SOLIQUA 100/33- insulin glargine and lixisenatide injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ), LIXISENATIDE (UNII: 74O62BB01U) (LIXISENATIDE - UNII:74O62BB01U)

Pieejams no:

sanofi-aventis U.S. LLC

SNN (starptautisko nepatentēto nosaukumu):

insulin glargine

Kompozīcija:

insulin glargine 100 U in 1 mL

Ievadīšanas:

SUBCUTANEOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : - SOLIQUA 100/33 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . Consider other antidiabetic therapies in patients with a history of pancreatitis. - SOLIQUA 100/33 is not recommended for use in combination with any other product containing a GLP-1 receptor agonist [see Warnings and Precautions (5.5)] . - SOLIQUA 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - SOLIQUA 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - SOLIQUA 100/33 has not been studied in combination with prandial insulin. SOLIQUA 100/33 is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.6)] . - In patients w

Produktu pārskats:

SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a clear, colorless to almost colorless solution in a 3 mL prefilled, disposable, single-patient-use pen: Needles are not included. Only use needles that are compatible for use with SOLIQUA 100/33 prefilled pen. Dispense in the original sealed carton with the enclosed Instructions for Use. Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Discard SOLIQUA 100/33 if it has been frozen. Protect from light. After first use, store at room temperature up to 77°F (25°C). Replace the pen cap after each use to protect from light. Discard pen 28 days after first use. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.

Autorizācija statuss:

Biologic Licensing Application

Lietošanas instrukcija

sanofi-aventis U.S. LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: September
2023
Medication Guide
SOLIQUA® 100/33 (So - lee - kwa)
(insulin glargine and lixisenatide)
injection, for subcutaneous use
What is the most important information I should know about SOLIQUA
100/33?
Do not share your SOLIQUA 100/33 pen with other people, even if the
needle has been changed. You
may give other people a serious infection or get a serious infection
from them.
SOLIQUA 100/33 can cause serious side effects including inflammation
of the pancreas (pancreatitis),
which may be severe and lead to death.
Before using SOLIQUA 100/33, tell your healthcare provider if you have
had:
•
pancreatitis
•
stones in your gallbladder (cholelithiasis)
•
a history of alcoholism
These medical problems may make you more likely to get pancreatitis.
Stop taking SOLIQUA 100/33 and call your healthcare provider right
away if you have pain in your
stomach area (abdomen) that is severe and will not go away. The pain
may be felt going from your
abdomen through to your back. The pain may happen with or without
vomiting. These may be symptoms
of pancreatitis.
What is SOLIQUA 100/33?
SOLIQUA 100/33 is an injectable prescription medicine that contains 2
diabetes medicines, insulin
glargine and lixisenatide, which may improve blood sugar (glucose)
control in adults with type 2 diabetes
when used with diet and exercise.
•
SOLIQUA 100/33 has not been studied in people with a history of
pancreatitis.
•
SOLIQUA 100/33 is not recommended for people who also take
lixisenatide or other medicines
called GLP-1 receptor agonists.
•
SOLIQUA 100/33 is not for use in people with type 1 diabetes or people
with diabetic
ketoacidosis.
•
SOLIQUA 100/33 has not been studied in people who have a stomach
problem that causes slow
emptying of the stomach (gastroparesis). SOLIQUA 100/33 is not for
people with slow emptying
of the stomach.
•
SOLIQUA 100/33 has not been studied in people who also take a
short-

Produkta apraksts

SOLIQUA 100/33- INSULIN GLARGINE AND LIXISENATIDE INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLIQUA 100/33 SAFELY AND EFFECTIVELY_ ._ SEE FULL
PRESCRIBING INFORMATION FOR SOLIQUA 100/33.
SOLIQUA 100/33 (INSULIN GLARGINE AND LIXISENATIDE) INJECTION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
SOLIQUA 100/33 is a combination of insulin glargine, an insulin
analog, and lixisenatide, 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. (1)
Limitations of Use (1):
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in patients with a history of
pancreatitis.
Not recommended for use in combination with any other product
containing a GLP-1 receptor agonist.
Not for treatment of type 1 diabetes mellitus or diabetic
ketoacidosis.
Not recommended for use in patients with gastroparesis.
Has not been studied in combination with prandial insulin.
DOSAGE AND ADMINISTRATION
Inject subcutaneously once a day within the hour prior to the first
meal of the day. (2.1)
SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. (2.1,
2.2)
Maximum daily dosage is 60 units (60 units of insulin glargine and 20
mcg of lixisenatide). (2.1)
Discontinue basal insulin or GLP-1 receptor agonist prior to
initiation. (2.2)
In patients naive to basal insulin or to a GLP-1 receptor agonist,
currently on less than 30 units of basal insulin, or on a GLP-1
receptor agonist, the recommended starting dosage is 15 units
subcutaneously once daily. (2.2)
In patients inadequately controlled on 30 to 60 units of basal
insulin, the starting dosage is 30 units subcutaneously once daily.
(2.2)
See Full Prescribing Information for titration recommendations. (2.3)
Inject subcutaneously in abdominal area, thigh, or upper arm and
rotate injection sites with