Dasiglucagon - A Descriptive Overview

Overview

The drug Dasiglucagon is used in the treatment of diabetic people aged six years and older. The drug is similar to the hormone glucagon, responsible for maintaining the levels of blood glucose, and is used in treating hypoglycemia. Symptomatic treatment can be done by providing supportive therapy. They are available in two forms such as an auto-injector and prefilled syringe. Precautions and warnings should be followed by the patients as well as taken care by the doctors to avoid major complications.

How Does Dasiglucagon Work?

Dasiglucagon works by producing an anti-hypoglycemic effect (an effect that is opposite to decreasing the levels of hypoglycemia). Glucose from the liver is released by stimulation of glycogen breakdown and by activating the receptors in the liver.

Available Dose and Dosage Forms:

The drug Dasiglucagon is available in the form of an injection. The injection fluid is a colorless solution and clear.

• 0.6 milligrams/0.6milliliter single dose - Auto-injector.

• 0.6 milligrams/0.6milliliter single dose - Prefilled syringe.

Contraindications:

• It is contraindicated in patients suffering from pheochromocytoma, which is a tumor present in the adrenal gland (a gland present on top of the kidneys).

• Also, the drug is not indicated in patients who are suffering from insulinoma (pancreatic tumor).

• Patients with a history of allergic reactions to the ingredients of the drug are also contraindicated for Dasiglucagon.

Warnings and Precautions:

• Patients With Pheochromocytoma: It is not advised in patients suffering from pheochromocytoma as there can be considerable blood pressure increase in them.

• Low Blood Sugar Levels in Patients With Insulinoma - At first, there can be a rise in blood glucose levels but subsequently, hypoglycemia can occur.

• Hypersensitivity and Allergy Reactions- Glucagon products tend to show allergic reactions that can lead to rash formation and, in certain cases, can also lead to anaphylactic shock with hypotension and breathing difficulties.

• Decreased or Lack of Efficacy in Patients With Decreased Levels of Hepatic Glycogen - Treatment of hypoglycemia is effective in patients with the required amount of hepatic glycogen. These levels of hepatic glycogen can be decreased in patients under starvation or adrenal insufficiency. Such patients can be treated with glucose.

Adverse Reactions:

• Adverse reactions associated with the administration of Dasiglucagon in adults and children.

• In Adults: Headache, vomiting, nausea, and diarrhea.

• Pediatrics: Nausea, headache, and injection site pain.

For Patients-

What Is Hypoglycemia?

Hypoglycemia, or low blood glucose, is a condition that occurs when the level of glucose in the blood drops down to the recommended level. It is a very common case in individuals with type 1 diabetes and type 2 diabetes who take insulin or any other medications related to diabetes.

Symptoms of Hypoglycemia:

In mild to moderate cases following symptoms occur.

• Hunger.

• Tiredness.

• Lightheadedness.

• Dizziness.

• Increased heartbeat.

• Altered speech.

In severe cases, hypoglycemia can present with

• Loss of consciousness.

• Presence of seizures.

Effects that damage the normal functioning of the brain which is dangerous and need immediate treatment.

Complications of Hypoglycemia:

Mild cases of low blood glucose are easily treated, whereas cases of severely low blood glucose can lead to complications such as coma or even death.

Treatment of Hypoglycemia:

• Immediate consumption of 15 to 20 grams of glucose or carbohydrates.

• Re-check blood glucose level every 15 minutes and repeat the intake until the level increases.

• Fruit juices are a common source of sugar that can be consumed.

• When in cases, the hypoglycemic condition is severe, it cannot be treated by self and needs medical attention.

• The availability of a glucagon emergency kit has to be handy in checking the expiry dates.

• Glucagon is a hormone that increases blood glucose levels which helps in the treatment of severe cases of severely low blood glucose.

Learn More About Dasiglucagon-

Why Is Dasiglucagon Prescribed?

Dasiglucagon is a next-generation ready-to-use glucagon that is used to treat severely decreased levels of blood glucose in patients with diabetes.

Things to Inform the Doctor Before Taking the Drug Dasiglucagon-

• The presence of any tumor, especially a tumor of the pancreas if diagnosed, should be informed to the doctor.

• Any allergy to the drug or the ingredients of the drugs should be informed prior.

• Prolonged starvation or fasting (not having water or food for a long time).

• Presence of adrenal insufficiency.

• Suffering from long-term low levels of blood sugar that do not recover.

• The doctor should also be informed if the patient is pregnant or planning for pregnancy.

• If the patient is breastfeeding or not should be made known to the doctor, as the drug can pass through the breast milk to the child.

