June 29, 2016
Recommended Topic Related To:

Novolin R

"One in five elderly and "clinically complex" patients with type 2 diabetes may be receiving unnecessarily intensive glucose-lowering treatment, leading to a dramatically increased risk for severe hypoglycemia, a new study finds.

The f"...

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Novolin R




Side Effects
Interactions

SIDE EFFECTS

  • Hypoglycemia
    Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R [see WARNINGS AND PRECAUTIONS].
  • Insulin initiation and glucose control intensification
    Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
  • Lipodystrophy
    Long-term use of insulin, including Novolin R, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.
  • Weight gain
    Weight gain can occur with insulin therapies, including Novolin R, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
  • Peripheral edema
    Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. These symptoms are usually transitory.
  • Allergic reactions
    As with other insulins, Novolin R can cause injection site reactions. Severe, life-threatening, generalized allergy, including anaphylaxis may occur with any insulin, including Novolin R [see WARNINGS AND PRECAUTIONS].

Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Adults With Type 1 Or Type 2 Diabetes

The incidence of adverse reactions during clinical trials comparing Novolin R and insulin aspart in adults with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 286 %
Insulin aspart + NPH
N=596 %
Hypoglycemia* 72 75
* Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms.

Table 2: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 2 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 91 (%)
Insulin aspart + NPH
N= 91 (%)
Hypoglycemia* 36 27
*Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms.

Children And Adolescents With Type 1 Diabetes

The incidence of adverse reactions during a 24-week clinical trial comparing Novolin R and insulin aspart in children and adolescents with type 1 diabetes mellitus are listed in the table below.

Table 3: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Children and Adolescents with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 96 (%)
Insulin aspart + NPH
N= 187 (%)
Hypoglycemia* 85 79
Injection site hypertrophy 8 8
*Hypoglycemia was defined as an episode of blood glucose concentration < 50 mg/dL, with or without symptoms.

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R [See WARNINGS AND PRECAUTIONS]. Tables 4 and 5 summarize the incidence of severe hypoglycemia in the Novolin R clinical trials. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring intervention of another person or hospitalization. The rates of severe hypoglycemia in the Novolin R clinical trials (see Clinical Studies for a description of the study designs) were comparable for all treatment regimens (see Tables 4 and 5).

Table 4: Severe Hypoglycemia in Patients with Type 1 Diabetes

  Type 1 Diabetes Adults 24 weeks in combination with NPH insulin Type 1 Diabetes Children and Adolescents (age 6-18) 24 weeks in combination with NPH insulin Type 1 Diabetes Children (age 2-6) 24 weeks in combination with NPH insulin
Novolin R Insulin aspart Novolin R Insulin aspart Novolin R Insulin aspart
Percent of patients (n/total N) 19 (55/286) 18 (105/596) 9 (9/96) 6 (11/187) 12 (3/25) 8 (2/26)
Event/patient/ year 1.1 0.9 0.3 0.2 0.5 0.3

Table 5: Severe Hypoglycemia in Patients with Type 2 Diabetes

  Type 2 Diabetes Adults 24 weeks in combination with NPH insulin
Novolin R Insulin aspart
Percent of patients (n/total N) 5 (5/91) 10 (9/91)
Event/patient/ year 0.2 0.3

Read the Novolin R (recombinant dna origin) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

A number of medications affect glucose metabolism that may require insulin dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.

  • The following are examples of medications that may increase the blood glucose-lowering effect of insulin and increase susceptibility to hypoglycemia: oral antidiabetic medications, pramlintide acetate, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.
  • The following are examples of medications that may reduce the blood glucose-lowering effect of insulin, leading to worsening of glycemic control: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), and atypical antipsychotics.
  • Beta-blockers, clonidine, and lithium salts may either potentiate or weaken the blood glucose-lowering effect of insulin.
  • Alcohol can increase susceptibility to hypoglycemia.
  • Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
  • The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic medications such as beta-blockers, clonidine, guanethidine, and reserpine.

Read the Novolin R Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/23/2016

Side Effects
Interactions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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