Albiglutide for Type 2 Diabetes Mellitus: A Comprehensive Overview

Overview

Albiglutide is indicated for treating type 2 diabetes mellitus (also known as insulin-independent diabetes or adult-onset diabetes), a condition in which the body can either not produce sufficient insulin or cannot use it effectively. Albiglutide injection is used along with diet and exercise to treat this condition when the blood glucose (sugar) levels cannot be controlled with other medications. The United States Food and Drug Administration (US FDA) approved the drug in April 2024 for type 1 diabetes mellitus. Therefore, the article discusses Albiglutide in detail, including its side effects, indications, contraindications, drug dosage and administration, clinical pharmacology, and drug interactions.

Drug Group:

Albiglutide belongs to the class of drugs called incretin mimetics or glucagon-like peptide 1 (GLP-1) receptor agonists. It stimulates insulin release in response to food or meals by mimicking the increasing hormones responsible for this process.

Indications

• Type 2 diabetes mellitus (DM).

Usage Limitation

• Albiglutide is not indicated for type 1 diabetes mellitus (a condition in which the pancreas produces negligible or absolutely no insulin).

• It is also not indicated for diabetic ketoacidosis (a condition in which the body produces excess ketones or blood acids).

• It is not indicated as a first-line treatment in people with inadequately managed diet and exercise.

• Not indicated for prandial insulin as a combination drug.

• The drug cannot be used in patients with severe gastrointestinal disorders or diseases and those with a history of pancreatitis (inflammation of the pancreas).

Dose Form and Strength

Injection (Lyophilized Powder for Reconstitution): 30 mg (milligram) or 50 mg in a single-dose pen for subcutaneous (under the skin) use only.

For Patients:

What Is Type 2 Diabetes Mellitus?

As mentioned above, type 2 diabetes is a chronic condition that affects blood sugar or glucose processing in the body. This type of diabetes usually occurs in adults but can also affect other age groups. The condition causes symptoms such as frequent urination, increased thirst, blurred vision, and fatigue. However, the condition can be managed with proper diet, regular exercise, medications, and insulin therapy (in case other medications are ineffective in controlling the blood sugar levels).

What Is Albiglutide Prescribed For?

Albiglutide injection is prescribed to a patient along with diet and exercise to manage blood sugar levels in the body in type 2 diabetes mellitus when other drugs or medications cannot control the condition well.

The drug is also effective in managing and reducing the risk of developing diabetes-related life-threatening complications, such as nerve damage, kidney failure, vision loss, gum diseases, and other risks, such as stroke (blood supply interruption to causing brain damage) or heart attacks.

How Should Albiglutide Be Taken?

Albiglutide injection is available in a powder form (lyophilized powder), which needs to be mixed with water in a dosing pen (prefilled) and injected under the skin or subcutaneously once a week, irrespective of meals. The injection is advised to be administered every week on the same day and time. The day of the week for taking the injection dose can be changed, but one should note that there should be at least a four-day gap since one took the last dosage. The instructions on the prescription label should be followed cautiously, and one must ask the pharmacist or the doctor if they do not understand any part of it and how to prepare and inject the medication.

The drug should be used exactly as the doctor prescribes, and the dosage, duration, and frequency should only be altered by consulting the healthcare professional. Also, an Albiglutide injection can only help control diabetes and does not cure it completely. Therefore, if a person starts feeling better, do not stop the drug without asking the doctor.

The drug should always be injected with its prefilled dosing pen, which contains medication for a single dose. It should not be mixed with any other medication. Additionally, one must always look for yellow, clear, and solid particles before injecting the medication.

The drug should be injected into specific areas of the body, such as the stomach, thigh, or upper arm, and should never be injected into the muscle or vein. A person should only change the injection site in these specific areas for each dose. Albiglutide and insulin can be injected in the same area of the body but should not be injected just next to each other.

Needles or pens should not be shared, and one must use a new needle for each drug dosage and safely discard the used one.

What Precautions Should Be Taken Before Using Albiglutide?

• One must inform the doctor about any history of allergic reactions to Albiglutide, its ingredients, or any other medication.