What Are the Side Effects of Dasiglucagon?

Side-effects of Dasiglucagon in adults include the following:

• High Blood Pressure: Dasiglucagon can lead to increased blood pressure in patients suffering from adrenal gland tumors.

• Low Blood Sugar: In certain people with pancreatic tumors called insulinomas, the drug Dasiglucagon can cause low blood sugar.

Other commonly occurring side effects in adults are listed below-

• Nausea.

• Vomiting.

• Headache.

• Injection site pain.

• Diarrhea.

• Allergic reactions include difficulty in breathing, rashes.

Children present with the following side effects-

• Headache.

• Vomiting.

• Nausea.

• Pain in the injection site.

How Should the Drug Dasiglucagon Be Used?

• Dasiglucagon should be available in handy, and hence the caregiver should be very diligent towards the situation and act right as it can cause serious issues to the patient.

• After consuming the drug, a caregiver should right away call for medical help.

• Fruit juice (fruit juice) or crackers with peanut butter (a long-acting source of sugar) are a few fast-acting sources of sugar that should be given once the patient can consume food.

• Another dose of sugar should be given if the patient does not respond even after 15 minutes of treatment.

• As the dose of the drug has to be changed for the betterment of the treatment, it is necessary to inform the doctor every time the individual administers the drug.

• The drug comes in a prefilled auto-injector or syringe, which cannot be reused.

Following Are the Steps to Administer the Drug Through an Auto-Injector:

Before Injection:

• The injection site is to be chosen, and the region is exposed.

• The injection site can be:

  • Outer upper arms.

  • Front or back of thighs.

  • Lower abdomen (two inches away from belly button).

  • Buttocks.

• The red case is held upright with the gray lid on the top, and the lid is removed.

• The drug Dasiglucagon is carefully removed from the protective case.

Steps to Inject From Auto-Injector:

• The gray lid is carefully pulled out, revealing the yellow needle guard.

• Do not put one’s fingers near the yellow needle guard, as it can cause injury.

• The drug Dasiglucagon is now pushed straight down until the needle guard is fully pressed on the skin. This gives a sound of the first click.

• The drug is held for up to ten seconds. The window present on the drug turns red, indicating the whole drug is given, and then a second click is heard.

• The auto-injector is removed by lifting it.

After Injection:

• If the person is unconscious, the person is rolled to the other side, which prevents choking.

• Medical emergency tea is called for help meanwhile.

• Even if the person recovers after administration of a drug, medical help is still called.

• If the person does not respond for 15 minutes, another dose of the drug is given.

• Once the patient feels comfortable eating and drinking, a source of sugar, like fruit juices, can be given.

Steps to Follow While Administering the Drug Through a Syringe:

All the steps are similar to the auto-injector except the following:

• The set comes with a red protective case and a prefilled syringe.

• The gray needle cover of the syringe is removed.

• The skin is gently pinched, and the needle is inserted at an angle of 45 degrees.

• After the needle is inserted, the pinched skin is slowly released, and the injection is given.

• After the full dose of the drug is injected, the needle is removed carefully from the injection site.

• Disposal and post-injection precautions are the same as that of auto-injector Dasiglucagon.

How Should a Dasiglucagon Be Disposed?

• The drug, after usage, should not be disposed of along with household trash.

• The auto-injector has to be disposed of in an FDA-cleared sharps disposal container. When in case the container is not available,

• A household container made up of heavy-duty plastic with a tight-fitting closure, resistant to puncture, can be used.

• It should also be leak-resistant, stable, and upright during use.

• Once the container is full, community guidelines following the disposal of auto-injectors should be followed.

What Should Be Done in Case of Dasiglucagon Overdose?

If higher doses of the drug are consumed, the patient can suffer from vomiting, nausea, and altered gastrointestinal tract motility which also increases the heart rate and blood pressure. If there is any suspected case of overdosing, serum potassium should be monitored and corrected if it is decreased. If there is increased blood pressure, the blood pressure can be lowered for a short time by the administration of Phentolamine mesylate, which acts effectively.

Based on the symptom the patients show up on overdosing, supportive treatment is provided to reduce the same.

How to Store Dasiglucagon?

• The drug Dasiglucagon should be stored at a temperature between two degree Celsius to eight degree Celsius in a refrigerator.

• Care should be taken not to freeze the drug.

• Dasiglucagon can also be kept at room temperature between 20 degree Celsius and 25 degree Celsius for nearly 12 months.

• Do not put the drug back into the refrigerator after keeping it at room temperature.

• If the drug is stored for more than 12 months, discard the drug.

