Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US
June 24 2024 - 8:00AM
Helsinn Group announces
AKYNZEO®
(fosnetupitant/palonosetron) injection is now available in
a ready-to-use vial in the US
Lugano, Switzerland – June 24,
2024 – Helsinn Group (“Helsinn”), a global pharmaceutical
company with a track record of over forty-five years of commercial
execution and a strong focus in supportive care, oncology and
dermato-oncology, is pleased to announce that AKYNZEO®
(fosnetupitant/palonosetron) injection is now available in the US
in a ready-to-use vial.
AKYNZEO injection (Ready-to-Use) is a new method
of administration and contains the same formulation as the prior
AKYNZEO Injection (To-be-Diluted).
The features of the new ready-to-use
presentation of AKYNZEO injection include:
- No
reconstitution or dilution required; infuse directly from the vial
using a built-in hanging strap
- No refrigeration
required at any point during distribution, storage, or
preparation
- Accessible via
automated dispensing machine, allowing the product to be stored and
available near the location of patient care
AKYNZEO injection is indicated in combination
with dexamethasone in adults for the prevention of acute and
delayed nausea and vomiting associated with initial and repeat
courses of highly emetogenic cancer chemotherapy. It has not been
studied for the prevention of nausea and vomiting associated with
anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection
does not contain polysorbate 80 or allergenic excipients such as
soy or egg lecithin. It can be administered simultaneously with
intravenous dexamethasone sodium phosphate.
Dr. Melanie Rolli, Helsinn Group CEO,
commented: “As a pioneer in cancer supportive care,
Helsinn continues to be unwavering in our pursuit to help patients
and clinicians in cancer care. We are very pleased to launch the
new AKYNZEO Ready-to-Use vial, building on our legacy of
innovation.”
Ordering information
Clinicians wishing to order the new vial should
contact their GPO or distributor. The National Drug Code (NDC)
number for AKYNZEO injection vial with hanger (Ready-to-Use) is
69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235
mg and palonosetron 0.25 mg); billing unit (single dose vial
[SDV]).
About
AKYNZEO®
AKYNZEO is the first and only 5-HT3 and NK1
receptor antagonists fixed combination approved for the prevention
of chemotherapy-induced acute and delayed nausea and vomiting. A
single dose of AKYNZEO given with dexamethasone has been shown to
prevent chemotherapy-induced nausea and vomiting for up to 5
days.
INDICATION
AKYNZEO (fosnetupitant/palonosetron) injection
is indicated in combination with dexamethasone in adults for the
prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of highly emetogenic cancer
chemotherapy.
Limitations of Use
AKYNZEO injection has not been studied for the
prevention of nausea and vomiting associated with anthracycline
plus cyclophosphamide chemotherapy.
AKYNZEO is a combination of palonosetron, a
serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a
substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron
prevents nausea and vomiting during the acute phase and
fosnetupitant prevents nausea and vomiting during both the acute
and delayed phase after cancer chemotherapy.
IMPORTANT SAFETY
INFORMATION
Warnings and Precautions
- Hypersensitivity
reactions, including anaphylaxis, have been reported in patients
receiving palonosetron, one of the components of AKYNZEO, with or
without known hypersensitivity to other 5-HT3 receptor
antagonists.
- Serotonin
syndrome has been reported with 5-HT3 receptor antagonists alone
but particularly with concomitant use of serotonergic drugs.
Serotonin syndrome can be life threatening. Symptoms associated
with serotonin syndrome may include the following combination of
signs and symptoms: mental status changes, autonomic instability,
neuromuscular symptoms, seizures, and gastrointestinal symptoms.
Patients should be monitored for the emergence of serotonin
syndrome, and if symptoms occur, discontinue AKYNZEO and initiate
supportive treatment. Patients should be informed of the increased
risk of serotonin syndrome, especially if AKYNZEO is used
concomitantly with other serotonergic drugs.
Adverse Reactions
Most common adverse reactions (≥3%) for AKYNZEO
capsules are headache, asthenia, dyspepsia, fatigue, constipation
and erythema. The safety profile of AKYNZEO injection was generally
similar to AKYNZEO capsules.
Drug Interactions
- Use with caution
in patients receiving concomitant medications primarily metabolized
by CYP3A4. The plasma concentrations of CYP3A4 substrates can
increase when co-administered with AKYNZEO. The inhibitory effect
on CYP3A4 can last for multiple days
- Dexamethasone
doses should be reduced when given with AKYNZEO. A more than two-
fold increase in the systemic exposure of dexamethasone was
observed 4 days after a single infusion of fosnetupitant.
- Consider the
potential effects of increased plasma concentrations of midazolam
or other benzodiazepines metabolized via CYP3A4 (alprazolam,
triazolam) when administering with AKYNZEO. When administered with
netupitant, the systemic exposure to midazolam was significantly
increased.
- Avoid
concomitant use of AKYNZEO in patients on chronic use of a strong
CYP3A4 inducer such as rifampin as this may decrease the efficacy
of AKYNZEO.
Use in Specific Populations
- Avoid use of
AKYNZEO in patients with severe hepatic impairment, severe renal
impairment, or end-stage renal disease.
- Advise women of
potential risk to fetus; limited data are available; may cause
fetal harm.
For more information about AKYNZEO® please see
the full US Prescribing Information.
About Helsinn Helsinn is a
global pharmaceutical company that builds, manufactures, launches,
and commercializes products to improve the quality of life for
patients with cancer and chronic disease, with a focus on
supportive care, oncology and dermato-oncology. Helsinn,
headquartered in Lugano, Switzerland, has direct commercial
operations in the U.S. and an extensive network of long-standing
trusted partners enabling a commercial presence in more than 90
countries.
Established in 1976, Helsinn is a third-generation family-owned
company with broad pharmaceutical and technical expertise. Helsinn
is proud of its history of operating with great integrity, passion
and quality. The company is committed to continuously striving for
innovation for its patients and embracing sustainable growth as a
core element of its strategic vision.
To learn more about Helsinn, please visit www.helsinn.com or
follow us on LinkedIn and X.
For more information: Helsinn Group
Media Contact:Sabrina PerucchiGroup Communication
ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email:
Info-hhc@helsinn.com