGEN PHARMACEUTICALS DJB)

NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION for irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. It is supplied as 1 mL/ampul in boxes of 10 mL, 50 mL and 20 mL multiple-dose vials in single vial cartons.

For more information about NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION, log in to biosupply.fffenterprises.com

DOXYCYCLINE (MAYNE PHARMA)

DOXYCYCLINE is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. It is supplied in a bottle of 30 beige opaque capsules imprinted with "GLD 40," each containing an amount equivalent to 40 mg of anhydrous doxycycline.

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

DORYX MPC (MAYNE PHARMA)

DORYX MPC is a tetracycline-class drug indicated for the treatment of rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy in acute intestinal amebiasis and severe acne; and prophylaxis of malaria. The DORYX MPC (doxycycline hyclate delayed-release) 60 mg and 120 mg tablets are white, oval tablets containing yellow pellets and debossed with "D6" on one face and plain on the other. The 60 mg tablets are supplied in bottles of 60 and 120, and the 120 mg tablet is supplied in bottles of 30.

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

ALTUVIIIO (BIOVERATIV THERAPEUTICS)

ALTUVIIIO (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) is a recombinant DNA-derived, factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding. It is supplied in kits comprising a single-dose vial containing nominally 250, 500, 750, 1000, 2000, 3000 or 4000 IU of factor VIII potency, a prefilled syringe with 3 mL sterile water for injection and a sterile vial adapter (reconstitution device).

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

ADAPALENE AND BENZOYL PEROXIDE GEL (MAYNE PHARMA)

ADAPALENE AND BENZOYL PEROXIDE GEL is a combination of adapalene, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris. It is supplied in a 45 gram pump.

For more information about ADAPALENE AND BENZOYL PEROXIDE GEL, log in to biosupply.fffenterprises.com

TACROLIMUS OINTMENT (MAYNE PHARMA)

TACROLIMUS OINTMENT 0.1% and 0.03% for adults and 0.03% for children aged 2 years to 15 years are indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. It is supplied in 60 gram and 100 gram laminate tubes.

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

DAPSONE GEL (MAYNE PHARMA)

DAPSONE GEL 7.5% is a sulfone indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. It is supplied in 60 gram and 90 gram airless polypropylene pumps containing a polypropylene bottle with a high-density polyethylene piston.

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

ADAPALENE CREAM (MAYNE PHARMA)

ADAPALENE CREAM 0.1% is indicated for the topical treatment of acne vulgaris. It is supplied in a 45 gram tube.

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

LIDOCAINE HYDROCHLORIDE 4% (SINTETICA US LLC)

LIDOCAINE HYDROCHLORIDE injection 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. It may be injected trans-tracheally to anesthetize the larynx and trachea, and it may be administered by retrobulbar injection to provide anesthesia for ophthalmic surgery. It is supplied in a pack of 10 200 mg/5 mL single-dose ampules.

For more information about LIDOCAINE HYDROCHLORIDE 4%, log in to biosupply.fffenterprises.com

LIDOCAINE HYDROCHLORIDE 1%/2% (SINTETICA US LLC)

LIDOCAINE HYDROCHLORIDE injection 1% and 2% are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal, and by central neural techniques such as lumbar and caudal epidural blocks when the accepted procedures for these techniques as described in standard textbooks are observed. The 1% injection is supplied in a pack of 10 20 mg/2mL, 50 mg/5 mL and 100 mg/10 mL single-dose ampules. The 2% injection is supplied in 40 mg/2 mL, 100 mg/5 mL and 200 mg/10 mL single-dose ampules.

For more information about LIDOCAINE HYDROCHLORIDE 1%/2%, log in to biosupply.fffenterprises.com

HEPARIN SODIUM (TECHDOW)

HEPARIN SODIUM injection is an anticoagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; atrial fibrillation with embolization; treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism; and use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures. It is supplied in a concentration of 1,000 mL in 2 mL single-dose vials and 1 mL, 10 mL and 30 mL multiple-dose vials; in a concentration of 5,000 mL in 1 mL and 10 mL multiple-dose vials; in a concentration of 10,000 mL in 1 mL and 5 mL multiple-dose vials; and in a concentration of 20,000 mL in 1 mL multiple-dose vials.

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

IVERMECTIN CREAM (PADAGIS)

IVERMECTIN CREAM is indicated for the treatment of inflammatory lesions of rosacea. The 1% white to pale yellow cream is supplied in a 45 gram laminated tube with a child-resistant cap.

