JARDIANCE Prescribing Information - Please refer to the full datasheet at www.medsafe.govt.nz or available on request before prescribing ...
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JARDIANCE®
Prescribing
Information
Please refer to the full datasheet
at www.medsafe.govt.nz or available
Not an actual patient on request before prescribing.
Index Indications
Indications 2
GLYCAEMIC CONTROL
Special Authority criteria 3 JARDIANCE® (empagliflozin) is indicated in the treatment of type 2 diabetes
mellitus to improve glycaemic control in adults as:
Dose and administration 5
Monotherapy
Method of administration 5 When diet and exercise alone do not provide adequate glycaemic control
in patients for whom use of metformin is considered inappropriate due to
Special populations 6 intolerance.
Contraindications 7 Add-on combination therapy
In combination with other glucose–lowering medicinal products including
Special warnings and 7 insulin, when these, together with diet and exercise, do not provide adequate
precautions for use glycaemic control.
JARDIAMET® 9 Prevention of cardiovascular events
(empagliflozin/metformin)
JARDIANCE is indicated in patients with type 2 diabetes mellitus and
established cardiovascular disease to reduce the risk of cardiovascular death.
To prevent cardiovascular deaths, JARDIANCE should be used in conjunction
with other measures to reduce cardiovascular risk in line with the current
standard of care.
FUNDING
JARDIANCE is a fully funded medicine from February 1st, 2021.
Restrictions apply.*
FULLY FUNDED
with Special Authority criteria*
From February 1st, 2021
*Pharmaceutical schedule
See references 1 and 2 for more information
Special Authority criteria
Initial application from any relevant practitioner. Approvals valid without further
renewal unless notified for applications meeting the following criteria:
All of the following:
1. Patient has type 2 diabetes; and
2. Any of the following:
2.1. Patient is Māori or any Pacific ethnicity; or
2.2. Patient has pre-existing cardiovascular disease or risk equivalent^; or
2.3. Patient has an absolute 5-year cardiovascular disease risk of 15%
or greater according to a validated cardiovascular risk assessment
calculator; or
2.4. Patient has a high lifetime cardiovascular risk due to being diagnosed
with type 2 diabetes during childhood or as a young adult; or
2.5. Patient has diabetic kidney diseaseß; and
3. Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the
regular use of at least one blood-glucose lowering agent (e.g. metformin,
vildagliptin, or insulin) for at least 3 months; and
4. Treatment will not be used in combination with a funded GLP-1 agonist.
Note: Criteria 2.1 – 2.5 describe patients at high risk of cardiovascular or renal complications
of diabetes. ^Defined as: prior cardiovascular disease event (i.e. angina, myocardial infarction,
percutaneous coronary intervention, coronary artery bypass grafting, transient ischaemic
attack, ischaemic stroke, peripheral vascular disease), congestive heart failure or familial
hypercholesterolaemia. ßDefined as: persistent albuminuria (albumin: creatinine ratio greater than or
equal to 3 mg/mmol, in at least two out of three samples over a 3-6 month period) and/or eGFR less
than 60 mL/min/1.73m2 in the presence of diabetes, without alternative cause.
Dose and administration Special populations
The recommended starting dose of JARDIANCE® is 10 mg once daily.
In patients tolerating empagliflozin 10 mg once daily and requiring
RENAL IMPAIRMENT
additional glycaemic control, the dose can be increased to 25 mg JARDIANCE® is not recommended for use in patients with eGFR < 30 mL/min/1.73 m2.
once daily. No dose adjustment is required for patients with eGFR ≥ 30 mL/min/1.73 m2.
When JARDIANCE is used in combination with a sulfonylurea Due to the mechanism of action, the efficacy of empagliflozin is dependent on
or with insulin, a lower dose of the sulfonylurea or insulin renal function. Therefore assessment of renal function is recommended:
may be considered to reduce the risk of hypoglycaemia. • rior to JARDIANCE initiation and periodically during treatment,
p
i.e. at least yearly;
• rior to initiation of concomitant medicines that may reduce renal function
p
JARDIANCE® provides convenient once-daily oral dosing and periodically thereafter.
