– Two poster presentations of
Mallinckrodt's research for adults
with HRS with rapid reduction in kidney
function1 provide further insight into treatment
with TERLIVAZ for appropriate patients –
DUBLIN, May 18, 2024
/PRNewswire/ -- Mallinckrodt plc, a
global specialty pharmaceutical company, today announced the
presentation of two posters on TERLIVAZ® (terlipressin)
for injection in patients with hepatorenal syndrome (HRS) with
rapid reduction in kidney function1 at the 2024
Digestive Disease Week® (DDW) taking place in
Washington, DC from May 18-21, 2024.
The posters feature a post-hoc analysis of data from the pivotal
Phase III CONFIRM trial, analyzing the impact of dose interruptions
on treatment response to TERLIVAZ in patients with hepatorenal
syndrome-acute kidney injury (HRS-AKI),2 and a pooled
analysis of three Phase III clinical studies assessing the impact
of TERLIVAZ treatment on patients with HRS and a baseline serum
creatinine (SCr) <5mg/dL.3
TERLIVAZ is the first and only FDA-approved product indicated to
improve kidney function in adults with HRS with rapid reduction in
kidney function,1 an acute and life-threatening
condition requiring hospitalization.4 HRS involving
rapid reduction in kidney function1 is estimated to
affect more than 42,000 Americans annually and rates of
hospitalizations are increasing.5
Please see Limitation of Use and Important Safety
Information, including Boxed Warning, below.
"We're excited to present our research at DDW. It represents our
ongoing commitment to add to the depth and breadth of data on
TERLIVAZ and its important role in the treatment of adult patients
with HRS with rapid reduction in kidney function,"1 said
Peter Richardson, MRCP (UK),
Executive Vice President & Chief Scientific Officer.
"Collectively, these data support our understanding of those who
are most likely to benefit from TERLIVAZ showing the potential
impact of use in the real-world, including when the dosing schedule
is interrupted."
Abstract #4025396: Treatment Response to Terlipressin is
Unaffected by Dose Interruptions in Patients with Hepatorenal
Syndrome-Acute Kidney Injury2
- Presenter: Khalid Mumtaz, MD, The Ohio State University Wexner Medical Center,
Columbus, OH
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other
Complications of Cirrhosis
- Session Date and Time: Saturday, May 18,
2024; 12:30 – 1:30 p.m. EDT
This analysis evaluated the effect of dose interruption on the
incidence of HRS reversal for patients with HRS-AKI.2
The recommended dose regimen includes administering TERLIVAZ 0.85
mg (1 vial) intravenously every six hours on days one to
three.1 On day four, assess SCr versus baseline and if
SCr has decreased by at least 30% from baseline continue TERLIVAZ
0.85 mg (1 vial) intravenously every six hours.1
Patients included in the analysis experienced a dose interruption
due to adverse events or any other reason.2 After a dose
interruption, treatment could be restarted at a reduced dose of 0.5
mg or 1 mg every 6-12 hours.2 The safety and efficacy of
this particular use has not been evaluated by FDA.
Abstract #4034883: Terlipressin Treatment Benefits Those
Patients with Baseline Serum Creatinine <5 mg/dl: The North
American Experience3
- Presenter: Prasun K. Jalal, MD, Baylor College of Medicine, Houston, TX
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other
Complications of Cirrhosis
- Session Date and Time: Saturday, May 18,
2024; 12:30 – 1:30 p.m. EDT
This analysis included pooled data from three Phase III,
placebo-controlled studies of TERLIVAZ in 608 patients with HRS
with rapid reduction in kidney function.1,3
Patients were dosed with 1 mg terlipressin acetate (equivalent to
0.85 mg terlipressin base) every six hours for ≤14
days.3 Data was assessed by SCr subgroup (baseline SCr
<5 mg/dL or ≥5 mg/dL) for the outcomes of HRS reversal (defined
as >/=1 SCr of </=1.5 mg/dL
while on treatment), incidence of renal replacement therapy (RRT),
overall survival, and transplant-free survival up to Day
90.3
These analyses were sponsored by Mallinckrodt
Pharmaceuticals.
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with
hepatorenal syndrome with rapid reduction in kidney function.
- Patients with a serum creatinine >5 mg/dL are unlikely to
experience benefit.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
- TERLIVAZ may cause serious or fatal respiratory failure.
Patients with volume overload or with acute-on-chronic liver
failure (ACLF) Grade 3 are at increased risk. Assess oxygenation
saturation (e.g., SpO2) before initiating
TERLIVAZ.
- Do not initiate TERLIVAZ in patients experiencing hypoxia
(e.g., SpO2 <90%) until oxygenation levels improve.
Monitor patients for hypoxia using continuous pulse oximetry during
treatment and discontinue TERLIVAZ if SpO2 decreases
below 90%.
