Lixisenatide- Adlyxin-@- (July 2016)- Anti-diabetic drug
Drug Name:Lixisenatide- Adlyxin-@- (July 2016)- Anti-diabetic drug
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
ADLYXIN delays gastric emptying which may impact absorption of
concomitantly administered oral medications. Oral medications that are
particularly dependent on threshold concentrations for efficacy, such as
antibiotics, or medications for which a delay in effect is undesirable, such
as acetaminophen, should be administered 1 hour before ADLYXIN
Oral contraceptives should be taken at least 1 hour before ADLYXIN
administration or 11 hours after the dose of ADLYXIN
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
16.Adlyxin Lixisenatide 7/27/2016
To improve glycemic control (blood sugar levels)
Press release
Approved by FDA on 7/27/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ADLYXIN safely and effectively. See full prescribing information for ADLYXIN.
ADLYXIN (lixisenatide) injection, for subcutaneous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
ADLYXIN is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated
as an adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus .
Limitations of Use :
Has not been studied in patients with chronic pancreatitis or a history of
unexplained pancreatitis. Consider other antidiabetic therapies in patients
with a history of pancreatitis.
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Has not been studied in combination with short acting insulin.
Has not been studied in patients with gastroparesis and is not recommended
in patients with gastroparesis.
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions (=5%) of patients treated with
ADLYXIN are nausea, vomiting, headache, diarrhea, dizziness, and
hypoglycemia
Contra-Indications:
CONTRAINDICATIONS
Hypersensitivity to ADLYXIN or any product components. Hypersensitivity
reactions including anaphylaxis have occurred with ADLYXIN
WARNINGS AND PRECAUTIONS
Anaphylaxis and Serious Hypersensitivity Reactions: Discontinue
ADLYXIN and promptly seek medical advice
Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do not
restart if pancreatitis is confirmed. Consider other antidiabetic therapies in
patients with a history of pancreatitis .
Never share ADLYXIN pen between patients, even if the needle is changed
.
Hypoglycemia with Concomitant use of Sulfonylurea or Basal Insulin:
When ADLYXIN is used with a sulfonylurea or basal insulin, consider
lowering the dose of the sulfonylurea or basal insulin to reduce the risk of
hypoglycemia.
Acute Kidney Injury: Monitor renal function in patients with renal
impairment reporting severe adverse gastrointestinal reactions. ADLYXIN
is not recommended in patients with end stage renal disease..
Immunogenicity: Patients may develop antibodies to lixisenatide. If there is
worsening glycemic control or failure to achieve targeted glycemic control,
significant injection site reactions or allergic reactions, alternative
antidiabetic therapy should be considered.
Macrovascular Outcomes: Clinical studies have not shown macrovascular
risk reduction with ADLYXIN or any other antidiabetic drug.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
ADLYXIN is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated
as an adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus .
Limitations of Use :
Has not been studied in patients with chronic pancreatitis or a history of
unexplained pancreatitis. Consider other antidiabetic therapies in patients
with a history of pancreatitis.
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Has not been studied in combination with short acting insulin.
Has not been studied in patients with gastroparesis and is not recommended
in patients with gastroparesis.
DOSAGE AND ADMINISTRATION
Initiate at 10 mcg once daily for 14 days. On Day 15, increase dosage
to 20 mcg once daily..
Administer once daily within one hour before the first meal of the day .
Inject subcutaneously in the abdomen, thigh or upper arm (2.2).
DOSAGE FORMS AND STRENGTHS
Injection: 50 mcg/mL in 3 mL in green prefilled pen
(for 14 pre-set doses; 10 mcg per dose).
Injection: 100 mcg/mL in 3 mL in burgundy prefilled pen
(for 14 pre-set doses; 20 mcg per dose).
OVERDOSAGE
During clinical studies, doses up to 30 mcg of lixisenatide twice daily
(3 times the daily recommended dose) were administered to
type 2 diabetic patients in a 13-week study. The 30 mcg dose of
lixisenatide is not an approved dose. An increased incidence of
gastrointestinal disorders was observed.
In case of overdose, appropriate supportive treatment should be
initiated according to the patient’s clinical signs and symptom
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling
(Medication Guide and Instructions for Use).
