RICHMOND, Va.--(BUSINESS WIRE)--Phlow, a U.S.-based, public benefit impact-driven pharmaceutical company, announced the launch of key essential medicines, sequentially over the coming quarter, for the Children’s Hospital Coalition™ (CHC), a first-in-kind coalition of leading pediatric institutions. The availability of these medications is an important first step demonstrating Phlow’s commitment to CHC members to provide a reliable and affordable supply of high-quality essential medicines to help prevent pediatric drug shortages. “Essential medicines” are defined as those that satisfy the priority health care needs of the American population to sustain life and conquer disease.
“We have worked closely with the CHC to identify critical essential medicines necessary to treat pediatric patients that are either at-risk of, or currently in, shortage,” said Dr. Eric Edwards, CEO of Phlow. “We are thrilled to have an initial portfolio of products going into the hands of children’s hospitals to start the process of bringing certainty and resiliency to the supply chain and we will continue to work with the hospital members to mitigate the impact of shortages.”
Children’s hospitals serve an especially vulnerable population and may struggle to access needed medicines, forcing patients onto alternative therapies or delaying needed treatments. The injectable medications being launched, manufactured through an alliance with Fresenius Kabi USA, include Furosemide Injection, USP, a diuretic which treats fluid retention and swelling; Dexamethasone Sodium Phosphate Injection, USP, a corticosteroid to treat disorders of many organ systems; Heparin Sodium Injection, USP, a blood thinner to prevent and treat blood clots; and Rocuronium Bromide Injection, which is typically given before general anesthesia in preparing for surgery and used to relax the muscles.
“As a founding member of this coalition, I'm excited to see our vision being realized – strengthening the essential medicine supply chain and delivering key pediatric medicines effectively and efficiently to children's hospitals across the country,” said Dr. Kurt Newman, president and CEO of Children's National Hospital. “This coalition demonstrates the power of public-private partnerships and how they can effect positive change. I invite more children's hospitals to join this innovative group addressing pediatric medication shortages.”
The founding members of the CHC, including Phlow, recognize that essential medicine supply is a critical problem in the U.S. and welcome new children’s hospital members to join in this bold initiative.
Furosemide Injection, USP
INDICATIONS AND USAGE
Furosemide Injection, USP is a diuretic approved for IV or IM use and is indicated for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome and as adjunctive therapy in acute pulmonary edema.
IMPORTANT SAFETY INFORMATION
WARNING: Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dose schedule must be adjusted to the individual patient’s needs.
Furosemide Injection is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Tinnitus, hearing impairment, and deafness: Furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA).
Excessive Diuresis: May cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Observe patients for signs and symptoms of fluid imbalance (dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, or gastrointestinal disturbances such as nausea and vomiting).
Electrolyte depletion: Observe patients for signs and symptoms of electrolyte imbalance. (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia).
Acute Urinary Retention: In patients with severe symptoms of urinary retention (bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine.
Patients allergic to sulfonamides may also be allergic to furosemide. The possibility exists of exacerbation or activation of systemic lupus erythematosus.
Common Adverse Reactions: Hyperuricemia, Hypomagnesemia, Loss of Appetite, and Spasm of Bladder.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Furosemide appears in breast milk. May inhibit lactation. Caution should be exercised.
Pediatric Use: Furosemide may precipitate nephrocalcinosis/nephrolithiasis. Monitor renal function.
This Important Safety Information does not include all the information needed to use Furosemide Injection, USP safely and effectively. Please see full prescribing information for Furosemide Injection, USP at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a44bdd-028d-41af-9d4e-70971b0bcc4e.
Dexamethasone Sodium Phosphate Injection, USP
INDICATIONS AND USAGE
Dexamethasone Sodium Phosphate Injection, USP is a corticosteroid approved for intravenous and intramuscular administration in disorders of many organ systems. When the strength and dosage form of the drug lend the preparation to the treatment of the conditions, dexamethasone can be administered via intra-articular, soft tissue, or intralesional routes.
IMPORTANT SAFETY INFORMATION
Dexamethasone is contraindicated in patients with systemic fungal infections and hypersensitivity to any component of this product, including sulfites.
Anaphylactoid and hypersensitivity reactions have been reported for dexamethasone sodium phosphate: Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Sodium Bisulfite: Dexamethasone sodium phosphate injection contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
Drug-induced secondary adrenocortical insufficiency: May result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.
Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium: Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids.
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Common Adverse reactions: fluid retention, hypertension, skin irritation, suppression of growth in children, development of cushingoid state, depression, and euphoria.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy: Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation: Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of Corticosteroids should be advised not to nurse.
