RIOMET ER™ (metformin hydrochloride for extended-release oral
suspension) is the first and only U.S. FDA-approved
extended-release liquid formulation of metformin
New product in Sun Pharma’s expanding novel portfolio designed
for the 40% of American adults who cannot or will not swallow solid
medication forms
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 one
of its wholly-owned subsidiaries has launched Riomet ER™ in the
U.S. as an adjunct to diet and exercise to improve glycemic control
in patients 10 years of age and older with type 2 diabetes
mellitus. Riomet ER™ was approved by the U.S. Food and Drug
Administration (FDA) on August 29, 2019.
Riomet ER™, dosed once daily, is the first and only FDA-approved
liquid formulation of extended-release metformin. It can be prepped
and poured, thereby eliminating the need to crush medication. The
availability of a liquid formulation addresses the needs of
patients with type 2 diabetes mellitus, including residents in
long-term care facilities, who often have issues swallowing solid
medications. Riomet ER™ offers dosing flexibility and an acceptable
taste.
“As the fourth Sun Pharma product designed to address the needs
of the 40% of U.S. adults who cannot or will not swallow solid
medications, Riomet ER™ reflects our continued commitment to
providing alternative formulations to underserved patient
populations,” said Abhay Gandhi, CEO, North America, Sun Pharma.
“Our sprinkle and liquid formulation products treat common, chronic
diseases – type 2 diabetes, hypertension, elevated cholesterol,
pain and depression – where adherence issues are common and can be
life-threatening.”
The label for Riomet ER™ carries a boxed warning about the risk
of lactic acidosis with excessive alcohol intake, as alcohol
increases the effect of Riomet ER™ on lactate metabolism. The label
also includes a warning about the risk of vitamin B12 deficiency,
as well as a warning about the risk of hypoglycemia with
concomitant use with insulin and insulin secretagogues. In
placebo-controlled clinical trials of Riomet ER™, the most common
adverse reactions (occurring in greater than 5% of participants)
were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion,
abdominal discomfort, and headache.
More than 30 million Americans, or about 1 person in 10 in the
U.S., have diabetes.1 The vast majority of those individuals (90%
to 95%) have type 2 diabetes1, which is also known as
non-insulin-dependent diabetes. Although type 2 diabetes can affect
people of any age, the disease occurs most often in middle-aged and
older people.2 The risk of developing type 2 diabetes is increased
in people who are age 45 or older, have a family history of
diabetes, or are overweight or obese.2
For more information about Riomet ER™, visit RiometER.com
About Riomet ER™
Riomet ER™ is a novel liquid formulation of metformin
hydrochloride extended-release, a biguanide agent used to lower
blood sugar in individuals with type 2 diabetes. It is indicated as
an adjunct to diet and exercise to improve glycemic control in
adults and pediatric patients 10 years of age and older with type 2
diabetes mellitus. Riomet ER™ is available in 16-ounce bottles in
strawberry and grape flavors, both of which were significantly
preferred to crushed immediate-release metformin tablets in a taste
study. The extended-release liquid formulation allows for
once-daily dosing without the need to crush, break, or chew a
tablet – an important consideration given that metformin pills
should not be crushed, chewed, or cut. The starting dose is 500 mg
(5 mL) orally once daily with the evening meal; the dose can be
increased in increments of 500 mg (5 mL) weekly, up to a maximum
dose of 2000 mg (20 mL) once daily with the evening meal.
Riomet ER™ is indicated as an adjunct to diet and exercise to
improve glycemic control in adults and pediatric patients 10 years
of age and older with type 2 diabetes mellitus. It is the first and
only liquid formulation of metformin hydrochloride extended-release
proven to be bioequivalent to metformin extended-release tablets.
In a placebo-controlled trial, long-term care residents who
received extended-release metformin tablets experienced
significantly fewer gastrointestinal side effects (diarrhea,
nausea/vomiting) than those taking immediate-release metformin.
IMPORTANT SAFETY INFORMATION
WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis
have resulted in death, hypothermia, hypotension, and resistant
bradyarrhythmias. The onset of metformin-associated lactic acidosis
is often subtle, accompanied only by nonspecific symptoms such as
malaise, myalgias, respiratory distress, somnolence, and abdominal
pain. Metformin-associated lactic acidosis was characterized by
elevated blood lactate levels (>5 mmol/L), anion gap acidosis
(without evidence of ketonuria or ketonemia), an increased
lactate/pyruvate ratio; and metformin plasma levels generally >5
mcg/mL.
Risk factors for metformin-associated lactic acidosis include
renal impairment, concomitant use of certain drugs (e.g., carbonic
anhydrase inhibitors such as topiramate), age 65 years old or
greater, having a radiological study with contrast, surgery and
other procedures, hypoxic states (e.g., acute congestive heart
failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated
lactic acidosis in these high-risk groups are provided.
If metformin-associated lactic acidosis is suspected,
immediately discontinue Riomet ER™ and institute general
supportive measures in a hospital setting. Prompt hemodialysis is
recommended.
