NovoLog Mix 70/30 Side Effects

Please note - some side effects for NovoLog Mix 70/30 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of NovoLog Mix 70/30 - for the Consumer

NovoLog Mix 70/30 Cartridges

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Mix 70/30 Cartridges:

Back pain; diarrhea; indigestion; redness, swelling, itching, or mild pain at the injection site; runny nose; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Mix 70/30 Cartridges:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); burning, numbness, or tingling of the arms, hands, legs, or feet; changes in vision; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; stomach pain; swelling; tremor; trouble concentrating; unusual hunger; unusual sweating; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

NovoLog Mix 70/30 Vials

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Mix 70/30 Vials:

Back pain; diarrhea; indigestion; redness, swelling, itching, or mild pain at the injection site; runny nose; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Mix 70/30 Vials:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); burning, numbness, or tingling of the arms, hands, legs, or feet; changes in vision; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; stomach pain; swelling; tremor; trouble concentrating; unusual hunger; unusual sweating; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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NovoLog Mix 70/30 Side Effects - for the Professional

Novolog Mix 70/30

Clinical Trial Experience

Clinical trials are conducted under widely varying designs, therefore, 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.

• Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolog Mix 70/30 [see Warnings and Precautions (5.2)]. Novolog Mix 70/30 should not be used during episodes of hypoglycemia [see Contraindications (4)] and [Warnings and Precautions (5)].

• Insulin initiation and glucose control intensification

Intensification or rapid improvement in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

• Lipodystrophy

Long-term use of insulin, including Novolog Mix 70/30, 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 some insulin therapies, including Novolog Mix 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

• Peripheral Edema

Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

• Frequencies of adverse drug reactions

The frequencies of adverse drug reactions during a clinical trial with Novolog Mix 70/30 in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below. The trial was a three-month, open-label trial in patients with Type 1 or Type 2 diabetes who were treated twice daily (before breakfast and before supper) with Novolog Mix 70/30.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 diabetes mellitus (Adverse events with frequency ≥ 5% are included.)

	Novolog Mix 70/30 (N=55)		Novolin 70/30 (N=49)
Preferred Term	N	%	N	%
Hypoglycemia	38	69	37	76
Headache	19	35	6	12
Influenza-like symptoms	7	13	1	2
Dyspepsia	5	9	3	6
Back pain	4	7	2	4
Diarrhea	4	7	3	6
Pharyngitis	4	7	1	2
Rhinitis	3	5	6	12
Skeletal pain	3	5	2	4
Upper respiratory tract infection	3	5	1	2

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 diabetes mellitus (Adverse events with frequency ≥ 5% are included.)

	Novolog Mix 70/30 (N=85)		Novolin 70/30 (N=102)
Preferred Term	N	%	N	%
Hypoglycemia	40	47	51	50
Upper respiratory tract infection	10	12	6	6
Headache	8	9	8	8
Diarrhea	7	8	2	2
Neuropathy	7	8	2	2
Pharyngitis	5	6	4	4
Abdominal pain	4	5	0	0
Rhinitis	4	5	2	2

Postmarketing Data

Additional adverse reactions have been identified during post-approval use of Novolog Mix 70/30. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. They include medication errors in which other insulins have been accidentally substituted for Novolog Mix 70/30 [see Patient Counseling Information (17)].

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Other cardiovascular risk factors that are accentuated in persons with carbohydrate intolerance and hypertension include abnormalities in platelet function, clotting factors, the fibrinolytic system, and dyslipidemia. The relationship between diabetes, insulin, and these disorders is currently under investigation.

Insulin may contribute to the pathogenesis of hypertension by stimulating the sympathetic nervous system, promoting renal sodium retention, and/or stimulating vascular smooth muscle hypertrophy. It may induce dyslipidemia by promoting hepatic synthesis of very low density lipoproteins (VLDLs).

Insulin may stimulate heart rate in the absence of hypoglycemia.

Cardiovascular side effects have included hyperinsulinemia. Given the high frequency of both microvascular and macrovascular diseases in patients with diabetes and hyperinsulinemia, some experts are evaluating insulin as a possible atherogenic agent. Controversy and continued study surround the role of hyperinsulinemia as the precursor of hypertension.

Dermatologic

Dermatologic side effects of insulin have included lipohypertrophy (insulin is lipogenic) and lipoatrophy (probably immunologically-mediated). The incidence of lipoatrophy is markedly decreased with the use of purer forms of pork insulin or biosynthetic human insulin and when injection sites are alternated. Without proper hygiene, subcutaneous insulin injections may be complicated by infection.

