PITTSBURGH, Jan. 13, 2022 /PRNewswire/ — PANTHERx Rare announces that it has been selected by Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc., as the exclusive U.S. pharmacy distribution partner for a new FDA-approved medication, Recorlev® (levoketoconazole). Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Cushing’s syndrome, a disease associated with increased production of cortisol, occurs most commonly in adults between ages 30-50 and affects women two times more often than men.
Endogenous Cushing’s syndrome is a rare and serious endocrine disease, often the result of a benign pituitary tumor stimulating the body to overproduce cortisol for long periods of time, leading to unwanted physical and emotional symptoms. Additionally, the internal manifestations of the disease are potentially life-threatening and include metabolic changes such as high blood sugar, or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle and bone, and psychological disturbances such as depression, anxiety and insomnia. Recorlev will be commercially available in the first quarter.
“PANTHERx is proud to partner with Xeris to address the needs of adults with endogenous Cushing’s syndrome,” said Rob Snyder, President of PANTHERx. “As the sole pharmacy for Recorlev, PANTHERx recognizes the importance of outstanding execution in order to deliver innovative medication, customized support services, and hope to this vulnerable patient population.”
PANTHERx is driven by our mission to transform the lives of people across the country who are living with rare diseases. Our communications and support services are tailored to the desires of each patient and the requirements of their life-changing medications. The culture of sincere care fostered at PANTHERx propels the company forward, encouraging the development of new systems, services, and programs for the benefit of each and every PANTHERx patient.
For more information about the symptoms, diagnosis, and treatment of endogenous Cushing’s syndrome, please click here.
Indication & Important Safety Information for Recorlev® (levoketoconazole)
BOXED WARNING: HEPATOTOXICITY AND QT PROLONGATION
Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease. Recorlev is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment
Recorlev is associated with dose-related QT interval prolongation. QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG and correct hypokalemia and hypomagnesemia prior to and during treatment
Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Limitations of Use
Recorlev is not approved for the treatment of fungal infections.
Cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT > 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease.
Taking drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes.
Prolonged QTcF interval > 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome.
Known hypersensitivity to levoketoconazole, ketoconazole or any excipient in Recorlev.
Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gp.
WARNINGS AND PRECAUTIONS
Serious hepatotoxicity has been reported in patients receiving Recorlev, irrespective of the dosages used or the treatment duration. Drug-induced liver injury (peak ALT or AST greater than 3 times upper limit of normal) occurred in patients using Recorlev. Avoid concomitant use of Recorlev with hepatotoxic drugs. Advise patient to avoid excessive alcohol consumption while on treatment with Recorlev. Routinely monitor liver enzymes and bilirubin during treatment.
Use Recorlev with caution in patients with other risk factors for QT prolongation, such as congestive heart failure, bradyarrhythmias, and uncorrected electrolyte abnormalities, with more frequent ECG monitoring considered. Routinely monitor ECG and blood potassium and magnesium levels during treatment.
Recorlev lowers cortisol levels and may lead to hypocortisolism with a potential for life-threatening adrenal insufficiency. Lowering of cortisol levels can cause nausea, vomiting, fatigue, abdominal pain, loss of appetite, and dizziness. Significant lowering of serum cortisol levels may result in adrenal insufficiency that can be manifested by hypotension, abnormal electrolyte levels, and hypoglycemia. Routinely monitor 24-hour urine free cortisol, morning serum or plasma cortisol, and patient’s signs and symptoms for hypocortisolism during treatment.
Hypersensitivity to Recorlev has been reported. Anaphylaxis and other hypersensitivity reactions including urticaria have been reported with oral ketoconazole.
Risks Related to Decreased Testosterone
Recorlev may lower serum testosterone in men and women. Potential clinical manifestations of decreased testosterone concentrations in men may include gynecomastia, impotence and oligospermia. Potential clinical manifestations of decreased testosterone concentrations in women include decreased libido and mood changes.
Most common adverse reactions (incidence > 20%) are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE prior to initiating Recorlev.
Sensitive CYP3A4 or CYP3A4 and P-gp Substrates: Concomitant use of Recorlev with these substrates is contraindicated or not recommended.
Atorvastatin: Use lowest atorvastatin dose possible and monitor for adverse reactions for dosages exceeding 20 mg daily.
Metformin: Monitor glycemia, kidney function, and vitamin B12 and adjust metformin dosage as needed.
Strong CYP3A4 Inhibitors or Inducers: Avoid use of these drugs 2 weeks before and during Recorlev treatment.
Gastric Acid Modulators: See Full Prescribing Information for recommendations regarding concomitant use with Recorlev.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed during treatment and for one day after final dose
To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information including Boxed Warning.
About PANTHERx Rare
PANTHERx Rare, part of Envolve Pharmacy Solutions, is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to patients living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy (NASP) and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care (ACHC). PANTHERx is a four-time winner of the prestigious MMIT Patient Choice Award, including the 2021 honor. PANTHERx is headquartered in Pittsburgh, Pennsylvania, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
About Xeris Biopharma
Xeris (Nasdaq: XERS) is a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology. Xeris has two commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis. In addition to Recorlev® for the treatment of endogenous Cushing’s syndrome, Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com or follow us on Twitter, LinkedIn, or Instagram.
Contact: Allyson Ayoob, 855-726-8479 x1142 or at [email protected]
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