Insulin Human Inhalation Powder - Pharmacological Aspect

Overview

Insulin human inhalation powder is a white powder that comes in single-use plastic cartridges. A person can use it by breathing in through the special Insulin human inhalation powder inhaler. The Insulin in Insulin human inhalation powder, is made using a safe lab version of a common bacteria and has a specific chemical structure. The human inhalation powder in insulin is attached to tiny particles to help it work when inhaled. Insulin human inhalation powder cartridges are available in two sizes: one in a four-unit cartridge with 0.35 mg (milligram) of Insulin and an eight-unit cartridge with 0.7 mg of Insulin. The United States Food and Drug Administration approved Insulin human inhalation powder on June 14, 2014.

Available Doses and Dosage Forms:

Insulin human inhalation powder comes in two strengths, one is four units and eight units. The cartridges are sold in blister strips. Each strip holds three cartridges, and each card has five strips, making 15 cartridges. There are two cards per foil package, so there are 30 cartridges in each foil pack. The four-unit cartridges are blue, and the eight-unit cartridges are green. Each cartridge is labeled with its strength.

The inhaler comes in a see-through package and is ready to use with a removable cover. It works for up to 15 days, after which it should be replaced.

• 60 Cartridges: 60 cartridges of four units each and two inhalers.
• 90 Cartridges: 90 cartridges of four units each and two inhalers.
• 90 Cartridges: 90 cartridges of eight units each and two inhalers.
• 90 Cartridges (Mixed): 60 cartridges of four units and 30 cartridges of eight units with two inhalers.
• 90 Cartridges (Mixed): 30 cartridges of four units and 60 cartridges of eight units with two inhalers.
• 180 Cartridges (Mixed): 90 cartridges of four units and 90 cartridges of eight units with two inhalers.

For Patients:

How Does Insulin Human Inhalation Powder Work?

Insulin inhalation powder helps by adding insulin that the body needs but is not making on its own. It helps move sugar from the blood into the cells, where it is used for energy. It also prevents the liver from making extra sugar.

What Is the Dosage of Insulin Human Inhalation Powder?

Insulin human inhalation powder comes in single-use cartridges of four units and eight units. A person can use these cartridges with the Insulin human inhalation powder to take the medication by inhaling it.

How Effective Is Insulin Human Inhalation Powder?

Inhaled insulin powder, when combined with a good diet and exercise, helps control high blood sugar. Keeping blood sugar levels in check can help prevent serious issues like kidney damage, blindness, nerve problems, loss of limbs, and sexual health problems.

What Are the Things to Inform the Doctor Before Taking the Insulin Human Inhalation Powder?

• Let the doctor and pharmacist know if the person is allergic to Insulin or any other medications or is sensitive to any of the ingredients in the Insulin inhaler.

• Tell the doctor and pharmacist about all the medications, vitamins, supplements, and herbal products they are taking or plan to take.

• If the person is using other inhaled medicines, make sure to mention that too. The doctor might need to adjust the medication doses or keep a close eye on side effects.

• Be aware that some nonprescription or herbal products, like Aspirin, might interact with Insulin inhalation. Inform the doctor and pharmacist about any new medications before starting insulin inhalation.

• Let the doctor know about low blood sugar (hypoglycemia). They might advise against using Insulin inhalation if anyone has this condition. Also, inform them if have an infection, smoke (or recently quit smoking), or have had low potassium levels, lung cancer, nerve damage from diabetes, heart failure, or liver and kidney problems.

• Tell the doctor if the patient is pregnant, planning to become pregnant, or breastfeeding. If a person gets pregnant while using insulin inhalation, contact the doctor.

• Inform the doctor or dentist if the person is having any type of surgery, including dental work, that they are using insulin inhalation.

• Ask the doctor how often to check the blood sugar levels. Low blood sugar can affect the ability to drive or use machinery, so ask if the person needs to check the blood sugar before doing these activities.

• Alcohol can affect the blood sugar levels. Check with the doctor about drinking alcohol while using Insulin inhalation.

• If the person gets sick, gains or loses weight, experiences stress, travels across time zones, or changes the exercise routine, let the doctor know. These changes might affect the Insulin needs and dosing schedule.

What Are the Side Effects of Insulin Human Inhalation Powder?

• Breathing Problems: It can cause sudden breathing issues in people with long-term lung conditions.

• Low Blood Sugar: It can lead to dangerously low blood sugar levels.

• Lung Function Decline: It may slowly reduce lung function over time.