Endocrine

Endocrine side effects have included hypoglycemia, which is the most common and serious side effect of insulin, occurring in approximately 16% of type 1 and 10% of type II diabetic patients (the incidence varies greatly depending on the populations studied, types of insulin therapy, etc). Although there are counterregulatory endocrinologic responses to hypoglycemia, some responses are decreased, inefficient, or absent in some patients. Severe hypoglycemia usually presents first as confusion, sweating, or tachycardia, and can result in coma, seizures, cardiac arrhythmias, neurological deficits, and death. Blood or urine glucose monitoring is recommended in patients who are at risk of hypoglycemia or who do not recognize the signs and symptoms of hypoglycemia. The risk for developing hypoglycemia is higher in patients receiving intensive or continuous infusion insulin therapy. The association between insulin and dyslipidemia is currently being evaluated.

Permanent neuropsychological impairment has been associated with recurrent episodes of severe hypoglycemia.

In one retrospective study of 600 randomly selected patients with insulin-treated diabetes mellitus, the only reliable predictors of severe hypoglycemia were a history of hypoglycemia, a history of hypoglycemia-related injury or convulsion, and the duration of insulin therapy. Those with a history of hypoglycemia had been treated with insulin for 17.4 years, which was significantly longer than the 14.3 years in the insulin-treated patients without a history of hypoglycemia.

Human insulin does not appear to be associated with hypoglycemic episodes more often than animal insulin. Caution is recommended when switching from animal (either bovine or pork) to purified porcine insulin or biosynthetic human insulin, however, because of increased potency or bioavailability.

Gastrointestinal

Gastrointestinal side effects have been reported rarely. GI distress has tended to resolve after dose reduction.

General

Intensive insulin therapy causes an increase in body fat as a result of the elimination of glycosuria and reduction in 24-hour energy expenditure. The reduction in 24-h energy expenditure is the result of an insulin-associated decrease in triglyceride/free fatty acid cycling and nonoxidative glucose and protein metabolism.

General side effects have included weight gain, sometimes presenting as edema associated with abrupt restoration of glucose control in a patient whose control was previously poor. Weight gain may have been due to more efficient use of calories during insulin therapy, suggesting additional benefits of dietary and exercise modifications. Patients on intensive insulin therapy may be more likely to experience weight gain.

Hematologic

Hematologic side effects have included an increase in the concentration of von Willebrand factor due to insulin-induced hypoglycemia. Increased von Willebrand factor, combined with hypoglycemia-associated decreased plasma volume and increased plasma viscosity, may have predisposed patients to reduced peripheral perfusion or embolic phenomenon. A single case of insulin-induced hemolytic anemia has been reported.

The effects of insulin-induced hypoglycemia on hemostasis may explain some of the clinical observations of embolic phenomenon during treatment of diabetic ketoacidosis.

Limited data show that diabetics have a significantly lower basal concentration of tissue plasminogen activator.

Hypersensitivity

Hypersensitivity side effects have included both local and systemic reactions. These reactions are becoming rare (less than 1% of patients) due to the use of purer forms of pork insulin or biosynthetic human insulin. Local reactions have presented as erythema, swelling, heat, or subcutaneous nodules. They usually occurred within the first two weeks of therapy, then disappeared. True allergy to insulin is rare, and sensitization is usually associated with specific animal proteins in bovine and less pure forms of porcine insulins.

A diabetic patient with true allergy to insulin can undergo desensitization. Desensitization kits and protocols are available from some insulin manufacturers.

Immunologic

Immunologic analysis of anaphylaxis to some insulin preparations in some cases has revealed markedly elevated serum levels of lgE and lgG to protamine, but not to regular insulin.

Immunologic side effects have included the formation of anti-insulin antibodies, particularly when animal insulin formulations were used. The presence of these antibodies caused the elimination half-life of insulin to increase.

Metabolic

Rare cases of hypophosphatemia have been associated with the use of glucose, insulin, and potassium infusions during the treatment of myocardial infarction.

Metabolic side effects have included reports of hypokalemia and hypomagnesemia, particularly in patients treated for diabetic ketoacidosis (DKA). Insulin increases the intracellular transport of phosphate, which often results in hypophosphatemia during treatment of DKA.

Ocular

Ocular side effects have included reports of disturbance during the beginning of therapy. This was thought to be due to changes in the bilateral presyopia (blurry vision) osmotic equilibrium between the lens and the ocular fluids, and was usually self-limited.

Renal

Hypoglycemia is associated with increased plasma dopamine, epinephrine, and plasma renin activity. Acute changes in renal function during insulin-induced hypoglycemia, therefore, may result from direct stimulation of the efferent sympathetic nerves to the kidney and hormonal counterregulatory mechanisms.

Renal effects have included reports of significantly decreased renal plasma flow, glomerular filtration rate, and significantly increased urinary albumin excretion rate from insulin-induced hypoglycemia. These changes were usually reversible upon resolution of hypoglycemia.

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