Basagine

Main information

  • Trade name:
  • Basagine 100 Units/ mL Solution for Injection (SC)
  • Dosage:
  • 100 Units/ mL
  • Pharmaceutical form:
  • Solution for Injection (SC)
  • Units in package:
  • In a box of 1-PVC tray containing 3mL solution in 5mL USP Type I clear glass vial with cream color rubber stopper and aluminium
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Getz Pharma Pvt., Ltd.

Documents

Localization

  • Available in:
  • Basagine 100 Units/ mL Solution for Injection (SC)
    Philippines
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Anti-Diabetic
  • Therapeutic indications:
  • To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Status

  • Source:
  • FDA - Food And Drug Administration - Philippines
  • Authorization number:
  • BR-1154
  • Authorization date:
  • 03-06-2021
  • Last update:
  • 26-01-2017

Summary of Product characteristics: dosage, interactions, side effects

Description:

Insulin Glargine (Basagine

) is a solution for injection used as antidiabetic

agent. Insulin Glargine (Basagine

) is a biosynthetic long-acting, human

insulin analogue administered subcutaneously to lower the excess blood-

glucose-level. It is synthesized by using recombinant DNA technology

and a special laboratory strain of non-pathogenic Escherichia coli.

Insulin Glargine differs from human insulin in that the amino acid asparagine

at position A21 is replaced by glycine and two arginines are added to the

C-terminus of the B-chain. Chemically, it is 21

-Gly-30

a-L-Arg-30

L-Arg-human insulin and has the molecular formula C

Formulation:

Insulin Glargine (Basagine

) is available as solution for injection for

subcutaneous administration as:

Insulin Glargine (Basagine

) 100Units/ mL:

Each mL contains:

Insulin Glargine (r-DNA origin) ... 100 Units (3.64mg)

Preservative: Metacresol... 0.27% w/v

CLINICAL PHARMACOLOGY

Mechanism of Action

The primary activity of insulin glargine is the regulation of glucose

metabolism. It inhibits hepatic glucose production and lowers blood

glucose level by enhancing peripheral glucose uptake especially by

skeletal muscle and fat. It also inhibits lipolysis in the adipocyte, inhibits

proteolysis and enhances protein synthesis. Insulin Glargine is a human

insulin analogue designed to have a low solubility at neutral pH. It is

completely soluble at the acidic pH of the injection solution (pH 4). After

injection into the subcutaneous tissue, the acidic solution is neutralized

leading to formation of micro-precipitates from which small amounts of

insulin glargine are continuously released, providing a smooth, peakless,

predictable concentration/ time profile with a prolonged duration of action.

PHARMACOKINETICS

Absorption and Bioavailability

Following subcutaneous injection, absorption of insulin glargine is slower

and more prolonged compared with that of isophane (NPH) human insulin;

the serum concentration-time profile for insulin glargine is relatively

constant over 24 hours. After subcutaneous injection of 0.3 units/kg

insulin glargine in patients with type 1 diabetes, a relatively constant

concentration/time profile has been demonstrated. The duration of action

after abdominal, deltoid, or thigh subcutaneous administration is almost

similar.

Insulin glargine injected once daily will reach steady state levels in 2-4

days after first dose.

Metabolism

Insulin glargine is partly metabolized in the subcutaneous depot at the

carboxyl terminus of the B-Chain to form the active metabolites i.e. M1

-Gly-insulin and M2 (21A-Gly-des-30

-Thr-insulin) having similar

invitro activity to insulin.

Special Population

Age, Race and Gender

Age, race and gender did not show difference in safety and efficacy

between insulin glargine and NPH human insulin.

Renal & Hepatic Insufficiency

The effect of the renal & hepatic insufficiency on the pharmacokinetics

of Insulin Glargine rDNA origin has not been studied. However, some

studies with human insulin have shown increased circulating levels of

insulin in patients with renal & hepatic failure. Careful glucose monitoring

and dose adjustments may be necessary in patients with renal & hepatic

dysfunction.