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

METHYLPREDNISOLONE ACETATE (AMNEAL PHARMACEUTICALS)

METHYLPREDNISOLONE ACETATE injectable suspension is indicated for 1) control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness and transfusion reactions; 2) dermatologic diseases, including bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome); 3) endocrine disorders, including primary or secondary adrenocortical, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsupportive thyroiditis; 4) gastrointestinal diseases, including regional enteritis (systemic therapy) and ulcerative colitis; 5) hematologic disorders, including acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia and select cases of secondary thrombocytopenia; 6) trichinosis with neurologic or myocardial involvement and tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; 7) neoplastic diseases, including leukemias and lymphomas; 8) cerebral edema associated with primary or metastatic brain tumor or craniotomy; 9) ophthalmic diseases, including sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; 10) to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus; 11) respiratory diseases, including berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias and symptomatic sarcoidosis; and 12) as adjunctive therapy for short-term administration in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis, including juvenile rheumatoid arthritis, and as treatment of dermatomyositis, polymyositis and systemic lupus erythematosus. It is supplied as a white to off-white homogenous suspension in 40 mg/mL and 80 mg/mL single-dose vials in cartons of 25.

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

ARTESUNATE (AMIVAS INC.)

ARTESUNATE for injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients. It is supplied as a white or almost white, sterile, fine crystalline powder for constitution in 110 mg single-dose, clear glass vials sealed with a rubber stopper and an aluminum overseal.

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

KETALAR (PAR PHARMACEUTICAL)

KETALAR (ketamine hydrochloride) injection for intravenous or intramuscular use is a general anesthetic indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation; for the induction of anesthesia prior to the administration of other general anesthetic agents; and as a supplement to other anesthetic agents. The clear, colorless solution is supplied as the hydrochloride salt in concentrations equivalent to 200 mg in 20 mL multiple-dose vials, 500 mg in 10 mL multiple-dose vials and 500 mg in 5 mL multiple-dose vials, all of which come in units of 10.

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

MENQUADFI (SANOFI)

MENQUADFI meningococcal (groups A, C, Y, W) conjugate vaccine solution for intramuscular injection is indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y for use in individuals 2 years of age and older. It is supplied in a single-dose vial in packages of five vials.

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

SODIUM BICARBONATE (EXELA PHARMA SCIENCES)

SODIUM BICARBONATE injection, USP, is indicated 1) in the treatment of metabolic acidosis that may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis, 2) in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products and 3) in severe diarrhea that is often accompanied by a significant loss of bicarbonate. It is supplied in 50 mL vials with either 20 or 25 vials per carton, and 10 mL vials with 25 vials per carton.

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

PRIORIX (GLAXOSMITHKLINE)

PRIORIX (vaccine, live) is indicated for active immunization for the prevention of measles, mumps and rubella in individuals 12 months of age and older. It is supplied in a box containing 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated syringes of sterile water diluent (packaged without needles). After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX.

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

EPINEPHRINESNAP™-EMS Kit (SNAP MEDICAL INDUSTRIES)

EpinephrineSnap™-EMS is an epinephrine convenience kit designed to treat a single episode of an allergic reaction/anaphylaxis. The epinephrine in this kit is a non-selective alpha and beta adrenergic agonist indicated for the emergency treatment of allergic reactions, including anaphylaxis. The kit is supplied with (1) vial of epinephrine injection, (4) alcohol prep pads, (2) 23-gauge, 1-inch safety needles, (2) 1 mL luer lock Epinephrine Syringes™, and (1) instructions for use card.

For more information about EPINEPHRINESNAP™-EMS Kit, log in to biosupply.fffenterprises.com

EPINEPHRINESNAP™-V Kit (SNAP MEDICAL INDUSTRIES)

EpinephrineSnap™-V is an epinephrine convenience kit designed to treat a single episode of an allergic reaction/anaphylaxis. The epinephrine in this kit is a non-selective alpha and beta adrenergic agonist indicated for the emergency treatment of allergic reactions, including anaphylaxis. The kit is supplied with (1) vial of epinephrine injection, (4) alcohol prep pads, (3) 23-gauge, 1-inch safety needles, (3) 1 mL luer lock Epinephrine Syringes™, and (1) instructions for use card.

For more information about EPINEPHRINESNAP™-V Kit, 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

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

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, 2023, through Sept. 30, 2023.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV J1554 $982.81 $967.05
BIVIGAM J1556 $145.93 $143.59
FLEBOGAMMA DIF J1572 $112.23 $110.43
GAMMAGARD SD J1566 $155.53 $153.04
GAMMAPLEX J1557 $118.97 $117.06
OCTAGAM J1568 $88.24 $86.82
PANZYGA 90283 / J1599 $131.48 $129.37
PRIVIGEN J1459 $95.98 $94.44
SCIG
CUTAQUIG J1551 $143.86 $141.55
CUVITRU J1555 $162.75 $160.14
HIZENTRA J1559 $128.03 $125.98
HYQVIA J1575 $166.55 $163.88
XEMBIFY J1558 $139.99 $137.74
IVIG / SCIG
GAMMAGARD LIQUID J1569 $92.06 $90.59
GAMMAKED J1561 $101.28 $99.66
GAMUNEX-C J1561 $101.28 $99.66
 

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

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