NOVOMEDLINK™

This page contains information about Novo Nordisk products.

Prescribing Information

NovoLog® Mix 70/30 provides glycemic control and reduces the risk of major hypoglycemic events

References:

  1. Valensi P, Benroubi M, Borzi V, et al, on behalf of IMPROVE™ Study Group Expert Panel. The IMPROVE™ study—a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62(11):1809-1819.
  2. Shah S, Benroubi M, Borzi V, et al; IMPROVE Study Group Expert Panel. Safety and effectiveness of biphasic insulin aspart 30⁄70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract. 2009;63(4):574-582.
  3. Gumprecht J, Benroubi M, Borzi V, et al, on behalf of the IMPROVE™ Study Group Expert Panel. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix® 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE™ observational study. Int J Clin Pract 2009;63(6):966-972.
  4. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 70/30 twice daily; a randomized trial in type 1 and type 2 diabetic patients. Diabet Med. 2002;19(5):393-399.
  5. Boehm BO, Vaz JA, Brøndsted L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med. 2004;15(8):496-502.
  6. Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation: pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997;20(10):1612-1614.
  7. Data on file, Novo Nordisk, Inc., Plainsboro, NJ.

  1. NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Indications and Usage

    NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

    Important Limitations of Use

    In premix insulins, such as NovoLog® Mix 70/30, the proportions of rapid-acting and long- acting insulins are fixed and do not allow for basal versus prandial dose adjustments.

    Important Safety Information

    NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients.

    NovoLog® Mix 70/30 should not be mixed with any other insulin product, administered intravenously, or used in insulin infusion pumps. NovoLog® Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation.

    Hypoglycemia is the most common adverse effect of insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin dose should be made cautiously and only under medical supervision.

    Insulin, particularly when given in settings of poor glycemic control, can cause hypokalemia. Use caution in patients predisposed to hypokalemia.

    Like all insulins, NovoLog® Mix 70/30 requirements may be reduced in patients with renal impairment or hepatic impairment.

    Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog® Mix 70/30.

    Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog® Mix 70/30.

    Adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

    Needles and NovoLog® Mix 70/30 FlexPen® must not be shared.

    The safety and effectiveness of NovoLog® Mix 70/30 have not been established in pediatric patients. Clinical studies of NovoLog® Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

    Please click here for Prescribing Information.

FlexPen® and NovoLog® are registered trademarks of Novo Nordisk A/S. NovoMedLink™ is a trademark of Novo Nordisk A/S.

Selected Important Safety Information

What are the possible side effects of Levemir® (insulin detemir [rDNA origin] injection), NovoLog® (insulin aspart [rDNA origin] injection), and NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])?

  • Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients.
  • NovoLog® and NovoLog® Mix 70/30 are contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin aspart or any of the excipients.
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulins, including Levemir®, NovoLog®, and NovoLog® Mix 70/30.

Please click here for additional Important Safety Information