FDA Approves Furoscix

Furoscix^® (furosemide 80mg/10mL – scPharmaceuticals) injection was approved by the U.S. Food and Drug Administration (FDA) on Oct. 7, 2022. A new formulation of a loop diuretic that was first FDA-approved in the 1960s, is indicated to relieve worsening congestion that results from fluid overload associated with NYHA Class II or Class III chronic heart failure in adult patients. Packaged in single-dose cartridges that fit into a one-use infusion device that adheres to the skin of the abdomen, Furoscix allows for subcutaneous (SC) self-administration of the medication. Previously, injectable furosemide had to be delivered by intravenous (IV) infusions in a healthcare facility. Each cartridge of Furoscix releases 30mg of furosemide over one hour, followed by 12.5mg/hr for the next four hours, providing a total dose of 80mg. Patients should not bend or move excessively while wearing the device, and they should not use it while sitting in a vehicle. The device should not get wet. It should not be activated within 12 inches of an electronic device, such as a cellphone or computer. Furoscix is not for emergency use, for patients who have acute pulmonary edema, or for long-term administration. Patients should be transitioned to an oral form of furosemide as soon as possible. The launch is expected during the first quarter of 2023, but the cost has not yet been announced. Here is its prescribing information.

FDA Approves Boostrix During Late Pregnancy

GlaxoSmithKline Biologicals’ combination booster vaccine, Boostrix (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine, adsorbed) injection, got an extension of its FDA approval on Oct. 7, 2022. Also known as Tdap, Boostrix is indicated to enhance immunity when given five years or longer after the patient’s last dose of diphtheria/tetanus toxoids/acellular pertussis (DTaP). Already approved for use to protect the woman during pregnancy, Boostrix now is indicated specifically for administration to women who are in the last three months before giving birth, so that their babies will have protection against pertussis (whooping cough). Children cannot begin to receive the three-dose DTaP immunizations until they are two months old. The FDA estimates that significant percentages of hospitalizations and deaths due to pertussis each year are in infants too young to be vaccinated. Boostrix is approved as one dose given as an intramuscular (IM) injection for children at least 10 years old, teens and adults. It also can be given as one additional dose nine years or more following its first injection. For detailed prescribing information, look here.

Bivalent mRNA COVID Vaccines Authorized for Children

The emergency use authorizations (EUA) for the two bivalent, mRNA-based COVID-19 vaccine boosters now include children younger than 12 years old. On Oct. 12, 2022, the FDA extended the authorizations for Moderna’s COVID-19 Vaccine, Bivalent, to children ages six years and older and for Pfizer/BioNTech’s bivalent COVID-19 vaccine to children at least five years old. The Centers for Disease Control and Prevention (CDC) endorsed the expansions on the same day. Because the new boosters are bivalent, they can protect against the widely circulating BA.4 and BA.5 variations of the SARS-CoV-2 virus’ Omicron variation, as well as against its original, Alpha form. Either booster is given as one injection at least 60 days following the patient’s last dose of the initial vaccine series or a previous booster. Pfizer/BioNTech’s original, monovalent vaccine no longer is authorized for boosting immunity among five-year-olds to 11-year-olds, and neither company’s bivalent boosters should be used for primary vaccination. Their original monovalent injections remain the standard of care for initial vaccinations as a two-dose series for patients as young as six months old. A revised Prescriber’s Fact Sheet for Moderna’s bivalent vaccine is here; an updated one for patients and caregivers is here. Current Fact Sheets about the Pfizer/BioNTech bivalent product are here for providers and here for patients and caregivers. Here is general information on bivalent vaccines.

MedWatch Update

Generic Immediate-Release Adderall

On Oct. 12, 2022, the FDA issued communication about generic versions for the immediate-release (IR) form of Adderall®. One of the main companies that manufacture generics for the C-II controlled substance, which may be called amphetamine/dextroamphetamine, mixed amphetamine salts or amphetamine aspartate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate is production issues that limit its ability to deliver the product. Although the brand and generics from other companies are still being made, the supply does not meet the current demand for the drug. Only the IR form is affected; however. Presently, sufficient amounts of long-acting amphetamine salts continue to be available. Healthcare providers may need to write new prescriptions substituting another drug or dosage form for their patients who take an IR Adderall generic while the FDA helps manufacturers to end the shortage as soon as possible. More information is in the FDA’s notice.