HUMALOG (Insulin Lispro)

What is this medication?

HUMALOG/ADMELOG (Insulin Lispro)
Rapid Acting Insulin

HUMALOG/ADMELOG (Insulin Lispro) is officially indicated for Diabetes mellitus types 1 and 2.

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

ADMELOG is a biosimilar to HUMALOG (Insulin Lispro)

What is the difference between the brands?

ADMELOG and HUMALOG are both insulin lispro products. Insulin lispro is an antidiabetic medicine for the treatment of patients with diabetes. Admelog (insulin lispro) is considered a “follow-on” biologic drug to Humalog.  HUMALOG is manufactured by Eli Lilly and was introduced to the market in May 2015.  ADMELOG is manufactured by Sanofi-Aventis and was approved and introduced to the market in September 2017.

How does this medication work? 

HUMALOG/ADMELOG (Insulin Lispro) works on liver, muscle and adipose (fat) tissue to regulate the metabolism of carbohydrates, protein, and fats.  In the liver and muscles, it increases glycogen synthesis which is the immediate storage form of glucose.  It increases fat production by increasing fatty acid release from the liver in the form of lipoproteins which adipose tissue converts to fatty acids then to triglycerides for storage whilst also stopping the metabolism of triglycerides (fat).  Insulin also increases the cellular uptake of amino acids and some electrolytes such as potassium into the cell.  In muscle tissue protein synthesis is increased.

Normally insulin is produced by the pancreas however insulin products for pharmaceutical use have been produced via recombinant DNA technology using certain bacteria (they splice the gene for insulin production into bacterial DNA so the cell produces insulin – a gene is a portion of DNA or RNA that produces one specific protein).  Insulin Lispro is different from human insulin as it has some modifications to make it work faster.  This is done by swapping the position of a proline and lysine at locations B28 and B29 in human insulin (these are all names of amino acids which are the building blocks of proteins such as insulin).

How should I take this medication? 

HUMALOG/ADMELOG (Insulin Lispro) is a rapid acting mealtime insulin.  It is injected subcutaneously in multiple daily dosages depending on the number of meals the patient consumes.  It should be given 15 minutes prior to the meal up to immediately after finishing eating. In type 2 diabetes someone usually starts around 4-5 units per day or 10% of basal insulin dose prior to largest meal of the day and the dosage is slowly increased until glucose control is achieved.  In type 1 diabetes 50-60% of total daily insulin is given as fast acting mealtime insulin with the rest going to intermediate or long acting basal insulins.  If converting from another insulin the number of units given may need to be lowered as a precaution.

How to Take: Follow instructions provided by physician/pharmacy label, use consistently at same times each day unless otherwise directed. Injection generally into abdomen, thighs, buttocks, or arms with absorption rates varying from site to site. Be consistent with the part of body you inject into but rotate injection site to avoid redistribution of fat and excessive irritation to the area.  For example, if you choose abdomen which is the most common, inject in circular order at least 2 inches from navel.

You Need to Avoid: Do not use if solution seems viscous (thick) or appears cloudy, only use if clear, colorless and with no visible particles.  Avoid injecting cold insulin as it may be painful.  

What should I watch for while using this medication? 

Before starting Insulin HUMALOG/ADMELOG (Insulin Lispro), make sure your physician is aware of any allergies or medications you currently take, if you have had bariatric surgery, cardiovascular disease, have kidney disease, liver disease, diabetic ketoacidosis, are pregnant or breastfeeding.  

What is the difference between a prefilled pen and a cartridge?

The prefilled pen (KwikPen) is in a ready to use format including a fixed needle, whereas a cartridge needle is separate from the glass body.

What if I miss a dose?

HUMALOG/ADMELOG (Insulin Lispro) must be injected shortly before or after a meal. If you remember your dose before or shortly after a meal, inject the missed dose right away. If some time has passed since your meal, follow the instructions provided by your doctor or call your doctor to find out what you should do. Do not take double or extra doses.

How should I store this medication?

Unopened prefilled pens should be stored in a refrigerator at 36° to 46°F (2° to 8°C) and can be used until the expiration date on the carton or label. Keep away from direct light, and heat. Do not freeze.

Opened prefilled pens should be kept at room temperature, below 86°F (30°C). Opened vials should be kept at room temperature or in a refrigerator. Opened prefilled pens must be thrown away 28 days after first use, even if they still contain insulin.

What are the possible side effects of using this medication?

Hypoglycemia, antibody development, nasopharyngitis, headaches, and irritation to injection site.  Hypoglycemia is the largest concern with rapid acting insulin and can be life-threatening so extra care should be taken when using insulin.  If you feel unsure of your dose contact your health care professional and always err on the side of caution.

Note this is not a complete list of side effects for HUMALOG/ADMELOG (Insulin Lispro), only common ones.