Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S.

April 8, 2019 Off By BusinessWire

INFUGEM™ (gemcitabine in sodium chloride injection) is the
first and only chemotherapy product in a premixed, ready-to-infuse
formulation

Use of ready-to-infuse bags eliminates steps in the complex
chemotherapy preparation process, reducing exposure and mitigating
inherent provider and patient safety risks

MUMBAI, India & PRINCETON, N.J.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/INFUGEM?src=hash” target=”_blank”gt;#INFUGEMlt;/agt;–Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN,
NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries
and/or associate companies) today announced that INFUGEM™ (gemcitabine
in sodium chloride injection), for intravenous use, is now commercially
available in the U.S. INFUGEM, the first chemotherapy product that comes
in a premixed, ready-to-infuse formulation, was approved by the U.S.
Food and Drug Administration (FDA) in July 2018 in combination with
other drugs for the treatment of breast, ovarian, non-small cell lung
cancers, and as a single agent for the treatment of pancreatic cancer.

INFUGEM is an alcohol-free, clear, colorless, sterile solution of
10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to
pharmacists in ready-to-infuse bags as a Spike & Go™ package. It
involves dose banding practice, whereby standardized doses of
intravenous cytotoxic drugs are used for ranges (or “bands”) of doses
calculated for individual patients. INFUGEM is the only available
gemcitabine formulation that does not require reconstitution and syringe
withdrawal prior to intravenous administration. Eliminating these steps
reduces complexity and minimizes the inherent risks of hazardous drug
exposure, contamination, and medication errors.

“INFUGEM is an example of our focus at Sun Pharma, which is to improve
provider and patient experiences by using high-tech delivery systems
and/or novel formulations for gold-standard medicines,” said Abhay
Gandhi, CEO-North America, Sun Pharma. “With an increasing number of
organizations strongly recommending the use of premixed parenteral
products due to concerns related to manual compounding, and with the
broad use of gemcitabine to treat various cancers, the timing couldn’t
be better to launch INFUGEM in the U.S.”

INFUGEM is the first product using Sun’s proprietary technology which
allows cytotoxic oncology products to be premixed in a sterile
environment and supplied to the prescribers in ready-to-infuse final
dosage bags. The product is stable at room temperature storage
conditions for two years, even without the use of alcohol and other
preservatives in the bag. By contrast, other gemcitabine products
require reconstitution and/or dilution for patient use, and remain
stable at room temperature for only 24 hours.

“The availability of gemcitabine in ready-to-infuse bags is a welcome
development, simplifying the complex delivery of this vital chemotherapy
medication,” commented Jeff Lombardo PharmD, BCOP, Research Assistant
Professor, Center of Integrated Global Biomedical Sciences, University
at Buffalo.

For more information about INFUGEM, please visit www.infugem.com.

INFUGEM™ Prescribing Information

INDICATIONS AND USAGE

INFUGEM is a nucleoside metabolic inhibitor indicated for:

Ovarian Cancer: in combination with carboplatin, for the
treatment of advanced ovarian cancer that has relapsed at least 6 months
after completion of platinum-based therapy.

Breast Cancer: in combination with paclitaxel, for first-line
treatment of metastatic breast cancer after failure of prior
anthracycline-containing adjuvant chemotherapy, unless anthracyclines
were clinically contraindicated.

Non-Small Cell Lung Cancer: in combination with cisplatin for the
first-line treatment of patients with inoperable, locally advanced
(Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung
cancer.

Pancreatic Cancer: as first-line treatment for patients with
locally advanced (nonresectable Stage II or Stage III) or metastatic
(Stage IV) adenocarcinoma of the pancreas. INFUGEM is indicated for
patients previously treated with fluorouracil.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INFUGEM is contraindicated in patients with a known hypersensitivity to
gemcitabine.

WARNINGS AND PRECAUTIONS

Schedule-Dependent Toxicity: In clinical trials evaluating the
maximum tolerated dose of gemcitabine, prolongation of the infusion time
beyond 60 minutes or more frequent than weekly dosing resulted in an
increased incidence of clinically significant hypotension, severe
flu-like symptoms, myelosuppression and asthenia.

Myelosuppression: Myelosuppression manifested by neutropenia,
thrombocytopenia and anemia occurs with INFUGEM as a single agent, and
the risks are increased when INFUGEM is combined with other cytotoxic
drugs. Monitor patients receiving INFUGEM prior to each dose with a
complete blood count (CBC), including differential and platelet count,
and modify the dosage as recommended.

Pulmonary Toxicity and Respiratory Failure: Permanently
discontinue INFUGEM in patients who develop unexplained dyspnea, with or
without bronchospasm, or have any evidence of pulmonary toxicity.