INDICATIONS

Insulin Glargine (Basagine

) is indicated to improve glycemic control in

adults and pediatric patients with type 1 diabetes mellitus and in adults

with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION

Dosing

Insulin Glargine (Basagine

) is a recombinant human insulin analogue

for once daily subcutaneous administration with potency that is

approximately the same as the potency of human insulin. Insulin Glargine

(Basagine) exhibits a relatively constant glucose-lowering profile over 24

hours that permits once-daily dosing.

Insulin Glargine (Basagine

) may be administered at any time during

the day. Insulin Glargine (Basagine

) should be administered

subcutaneously once a day at the same time every day. The dose of

Insulin glargine must be individualized based on clinical response. Blood

glucose monitoring is essential in all patients receiving insulin therapy.

Patients adjusting the amount or timing of dosing with Insulin Glargine

(Basagine ), should only do so under medical supervision with appropriate

glucose monitoring.

In patients with type 1 diabetes, Insulin Glargine (Basagine

) must be

used in regimens with short-acting insulin.

The intended duration of activity of Insulin Glargine is dependent on

injection into subcutaneous tissue. Insulin Glargine should not be

administered intravenously or via an insulin pump. Intravenous

administration of the usual subcutaneous dose could result in severe

hypoglycemia As with all insulins, injection sites should be rotated within

the same region (abdomen, thigh, or deltoid) from one injection to the

next to reduce the risk of lipodystrophy.

Initiation therapy:

The recommended starting dose of Insulin Glargine (Basagine

) in

patients with type 1 diabetes should be approximately one-third of the

total daily insulin requirements. Short-acting, pre-meal insulin should be

used to satisfy the remainder of the daily insulin requirements.

The recommended starting dose of Insulin Glargine (Basagine

) in

patients with type 2 diabetes who are not currently treated with insulin

is 10 units (or 0.2 Units/kg) once daily, which should subsequently be

adjusted to the patient's needs.

The dose of Insulin Glargine (Basagine

) should be adjusted according

to blood glucose measurements. The dosage of Insulin Glargine

(Basagine

) should be individualized under the supervision of healthcare

provider in accordance with the needs of the patient.

Converting to Insulin Glargine (Basagine

) from other insulin therapies

If changing from a treatment regimen with an intermediate-or long-acting

insulin to a regimen with Insulin Glargine (Basagine

), the amount and

timing of shorter-acting insulins and doses of any oral antidiabetic drugs

may need to be adjusted.

If transferring patients from once-daily NPH insulin to once-daily Insulin

Glargine (Basagine

), the recommended initial Insulin Glargine dose

is the same as the dose of Insulin Glargine that is being discontinued.

If transferring patients from twice-daily NPH insulin to once-daily Insulin

Glargine (Basagine

), the recommended initial Insulin Glargine dose

is 80% of the total NPH dose that is being discontinued. This dose

reduction will lower the likelihood of hypoglycemia.

ADVERSE REACTIONS

Very Common:

Hypoglycemia is the most frequently occurring undesirable effect of insulin

therapy that a patient with diabetes may suffer.

Common:

Lipohypertrophy, injection site reactions such as redness, pain, itching,

swelling or inflammation.

Uncommon:

Lipoatrophy

Rare:

Allergic reaction, visual impairment, retinopathy, edema (insulin may

cause sodium retention and edema particularly if previously poor metabolic

control is improved by intensified insulin therapy.

Very Rare:

Myalgia, Dysgeusia

CONTRAINDICATIONS

Insulin Glargine (Basagine

) must not be used in patients hypersensitive

to Insulin glargine or any of its excipients.

WARNINGS AND PRECAUTIONS

Dosage adjustment and monitoring

Glucose monitoring is essential for all patients receiving insulin therapy.

Changes to an insulin regimen should be made cautiously and only under

medical supervision.

Changes in insulin strength, manufacturer, type, or method of administration

may result in the need for a change in insulin dose or an adjustment in

concomitant oral anti-diabetic treatment.