• Lung Cancer: There have been cases of lung cancer associated with Insulin human inhalation powder.

• Diabetic Ketoacidosis (DKA): It can increase the risk of a serious diabetes complication called DKA.

• Allergic Reactions: It can cause severe allergic reactions in some people.

Missed Dose:

When a person starts using Insulin inhalation, ask the doctor what to do if they miss a dose. Write down the instructions so that it can be remembered later.

Overdose:

Using too much Insulin can cause low blood sugar (hypoglycemia) and low potassium levels (hypokalemia).

• For Mild Low Blood Sugar: Eating or drinking something with glucose usually helps. A person might need to adjust the insulin dose, eat more, or exercise.

• For Severe Low Blood Sugar: If a person has serious symptoms like passing out, seizures, or mental confusion, they may need an injection of glucagon or a special sugar solution given through an IV. Even after symptoms improve, they should keep monitoring and possibly eat more carbohydrates to prevent low blood sugar from coming back. Make sure to correct any low potassium levels as well.

Storage: Keep Insulin human inhalation powder in the fridge (two to eight degrees Celsius or 36 to 46 degrees Fahrenheit) until the package expires.

For Doctors:

Indication:

Insulin human inhalation powder is a type of insulin that can be breathed in to help control blood sugar levels in adults with diabetes.

What Are the Pharmacological Aspects of Insulin Human Inhalation Powder?

• Pharmacodynamics: In a study comparing Insulin human inhalation powder and Insulin lispro in people with type 1 diabetes:

  • Insulin Human Inhalation Powder: The time it took for Insulin human inhalation powder to have its strongest effect was around 53 minutes on average, but the effect started to wear off after about 160 minutes.

  • Insulin Lispro: Insulin human inhalation powder and Insulin lispro had similar onset times in terms of lowering blood sugar.

• Mechanism of Action: Insulin helps lower blood sugar levels by helping muscles and fat cells absorb glucose and by reducing the amount of glucose made by the liver. It also prevents fat breakdown in fat cells, stops the breakdown of proteins, and helps build new proteins.

• Pharmacokinetics:

  • Insulin Human Inhalation Powder: Insulin in human inhalation powder is regular human insulin. Once inhaled, it gets into the bloodstream and works the same way as regular Insulin injected under the skin.

  • Absorption: After inhaling insulin in human inhalation powder, the highest level of insulin in the blood appears within 12 to 15 minutes, but it goes back to normal levels in about 180 minutes. Even though insulin from insulin is absorbed faster by human inhalation powder, it does not start working faster than injected insulin.

  • Duration: The Insulin from Insulin human inhalation powder stays in the system for about 28 to 39 minutes, while injected Insulin lasts around 145 minutes.

  • Carrier Particles: The tiny particles used to carry the Insulin into the lungs are not broken down by the body. About 39 percent of these particles go to the lungs, and seven percent are swallowed. The swallowed particles pass through the digestive system unchanged and are removed from the stool.

Toxicity: In long-term studies with rats and mice, no increased risk of cancer was found with Insulin human inhalation powder or its carrier particles, even at high doses. Insulin human inhalation powder did not cause genetic damage in lab tests that looked for changes to DNA. In male rats, Insulin human inhalation powder did not affect fertility at high doses. In female rats, there was some loss of pregnancies and babies at very high doses but not at lower doses.

Clinical Studies:

• Type 1 Diabetes (Study Details): Adults with type 1 diabetes took Insulin human inhalation powder with a long-acting Insulin for 24 weeks. They were compared to those using a different type of Insulin (Insulin aspart) with the same long-acting insulin. Insulin human inhalation powder lowered blood sugar, but not as effectively as Insulin aspart. After 24 weeks, people using Insulin aspart had a better reduction in their blood sugar levels and were more likely to reach the target blood sugar goal.

• Type 2 Diabetes (Study Details): Adults with type 2 diabetes who did not have well-controlled diabetes with their current oral medications took Insulin human inhalation powder for 24 weeks. They were compared to those who used a placebo inhaler with their oral medications. Insulin human inhalation powder was more effective at reducing blood sugar levels compared to the placebo. More people using insulin human inhalation powder reached the target blood sugar level than those using the placebo.

What Are the Contraindications of Insulin Human Inhalation Powder?

Insulin human inhalation powder should not be used if a person has:

• Low blood sugar (hypoglycemia) at the moment.