• One must also inform the doctor if they have had any gastrointestinal-related condition, such as gastroparesis (paralysis of stomach muscles that help in food movement), pancreatitis (inflammation of the pancreas), digestion-related issues, or liver or kidney diseases.

• The doctor should also be informed about all the non-prescription and prescription drugs that a person is taking or planning to take, including nutritional supplements, vitamins, or herbal products. The doctor might need to alter the drug dosage or monitor the patient for side effects.

• A person should also inform the doctor if one is pregnant, planning to conceive, breastfeeding, or getting pregnant while taking Albiglutide.

• If someone has a fever, infection, or unusual tiredness, they must call the doctor. This condition can impact the blood glucose levels in the body, and the amount of Albiglutide dosage needed.

What Are the Side Effects of Albiglutide?

The side effects of Albiglutide are as follows:

Common Side Effects:

• Nausea

• Diarrhea (watery or loose stool).

• Heartburn.

• Cough.

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

Serious Side Effects:

• Rash.

• Vomiting.

• Itching.

• Hives.

• Breathing difficulty.

• Pain starts from the stomach (upper left or middle) and radiates towards the back.

Missed Dose

The missed dose should be taken as soon as one remembers it. However, in case the

drug dose has been missed for more than three days, one should skip the dose (missed one) and continue with the regular scheduled dose. A person should only take one dose to compensate for the missed one.

Overdose

In case of an overdose from Albiglutide, one should contact the poison control helpline. However, if the victim has seizures (uncontrolled electrical activity in the brain cells), collapses, and has trouble breathing, a medical emergency should be contacted immediately.

Storage and Disposal

Albiglutide should be stored in their original airtight containers and away from children. Before use, the injection pens should be stored in refrigerators at 36 to 46 degrees Fahrenheit (or two to eight degrees Celsius). The patients can also store the drug in the refrigerator until the expiration date. Moreover, the injection pens can be stored at the same refrigeration temperature after dispensing. Still, the patient can also store the pens at room temperature of not more than 30 degrees Celsius or 86 degrees Fahrenheit for about four weeks before use.

One should not freeze the drug, and it should not be used beyond the date of expiration. After reconstitution, the drug should be used for eight hours.

For Doctors:

Clinical Pharmacology

Mechanism of Action of Albiglutide

Albiglutide is an agonist of the GLP-1 receptor and increases glucose-dependent insulin. Secretion also slows gastric emptying.

Pharmacodynamics

Albiglutide lowers fasting blood glucose and reduces postprandial glucose excursions in type 2 diabetes mellitus patients. Most of the reduction in fasting blood glucose occurs after a single drug dose.

When 100 mg (2 times the maximum approved dosage) of the drug is administered as a single dose, it also slows gastric emptying compared with a placebo for solids and liquids.

Additionally, at doses up to the maximum recommended dose of 50 mg, Albiglutide does not prolong QTc to a clinically relevant extent.

Pharmacokinetics

Absorption - Post-dosing Albiglutide’s maximum concentrations reach three to five days following a single 30mg dose. The mean peak concentration (Cmax) is 1.74 mcg/mL (microgram per milliliters), and the mean area under the time-concentration curve (AUC) is 465 mcg/h/mL (microgram per hour per milliliters).

Distribution - Following subcutaneous administration of Albiglutide, the mean volume of distribution of the drug is 11 liters (L).

Metabolism - Albiglutide is known to follow a metabolic pathway similar to native human serum albumin because it is an albumin fusion protein, and gets primarily catabolized in the vascular endothelium.

Elimination - The mean clearance of the drug is 67 mL/h (milliliter per hour) with an elimination half-life of approximately five days, thus, making Albiglutide suitable for once-a-week administration.

Ingredients:

Active Ingredients: Albiglutide.

Inactive Ingredients: Polysorbate 80, mannitol, trehalose dihydrate, and sodium phosphate.

Albiglutide Dosing and Administration

Dosage:

The recommended dosing of Albiglutide is 30 mg (milligrams) once weekly as a subcutaneous injection in the thigh, abdomen, or upper arm region. If the glycemic response is inadequate, the dosage may be increased to 50 mg once weekly.

Reconstitution of Lyophilized Powder:

The Albiglutide injection pen's lyophilized powder must be reconstituted before administration. The doctor should give the following instructions to the patient:

1. Pen Reconstitution

• The pen body should be held with the clear cartridge pointing up to see the number window.

