DRUG UPDATE
APRIL 2018
SEGLUROMET (ertugliflozin+metformin)
HIGHLIGHTS OF
PRESCRIBING INFORMATION
INDICATIONS AND USAGE
SEGLUROMET is a combination of ertugliflozin,
a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide,
indicated as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus who are not adequately controlled on a
regimen containing ertugliflozin or metformin, or in patients who are already
treated with both ertugliflozin and metformin. (1)
Limitations of
Use:
• Not for the treatment of type 1 diabetes
mellitus or diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose based on the
patient’s current regimen. (2.1)
Maximum recommended dose is 7.5 mg
ertugliflozin/1,000 mg metformin twice daily. (2.1)
Take twice daily with meals, with gradual
dose escalation. (2.1)
Assess
renal function before initiating SEGLUROMET (2.2):
o Do not use in patients with an
estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.
o Initiation is not recommended in
patients with an eGFR of 30 to less than 60 mL/minute/1.73 m2.
o Continued use is not recommended in
patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2.
SEGLUROMET may need to be discontinued at
time of, or prior to, iodinated contrast imaging procedures. (2.3)
DOSAGE FORMS AND
STRENGTHS
Tablets:
•
Ertugliflozin 2.5
mg and metformin hydrochloride 500 mg (3)
•
Ertugliflozin 2.5
mg and metformin hydrochloride 1,000 mg (3)
•
Ertugliflozin 7.5
mg and metformin hydrochloride 500 mg (3)
•
Ertugliflozin 7.5
mg and metformin hydrochloride 1,000 mg (3)
CONTRAINDICATIONS
•
Severe renal
impairment, end stage renal disease, or dialysis. (4, 5.1, 5.4)
•
Metabolic
acidosis, including diabetic ketoacidosis. (4, 5.1)
•
History of serious
hypersensitivity reaction to ertugliflozin or metformin. (4)
WARNINGS AND PRECAUTIONS
Lactic Acidosis: See boxed warning. (5.1)
Hypotension: May occur particularly in patients
with renal impairment, the elderly, or patients on diuretics. Before
initiating, assess and correct volume status. Monitor for signs and symptoms
during therapy. (5.2)
Ketoacidosis:
Assess patients who present with signs and symptoms of metabolic acidosis
for ketoacidosis, regardless of blood glucose level. If suspected, discontinue,
evaluate, and treat promptly. Before initiating, consider risk factors for
ketoacidosis. Patients may require monitoring and temporary discontinuation of
therapy in clinical situations known to predispose to ketoacidosis. (5.3)
Acute Kidney Injury and Impairment in
Renal Function: Consider
temporarily discontinuing in settings of reduced oral intake or fluid losses.
If acute kidney injury occurs, discontinue and promptly treat. Monitor renal
function. (5.4)
Urosepsis
and Pyelonephritis: Evaluate patients for signs and symptoms of urinary
tract infections and treat promptly, if indicated. (5.5)
Lower Limb Amputation: Before initiating, consider factors
that may increase risk of amputation. Monitor patients for infections or ulcers
of lower limbs, and discontinue if these occur. (5.6)
Hypoglycemia: Consider a lower dose of insulin or
insulin secretagogue to reduce risk of hypoglycemia when used in combination.
(5.7)
Genital Mycotic Infections: Monitor and treat if indicated. (5.8)
Vitamin B12 Deficiency: Metformin may lower vitamin
B12 levels. Measure hematological parameters annually. (5.9)
Increased LDL-C: Monitor and treat as appropriate.
(5.10)
ADVERSE REACTIONS
•
The most common
adverse reactions associated with ertugliflozin (incidence ≥5%) were female
genital mycotic infections. (6.1)
•
Most common
adverse reactions associated with metformin (incidence ≥5%): diarrhea, nausea,
vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and
headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS,
contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•
Carbonic anhydrase
inhibitors may increase risk of lactic acidosis. Consider more frequent
monitoring. (7.2)
•
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. (7.2)
•
Alcohol can
potentiate the effect of metformin on lactate metabolism. Warn patients against
excessive alcohol intake. (7.2)
USE IN SPECIFIC
POPULATIONS
•
Pregnancy: Advise females of
the potential risk to a fetus, especially during the second and third
trimesters. (8.1)
•
Lactation: Breastfeeding not
recommended. (8.2)
•
Females and Males of Reproductive Potential: Advise premenopausal females of the
potential for an unintended pregnancy. (8.3)
•
Geriatrics: Higher incidence
of adverse reactions related to reduced intravascular volume. (5.2, 8.5)
•
Renal impairment: Higher incidence of adverse reactions related to reduced intravascular
volume and renal function. (5.1, 5.4, 8.6)
•
Hepatic impairment: Avoid
use in patients with hepatic impairment.
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