PITTSBURGH, January 13, 2022 / PRNewswire / – PANTHERx Rare announces that Xeris Pharmaceuticals, Inc., a wholly-owned subsidiary of Xeris Biopharma Holdings, Inc., is the exclusive US pharmacy distributor for the new FDA-approved drug Recorlev. selected® (Levoketoconazole). Recorlev is an inhibitor of cortisol synthesis 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 cortisol production, is most common in adults between the ages of 30 and 50 and affects women twice more often than men.
Endogenous Cushing’s Syndrome is a rare and serious endocrine disorder that is often the result of a benign pituitary tumor that causes the body to overproduce cortisol for long periods of time, leading to undesirable physical and emotional symptoms. In addition, 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 such as blood vessels, skin, muscles and bones, and mental disorders such as depression, anxiety and insomnia. Recorlev will be available in stores in the first quarter.
“PANTHERx is proud to partner with Xeris to meet the needs of adults with Endogenous Cushing’s Syndrome,” said Rob Snyder, President of PANTHERx. “As Recorlev’s only pharmacy, PANTHERx recognizes the importance of excellence in delivering innovative drugs, tailored support services and hope to this vulnerable patient population.”
PANTHERx is powered by our mission to change the lives of people across the country living with rare diseases. Our communication and support services are tailored to the needs of each patient and the needs of their life-changing medication. The culture of sincere care cultivated at PANTHERx drives the company forward and promotes the development of new systems, services and programs for the benefit of every single PANTHERx patient.
For more information about the symptoms, diagnosis, and treatment of Endogenous Cushing’s Syndrome, see click here.
Indication and important safety information for Recorlev® (Levoketoconazole)
BOX WARNING: HEPATOTOXICITY AND QT RENEWAL
Cases of fatal hepatotoxicity or liver transplantation have been reported with oral ketoconazole. Some patients had no apparent risk factors for liver disease. Recorlev has been associated with severe hepatotoxicity. Assess liver enzymes before and during treatment
Recorlev is associated with a dose-dependent prolongation of the QT interval. Prolonging the QT interval can lead to life-threatening ventricular dysrhythmias such as torsades de pointes. Take an EKG and correct hypokalemia and hypomagnesaemia before and during treatment
Recorlev is an inhibitor of cortisol synthesis 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.
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, relapsing symptomatic cholelithiasis, a history of drug-induced liver damage from ketoconazole or other azole antifungal therapy requiring discontinuation of the Treatment required or extensive metastatic liver disease.
- Use of drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes.
- Prolonged QTcF interval> 470 ms at baseline, history of torsade de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome.
- Known hypersensitivity to levoketoconazole, ketoconazole or any of the other ingredients of Recorlev.
- Use of 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 regardless of the dose used or the duration of treatment. Drug-induced liver damage occurred in patients taking Recorlev (maximum ALT or AST value greater than 3 times the upper limit of normal). Avoid using Recorlev at the same time as hepatotoxic medicinal products. Instruct the patient to avoid excessive alcohol consumption while being treated with Recorlev. Routinely check 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 imbalances, with more frequent EKG monitoring being considered. During treatment, you should routinely check the ECG and the potassium and magnesium levels in the blood.
Recorlev lowers cortisol levels and can lead to hypocortisolism with the possibility of life-threatening adrenal insufficiency. Lowering cortisol levels can cause nausea, vomiting, tiredness, abdominal pain, loss of appetite, and dizziness. A significant decrease in serum cortisol levels can lead to adrenal insufficiency, which can manifest itself in hypotension, abnormal electrolyte levels, and hypoglycaemia. During treatment, routinely monitor 24-hour urine-free cortisol, morning serum, or plasma cortisol and the patient’s signs and symptoms for hypocortisolism.
Hypersensitivity to Recorlev has been reported. Anaphylaxis and other hypersensitivity reactions including urticaria have been reported with oral ketoconazole.
Risks Associated with Decreased Testosterone
Recorlev can lower serum testosterone in both men and women. Potential clinical manifestations of decreased testosterone levels in men can include gynecomastia, impotence, and oligospermia. Possible clinical manifestations of decreased testosterone levels in women include decreased libido and mood swings.
The most common side effects (incidence> 20%) are nausea / vomiting, hypokalaemia, bleeding / contusion, systemic hypertension, headache, liver damage, abnormal uterine bleeding, erythema, fatigue, abdominal pain / dyspepsia, arthritis, upper respiratory tract infection, myalgia, arrhythmia, back pain , Insomnia / sleep disorders and peripheral edema.
INTERACTIONS WITH OTHER DRUGS
- Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2 and MATE before starting Recorlev.
- Sensitive CYP3A4 or CYP3A4 and P-gp substrates: Concomitant use of Recorlev with these substrates is contraindicated or not recommended.
- Atorvastatin: For doses greater than 20 mg daily, use the lowest possible dose of atorvastatin and watch out for side effects.
- Metformin: Monitor blood sugar, kidney function, and vitamin B12, and adjust the dose of metformin as needed.
- Strong CYP3A4 inhibitors or inducers: Avoid taking these medicines for 2 weeks before and during treatment with Recorlev.
- Gastric acid modulators: See full prescribing information for recommendations on concomitant use with Recorlev.
USE IN CERTAIN POPULATIONS
Breastfeeding: It is recommended not to breast-feed during treatment and for the day after the last dose
To report any suspected SIDE EFFECTS, contact Xeris Pharmaceuticals, Inc. at the 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Complete 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 changes lives by delivering medical breakthroughs, clinical excellence, and access solutions for patients with rare and devastating diseases. While the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating diseases have an approved therapy. Changes in federal policy and advances in science have resulted in an increase in FDA approvals for orphan drugs, which gives great hope to the rare disease community.
PANTHERx was recently named Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy (NASP) and received the ACHC’s first accredited rare disease and orphan drug award. PANTHERx is a four-time winner of the prestigious MMIT Patient Choice Award, including the 2021 award. PANTHERx is headquartered in Pittsburgh, Pennsylvania, licensed in all 50 states and accredited by URAC, NABP and ACHC.
About Xeris Biopharma®
Xeris (Nasdaq: XERS) is a biopharmaceutical company that develops and commercializes unique therapies for patient populations in the endocrinology, neurology, and gastroenterology. Xeris offers two commercially available products; Gvoke®, a ready-to-use liquid glucagon used to treat 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 solid pipeline of development programs to expand the products currently marketed to key new indications and applications and to develop new products using its proprietary XeriSol formulation technology platforms. move forward™ and XeriJect™which supports long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, please 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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