aweekly^®

Aweekle (Semaglutide) is a GLP-I analogue which acts as a GI-P.I receptor agonist that selectively binds to and activates the GLP-I receptor, the target for native GLP-I. Aweekly
reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying.

No Data

Aweeky is indicated:
• As an adjunct to diet and exercise to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with
established cardiovascular disease and either Obesity or overweight
• To reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition.

 Aweekly should be administered as a subcutaneous injection.

Adult Patients
Initially treatment should be started with Aweekly 0.25 mg once weekly. Then the dose escalation schedule presented below to minimise GI adverse reaction to be followed. If patient
do not tolerate a dose during dosage escalation, delaying dosage escalation for four weeks should be considered.

The maintenance dosage of Aweeklye in adults is either 2.4 mg (recommended) or 1.7 mg once weekly (based on treatment response and patient tolerability).
Pediatric patients aged 12 years and older

• It should be initiated according to the dosage escalation schedule as below to minimize
gastrointestinal adverse reactions.
• If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation
for 4 weeks.

*Not approved as maintenance dose
• The maintenance dosage of Aweekly in pediatric patients aged 12 years and older is 2.4 mg once weekly.
• If patients do not tolerate the 2.4 mg once-weekly maintenance dosage, the maintenance dosage may be reduced to 1.7 mg once weekly.
• Discontinue Aweekly@ if the patient cannot tolerate the 1.7 mg once-weekly dosage. If one dose is missed and the next scheduled dose is more than 2 days away (48 hours),
administer Aweeklye as soon as possible. If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the missed dose. Resume dosing on the regularly scheduled day of the week. If two or more consecutive doses are missed, resume dosing as scheduled or if needed, reinitiate Aweekly@ and follow the dose escalation schedule, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.

Pregnancy: Semaglutide should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.

Lactation: There are no data regarding the presence of semaglutide in human milk, the effects
on the breastfed infant or the effects on milk production. The developmental and health benefits of
breastfeeding should be considered along with the mother's clinical need and any potential
adverse effects on the breastfed infant from semaglutide or from the underlying maternal
condition.

Use in children and adolescents
Safety and efficacy of semaglutide have not been established in patients younger than 12 years.

After initiation of treatment, observe patients carefully for signs and symptoms of MTC, thyroid tumors, cholelithiasis and pancreatitis. If pancreatitis is suspected, it should be discontinued and appropriate management should be initiated. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Monitor renal function when initiating or escalating doses in patients reporting severe adverse gastrointestinal reactions. If hypersensitivity reactions occur, discontinue it, treat promptly per standard of care and monitor until signs and symptoms resolve. Blood glucose should be monitored before initiation in case of type-2 DM. Patients should be trained on proper injection technique and to check the syringe prior to each injection. It is not indicated for use in patients with type 1 diabetes mellitus.

The most common side effects are nausea, vomiting, diarrhea, abdominal pain and constipation.

It is contraindicated in patients with known hypersensitivity to semaglutide or any other components of this product. It is also contraindicated in a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).

Drug interaction with medication: When initiating semaglutide, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Co-administration with other semaglutide-containing products or with any other GLP-I receptor agonist is not recommended.

Drug interaction with food and others: Not applicable.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.

• The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
• Do not freeze. Do not use Aweekly@that has been frozen.
• Protect pre-filled syringes from light.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any pre-filled syringes exhibiting particulate matter and discoloration.
• Do not dilute Aweekly@and do not administer in conjunction with other drug solutions.
• Discard unused portion of Aweeklye in pre-filled syringes.

Administration instructions
Administer once weekly, any time of day, with or without meals. Inject it subcutaneously in the
abdomen, thigh or upper arm. Rotate injection sites with each dose. When using with insulin,
administer as separate injections and never mix. It is acceptable to inject Aweeklye and insulin in
the same body region, but the injections should not be adjacent to each other.

No Data

Aweekly 0.25 mg Solution for SC Injection: Each pre-filled syringe contains 0.5 ml sterile solution of Semaglutide INN 0.25 mg.
Aweekly 0.5 mg Solution for SC Injection: Each pre-filled syringe contains 0.5 ml sterile solution of Semaglutide INN 0.5 mg.

Storage
Store in a refrigerator at 20C to 80C. Do not freeze and protect from light. Do not use if it has been frozen. Keep out of the reach and sight of children.

Packing
Aweekly 0.25 mg Solution for SC Injection: Each box contains 1 pre-filled syringe with a needle and needle cap containing 0.5 ml sterile solution of Semaglutide INN 0.25 mg, a first aid bandage and an alcohol pad.
Aweeklye 0.5 mg Solution for SC Injection: Each box contains 1 pre-filled syringe with a needle and needle cap containing 0.5 ml sterile solution of Semaglutide INN 0.5 mg, a first aid bandage and an alcohol pad.