Experts who advise the U.S. Food and Drug Administration (FDA) on vaccine-related issues voted unanimously to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so. The Vaccines and Related Biological Products Advisory Committee has been pushing for the removal of one of the influenza B components in flu vaccines, the portion that targeted B/Yamagata viruses, for some time now since these viruses haven’t been detected anywhere in the world since late March 2020, when the COVID-19 pandemic lockdowns and social distancing appeared to have halted circulation of this family of lineage of flu B. [ read more ]

New COVID Vaccine Dose Is Now Available for People Age 65 and Older

Older adults age 65 and older can now get another COVID vaccine this spring, after the Centers for Disease and Control and Prevention formally recommended an extra shot for this age group. The additional vaccine being offered is another dose of the same updated COVID vaccine that became widely available last fall for everyone age 6 months and older. [ read more ]

With Measles Cases on the Rise, CDC Urges Vaccination

At least 45 cases of measles have been reported in the U.S. across 17 states so far this year, according to a report by the Centers for Disease Control and Prevention, marking one of the steepest increases in recent history of the virus at this time of the year and highlighting the importance of measles vaccination that has declined in many parts of the country. [ read more ]

IQVIA Study Highlights Importance of Adult Vaccinations

Despite their overall health benefits, U.S. adult vaccination rates remain alarmingly low, especially among those enrolled in Medicaid programs, with rates for the flu vaccine in this group nearly eight to 10 percent lower than the general population, with that rate increasing to 30 percent when compared to individuals with Medicare coverage, according to a report published by IQVIA. As a result, the team of researchers stressed the importance of strengthening vaccination coverage for this group of people. [ read more ]

From argenx

The U.S. Food and Drug Administration has accepted for priority review a supplemental biologics license application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy. [ read more ]

From KORU Medical Systems

KORU Medical Systems has entered into a clinical supply agreement related to a novel subcutaneous immune globulin (SCIG) drug, now proceeding to a Phase III trial that will evaluate the drug’s safety, efficacy and performance across a variety of medical conditions, including autoimmune diseases, primary immunodeficiency disorders and neurological disorders. KORU has developed a custom device for the trial, which is based on the company’s existing Freedom System but tailored to the specific requirements of the new drug. [ read more ]

From Fresenius Kabi

The U.S. Food and Drug Administration (FDA) has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech) to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Tyenne is the first tocilizumab biosimilar to be approved by FDA for intravenous and subcutaneous use. [ read more ]

• IXCHIQ (VALNEVA USA)

IXCHIQ is a vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. It is supplied in a carton containing one single-dose vial of lyophilized antigen component, live, and one prefilled ungraduated syringe of sterile water diluent component (packaged without needles).

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• AMPHOTERICIN B (XGEN)

AMPHOTERICIN B for injection is specifically intended to treat potentially life-threatening fungal infections: aspergillosis; cryptococcosis (torulosis); North American blastomycosis; systemic candidiasis; coccidioido-mycosis; histoplasmosis; zygomycosis, including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus; and infections due to related susceptible species of Conidiobolus and Basidiobulus and sporotrichosis. It is supplied as single vials providing 50 mg amphotericin B as a yellow to orange lyophilized cake (which may partially reduce to powder following manufacture).

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• HEPARIN SODIUM (MEITHEAL PHARMACEUTICALS)

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 transfusion, extracorporeal circulation and dialysis procedures. It is supplied in single-dose vials in 1,000, 5,000 and 10,000 USP units per mL, and multi-dose vials in 10,000 USP units per 10 mL, 30,000 units per 30 mL, 50,000 units per 10 mL and 40,000 USP units per 4 mL, packaged in 25 vials per carton.

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• HIBERIX (GLAXOSMITHKLINE)

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenza type b in children aged 6 weeks through 4 years (prior to fifth birthday). HIBERIX vial and vial presentation is supplied in a carton packaged without syringes or needles containing 10 single-dose vials of lyophilized antigen component and 10 single-dose vials of sterile saline diluent. HIBERIX vial and prefilled syringe presentation is supplied in a carton containing 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated TIP-LOK syringes of sterile saline diluent packaged without needles.

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• WINRHO SDF (KAMADA INC.)

WINRHO SDF is a Rho(D) immune globulin intravenous (IGIV; human) indicated for immune thrombocytopenic purpura (ITP) to raise platelet counts in Rho(D) positive, non-splenectomized children with chronic or acute ITP, adults with chronic ITP and children and adults with ITP secondary to HIV infection; and as a suppression of Rhesus (Rh) isoimmunization in pregnancy and other obstetric conditions in non-sensitized Rho(D) negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in obstetric complications or invasive procedures, and incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells. It is supplied in cartons containing a single-dose vial of 600 IU (120 mcg), 1,500 IU (300 mcg), 2,500 IU (500 mcg), 5,000 IU (1,000 mcg) or 15,000 IU (3,000 mcg) anti-Rho(D) IGIV and a package insert.

