KOMBIGLYZE XR- saxagliptin and metformin hydrochloride tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

saxagliptin hydrochloride (UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ), metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

saxagliptin hydrochloride

Composition:

saxagliptin anhydrous 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see Clinical Studies (14) ]. KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. KOMBIGLYZE XR is contraindicated in patients with: Limited available data with KOMBIGLYZE XR or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ]. No adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis [see Data ]. The estimated background risk of major birth defects is 6 to 10% in women w

Product summary:

How Supplied KOMBIGLYZE® XR (saxagliptin and metformin HCl extended-release) tablets have markings on both sides and are available in the strengths and packages listed in Table 15. 5 mg/500 mg light brown to brown, biconvex, capsule-shaped “5/500” on one side and “4221” on the reverse, in blue ink Bottles of 30 0310-6135-30 5 mg/1000 mg pink, biconvex, capsule-shaped “5/1000” on one side and “4223” on the reverse, in blue ink Bottles of 30 0310-6145-30 2.5 mg/1000 mg pale yellow to light yellow, biconvex, capsule-shaped “2.5/1000” on one side and “4222” on the reverse, in blue ink Bottles of 60 0310-6125-60 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
KOMBIGLYZE® XR (kom-be-glyze X-R)
(saxagliptin and metformin HCl extended-release)
tablets, for oral use
What is the most important information I should know about KOMBIGLYZE
XR?
Serious side effects can happen in people taking KOMBIGLYZE XR,
including:
1.
Lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, can
cause a rare but
serious condition called lactic acidosis (a build-up of an acid in the
blood) that can cause death.
Lactic acidosis is a medical emergency and must be treated in the
hospital.
Call your doctor right away if you have any of the following symptoms,
which could be signs of
lactic acidosis:
•
you feel cold in your hands or feet
•
you feel dizzy or lightheaded
•
you have a slow or irregular heartbeat
•
you feel very weak or tired
•
you have unusual (not normal) muscle pain
•
you have trouble breathing
•
you feel sleepy or drowsy
•
you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other
things that, combined with the
metformin, led to the lactic acidosis. Tell your doctor if you have
any of the following, because you have
a higher chance for getting lactic acidosis with KOMBIGLYZE XR if you:
•
have severe kidney problems or your kidneys are affected by certain
x-ray tests that use injectable
dye
•
have liver problems
•
drink alcohol very often, or drink a lot of alcohol in short-term
"binge" drinking
•
get dehydrated (lose a large amount of body fluids). This can happen
if you are sick with a fever,
vomiting, or diarrhea. Dehydration can also happen when you sweat a
lot with activity or exercise
and do not drink enough fluids
•
have surgery
•
have a heart attack, severe infection, or stroke
The best way to keep from having a problem with lactic acidosis from
metformin is to tell your doctor if
you have any of the problems in the list above. Your doctor may decide
to stop your KOMBIGLYZE XR
for a while if you have any of these things.
KOMBIGL

Summary of Product characteristics

KOMBIGLYZE XR- SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KOMBIGLYZE XR SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOMBIGLYZE XR.
KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE) TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
KOMBIGLYZE XR is a combination of saxagliptin, a dipeptidyl
peptidase-4 (DPP4) inhibitor, and metformin,
a biguanide, indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2
diabetes mellitus when treatment with both saxagliptin and metformin
is appropriate. (1, 14)
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
®
POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN
DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS.
SYMPTOMS
INCLUDED MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND
ABDOMINAL PAIN.
LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION
GAP
ACIDOSIS, INCREASED LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA
LEVELS GENERALLY
>5 MCG/ML. (5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE >65
YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER
PROCEDURES,
HYPOXIC STATES, 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 IN THE FULL PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE KOMBIGLYZE XR AND
INSTITUTE GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED.
(5.1)
Not used for the treatment of type 1 diabetes mellitus or diabetic
ketoacidosis. (1.1)
Administer once daily with the evening meal.