• Long-term lung conditions like asthma or COPD (chronic obstructive pulmonary disease) might cause sudden breathing problems.

• An allergy or bad reaction to regular human Insulin or any ingredients in Insulin human inhalation powder.

Warnings and Precautions:

• Breathing Problems with Chronic Lung Disease: If a person has long-term lung issues like asthma or COPD, they should not use Insulin human inhalation powder because it can cause sudden breathing problems. Before starting the human inhalation of insulin powder, doctors should check the health of the lungs.

• Changes in Insulin Routine: If the type of insulin or dose of insulin is changed then Insulin human inhalation powder can be used, it can affect blood sugar control and increase the risk of low or high blood sugar. It is important to monitor the blood sugar more often and adjust other diabetes medications if needed.

• Low Blood Sugar (Hypoglycemia): Low blood sugar is a common side effect of Insulin, including Insulin human inhalation powder. Severe low blood sugar can be dangerous and even life-threatening. It can also affect the ability to concentrate and react quickly, which is important for activities like driving. A person will need to watch for low blood sugar symptoms and monitor the blood sugar levels regularly.

• Decline in Lung Function: Insulin powder in human inhalation can slowly decrease lung function over time. In studies, patients using Insulin human inhalation powder had a slight but noticeable decline in lung function. Regular lung function tests are recommended, and if there is a significant decline, they may need to stop using Insulin human inhalation powder.

• Lung Cancer Risk: There have been a few cases of lung cancer in people using Insulin human inhalation powder, but it is unclear if the drug is the cause. If a person has a history of lung cancer or is at high risk, discuss with the doctor whether Insulin human inhalation powder is right.

• Diabetic Ketoacidosis (DKA): DKA, a serious complication of diabetes, was more common in people using Insulin human inhalation powder compared to other insulins. If the person is at risk for DKA, such as during illness, monitor the blood sugar more frequently and consider other insulin options.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, can happen with Insulin human inhalation powder. If a person has an allergic reaction, stop using Insulin human inhalation powder and get medical help.

• Low Potassium Levels (Hypokalemia): Insulin human inhalation powder can cause potassium levels to drop, which can be dangerous. If a person is at risk for low potassium, their levels should be monitored.

• Fluid Retention and Heart Failure: If the person is using Insulin human inhalation powder along with certain other diabetes medications (like TZDs), they might retain fluid, which can worsen heart failure. Watch for signs of heart failure and adjust the medications if needed.

What Are the Drug Interactions of Insulin Human Inhalation Powder?

• Drugs That Can Cause Low Blood Sugar: Using Insulin human inhalation powder with certain medications like other diabetes drugs, ACE (Angiotensin-converting enzyme) inhibitors, or antidepressants can increase the risk of low blood sugar. If a person is taking these, they might need to adjust the dose and check the blood sugar more often.

• Drugs That Can Reduce Insulin Human Inhalation Powder's Effect: Some medications, including certain antipsychotics, steroids, and birth control pills, can make Insulin human inhalation powder less effective at lowering blood sugar. A person might need to adjust the dose and monitor their blood sugar levels more frequently if a person is using these drugs.

• Drugs That Can Affect Blood Sugar in Different Ways: Alcohol, beta-blockers, and some other drugs can either increase or decrease the effect of Insulin human inhalation powder. A person might need to adjust the dose and monitor the blood sugar more closely with these medications.

• Drugs That Can Hide Low Blood Sugar Symptoms: Some medications, like beta-blockers and certain blood pressure drugs, can make it harder to notice when the blood sugar is low.

Specific Considerations:

• Pregnancy: Insulin human inhalation powder should only be used if the benefits outweigh the risks to the baby.

• Breastfeeding: Ingredients from Insulin human inhalation powders can likely pass into breast milk. If a person is breastfeeding, they will need to decide whether to stop nursing or not use Insulin human inhalation powder.

• Children: Insulin human inhalation powder has not been tested in children under 18 years old.

• Older Adults: Insulin human inhalation powder was used safely in people 65 and older, including those 75 and up. No significant differences in safety or effectiveness were found between older and younger patients.

• Liver Issues: The impact of liver problems on insulin in human inhalation powder has not been studied. If a person has liver issues, they might need more frequent blood sugar checks and dose adjustments.

• Kidney Issues: The effect of kidney problems on insulin in human inhalation powder has not been studied either. Some insulin can build up in the body if a person has kidney problems, so they might need to monitor their blood sugar more often and adjust their dose if they have kidney issues.