10 mg 25 mg HEPATIC IMPAIRMENT
Any time of day With or without food No dose adjustment is recommended for patients with hepatic impairment.
ELDERLY PATIENTS
No dosage adjustment is recommended based on age. Therapeutic experience
Method of administration in patients aged 85 years and older is limited. Initiation of empagliflozin
therapy in this population is not recommended. Patients aged 75 years and
JARDIANCE can be taken with or without food.
older should be prescribed with caution.
It should be swallowed whole and taken with a glass of water.
If a dose is missed it should only be taken if it is less than 12 hours before the PAEDIATRIC POPULATION
next dose. Safety and effectiveness of JARDIANCE in children under 18 years of age have
not been established.
Contraindications For practical advice regarding recognition and management, risk mitigation
and peri-procedure advice, please refer to the Australian Diabetes Society DKA
position statement or ask your Boehringer Ingelheim (NZ) Ltd representative.3
Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE®.
Patients with CKD stage 4 or 5 (severely impaired renal function including FOURNIER’S GANGRENE
patients receiving dialysis; eGFR < 30mL/min/1.73 m2 or CrCl < 30mL/min). Post-marketing reports of necrotising fasciitis (Fournier’s gangrene) have been
The efficacy of JARDIANCE is dependent on renal function. associated with the use of SGLT2i’s. Fournier’s gangrene is a rare but serious and
potentially life-threatening infection of the perineum. Patients should be advised
Special warnings and precautions for use to tell their doctor immediately if they experience pain or tenderness, itching,
swelling in the genital or back passage area, fever or are generally feeling unwell.
JARDIANCE should not be used in patients with type 1 diabetes.
These may be symptoms of Fournier’s gangrene.
DIABETIC KETOACIDOSIS
UROGENITAL TRACT INFECTIONS
Cases of diabetic ketoacidosis (DKA), a serious life-threatening condition
Clinical trials report the frequency of urinary tract infection as higher than placebo
requiring urgent hospitalisation, have been reported in patients treated
in patients treated with JARDIANCE 10 mg and similar to placebo in patients
with empagliflozin, including fatal cases. In a number of reported cases, the
treated with JARDIANCE 25 mg. Temporary interruption of JARDIANCE should be
presentation of the condition was atypical with only moderately increased blood
considered in patients with complicated urinary tract infections. Patients should be
glucose values, below 14 mmol/L.
counselled to practice good urogenital hygiene to minimise the risk of infection.
The risk of diabetic ketoacidosis must be considered in the event of non-specific
symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, INCREASED URINATION
difficulty breathing, confusion, unusual fatigue or sleepiness.
Initially patients may note an increase in urination. This is mostly mild-moderate
Patients should be assessed for ketoacidosis immediately if these symptoms in intensity. The rate of nocturia is similar between patients taking JARDIANCE
occur, regardless of blood glucose level. If ketoacidosis is suspected, JARDIANCE and placebo.
should be discontinued, the patient should be evaluated, and prompt treatment
should be instituted. DEHYDRATION
Patients who may be at higher risk of ketoacidosis while taking JARDIANCE include JARDIANCE may add to the diuretic effects of thiazide and loop diuretics and
patients on a very low carbohydrate diet (as the combination may further increase may increase the risk of dehydration and hypotension.
ketone body production), patients with an acute illness, pancreatic disorders
suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or HYPOGLYCAEMIA
pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol JARDIANCE has a low risk of hypoglycaemia but is associated with an increased
abuse, severe dehydration, and patients with a history of ketoacidosis. JARDIANCE risk when given in combination with an SU or insulin. Consider lowering the SU
should be used with caution in these patients. When reducing the insulin dose, and insulin dose to reduce the risk of hypoglycaemia.
caution should be taken. In patients treated with JARDIANCE consider
monitoring for ketoacidosis and temporarily discontinuing JARDIANCE FLUID LOSS
in clinical situations known to predispose to ketoacidosis (e.g. Conditions that may lead to fluid loss (e.g. gastrointestinal illness), consider
prolonged fasting due to acute illness or surgery). In these temporary interruption of JARDIANCE until fluid loss is corrected.
situations, consider monitoring of ketones, even if
JARDIANCE treatment has been interrupted.JARDIAMET® JARDIAMET should be dose adjusted with
declining eGFR.