• Do not use the drug until the last date of the expiry date; replace the medication in advance.

• A red protective case is provided along with the drug, which should be used for storage.

• Keep the drug Dasiglucagon out of children's reach.

Avoid Self-Medication:

It is advised not to administer the medication unless it is prescribed by the physician. Do not suggest other individuals even though they are suffering from the same symptoms as the patient. It can be harmful to them.

For Doctors:

Indication:

The drug Dasiglucagon is indicated mainly for treating adult and pediatric severe hypoglycemic patients with diabetes.

Dosing:

The recommended dosage of the drug Dasiglucagon is around 0.6 mg which can be administered subcutaneously into the lower abdomen, thigh, buttocks, or outer upper arm. An additional dose of 0.6 mg has to be administered in case there is no response for the first dose.

Clinical Pharmacology-

Mechanism of Action:

The drug Dasiglucagon is a glucagon receptor agonist, which helps by increasing blood glucose levels by activating certain receptors called hepatic glucagon receptors, which in turn stimulate the glycogen breakdown and simultaneously release glucose from the liver. Reserved hepatic stores are necessary for the drug to produce an effect that decreases hypoglycemia.

Pharmacodynamics:

After the drug was administered to patients with type 1 diabetes, the mean baseline of glucose was increased to 168 mg/dL. In pediatric patients with type 1 diabetes, the increase was 162 mg/dL at 60 minutes.

Pharmacokinetics-

• Absorption: Following subcutaneous injection of the drug Dasiglucagon, absorption of 0.6mg resulted in peak plasma concentration at around 35 minutes.

• Metabolism: The drug Dasiglucagon is cleared like normal glucagon through certain proteolytic pathways in the blood, kidney, and liver.

• Elimination: The half-life of the drug was approximately 30 minutes.

Nonclinical Toxicology-

• Carcinogenesis: Studies to evaluate the carcinogenicity of the drug have not been reported.

• Mutagenesis: The drug Dasiglucagon was not clastogenic or mutagenic in the results from genotoxicity tests such as human lymphocyte chromosome aberration, bacterial mutagenicity, and rat bone marrow micronucleus.

• Impairment of Fertility: The administration of the drug did not alter the fertility in male and female test animals.

Warnings and Precautions:

• Substantial Blood Pressure Increase in Patients With Pheochromocytoma:

Dasiglucagon is contraindicated in patients suffering from pheochromocytoma as the products of glucagon stimulate the catecholamines released from the tumor. Intravenous administration of Phentolamine mesylate can be done if there is increased blood pressure and no history of pheochromocytoma to lower the blood pressure.

• Hypoglycemia in Patients With Pancreatic Tumor:

Administration of products related to glucagon can produce an increase in blood glucose. Administration of the drug directly or indirectly can stimulate the release of insulin and lead to hypoglycemia. On the development of hypoglycemic symptoms after administration of a single dose of Dasiglucagon, glucose can be given intravenously or orally.

• Hypersensitivity and Allergic Reactions:

Glucagon products can tend to show allergic reactions, which lead to rashes and shock with breathing difficulties and decreased blood pressure. Patients should seek medical attention immediately upon experiencing any hypersensitivity reactions.

• Lack of Efficacy in Patients With Reduced Hepatic Glycogen:

Dasiglucagon is very effective in treating lower blood glucose levels only if adequate glycogen in the liver is present. Patients suffering from starvation with adrenal insufficiency may not have the required levels of hepatic glycogen, and such conditions can be treated with glucose.

Drug Interactions-

• Beta-Blockers: Transient increases in blood pressure and pulse can be done by taking beta blockers when beta-blockers are administered.

• Indomethacin: Dasiglucagon can lose the ability to increase blood glucose or can even lead to hypoglycemia when Indomethacin is administered.

• Warfarin: The drug Dasiglucagon can increase the anticoagulant effect of Warfarin.

Use in Specific Populations:

• Pregnancy: There is a higher risk of miscarriage, birth defects, and fetal or maternal outcomes. Hypoglycemia left untreated in pregnant women can cause complications that can be fatal.

• Lactation: Dasiglucagon being a peptide, is expected to be broken down into its amino acids in the digestive tract of the infant and can be harmful to an exposed infant. No specific information is available if Dasiglucagon is present in animal or human milk.

• Pediatric Use: The effectiveness and safety of Dasiglucagon for severe hypoglycemia treatment in diabetic patients were established. The use of Dasiglucagon is supported in treating pediatric patients with type 1 diabetes. In patients younger than six years of age, effectiveness and safety evaluation of the drug have not been established yet.