Insulin Glargine;100 international units/mL injection, 5x3mL cartridges;Basaglar®, Basaglar KwikPen®
FDA has approved Basaglar® (insulin glargine injection), a long–acting human insulin analog, as the first follow-on" insulin glargine product to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Dosing of Basaglar should be individualized based on the patient’s needs. Basaglar is administered subcutaneously once daily at any time of day, but at the same time every day. It should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine or one of its ingredients.
Basaglar KwikPens must never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood–borne pathogens. Patients or caregivers should monitor blood glucose in all patients treated with insulin products. Insulin regimens should be modified cautiously and only under medical supervision. Basaglar may cause hypoglycemia, which can be life–threatening. Patients should be monitored more closely with changes to insulin dosage, co–administration of other glucose–lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. Severe, life–threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin. The most common adverse reactions associated with Basaglar in clinical trials were hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain.
BASAGLAR Rx
Pharmacological Class:
Insulin.

Active Ingredient(s):
Insulin glargine (recombinant) 100Units/mL; for SC inj; contains m-cresol.

Company
Boehringer Ingelheim and Lilly
Indication(s):
Type 1 diabetes (in adults and children) and type 2 diabetes (in adults). Limitations of use: not for treating diabetic ketoacidosis.

Pharmacology:
Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It inhibits lipolysis and proteolysis, and enhances protein synthesis.

Clinical Trials:
The safety and efficacy of another insulin glargine product, 100 Units/mL, given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus. In general, the reduction in HbA1c with this other insulin glargine product was similar to that with NPH insulin.

For more clinical trial data, see full labeling.

Legal Classification:
Rx

Contraindication(s):
During episodes of hypoglycemia.

Adults & Children:
Give by SC inj once at same time each day into abdominal, thigh, or deltoid; rotate inj sites. <6yrs: not established. ≥6yrs: individualize. Type 1: initially ⅓ of total daily insulin dose; give remainder of the total dose as short- or rapid-acting, premeal insulin. Type 2: initially 0.2 Units/kg or up to 10 Units/day. May need to adjust amount, timing of short- or rapid-acting insulins, doses of any antidiabetics. Switching from another insulin glargine 100 Units/mL: initial Basaglar dose should be the same as previous insulin glargine 100 Units/mL dose. Switching from once-daily insulin glargine 300 Units/mL: initially 80% of the previous insulin glargine 300 Units/mL dose. Switching from an intermediate- or long-acting insulin regimen (other than insulin glargine 100 Units/mL): may need to change basal insulin dose; and adjust the amount, timing of the short-acting insulins and doses of any antidiabetics. Switching from twice-daily NPH: initially 80% of the previous total NPH dose.

Warnings/Precautions:
Instruct patients on proper administration of insulin, type of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients. Increased risk of hyperglycemia or hypoglycemia if changes in ­physical activity, meal patterns, renal or hepatic function, insulin regimen and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Discontinue if hypersensitivity reactions occur. Pregnancy (Category C). Nursing mothers: may need to adjust dose.

Interaction(s)
Do not mix or dilute with other insulins. Potentiated by oral antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics. Antagonized by corticosteroids, isoniazid, niacin, danazol, diuretics, phenothiazines, sympathomimetics, somatropin, thyroid hormones, estrogens, glucagon, oral contraceptives, progestogens, atypical antipsychotics, protease inhibitors. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Variable effects with β-blockers, clonidine, lithium salts, alcohol, pentamidine. Concomitant β-blockers, clonidine, guanethidine, reserpine may mask signs of hypoglycemia.

Adverse Reaction(s)
Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia.

How Supplied:
Basaglar KwikPen prefilled pen (3mL)—5

LAST UPDATED:
2/26/2016
BASAGLAR