JARDIAMET is a funded medicine. Restrictions apply
eGFR
(mL/min) Empagliflozin Metformin
JARDIAMET (empagliflozin and metformin)
®
can be considered as: 60 - 89 Maximum daily dose is Maximum daily dose is
25 mg. 3000 mg.
an adjunct to diet and exercise to improve glycaemic control in adult patients
with type 2 diabetes mellitus: No dose adjustment is required. Dose reduction may be
considered in relation to
• when treatment with both empagliflozin and metformin is appropriate
declining renal function.
• inadequately controlled with metformin or empagliflozin alone
45 - 59 No dose adjustment is required. Maximum daily dose is
• inadequately controlled with empagliflozin or metformin in combination with 2000 mg.
other glucose-lowering products including insulin
The starting dose is at most
• lready treated with empagliflozin and metformin co-administered as
a half of the maximum dose.
separate tablets.
30 - 44 No dose adjustment is required. Maximum daily dose is
1000 mg.
Recommended starting dose For patients requiring additional control
The starting dose is at most
5 mg / 500 mg 12.5 mg / 500 mg half of the maximum dose.
OR OR
5 mg / 1000 mg 12.5 mg / 1000 mgJARDIANCE® empagliflozin 10mg, 25mg film coated tablets JARDIAMET® empagliflozin/metformin 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, 12.5mg/1000mg film coated tablet ABRIDGED PRESCRIBING INFORMATION Before prescribing, please review full Data Sheet which is available on request from Boehringer Ingelheim or from http://www.medsafe.govt.nz/profs/datasheet/dsform.asp INDICATION: JARDIANCE: Glycaemic control: Treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults as: Monotherapy - When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; Add-on combination therapy - With other glucose- lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Prevention of cardiovascular (CV) events: In patients with T2DM and established CV disease to reduce the risk of CV death. To prevent CV deaths, Jardiance should be used in conjunction with other measures to reduce CV risk in line with the current standard of care. JARDIAMET: Glycaemic control: As an adjunct to diet and exercise to improve glycaemic control in adults with T2DM: when treatment with both empagliflozin and metformin is appropriate; inadequately controlled with metformin or empagliflozin alone; inadequately controlled with empagliflozin or metformin in combination with other glucose-lowering products including insulin; already treated with empagliflozin and metformin co-administered as separate tablets. Prevention of CV events: In patients with T2DM and established CV disease when treatment with empagliflozin and metformin is appropriate and empagliflozin is needed to reduce the risk of CV death. To prevent CV deaths, Jardiamet should be used in conjunction with other measures to reduce CV risk in line with the current standard of care. DOSAGE AND ADMINISTRATION: JARDIANCE: Recommended starting dose is 10mg once daily taken with or without food. Patients tolerating 10mg once daily and requiring additional glycaemic control, increase dose to 25mg once daily. No dose adjustment is recommended based on age, patients with eGFR ≥30mL/min/1.73m2 or hepatic impairment. When Jardiance is used in combination with a sulfonylurea (SU) or with insulin, a lower dose of the SU or insulin may be considered. JARDIAMET: Recommended dose is one tablet twice daily taken with meals. Maximum recommended daily dose is 25 mg of empagliflozin and 2000 mg of metformin. Patients inadequately controlled on metformin alone or in combination with other products, including insulin: Recommended starting dose is empagliflozin 5mg twice daily plus the dose of metformin already being taken. Total daily dose of empagliflozin can be increase to 25mg. Patients already treated with empagliflozin: Initiate at the same daily dose of empagliflozin already being taken. Patients switching from co-administration of empagliflozin and metformin: Initiate at the dose of empagliflozin and metformin already being taken. When used in combination with a SU and/or insulin: A lower dose of the SU and/or insulin may be required to reduce the risk of hypoglycaemia. Renal impairment: Dose adjustment is based on metformin component and patients eGFR, see full Data Sheet. CONTRAINDICATIONS: Hypersensitivity to any component of the products. JARDIANCE: Patients with CKD stage 4 or 5 (severely impaired renal function including patients receiving dialysis; eGFR
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