Indication:
LIST OF APPROVED DRUG FROM 01-01-2015 To 31-12-2015
ISSUED BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
4. Dapagliflozain Tablet 5mg/10mg 25-02-2015
In adult aged 18 years and older with Type -II diabetes
mellitus to improve glycemic control:
As monotherapy when diet and excercise
alone do not provide glycemic control in patients for
whom Metformin is considered inappropiate due to
intolerance
As an add-on combination with other glucose-lowering
medicinal products including insulin when these together
with diet and excercise do not provide adequate glycemic
control
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2015 To 31-12-3015)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FARXIGA safely and effectively.
See full prescribing information for FARXIGA. FARXIGA® (dapagliflozin) tablets, for oral use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
(1) Limitation of use: ? Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
DOSAGE AND ADMINISTRATION
The recommended starting dose is 5 mg once daily, taken in the morning, with or without food.
Dose can be increased to 10 mg once daily in patients tolerating FARXIGA who require additional glycemic control.
Assess renal function before initiating FARXIGA and periodically thereafter.
Initiation is not recommended in patients with an eGFR less than 60 mL/min/1.73 m2.
Use of FARXIGA is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions associated with FARXIGA
(5% or greater incidence) were female genital mycotic infections,
nasopharyngitis, and urinary tract infections.
Contra-Indications:
CONTRAINDICATIONS
History of serious hypersensitivity reaction to FARXIGA.
Severe renal impairment, end-stage renal disease, or dialysis.
WARNINGS AND PRECAUTIONS
Hypotension: Before initiating FARXIGA, assess volume status and
correct hypovolemia in the elderly, in patients with renal impairment
or low systolic blood pressure, and in patients on diuretics.
Monitor for signs and symptoms during therapy.
Impairment in renal function: Monitor renal function during therapy.
Hypoglycemia:
In patients taking insulin or an insulin secretagogue with FARXIGA,
consider a lower dose of insulin or the insulin secretagogue
to reduce the risk of hypoglycemia.
Genital mycotic infections:
Monitor and treat if indicated.
Increased LDL-C:
Monitor and treat per standard of care.
Bladder Cancer:
An imbalance in bladder cancers was observed in clinical trials.
FARXIGA should not be used in patients with active bladder cancer and
should be used with caution in patients with a prior history of bladder cancer.
Macrovascular outcomes:
There have been no clinical studies establishing conclusive evidence
of macrovascular risk reduction with FARXIGA or any other antidiabetic drug.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated
as an adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus.
Limitation of use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
DOSAGE AND ADMINISTRATION
The recommended starting dose is 5 mg once daily, taken in the morning,
with or without food.
Dose can be increased to 10 mg once daily in patients tolerating
FARXIGA who require additional glycemic control.
Assess renal function before initiating FARXIGA. Do not initiate
FARXIGA if eGFR is below 60 mL/min/1.73 m2.
Discontinue FARXIGA if eGFR falls persistently below 60 mL/min/1.73 m2
.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Instructions
Instruct patients to read the Medication Guide before starting treatment with
FARXIGA and to reread it each time the prescription is renewed.
Inform patients of the potential risks and benefits of FARXIGA and of alternative
modes of therapy.
Also inform patients about the importance of adherence to dietary instructions,
regular physical activity, periodic blood glucose monitoring
and HbA1c testing, recognition and management of hypoglycemia and
hyperglycemia, and assessment of diabetes complications.
Advise patients to seek medical advice promptly during periods of stress
such as fever, trauma, infection, or surgery, as medication requirements may change.
Instruct patients to take FARXIGA only as prescribed. If a dose is missed,
advise patients to take it as soon as it is remembered unless it is almost time
for the next dose, in which case patients should skip the missed dose and take
the medicine at the next regularly scheduled time.
Advise patients not to take two doses of FARXIGA at the same time.
Inform patients that the most common adverse reactions associated with use
of FARXIGA are genital mycotic infections, nasopharyngitis, and urinary tract infections.
Instruct patient to immediately inform her healthcare provider if she is pregnant
or plans to become pregnant. Based on animal data,
FARXIGA may cause fetal harm in the second and third trimesters of pregnancy.
Instruct patient to immediately inform her healthcare provider if she is breastfeeding
or planning to breastfeed. It is not known if FARXIGA is excreted in breast milk;
however, based on animal data, FARXIGA may cause harm to nursing infants.
Hypotension
Inform patients that symptomatic hypotension may occur with FARXIGA and advise
them to contact their healthcare provider if they experience such symptoms
Inform patients that dehydration may increase the risk for hypotension, and to
have adequate fluid intake.
Genital Mycotic Infections in Females (e.g., Vulvovaginitis)
Inform female patients that vaginal yeast infections may occur and provide them
with information on the signs and symptoms of vaginal yeast infections.
Advise them of treatment options and when to seek medical advice
Genital Mycotic Infections in Males (e.g., Balanitis)
Inform male patients that yeast infections of the penis (e.g., balanitis or
balanoposthitis) may occur, especially in patients with prior history.
Provide them with information on the signs and symptoms of balanitis
and balanoposthitis (rash or redness of the glans or foreskin of the penis).
Advise them of treatment options and when to seek medical advice .
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions (e.g., urticaria and
angioedema) have been reported with FARXIGA.
Advise patients to immediately report any signs or symptoms suggesting
allergic reaction or angioedema, and to take no more of the drug until they
have consulted prescribing physicians.
Urinary Tract Infections
Inform patients of the potential for urinary tract infections.
Provide them with information on the symptoms of urinary tract infections.
Advise them to seek medical advice if such symptoms occur.
Bladder Cancer
Inform patients to promptly report any signs of macroscopic hematuria or other
symptoms potentially related to bladder cancer.
Laboratory Tests
Due to its mechanism of action, patients taking FARXIGA will test positive
for glucose in their urine.
Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA
Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543
and AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
Product of Ireland
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 Mechanism of Action
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules,
is responsible for the majority of the reabsorption of filtered glucose from the
tubular lumen. Dapagliflozin is an inhibitor of SGLT2.
By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose
and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
2. Pharmacokinetics
Absorption
Following oral administration of dapagliflozin, the maximum plasma concentration (C max )
is usually attained within 2 hours under fasting state. The C max and AUC values
increase dose proportionally with increase in dapagliflozin dose in the therapeutic
dose range.
The absolute oral bioavailability of dapagliflozin following the administration
of a 10 mg dose is 78%. Administration of dapagliflozin with a high-fat meal
decreases its Cmax by up to 50% and prolongs T max by approximately 1 hour,
but does not alter AUC as compared with the fasted
state.
These changes are not considered to be clinically meaningful and
dapagliflozin can be administered with or without food.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy:
There are no adequate and well-controlled studies in pregnant women.
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Discontinue FARXIGA or discontinue nursing.
Geriatrics:
Higher incidence of adverse reactions related to reduced intravascular
volume.
Renal Impairment:
Higher incidence of adverse reactions related to reduced intravascular
volume and renal function.
