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.
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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
HEPATOTOXICITY
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
QT PROLONGATION
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
INDICATION
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.
CONTRAINDICATIONS
- 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
Hepatotoxicity
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.
QT Prolongation
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.
Hypocortisolism
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 Reactions
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.
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
- 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 aayoob@pantherxrare.com
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