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BASAGLAR is a brand name for Insulin Glargine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between Basaglar and the reference biologic drug Lantus. Basaglar (insulin glargine (rDNA origin) injection) is a recombinant human insulin analogue indicated for once-daily subcutaneous administration in the treatment of patients over 17 years of age with type…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 03/2021 7 WARNINGS AND PRECAUTIONS 03/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ................................................................................
2 TABLE OF CONTENTS....................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4 1 INDICATIONS ...........................................................................................................
1 Pediatrics .................................................................................................. 2 Geriatrics ................................................................................................... 4 2 CONTRAINDICATIONS ...........................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................. 4 4 DOSAGE AND ADMINISTRATION ......................................................................... 1 Dosing Considerations .............................................................................
2 Recommended Dose and Dosage Adjustment....................................... 4 Administration ........................................................................................... 6 5 OVERDOSAGE .........................................................................................................
7
). Patients should be rigorous with site rotation secondary to prolonged deposition. In clinical studies with the reference product (Lantus), there was no relevant difference in insulin glargine absorption after abdominal, thigh, or deltoid subcutaneous administration.
As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables. Preparation and handling Basaglar is a clear, colourless solution for injection, it is not a suspension.
Parenteral drug products should be inspected visually prior to administration. Basaglar must only be used if the solution is clear and colourless with no particles visible. To minimize local irritation at the injection site, it is recommended to allow the insulin to reach room temperature before injection.
Patient must be instructed to not re-use needles. INJECTION PENS, CARTRIDGES, AND NEEDLES MUST NOT BE SHARED. To prevent the possible transmission of disease, never share a Basaglar pen or cartridge between patients, even if the needle on the pen is changed.
Mixing and diluting Basaglar must not be mixed with any other insulin. Mixing can change the time/action profile of Basaglar and cause precipitation. BASAGLAR , Insulin glargine injection (rDNA origin) Page 7 of 64 When the reference product (Lantus) and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and time to maximum effect for regular human insulin was observed.
The total bioavailability of the mixture was also slightly decreased compared to separate injections of insulin glargine and regular human insulin. The relevance of these observations in dogs to humans is not known. Basaglar must not be diluted.
Diluting can change the time/action profile of Basaglar. 5 OVERDOSAGE Symptoms An excess of insulin relative to food intake, energy expenditure or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia (see 7 WARNINGS AND PRECAUTIONS).
03/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ................................................................................ 2 TABLE OF CONTENTS.......................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4 1 INDICATIONS ........................................................................................................... 1 Pediatrics ..................................................................................................
2 Geriatrics ................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..............................................
4 4 DOSAGE AND ADMINISTRATION ......................................................................... 1 Dosing Considerations ............................................................................. 2 Recommended Dose and Dosage Adjustment.......................................
4 Administration ........................................................................................... 6 5 OVERDOSAGE ......................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............
7 7 WARNINGS AND PRECAUTIONS.......................................................................... 1 Special Populations ................................................................................ 1 Pregnant Women....................................................................................
Basaglar is contraindicated during episodes of hypoglycemia (see 5 OVERDOSAGE) and in patients who are hypersensitive to insulin glargine or to any ingredient in the formulation or component of the container. For a complete list of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Insulin Glargine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Symptoms of hypoglycemia may occur suddenly. They may include cold sweat, cool pale skin, fatigue, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation. Nocturnal hypoglycemia is common in people taking insulin and symptoms can include restlessness, making unusual noises, attempting to get out of bed or accidentally rolling out of bed, sleepwalking, nightmares and sweating.
Patients may wake with a headache in the morning if their blood sugar was low during the night. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may be fatal. In some cases, the first sign of hypoglycemia may be confusion or loss of consciousness (hypoglycemia unawareness).
Severe hypoglycemia, resulting in seizures, is more likely to occur at nighttime (nocturnal hypoglycemia) than during the day. Management Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.
