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Rezvoglar Generic Name & Formulations
Legal Class
General Description
How Supplied
KwikPen prefilled pens (3mL)—5
Manufacturer
Generic Availability
NO
Mechanism of Action
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Rezvoglar Indications
Indications
Diabetes mellitus (types 1 & 2).
Limitations of Use
Not for treating diabetic ketoacidosis.
Rezvoglar Dosage and Administration
Adults and Children
Give by SC inj once daily at same time each day into abdominal area, thigh, or deltoid; rotate inj sites. Onset ~1hr, no pronounced peak, duration ≥24hrs. <6yrs: not established. ≥6yrs: individualize; monitor and adjust as needed. Type 1 diabetes: Initially ⅓ of total daily insulin dose. Give remainder of the total dose as short-acting, premeal insulin. Insulin-naïve with type 2 diabetes: Initially 0.2 Units/kg or up to 10 Units once daily. May need to adjust amount, timing of short- or rapid-acting insulins and doses of any oral antidiabetics. Switching from once-daily insulin glargine 300 Units/mL: reduce initial Rezvoglar dose by 20% of the previous insulin glargine dose. Switching from once-daily NPH: initial Rezvoglar dose should be the same as previous NPH dose. Switching from twice-daily NPH: reduce initial Rezvoglar dose by 20% of the previous total NPH dose.
Rezvoglar Contraindications
Contraindications
During episodes of hypoglycemia.
Rezvoglar Boxed Warnings
Not Applicable
Rezvoglar Warnings/Precautions
Warnings/Precautions
Instruct patients on diet, exercise, blood or urine testing, proper administration of insulin, change in species of origin, type or purity of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients, even if the needle is changed. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Increased risk of hyperglycemia or hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, administration site, and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Discontinue if hypersensitivity reactions occur. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Renal or hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Rezvoglar Pharmacokinetics
Rezvoglar Interactions
Interactions
Do not mix or dilute with other insulins. Increased risk of hypoglycemia with concomitant antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, salicylates, somatostatin analogs (eg, octreotide), sulfonamide antibiotics; may need to reduce dose and monitor more frequently. Reduced efficacy with concomitant atypical antipsychotics (eg, olanzapine, clozapine), steroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones; may need to increase dose and monitor more frequently. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine. Concomitant β-blockers, clonidine, guanethidine, or reserpine may blunt hypoglycemia; monitor.
Rezvoglar Adverse Reactions
Adverse Reactions
Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia.
Rezvoglar Clinical Trials
See Literature
Rezvoglar Note
Not Applicable
Rezvoglar Patient Counseling
See Literature