• Next, twist the clear cartridge on the pen in the arrow’s direction until the pen produces a click sound into place and is seen in the number window to reconstitute the lyophilized powder with the diluent in the pen. This mixes the diluent with the lyophilized powder.

• Rock the pen side-to-side five times, slowly and gently, to mix the reconstituted solution of Albiglutide. The patient should be advised not to shake the Pen hard to avoid foaming.

• Wait 15 and 30 minutes, respectively, for the 30—and 50-mg injection pens to ensure that the reconstituted solution is mixed.

2. Preparing Pen for Injection:

• To mix the reconstituted solution, again rock the pen side-to-side five additional times.

• Check for particulate matter by visually inspecting the reconstituted solution in the viewing window. In such a case, the reconstituted solution will be yellow. After reconstitution, use Albiglutide within eight hours.

• Now, hold the pen upright and attach the needle to it by pushing it straight down until a click sound is heard and the needle snaps into place. Tap the clear cartridge gently to bring large bubbles to the top.

Contraindications of Albiglutide

• Albiglutide is contraindicated in patients with known serious hypersensitivity to the drug or any of its ingredients.

• The drug is also contraindicated if one has a family or personal medical history of medullary thyroid carcinoma (a tumor arising from cells of the thyroid gland) or in case of type 2 multiple endocrine neoplasia (tumors in adrenal, parathyroid, thyroid glands, and also eyes, mouth, lips, and digestive tract).

What Are the Warnings and Precautions for Albiglutide?

1. Thyroid C-Cell Tumors: (Boxed Warning)

• Albiglutide can cause thyroid C-cell tumors in rodents, and thus, human risk could not be determined.

• The drug is also contraindicated in patients with family or personal history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2.

• Also, in patients treated with Albiglutide, routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of medullary thyroid carcinoma.

2. Pancreatitis: Albiglutide should be immediately stopped if this condition is suspected, and the doctor must consider some other anti-diabetic medications for pancreatitis cases.

3. Hypersensitivity: If severe hypersensitivity reactions, such as angioedema, occur, Albiglutide should be discontinued immediately.

4. Hypoglycemia: The drug can cause hypoglycemia when combined with insulin, such as sulfonylureas or other insulin. Therefore, the doctor should lower the insulin dosage when Albiglutide is prescribed.

5. Macrovascular Outcomes: No clinical trials have established any specific evidence related to risk reduction of macrovascular outcomes with Albiglutide or any other anti-diabetic medication.

6. Renal Impairment: The doctor must monitor the renal (kidney) function of patients suffering from renal impairment and reporting severe gastrointestinal reactions

What Are the Drug Interactions of Albiglutide?

• Ramipril.

• Saquinavir.

• Sitagliptin.

• Ritonavir.

• Sacubitril or Valsartan.

• Tipranavir.

• Tolazamide.

• Somatrogon.

• Telmisartan.

• Tolbutamide.

• Trifluoperazine.

• Ziprasidone.

• Acetaminophen IV (intravenous).

• Repaglinide.

• Saxagliptin.

• Risperidone.

• Rosiglitazone.

• Thioridazine.

• Somapacitan.

• Somatropin.

• Triamcinolone acetonide injectable suspension.

• Valsartan.

• Acetaminophen.

• Digoxin.

Uses In Specific Populations

Pregnancy

No specific data is showing reproductive or fertility-related toxicity in humans caused by Albiglutide. However, the drug should not be given during pregnancy unless the expected benefits of the drug outweigh the associated potential risks.

Breastfeeding

No specific data suggests the use of Albiglutide in humans during lactation. The drug will likely be excreted in human milk as it is an albumin-based protein therapeutics. Therefore, the decision to give the drug to this population should be based on the mother's need for the medication and the potential risks to the baby.

Pediatric Use

The safety and effectiveness of Albiglutide have not yet been established in the pediatric population.

Geriatric Use

The safety and effectiveness of Albiglutide do not show much difference between the geriatric population and younger ones.

Renal Impairment

No dose adjustment is recommended in this population group. However, renal function monitoring should be performed for those reporting severe gastrointestinal adverse reactions.