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions, including anaphylaxis,
have been reported in clinical trials of ADLYXIN and during postmarketing use
of GLP-1 receptor agonists.
If symptoms of hypersensitivity reactions occur, inform patients that they must
stop taking ADLYXIN and seek medical advice promptly.
Risk of Pancreatitis
Inform patients that persistent severe abdominal pain that may radiate to the
back and which may or may not be accompanied by vomiting is the hallmark
symptom of acute pancreatitis.
Instruct patients to promptly discontinue ADLYXIN and contact their physician
if persistent severe abdominal pain occurs.
Never Share ADLYXIN Pen Between Patients
Advise patients that they should never share ADLYXIN pen with another person,
even if the needle is changed, because doing so carries a risk for transmission
of blood-borne pathogens.
Risk of Hypoglycemia
Inform patients that the risk of hypoglycemia increased when ADLYXIN is used
in combination with a sulfonylurea or basal insulin.
Dehydration and Renal Failure
Advise patients treated with ADLYXIN of the potential risk of dehydration due to
gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Inform patients of the potential risk for worsening renal function, which in some
cases may require dialysis.
Use in Pregnancy
Advise patients to inform their physicians if they are pregnant or intend to
become pregnant.
Sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Lixisenatide is a GLP-1 receptor agonist. Lixisenatide increases glucose-dependent
insulin release, decreases glucagon secretion, and slows gastric emptying
2. Pharmacokinetics
Absorption
Following subcutaneous administration in patients with type 2 diabetes, the median
tmax is 1 to 3.5 hours. There are no clinically relevant differences in the rate of
absorption when lixisenatide is administered subcutaneously in the abdomen,
thigh, or arm.
Distribution
The apparent volume of distribution after subcutaneous administration of
lixisenatide (Vz/F) is approximately 100 L.
Elimination
Metabolism and Elimination
Lixisenatide is presumed to be eliminated through glomerular filtration, and
proteolytic degradation.
After multiple dose administration in patients with type 2 diabetes, mean
terminal half-life was approximately 3 hours and the mean apparent clearance
(CL/F) about 35 L/h.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
The limited available data with lixisenatide in pregnant women are no
miscarriage. There are risks to the mother and fetus associated with
poorly controlled diabetes in pregnancy.
Based on animal reproduction studies, there may be risks to the fetus from
exposure to lixisenatide during pregnancy. ADLYXIN should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
2. Lactation
Risk Summary
There is no information regarding the presence of ADLYXIN in human milk, the
effects on the breastfed infant, or the effects on milk production. However,
lixisenatide is present in rat milk .
The developmental and health benefits of breastfeeding should be considered
along with the mother’s clinical need for lixisenatide and any potential adverse
effects on the breastfed infant from lixisenatide or from the underlying maternal
condition.
3.Pediatric Use
Safety and effectiveness of ADLYXIN have not been established in pediatric
patients below 18 years of age.
4.Geriatric Use
In Phase 2 and 3controlled clinical studies of ADLYXIN, a total of 1837 (25%)
of the patients exposed to the study medication were 65 years of age and
over and 288 (4%) were 75 years of age and over. No overall differences
were observed in safety or effectiveness between these patients and younger
patients, but individual sensitivity cannot be ruled out.
5. Renal Impairment
In patients with mild renal impairment (eGFR: 60-89 mL/min/1.73 m2) no
dose adjustment is required but close monitoring for ADLYXIN related adverse
reactions(6.1)] and for changes in renal function is recommended
because a higher incidence of hypoglycemia, nausea and vomiting were
observed in these patients.
6. Patients with Gastroparesis
ADLYXIN slows gastric emptying. Patients with preexisting gastroparesis
were excluded from clinical trials of ADLYXIN. ADLYXIN should not be initiated
in patients with severe gastroparesis
7.OVERDOSAGE
During clinical studies, doses up to 30 mcg of lixisenatide twice daily
(3 times the daily recommended dose) were administered to type 2 diabetic
patients in a 13-week study. The 30 mcg dose of lixisenatide is not an
approved dose. An increased incidence of gastrointestinal disorders was
observed.
In case of overdose, appropriate supportive treatment should be initiated
according to the patient’s clinical signs and symptom