It is therefore recommended that patients with diabetes carry sugar-containing products. Severe hypoglycemic episodes, where the patient has become unconscious, can be treated by glucagon given intramuscularly, nasally, or subcutaneously by a trained person, or by glucose given intravenously by a health professional.
Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse. After apparent clinical recovery from hypoglycemia, continued observa tion and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 1:
Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients BASAGLAR , Insulin glargine injection (rDNA origin) Page 8 of 64 Basaglar is a clear, colourless, aqueous solution for subcutaneous administration.
Each milliliter of Basaglar contains insulin glargine 100 units. Basaglar has a pH of approximately 4. Basaglar is available in cartridges or KwikPens (prefilled insulin delivery devices): Cartridge, 3 mL, 100 units/mL, 5 cartridges/box KwikPen, 3 mL prefilled pen, 100 units/mL, 5 pens/box KwikPen, 3 mL prefilled pen, 100 units/mL, 2 pens/box Not all pack sizes and presentations may be marketed.
Reusable pens to be used with Basaglar cartridge Basaglar cartridges are designed for use only with Lilly’s insulin delivery devices. The cartridge containing Basaglar is not designed to allow any other insulin to be mixed in the cartridge or for the cartridge to be reused.
The Basaglar cartridge should only be used with the following pens: HumaPen® Savvio™ which delivers Basaglar in 1 unit dose increments. 5 unit dose increments. HumaPen Luxura®, which delivers Basaglar in 1 unit increments. This cartridge should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Description Basaglar [insulin glargine injection (rDNA origin)] is a recombinant human insulin analogue that is a long-acting, parenteral blood-glucose-lowering agent. Basaglar is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism.
Insulin glargine differs from natural human insulin in that the amino acid asparagine at position 21 of the A-chain is replaced by glycine and two arginines are added to the C-terminus […]
2 Breast-feeding ........................................................................................ 3 Pediatrics ................................................................................................ 4 Geriatrics .................................................................................................
12 8 ADVERSE REACTIONS......................................................................................... 1 Adverse Reaction Overview ................................................................... 2 Clinical Trial Adverse Reactions ............................................................
1 Clinical Trial Adverse Reactions – Pediatrics ....................................... 5 Post-Market Adverse Reactions ............................................................ 18 9 DRUG INTERACTIONS..........................................................................................
2 Drug Interactions Overview.................................................................... 4 Drug-Drug Interactions ........................................................................... 5 Drug-Food Interactions...........................................................................
6 Drug-Herb Interactions ........................................................................... 7 Drug-Laboratory Test Interactions ......................................................... 19 10 CLINICAL PHARMACOLOGY...............................................................................
1 Mechanism of Action .............................................................................. 2 Pharmacodynamics ................................................................................ 3 Pharmacokinetics ...................................................................................
20 11 STORAGE, ST ABILITY AND DISPOSAL ............................................................ 22 12 SPECIAL HANDLING INSTRUCTIONS................................................................ 22 PART II: SCIENTIFIC INFORMATION .............................................................................
24 13 PHARMACEUTICAL INFORMATION ................................................................... 24 14 CLINICAL TRIALS .................................................................................................. 1 Trial Design and Study Demographics..................................................
2 Study Results .......................................................................................... 3 Comparative Bioavailability Studies ...................................................... 1 Comparative PK/PD Study: Pivotal PK/PD Study ................................
2 Comparative Safety and Efficacy .......................................................... 1 Efficacy Results ...................................................................................... 2 Safety Results .........................................................................................
4 Immunogenicity....................................................................................... 5 Clinical Trials - Reference Biologic Drug............................................... 36 15 MICROBIOLOGY ....................................................................................................
41 16 NON-CLINICAL TOXICOLOGY............................................................................. 1 Comparative Non-Clinical Pharmacology and Toxicology ................... 1 Comparative Non-Clinical Pharmacodynamics ....................................
2 Comparative Toxicology......................................................................... 43 17 SUPPORTING PRODUCT MONOGRAPHS ......................................................... 44 PATIENT MEDICATION […]