Hemolytic Uremic Syndrome: Hemolytic uremic syndrome (HUS),
including fatalities from renal failure or the requirement for dialysis,
can occur in patients treated with INFUGEM. Assess renal function prior
to initiation of INFUGEM and periodically during treatment. Consider the
diagnosis of HUS in patients who develop anemia with evidence of
microangiopathic hemolysis, elevation of bilirubin or LDH, or
reticulocytosis; severe thrombocytopenia; or evidence of renal failure
(elevation of serum creatinine or BUN). Permanently discontinue INFUGEM
in patients with HUS or severe renal impairment. Renal failure may not
be reversible even with discontinuation of therapy.

Hepatic Toxicity: Drug-induced liver injury, including liver
failure and death, has been reported in patients receiving gemcitabine
alone or in combination with other potentially hepatotoxic drugs.
Administration of INFUGEM in patients with concurrent liver metastases
or a preexisting medical history of hepatitis, alcoholism or liver
cirrhosis can lead to exacerbation of the underlying hepatic
insufficiency. Assess hepatic function prior to initiation of INFUGEM
and periodically during treatment. Permanently discontinue INFUGEM in
patients that develop severe liver injury.

Embryo-Fetal Toxicity: INFUGEM can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential
risk to a fetus. Advise females of reproductive potential to use
effective contraception during treatment with INFUGEM and for 6 months
after the final dose. Advise male patients with female partners of
reproductive potential to use effective contraception during and for 3
months following the final dose of INFUGEM.

Exacerbation of Radiation Therapy Toxicity: INFUGEM is not
recommended for use in combination with radiation therapy.

Concurrent (given together or ≤7 days apart): Life-threatening
mucositis, especially esophagitis and pneumonitis, occurred in a trial
in which gemcitabine was administered at a dose of 1000 mg/m²
to patients with non-small cell lung cancer for up to 6 consecutive
weeks concurrently with thoracic radiation.

Non-concurrent (given >7 days apart): Excessive toxicity has not been
observed when gemcitabine is administered more than 7 days before or
after radiation. Radiation recall has been reported in patients who
receive gemcitabine after prior radiation

Capillary Leak Syndrome: Capillary leak syndrome (CLS) with
severe consequences has been reported in patients receiving gemcitabine
as a single agent or in combination with other chemotherapeutic agents.
Permanently discontinue INFUGEM if CLS develops during therapy.

Posterior Reversible Encephalopathy Syndrome: Posterior
reversible encephalopathy syndrome (PRES) has been reported in patients
receiving gemcitabine as a single agent or in combination with other
chemotherapeutic agents. PRES can present with headache, seizure,
lethargy, hypertension, confusion, blindness and other visual and
neurologic disturbances. Confirm the diagnosis of PRES with magnetic
resonance imaging (MRI) and permanently discontinue INFUGEM if PRES
develops during therapy.

ADVERSE REACTIONS

The most common adverse reactions for the single agent (≥20%) are
nausea/vomiting, anemia, hepatic transaminitis, neutropenia, increased
alkaline phosphatase, proteinuria, fever, hematuria, rash,
thrombocytopenia, dyspnea and peripheral edema.

USE IN SPECIFIC POPULATIONS

Due to the potential for serious adverse reactions in nursing infants
from INFUGEM, women should not breastfeed during treatment with INFUGEM
and for at least one week after the last dose.

The safety and effectiveness of INFUGEM have not been established in
pediatric patients.

Please see Full Prescribing Information for INFUGEM™ at http://www.infugem.com/infugem-PI.

INFUGEM is a trademark of Sun Pharma Global FZE.

Disclaimer:

Statements in this “Document” describing the Company’s objectives,
projections, estimates, expectations, plans or predictions or industry
conditions or events may be “forward looking statements” within the
meaning of applicable securities laws and regulations. Actual results,
performance or achievements could differ materially from those expressed
or implied.

About Sun Pharmaceutical Industries Inc., USA (SPII)

SPII is a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd,
a global specialty generic company based in Mumbai, which provides
innovative, high-quality, affordable medicines trusted by customers and
patients in more than 100 countries around the world. Sun Pharma’s
global presence is supported by 44 manufacturing facilities spread
across 6 continents, R&D centers across the globe and a multi-cultural
workforce comprising over 50 nationalities. In India, the company enjoys
leadership across 10 different classes of doctors with 30 brands
featuring amongst the top 300 pharmaceutical brands. Its footprint
across emerging markets covers over 100 markets and 6 markets in Western
Europe, and our Global Consumer Healthcare business is ranked amongst
the top 10 across 3 global markets. Sun Pharma’s API business footprint
is strengthened through 14 world-class API manufacturing facilities
across the globe. It fosters excellence through innovation supported by
strong R&D capabilities comprising about 2,000 scientists and R&D
investments of approximately 8% of annual revenues. For further
information, please visit www.sunpharma.com
& follow us on Twitter @SunPharma_Live.