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Novolog Mix 70-30

Last reviewed on RxList: 2/2/2017
Novolog Mix 70-30 Side Effects Center

Last reviewed on RxList 11/22/2016

NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is a form of insulin, a hormone that is produced in the body, used to treat type 1 (insulin-dependent) diabetes in adults. Common side effects of NovoLog Mix 70/30 include:

  • redness,
  • swelling or itching at the injection site.

Side effects of NovoLog Mix 70/30 usually go away after a few days or weeks. Low blood sugar (hypoglycemia) is the most common side effect of NovoLog Mix 70/30 (insulin). Symptoms of low blood sugar include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure.

NovoLog Mix 70/30 is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). Dosage is individualized. NovoLog Mix 70/30 may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Many other medicines can increase or decrease the effects of insulin aspart and insulin aspart protamine on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Tell your doctor if you are pregnant before using NovoLog Mix 70/30. Consult your doctor to manage blood sugars before becoming pregnant. Your doctor may switch the type of insulin used during pregnancy. It is unknown if this drug passes into breast milk. Insulin needs may change while breastfeeding. Consult your doctor before breastfeeding.

Our NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Novolog Mix 70-30 Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, wheezing, rapid pulse, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low potassium;
  • itching, mild skin rash; or
  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Novolog Mix 70-30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin))

QUESTION

Diabetes is defined best as... See Answer
Novolog Mix 70-30 Professional Information

SIDE EFFECTS

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]. NovoLog Mix 70/30 should not be used during episodes of hypoglycemia [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
  • 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 (insulin aspart protamine and insulin aspart (rdna origin)) , 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 (insulin aspart protamine and insulin aspart (rdna origin)) , 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 (insulin aspart protamine and insulin aspart (rdna origin)) .

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

Preferred Term NovoLog Mix70/30
(N=55)
Novolin 70/30
(N=49)
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.)

Preferred Term NovoLog Mix70/30 (N=85) Novolin 70/30 (N=102)
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 (insulin aspart protamine and insulin aspart (rdna origin)) . 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 INFORMATION].

Read the entire FDA prescribing information for Novolog Mix 70-30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin))

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