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• IVERMECTIN (MAYNE PHARMA)

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

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• ISOTRETINOIN CAPSULES (MAYNE PHARMA)

ISOTRETINOIN CAPSULES are indicated for the treatment of severe recalcitrant nodular acne. They are supplied in boxes of 30 with three prescription packs of 10 mg, 20 mg, 30 mg or 40 mg capsules.

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• BIJUVA (MAYNE PHARMA)

BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. It is supplied as 0.5 mg/100 mg capsules and 1 mg/100 mg capsules in blister packages of 30.

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• MELPHALAN HYDROCHLORIDE (APOTEX CORP)

MELPHALAN HYDROCHLORIDE for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It is supplied in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.

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• CUPRIC CHLORIDE (EXELA PHARMA SCIENCES)

CUPRIC CHLORIDE injection, USP 0.4 mg/mL, is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition to help maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. It is supplied in 10 mL plastic vials in cartons of 10 and 25.

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• ZINC CHLORIDE (EXELA PHARMA SCIENCES)

ZINC CHLORIDE injection, USP 1 mg/mL, is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition to help maintain zinc serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. It is supplied in an individual 10 mL vial or in cartons of 25 10 mL vials.

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• POTASSIUM ACETATE (EXELA PHARMA SCIENCES)

POTASSIUM ACETATE injection, USP 2 mEq/mL, is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake; it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. It is supplied in 100 mEq/50 mL and 200 mEq/100 mL clear glass vials in cartons of one and 25.

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• POTASSIUM PHOSPHATES (AMNEAL PHARMACEUTICALS)

POTASSIUM PHOSPHATES injection is a phosphorus replacement product indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated; and for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. It is supplied in 15 mmol/5 mL and 22 mEq/5 mL single-dose polypropylene vials in 5 and 25 units; 45 mmol/15 mL and 66 mEq/15 mL 20 mL single-dose polypropylene vials in 10 and 25 units; and 150 mmol/50 mL and 220 mEq/50 mL bulk package polypropylene vials in 10 and 25 units.

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• GAMMAGARD LIQUID (BAXALTA)

GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as a replacement therapy for primary humoral immunodeficiency in adult and pediatric patients 2 years of age or older; maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy; and therapy to improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy. It is supplied in 10 mL, 25 mL, 50 mL, 100 mL, 200 mL and 300 mL single-use bottles.

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• BALFAXAR (OCTAPHARMA USA)

BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. It is supplied in a package with either a 20 mL or a 40 mL single-dose vial of lyophilized powder and a vial of diluent (sterile water for injection), together with a transfer device.

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• ZEMAIRA (CSL BEHRING)

ZEMAIRA is an alpha1-proteinase inhibitor (A₁-PI; human) indicated for chronic augmentation and maintenance therapy in adults with A₁-PI deficiency and clinical evidence of emphysema. It is supplied in single-dose vials containing 1,000 mg, 4,000 mg or 5,000 mg functionally active A₁-PI.

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• COMIRNATY (PFIZER-BIONTECH)

COMIRNATY (mRNA) 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 single-dose glass prefilled syringes, single-dose plastic prefilled syringes and single-dose vials.

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• CARBOPLATIN (BPI LABS)

CARBOPLATIN injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. It is supplied in 5 mL fill in 10 mL, 15 mL fill in 20 mL, 45 mL fill in 50 mL and 60 mL fill in 100 mL multiple-dose vials.

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• CISPLATIN (ACCORD HEALTHCARE)

CISPLATIN injection is a platinum-based drug indicated for the treatment of advanced testicular cancer, advanced ovarian cancer and advanced bladder cancer. It is supplied in 50 mg/50 mL (1 mg/mL) multiple-dose amber vials.

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• YCANTH™ (VERRICA PHARMACEUTICALS)

YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is supplied in a sealed glass ampule contained within a single-use applicator and enclosed in a protective paperboard sleeve. Each ampule contains 7 mg/mL of YCANTH.

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• NOVAVAX COVID-19 VACCINE (NOVAVAX, INC)

The Novavax COVID-19 Vaccine (Adjuvanted/Protein Subunit) is a vaccine indicated for active immunization to prevent coronavirus disease (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 boxes of 10 doses of two 2.5mL-5 dose multi-dose vials.

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• AREXVY (GLAXOSMITHKLINE)

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied as two components: a single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles) in cartons of 10 vials.

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• ABRYSVO (PFIZER INC.)

ABRYSVO is a vaccine indicated for active immunization for the prevention of lower respiration tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied in a kit that includes a vial of lyophilized antigen component, a prefilled syringe containing sterile water diluent component and a vial adapter in cartons of one, five and 10 kits.

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• INDOCIN (ASSERTIO)

INDOCIN is a nonsteroidal anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; moderate to severe osteoarthritis; acute painful shoulder (bursitis and/or tendinitis); and acute gouty arthritis. The 50 mg suppositories (indomethacin suppositories USP) are white, opaque and rectal supplied in boxes of 30.

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• 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.

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• 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.

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 January 1, 2024, through March 31, 2024.

Resources

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