XULTOPHY 100/3.6 (- insulin degludec and liraglutide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN DEGLUDEC (UNII: 54Q18076QB) (INSULIN DEGLUDEC - UNII:54Q18076QB), LIRAGLUTIDE (UNII: 839I73S42A) (LIRAGLUTIDE - UNII:839I73S42A)

Available from:

Novo Nordisk

INN (International Name):

INSULIN DEGLUDEC

Composition:

INSULIN DEGLUDEC 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: XULTOPHY 100/3.6 is contraindicated: Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. XULTOPHY 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no available data with XULTOPHY 100/3.6, insulin degludec or liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. For insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. No adverse outcomes were observed for pregnant ani

Product summary:

XULTOPHY 100/3.6 (insulin degludec and liraglutide) injection is an injection supplied as a clear, colorless solution in a 3 mL pre-filled, disposable, single-patient use pen injector. The XULTOPHY 100/3.6 pen dials in one unit increments. Dosage Unit/Strength Package size NDC # 3 mL single-patient-use XULTOPHY 100/3.6 pen (100 units/mL insulin degludec and 3.6 mg/mL liraglutide) Package of 5 0169-2911-15 Dispense in the original sealed carton with the enclosed Instructions for Use. Prior to first use, XULTOPHY 100/3.6 should be stored between 2°C and 8°C (36°F to 46°F) until the expiration date printed on the label. Store prefilled pens in the carton so they will stay clean and protected from light. Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use XULTOPHY 100/3.6 if it has been frozen. After first use, the XULTOPHY 100/3.6 pen can be stored for 21 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Keep all XULTOPHY 100/3.6 pens away from direct heat and light. Always remove the needle after each injection and store the XULTOPHY 100/3.6 pen without a needle attached. This prevents contamination and/or infection, or leakage of the XULTOPHY 100/3.6 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination. The storage conditions are summarized in Table 11: Table 11: Storage Conditions for XULTOPHY 100/3.6 Pen Prior to first use After first use Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature 59°F to 86°F (15°C to 30°C) Refrigerated 36°F to 46°F (2°C to 8°C) Until expiration date 21 Days

Authorization status:

Biologic Licensing Application

Patient Information leaflet

XULTOPHY 100/3.6- (INSULIN DEGLUDEC AND LIRAGLUTIDE) INJECTION,
SOLUTION
Novo Nordisk
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MEDICATION GUIDE
XULTOPHY® 100/3.6 (ZUL-to-fye)
(insulin degludec and liraglutide) injection for subcutaneous
injection
Read this Medication Guide before you start using XULTOPHY 100/3.6 and
each
time you get a refill. There may be new information. This information
does not take
the place of talking to your healthcare provider about your medical
condition or your
treatment.
What is the most important information I should know about XULTOPHY
100/3.6?
XULTOPHY 100/3.6 may cause serious side effects, including:
•
Possible thyroid tumors, including cancer. Tell your healthcare
provider if you
get a lump or swelling in your neck, hoarseness, trouble swallowing,
or shortness
of breath. These may be symptoms of thyroid cancer. In studies with
rats and
mice, liraglutide, one of the components of XULTOPHY 100/3.6, and
medicines
that work like liraglutide caused thyroid tumors, including thyroid
cancer. It is
not known if XULTOPHY 100/3.6 will cause thyroid tumors or a type of
thyroid
cancer called medullary thyroid carcinoma (MTC) in people.
•
Do not use XULTOPHY 100/3.6 if you or any of your family have ever had
a
type of thyroid cancer called medullary thyroid carcinoma (MTC), or if
you have
an endocrine system condition called Multiple Endocrine Neoplasia
syndrome
type 2 (MEN 2).
What is XULTOPHY 100/3.6?
•
XULTOPHY 100/3.6 is an injectable prescription medicine that contains
2
diabetes medicines, insulin degludec, 100 units/mL, and liraglutide,
3.6 mg/mL.
XULTOPHY 100/3.6 should be used along with diet and exercise to lower
blood
sugar (glucose) in adults with type 2 diabetes mellitus.
•
XULTOPHY 100/3.6 is not recommended as the first choice of medicine
for
treating diabetes.
•
XULTOPHY 100/3.6 is not recommended for use in combination with any
other
product containing liraglutide or another glucagon-like peptide 1
receptor
agonist (GLP-1 receptor agonist).
•
XULTOPHY 100/3.6 is not for use in people with typ

Summary of Product characteristics

XULTOPHY 100/3.6- (INSULIN DEGLUDEC AND LIRAGLUTIDE) INJECTION,
SOLUTION
NOVO NORDISK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XULTOPHY 100/3.6 SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XULTOPHY
100/3.6.
XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE) INJECTION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2016
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
XULTOPHY 100/3.6 is a combination of insulin degludec, a long-acting
human insulin analog, and
liraglutide, 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 (1):
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Injection 100 units/mL of insulin degludec and 3.6 mg/mL of
liraglutide available in:
•
CONTRAINDICATIONS
•
•
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WARNINGS AND PRECAUTIONS
•
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®
LIRAGLUTIDE, ONE OF THE COMPONENTS OF XULTOPHY 100/3.6, CAUSES THYROID
C-CELL
TUMORS AT CLINICALLY RELEVANT EXPOSURES IN BOTH GENDERS OF RATS AND
MICE. IT IS
UNKNOWN WHETHER XULTOPHY 100/3.6 CAUSES THYROID C-CELL TUMORS,
INCLUDING
MEDULLARY THYROID CARCINOMA (MTC), IN HUMANS, AS THE HUMAN RELEVANCE
OF
LIRAGLUTIDE-INDUCED RODENT THYROID C-CELL TUMORS HAS NOT BEEN
DETERMINED (5.1,
13.1).
XULTOPHY 100/3.6 IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR
FAMILY HISTORY
OF MTC OR IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE
2 (MEN 2).
COUNSEL PATIENTS REGARDING THE POTENTIAL RISK OF MTC AND THE SYMPTOMS
OF THYROID
TUMORS (4, 5.1).
Not recommended as first-line therapy for patients inadequately
controlled on diet and exercise.
Not recommended for use in combination with any other product
containing liraglutide or another
GLP-1 receptor agonist.
Not for the treatment of type 1 diabetes mellitus or diabetic
ket