Pediatrics: Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed
This Important Safety Information does not include all the information needed to use Dexamethasone Sodium Phosphate Injection, USP safely and effectively. Please see full prescribing information for Dexamethasone Sodium Phosphate Injection, USP at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02d25ab8-8f51-452b-b944-f569fbae36fe.
Heparin Sodium Injection, USP
INDICATIONS AND USAGE
Heparin Sodium Injection is an anticoagulant indicated for:
- Prophylaxis and treatment of venous thromboembolism 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
- Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.
IMPORTANT SAFETY INFORMATION
Heparin Sodium is contraindicated in patients with history of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITTS), known hypersensitivity to heparin or pork products, those whom suitable blood coagulation tests cannot be performed at appropriate intervals, and patients with uncontrolled bleeding states, except when this is due to disseminated intravascular coagulation.
Fatal Medication Errors: Confirm choice of correct strength prior to administration.
Hemorrhage: Hemorrhage, including fatal events, has occurred in patients receiving heparin. Use caution in conditions with increased risk of hemorrhage.
Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITTS): Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS.
Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Periodically monitor platelet count, hematocrit, and occult blood in stool in all patients receiving heparin.
Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions: Drugs that interfere with coagulation, platelet aggregation, or drugs that counteract coagulation may induce bleeding.
Use In Specific Populations:
Pregnancy: Preservative-free formulation recommended.
Lactation: Preservative-free formulation recommended.
Pediatric Use: Use preservative-free formulation in neonates and infants.
This Important Safety Information does not include all the information needed to use Heparin Sodium Injection, USP safely and effectively. Please see full prescribing information for Heparin Sodium Injection, USP at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cece935c-1c0a-4949-b023-d6df3d53fbfa.
Rocuronium Bromide Injection
INDICATIONS AND USAGE
Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
IMPORTANT SAFETY INFORMATION
Rocuronium Bromide Injection is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of Rocuronium Bromide Injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
Rocuronium is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.
Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available.
Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents.
Risk of Death due to Medication Errors: Accidental administration can cause death. Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product.
Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation.
Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur.
Most common adverse reactions (2%) are transient hypotension and hypertension.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Succinylcholine: Use before succinylcholine has not been studied.
Nondepolarizing muscle relaxants: Interactions have been observed.
Enhanced Rocuronium Bromide Injection activity possible: When used in conjunction with Inhalation anesthetics, certain antibiotics, quinidine, magnesium, lithium, local anesthetics, procainamide.
Reduced Rocuronium Bromide Injection activity possible: When used in patients on chronic anticonvulsant therapy.
Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section.
Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients.
This Important Safety Information does not include all the information needed to use Rocuronium Bromide Injection safely and effectively. Please see full prescribing information for Rocuronium Bromide Injection at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad34ecc7-ff1f-4ee5-a235-e453873d0313.
About Children’s Hospital Coalition: Powered by PhlowTM
The Children’s Hospital Coalition (CHC) is a first-in-kind coalition that brings together some of the Nation’s top children’s hospitals with Phlow™, an innovative essential medicines impact company. Together, coalition members seek to provide certainty in availability, quality, access, and affordability for key medicines necessary to sustain life and conquer disease and to address the nation’s broken essential medicines supply chain. The care of America’s children is unnecessarily impacted by shortages of essential medicines that may result in compromised patient care, clinician frustration, and increased hospital pharmacy costs and inefficiencies. This is why the CHC is working to revolutionize the way essential medicines are brought to children in need. Other children’s hospitals are encouraged to join in this cause. For more information, visit https://childrenshospitalcoalition.org/.
About Phlow
Phlow Corp. is a U.S. -based innovative essential medicines impact company that is reimagining the essential medicine supply chain through innovation in how these medicines are manufactured. Founded in 2020, Phlow is committed to securing for the nation with a predictable and stable domestic supply of essential medicines. Phlow is working to establish a resilient end-to-end solution that is U.S.-based, comprehensive, and fully integrated so no patient has to go to a hospital to find out that the medicine they need is not available. With the support of an exceptional team, experienced strategic partners, and established relationships at the policy, regulatory, and federal levels, Phlow will manufacture active pharmaceutical ingredients (APIs) and finished pharmaceutical products domestically for essential medicines critical to healthcare. Through the use of state-of-the-art green chemistry, continuous flow technology, and other advanced manufacturing processes, Phlow is able to reduce costs and waste, improve quality and yield, and offer a more environmentally friendly alternative to batch manufacturing. For more information, visit www.phlow-usa.com.