CONTRAINDICATIONS
Riomet ER™ is contraindicated in patients with:
- Severe renal impairment (estimated glomerular filtration rate
[eGFR] below 30 mL/min/1.73 m2)
- Hypersensitivity to metformin
- Acute or chronic metabolic acidosis, including diabetic
ketoacidosis, with or without coma
WARNINGS AND PRECAUTIONS
- Lactic Acidosis: See boxed warning
- Vitamin B12 Deficiency: Metformin may lower vitamin B12
levels. Individuals with inadequate vitamin B12 or calcium intake
or absorption appear to be predisposed to developing subnormal
vitamin B12 levels. Measure hematologic parameters on an annual
basis and vitamin B12 at 2 to 3 year intervals in patients on
Riomet ER™ and manage any abnormalities.
- Hypoglycemia with Concomitant Use with Insulin and Insulin
Secretagogues: Insulin and insulin secretagogues (e.g.,
sulfonylurea) are known to cause hypoglycemia. Riomet ER™may
increase the risk of hypoglycemia when combined with insulin and/or
an insulin secretagogue. Therefore, a lower dose of insulin or
insulin secretagogue may be required to minimize the risk of
hypoglycemia when used in combination with Riomet ER™.
ADVERSE REACTIONS
The most common adverse reactions (>5.0%) are diarrhea,
nausea/vomiting, flatulence, asthenia, indigestion, abdominal
discomfort, and headache.
DRUG INTERACTIONS
- Carbonic Anhydrase Inhibitors: may increase the risk of
lactic acidosis. Consider more frequent monitoring of these
patients
- Drugs that Reduce Metformin Clearance: (such as
ranolazine, vandetanib, dolutegravir, and cimetidine) may increase
the accumulation of metformin. Consider the benefits and risks of
concomitant use with Riomet ER™
- Alcohol and Medications Containing Alcohol: Alcohol is
known to increase the effect of metformin on lactate metabolism.
Warn patients against excessive alcohol intake while receiving
Riomet ER™
- Drugs Affecting Glycemic Control: Certain drugs (e.g.,
thiazides and other diuretics) tend to produce hyperglycemia and
may lead to loss of glycemic control. When such drugs are
administered concomitantly with Riomet ER™, observe the patient
closely for loss of blood glucose control. When such drugs are
withdrawn from a patient receiving Riomet ER™, observe the patient
closely for hypoglycemia
USE IN SPECIFIC POPULATIONS
- Pregnancy: Poorly controlled diabetes mellitus in
pregnancy increases the maternal risk for diabetic ketoacidosis,
preeclampsia, spontaneous abortions, preterm delivery, stillbirth,
and delivery complications. Poorly controlled diabetes mellitus
increases the fetal risk for major birth defects, stillbirth, and
macrosomia-related morbidity
- Females and Males of Reproductive Potential: Advise
premenopausal females of the potential for an unintended pregnancy.
Riomet ER™ can cause ovulation, increasing the chance of getting
pregnant
- Geriatric Use: Dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing
range to reflect the greater frequency of decreased hepatic, renal,
or cardiac function and of concomitant disease or other drug
therapy, and the higher risk of lactic acidosis. Assess renal
function more frequently in elderly patients
- Hepatic Impairment: Use of metformin in patients with
hepatic impairment has been associated with some cases of lactic
acidosis. Riomet ER™is not recommended in patients with hepatic
impairment
To report SUSPECTED ADVERSE REACTIONS, contact Sun
Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for Riomet ER™
References:
1 Type 2 diabetes. U.S. Department of Health & Human
Services, Centers for Disease Control and Prevention; 2020.
Available at: https://www.cdc.gov/diabetes/basics/type2.html.
Accessed January 11, 2020. 2 Type 2 diabetes. U.S. Department of
Health & Human Services, National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases;
2020. Available at:
https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes.
Accessed January 11, 2020.
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
Ltd. (CIN - L24230GJ1993PLC019050)
Sun Pharma is the world's fourth largest specialty generic
pharmaceutical company and India's top pharmaceutical company. A
vertically integrated business and a skilled team enables it to
deliver high-quality products, trusted by customers and patients in
over 100 countries across the world, at affordable prices. Its
global presence is supported by manufacturing facilities spread
across 6 continents and approved by multiple regulatory agencies,
coupled with a multi-cultural workforce comprising over 50
nationalities. Sun Pharma fosters excellence through innovation
supported by strong R&D capabilities across multiple R&D
centers, with investments of approximately 7% of annual revenues in
R&D. For further information, please visit www.sunpharma.com
& follow us on Twitter @SunPharma_Live
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200226005104/en/
Investors: Nimish Desai Tel +91 22 4324 4324, Xtn 2778
Tel Direct +91 22 4324 2778 Mobile +91-98203 30182 Email
nimish.desai@sunpharma.com Media: Gaurav Chugh Tel +91 22
4324 4324, Xtn 5373 Tel Direct +91 22 4324 5373 Mobile +91 98104
71414 Email gaurav.chugh@sunpharma.com US Media: Vinita
Alexander Tel Direct +1 609-720-8197 Email
Vinita.alexander@sunpharma.com Reba Auslander Tel Direct +1
917-836-9308 Email reba@raliancecommunications.com
New Stratus Energy (TSXV:NSE)
Historical Stock Chart
Von Nov 2024 bis Dez 2024
New Stratus Energy (TSXV:NSE)
Historical Stock Chart
Von Dez 2023 bis Dez 2024
