Vibrenta(Insulin Glargin (rDNA))

Therapeutic Group: Bio Tech

Presentation

Vibrenta User Pack: Each user pack contains 1 vial of 3 ml Insulin Glargin (rDNA), 2 sterile disposable 1 ml 100 IU syringes with needle, user manual & styrofoam for heat insulation.

Vibrenta 100 IU vial: Each ml solution contains Insulin Glargine (rDNA) INN 100 IU.



Description

Vibrenta (Insulin glargine [rDNA] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. Vibrenta is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism.

Primary function of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

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.

Indications

Vibrenta is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Dosage & Administration

Vibrenta exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. Potency of insulin glargine is approximately the same as human insulin.

Vibrenta is recommended for once daily subcutaneous administration & may be administered at any time during the day. However, once started should be administered at the same time every day. The dose of Vibrenta must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Vibrenta must be used in regimens with short-acting insulin. Vibrenta is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next.

Initiation of Vibrenta therapy:
The recommended starting dose of Vibrenta in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
The recommended starting dose of Vibrenta 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.

Converting to Vibrenta from other insulin therapies
If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with Vibrenta, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

- If transferring patients from once-daily NPH insulin to once-daily Vibrenta, the recommended initial Vibrenta dose is the same as the dose of NPH that is being discontinued.

- If transferring patients from twice-daily NPH insulin to once-daily Vibrenta, the recommended initial Vibrenta dose is 80% of the total NPH dose that is being discontinued.

Side Effects

Side effects of Insulin glargine are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.

Precautions

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.

Administration: Insulin glargine must not be diluted or mixed with any other insulin or solution. It should not be administered subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur.

Renal or hepatic impairment: Reduction in the Insulin glargine dose may require in these cases.

Use in Pregnancy & Lactation

Pregnancy: Pregnancy category C. Insulin glargine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: 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. Lactating women may require adjustments in insulin dose & diet.