As with all insulin preparations, the time course of action for Insulin

Glargine (Basagine) may vary in different individuals or at different times

in the same individual and is dependent on many conditions including

the local blood supply, local temperature, and physical activity.

Administration

Do not administer Insulin Glargine intravenously or via an insulin pump.

The intended duration of activity of Insulin Glargine is dependent on

injection into subcutaneous tissue.

Intravenous administration of the usual subcutaneous dose could result

in severe hypoglycaemia.

Do not dilute or mix Insulin Glargine with any other insulin or solution.

If Insulin Glargine is diluted or mixed, the solution may become cloudy,

and the pharmacokinetic or pharmacodynamic profile (e.g., onset of

action, time to peak effect) of Insulin Glargine and the mixed insulin may

be altered in an unpredictable manner.

Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin, including

Insulin Glargine. The risk of hypoglycemia increases with intensive

glycemic control. Patients must be educated to recognize and manage

hypoglycemia. Severe hypoglycemia can lead to unconsciousness or

convulsions and may result in temporary or permanent impairment of

brain function or death. The timing of hypoglycemia usually reflects the

time-action profile of the administered insulin formulations. Other factors

100Units/mL Solution for injection (SC), 3mL Vial

Antidiabetic

such as changes in food intake (e.g., amount of food or timing of meals),

exercise, and concomitant medications may also alter the risk of

hypoglycemia.

The prolonged effect of subcutaneous Insulin Glargine may delay recovery

from hypoglycemia. Patients being switched from twice daily NPH insulin

to once-daily Insulin Glargine should have their initial Insulin Glargine

dose reduced by 20% from the previous total daily NPH dose to reduce

the risk of hypoglycemia.

As with all insulins, use caution in patients with hypoglycemia unawareness

and in patients who may be predisposed to hypoglycemia (e.g., the

pediatric population and patients who fast or have erratic food intake).

The patient's ability to concentrate and react may be impaired as a result

of hypoglycemia. This may present a risk in situations where these abilities

are especially important, such as driving or operating other machinery.

Early warning symptoms of hypoglycemia may be different or less

pronounced under certain conditions, such as longstanding diabetes,

diabetic neuropathy, use of medications such as betablockers, or intensified

glycemic control. These situations may result in severe hypo glycaemia

(and, possibly, loss of consciousness) prior to the patient's awareness

of hypoglycemia.

Hypersensitivity and allergic reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can

occur

with

insulin

products,

including

Insulin

G l a r g i n e .

Renal impairment

Due to its long duration of action, Insulin Glargine is not recommended

during periods of rapidly declining renal function because of the risk for

prolonged hypoglycemia.

Although studies have not been performed in patients with diabetes and

renal impairment, a reduction in the Insulin Glargine dose may be required

in patients with renal impairment because of reduced insulin metabolism,

similar to observations found with other insulins.

Hepatic impairment

Due to its long duration of action, Insulin Glargine is not recommended

during periods of rapidly declining hepatic function because of the risk

for prolonged hypoglycemia.

Although studies have not been performed in patients with diabetes and

hepatic impairment, a reduction in the Insulin Glargine dose may be

required in patients with hepatic impairment because of reduced capacity

for gluconeogenesis and reduced insulin metabolism, similar to

observations found with other insulins.

Drug interaction

Some medications may alter insulin requirements and subsequently

increase the risk for hypoglycemia or hyperglycemia.

Fluid retention and heart failure with concomitant use of PPAR-gamma

agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated

receptor (PPAR) gamma agonists, can cause dose-related fluid retention,

particularly when used in combination with insulin. Fluid retention may

lead to or exacerbate heart failure. Patients treated with insulin, including

Insulin Glargine, and a PPAR-gamma agonist should be observed for

signs and symptoms of heart failure. If heart failure develops, it should

be managed according to current standards of care, and discontinuation

or dose reduction of the PPAR-gamma agonist must be considered.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no well-controlled clinical studies of the use of Insulin Glargine

in pregnant women. Because animal reproduction studies are not always

predictive of human response, this drug should be used during pregnancy

only if the potential benefit justifies the potential risk to the fetus. It is

essential for patients with diabetes or a history of gestational diabetes

to maintain good metabolic control before conception and throughout

pregnancy. Insulin requirements may decrease during the first trimester,

generally increase during the second and third trimesters, and rapidly

decline after delivery. Careful monitoring of glucose control is essential

in these patients.

