INVOKANA- canagliflozin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CANAGLIFLOZIN (UNII: 0SAC974Z85) (CANAGLIFLOZIN ANHYDROUS - UNII:6S49DGR869)

Available from:

Janssen Pharmaceuticals, Inc.

INN (International Name):

canagliflozin

Composition:

canagliflozin anhydrous 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INVOKANA (canagliflozin) is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). - to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. Limitations of Use INVOKANA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)] . INVOKANA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . INVOKANA is likely to be ineffective in this setting based upon i

Product summary:

INVOKANA ® (canagliflozin) tablets are available in the strengths and packages listed below: 100 mg tablets are yellow, capsule-shaped, film-coated tablets with "CFZ" on one side and "100" on the other side. 300 mg tablets are white, capsule-shaped, film-coated tablets with "CFZ" on one side and "300" on the other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Patient Information leaflet

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 07/2023
Medication Guide
INVOKANA ®(in-vo-KAHN-uh)
(canagliflozin)
tablets, for oral use
What is the most important information I should know about INVOKANA?
INVOKANA can cause serious side effects, including:
•
Diabetic ketoacidosis (increased ketones in your blood or urine) in
people with type 1 and other
ketoacidosis.INVOKANA can cause ketoacidosis that can be
life-threatening and may lead to
death. People with type 1 diabetes, type 2 diabetes, or pancreas
problems have a high risk of
getting ketoacidosis. Ketoacidosis can happen even if your blood sugar
is less than 250 mg/dL.
Your healthcare provider may ask you to periodically check ketones in
your urine or blood.
Ketoacidosis can also happen in people who are sick or who have
surgery during treatment with
INVOKANA. Ketoacidosis is a serious condition which needs to be
treated in a hospital.
Ketoacidosis may lead to death.
•
Stop taking INVOKANA and call your healthcare provider or get medical
help right away if you
get any of the following. If possible, check for ketones in your urine
or blood, even if your blood
sugar is less than 250 mg/dL:
•
nausea
•
vomiting
•
stomach-area (abdominal) pain
•
tiredness
•
trouble breathing
•
ketones in your urine or
blood
•
Amputations. INVOKANA may increase your risk of lower limb
amputations. Amputations
mainly involve removal of the toe or part of the foot, however,
amputations involving the leg,
below and above the knee, have also occurred. Some people had more
than one amputation, some
on both sides of the body.
You may be at a higher risk of lower limb amputation if you:
•
have a history of amputation
•
have heart disease or are at risk for heart disease
•
have had blocked or narrowed blood vessels, usually in your leg
•
have damage to the nerves (neuropathy) in your leg
•
have had diabetic foot ulcers or sores
Call your doctor right away if you have new pa

Summary of Product characteristics

INVOKANA- CANAGLIFLOZIN TABLET, FILM COATED
JANSSEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INVOKANA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INVOKANA.
INVOKANA
(CANAGLIFLOZIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Indications and Usage ( 1)
07/2023
Dosage and Administration ( 2)
07/2023
Contraindications ( 4)
07/2023
Warnings and Precautions ( 5.1)
07/2023
INDICATIONS AND USAGE
INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
indicated:
As an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus (
1)
To reduce the risk of major adverse cardiovascular events in adults
with type 2 diabetes mellitus and
established cardiovascular disease ( 1)
To reduce the risk of end-stage kidney disease, doubling of serum
creatinine, cardiovascular death, and
hospitalization for heart failure in adults with type 2 diabetes
mellitus and diabetic nephropathy with
albuminuria ( 1).
Limitations of Use:
Not recommended for use to improve glycemic control in patients with
type 1 diabetes mellitus ( 1)
Not recommended for use to improve glycemic control in adults with
type 2 diabetes mellitus with an
eGFR less than 30 mL/min/1.73 m
( 1)
DOSAGE AND ADMINISTRATION
Assess renal function before initiating and as clinically indicated (
2.1)
The recommended starting dose is 100 mg once daily, taken before the
first meal of the day ( 2.2)
Dose can be increased to 300 mg once daily in patients tolerating 100
mg once daily who have an eGFR
of 60 mL/min/1.73 m
or greater and require additional glycemic control ( 2.2)
Dose adjustment for patients with renal impairment may be required (
2.3)
See full prescribing information for INVOKANA dosage modifications due
to drug interactions ( 2.4)
Withhold INVOKANA at least 3 days, if possible, prior to major surgery
or procedures associated with
prolonged fasting ( 2.5).
DOSAGE FORMS AND STRENGTHS
Tabl