Contraindications
TERLIVAZ is contraindicated:
- In patients experiencing hypoxia or worsening respiratory
symptoms.
- In patients with ongoing coronary, peripheral, or mesenteric
ischemia.
Warnings and Precautions
- Serious or Fatal Respiratory Failure: Obtain baseline
oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
Monitor patients for changes in respiratory status using continuous
pulse oximetry and regular clinical assessments. Discontinue
TERLIVAZ in patients experiencing hypoxia or increased respiratory
symptoms.
Manage intravascular volume overload by reducing or discontinuing
the administration of albumin and/or other fluids and through
judicious use of diuretics. Temporarily interrupt, reduce, or
discontinue TERLIVAZ treatment until patient volume status
improves. Avoid use in patients with ACLF Grade 3 because they are
at significant risk for respiratory failure.
- Ineligibility for Liver Transplant: TERLIVAZ-related
adverse reactions (respiratory failure, ischemia) may make a
patient ineligible for liver transplantation, if listed. For
patients with high prioritization for liver transplantation (e.g.,
MELD ≥35), the benefits of TERLIVAZ may not outweigh its
risks.
- Ischemic Events: TERLIVAZ may cause cardiac,
cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of
TERLIVAZ in patients with a history of severe cardiovascular
conditions or cerebrovascular or ischemic disease. Discontinue
TERLIVAZ in patients who experience signs or symptoms suggestive of
ischemic adverse reactions.
- Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm
when administered to a pregnant woman. If TERLIVAZ is used during
pregnancy, the patient should be informed of the potential risk to
the fetus.
Adverse Reactions
- The most common adverse reactions (≥10%) include abdominal
pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please click here to see full Prescribing Information,
including Boxed Warning.
ABOUT HEPATORENAL SYNDROME (HRS)
Hepatorenal syndrome
(HRS) involving rapid reduction in kidney function1 is
an acute and life-threatening condition that occurs in people with
advanced liver disease.4 HRS is classified into two
distinct types – a rapidly progressive type that leads to acute
renal failure where patients are typically hospitalized for their
care and a more chronic type that progresses over weeks to
months.4 HRS involving rapid reduction in kidney
function1 is estimated to affect more than 42,000
Americans annually and rates of HRS hospitalizations are
increasing.5 If left untreated, HRS with rapid reduction
in kidney function1 has a median survival time of less
than two weeks and greater than 80 percent mortality within three
months.6
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of
multiple wholly owned subsidiaries that develop, manufacture,
market and distribute specialty pharmaceutical products and
therapies. The company's Specialty Brands reportable segment's
areas of focus include autoimmune and rare diseases in specialty
areas like neurology, rheumatology, hepatology, nephrology,
pulmonology, ophthalmology, and oncology; immunotherapy and
neonatal respiratory critical care therapies; analgesics; and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
This release contains forward-looking statements,
including with regard to TERLIVAZ®, its potential to
improve health and treatment outcomes, and its potential impact on
patients. The statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those in the
forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy;
satisfaction of, and compliance with, regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; changes in laws and regulations; issues with product
quality, manufacturing or supply, or patient safety issues or
adverse side effects or adverse reactions associated with TERLIVAZ;
and other risks identified and described in more detail in the
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections section of
Mallinckrodt's most recent Annual
Report on Form 10-K and other filings with the SEC, all of which
are available on its website. The forward-looking statements made
herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events and developments or otherwise,
except as required by law.
CONTACT
Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com
Investor Relations
Derek
Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Mallinckrodt, the "M" brand mark,
TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are
trademarks of a Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or their respective
owners.
©2024 Mallinckrodt. US-2400300
05/24
References
1 TERLIVAZ® (terlipressin) for
Injection. Prescribing Information. Mallinckrodt Hospital Products
Inc. 2023.
2 Mumtaz K, Bari K, Reddy G, et al. Treatment
Response to Terlipressin is Unaffected by Dose Interruptions in
Patients with Hepatorenal Syndrome-Acute Kidney Injury.
Presentation to be shared at the 2024 Digestive Disease Week
(DDW). May 2024.
3 Jalal P, Verna EC, Rahimi RS, et al. Terlipressin
Treatment Benefits Those Patients with Baseline Serum Creatinine
<5 mg/dl: The North American Experience. Presentation to be
shared at the 2024 Digestive Disease Week (DDW). May 2024.
4 National Organization for Rare
Disorders. Hepatorenal Syndrome. Available at:
https://rarediseases.org/rare-diseases/hepatorenal-syndrome/.
Accessed January 2024.
5 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin
K, Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from
2008 to 2018. Annals of Med. 2021;53:1. 2018-2024
doi.org/10/1080/07853890.
6 Flamm, S.L., Brown, K., Wadei, H.M., et al. The
Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
the United States and the
Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202.
https://doi.org/10.1002/lt.26072.
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SOURCE Mallinckrodt plc