Nursing Mothers

It is unknown whether insulin glargine is excreted in human milk. Because

many drugs, including human insulin, are excreted in human milk, caution

should be exercised when Insulin Glargine is administered to a nursing

woman. Use of Insulin Glargine is compatible with breastfeeding, but

women with diabetes who are lactating may require adjustments of their

insulin doses.

Pediatric Use

The safety and effectiveness of subcutaneous injections of Insulin Glargine

have been established in pediatric patients (age 6 to 15years) with type

1 diabetes. Insulin Glargine has not been studied in pediatric patients

younger than 6 years of age with type 1diabetes. Insulin Glargine has

not been studied in pediatric patients with type 2 diabetes.

Geriatric Use

Caution should be exercised when it is administered to geriatric patients.

In elderly patients with diabetes, the initial dosing, dose increments, and

maintenance dosage should be conservative to avoid hypoglycemic

reactions. Hypoglycemia may be difficult to recognize in the elderly.

DRUG INTERACTIONS

A number of drugs affect glucose metabolism and may require insulin

dose adjustment and particularly close monitoring.

The following are examples of drugs that may increase the blood-glucose-

lowering effect of insulins including Insulin Glargine and, therefore,

increase the susceptibility to hypoglycemia: oral anti-diabetic products,

pramlintide, angiotensin converting enzyme (ACE) inhibitors, disopyramide,

fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene,

pentoxifylline, salicylates, somatostatin analogs, and sulfonamide

antibiotics.

The following are examples of drugs that may reduce the blood-glucose-

lowering effect of insulins including Insulin Glargine: corticosteroids,

niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine,

albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives,

somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral

contraceptives), protease inhibitors and atypical antipsychotic medications

(e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate

or weaken the blood glucose-Iowering effect of insulin. Pentamidine may

cause hypoglycemia, which may sometimes be followed by hyperglycemia.

The signs of hypoglycemia may be reduced or absent in patients taking

sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and

reserpine.

OVERDOSAGE

An excess of insulin relative to food intake, energy expenditure, or both

may lead to severe and sometimes prolonged and life-threatening

hypoglycemia. Mild episodes of hypoglycemia can usually be treated

with oral carbohydrates. Adjustments in drug dosage, meal patterns, or

exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic

impairment may be treated with intramuscular/subcutaneous glucagon

or concentrated intravenous glucose. After apparent clinical recovery

from hypoglycemia, continued observation and additional carbohydrate

intake may be necessary to avoid recurrence of hypoglycemia.

STORAGE CONDITIONS

Store in a refrigerator (2C - 8C).

Do not freeze.

Protect from heat and sunlight.

Once opened, the vial may be used for up to four weeks when stored

below 25

C. Do not use beyond this period. Solution for subcutaneous

injection only.

Keep out of reach of children.

AVAILABILITY

In a box of I-PVC tray containing 3mL solution in 5mL USP Type I clear

glass vial with cream color rubber stopper and aluminum seal with purple

color flip off cap.

CAUTION

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without

prescription.

For suspected adverse drug reaction, report to FDA: www.fda.gov.ph

REGISTRATION NUMBER

BR-1154.

DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

03 June, 2016.

DATE OF REVISION OF PACKAGING INSERT

20 Aug, 2016.

Please read the contents carefully before use.

This package insert is continually updated from time to time.

Manufactured by: Getz Pharma (Pvt.) Ltd., 29-30/27, K.I.A., Karachi - 74900, Pakistan.

Imported by: Getz Pharma (Phils.) Inc., 2/F Tower 1, The Rockwell Business Center,

Ortigas Ave., Pasig City, Philippines.

PH-200008909