Semaglutide (a human glucagon-like peptide-1 (GLP-1) analogue produced by saccharomyces cerevisiae cells through genetic recombination technology). 1ml injection contains 1.34mg of Semaglutide. Each pre-filled inje
ction pen contains 2mg of semaglutide in 1.5ml solution
Chemical name: Nε26[(S)- (22, 40-dicarboxylate -10, 19, 24-trioxy-3, 6, 12, 15-tetraoxane -9, 18, 23-triazane - 1-acyl)][Aib8, Arg34]GLP-1- (7-37) peptide
Chemical structure formula:
Molecular formula: C187H291N45O59
Molecular weight: 4113.58g/mol
Excipients: Disodium hydrogen phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (for pH regulation), sodium hydroxide (for pH regulation) and water for injection. This product uses phenol as a bacteriostatic agent, and 0.550g of phenol is added into every 100ml of this product
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This product is colorless or almost colorless clear isotonic liquid; pH=7.4
The indications are edited
This product is suitable for blood glucose control in adults with type 2 diabetes: Adults with type 2 diabetes who receive metformin and/or sulfonylureas on the basis of diet control and exercise and still have poor blood glucose control .
It is suitable for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus with cardiovascular disease .
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The specifications of this product are:
1.34mg/ml, 1.5ml (pre-filled injection pen)
1.34mg/ml, 3ml (pre-filled injection pen)
Usage and dosage edit broadcast
Usage
This product should be injected once a week and can be injected at any time of the day, without the need to be administered according to meal times.
This product is administered by subcutaneous injection, and the injection site can be selected from the abdomen, thigh or upper arm. No dose adjustment is required when changing the injection site. This product cannot be injected intravenously or intramuscularly .
If necessary, the weekly dosing date can be changed, as long as the two doses are spaced at least 2 days (>48 hours) apart. After a new dosing time has been selected, dosing should continue once a week.
More information on administration can be found in the Special Notes for use and other procedures.
dosage
The starting dose of semaglutide is 0.25mg once a week. After 4 weeks, it should be increased to 0.5mg once a week. After treatment with 0.5mg once a week for at least 4 weeks, the dose can be increased to 1mg once a week to further improve blood sugar control levels. 0.25mg is not a maintenance dose. Doses greater than 1mg per week are not recommended.
When used in combination with existing metformin therapy, the current dose of metformin can be maintained .
When this product is used in combination with existing sulfonylureas, consideration should be given to reducing the dose of sulfonylureas to reduce the risk of hypoglycemia (see [Adverse reactions] and [Precautions]] .
Self-glucose monitoring is not required to adjust the dosage of this product. However, when starting treatment with this product in combination with sulfonylureas, self-monitoring of blood sugar may be required to adjust the dose of sulfonylureas to reduce the risk of hypoglycemia (see [Precautions]) .
Missed medication
If missed medication occurs, it should be administered as soon as possible within 5 days of the missed medication. If the missed medication has been taken for more than 5 days, the missed dose should be skipped and the next dose should be taken on the normal scheduled medication day. In each case, patients should return to a regular weekly dosing schedule.
Adverse reactions are edited
Security characteristics summary
In eight Phase III a trials, a total of 4792 patients were exposed to semaglutide. The most commonly reported adverse events in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhea (very common), and vomiting (common). Typically, these reactions are mild or moderate in severity and short in duration
2-year cardiovascular outcomes and safety trial
In the cardiovascular high-risk population, the characteristics of adverse reactions were similar to those observed in other Phase IIA trials (see [Clinical trials]] .
Some adverse reactions are described
Hypoglycemia: No severe hypoglycemia events were observed during monotherapy with this product .
Gastrointestinal adverse reactions: Gastrointestinal adverse reactions, including nausea, vomiting and diarrhea, were observed during treatment with this product, most of which were mild to moderate in severity and of short duration .
Acute pancreatitis: In the Phase III a trial, the confirmed incidence of acute pancreatitis was 0.3% in the Semaglutide group and 0.2% in the control group. In the 2-year cardiovascular outcome trial, the incidence of confirmed acute pancreatitis was 0.5% and 0.6% in the semaglutide and placebo groups, respectively .
Complications of diabetic retinopathy: Rapid improvement in glycemic control is associated with transient exacerbation of diabetic retinopathy.
Injection site reactions: Injection site reactions (e.g. injection site rash, erythema) have been reported, and these reactions are usually mild .
Immunogenicality: The proportion of patients who tested positive for anti-semiglutide antibodies at any time point after baseline was low (1-2%), and no patients developed anti-semiglutide neutralizing antibodies or anti-semiglutide antibodies with endogenous GLP-1 neutralizing effects at the end of the trial.
Increased heart rate: In subjects treated with this product in the Phase III a trial, an average increase of 1 to 6 beats per minute was observed .
Reporting of suspected adverse reactions: It is important to report suspected adverse reactions after a drug is approved for continuous monitoring of the benefit/risk balance of the drug. Medical professionals should report any suspected adverse reactions through the relevant national reporting system .
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Allergic to the active ingredient or any excipients in this product.
Patients with a personal or family history of medullary thyroid cancer (MTC), or multiple endocrine tumor syndrome type 2 (MEN 2) (see [Precautions]) .
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This product should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. This product is not a replacement for insulin .
There is no experience with this product in New York College of Cardiology (NYHA) Grade IV patients with congestive heart failure, and therefore it is not recommended for such patients .
Gastrointestinal reactions: The use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions .
Acute pancreatitis: There have been cases of acute pancreatitis following the use of GLP-1 agonists. If pancreatitis is suspected, this product should be discontinued; If pancreatitis is confirmed, this product should not be used for treatment. Patients with a history of pancreatitis should use this product with caution .
Hypoglycemia: Patients treated with this product in combination with sulfonylureas or insulin may be at increased risk for hypoglycemia. After starting treatment with this product, the risk of hypoglycemia can be reduced by reducing the dose of sulfonylureas or insulin.
Diabetic retinopathy: An increased risk of developing complications of diabetic retinopathy was observed in patients treated with insulin and semiglutide with diabetic retinopathy. Patients with existing diabetic retinopathy should be cautious when using this product in addition to insulin treatment .
Thyroid C-cell tumor risk: It is not known whether Semaglutide causes human thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). This product should not be used in patients with a personal or family history of MTC, or in MEN 2 patients. Patients should be informed of the possible risk of MTC with the use of this product, as well as the symptoms of thyroid tumors (e.g. neck mass, dysphagia, dyspnea, persistent hoarseness) .
Acute kidney damage: Postmarketing reports of acute kidney damage and exacerbation of chronic kidney failure have been reported in patients treated with GLP-1 receptor agonists, and these cases may sometimes require hemodialysis. Some of these events occurred in patients with no known underlying kidney disease. Most of the reported incidents occurred in patients who had a history of nausea, vomiting, diarrhea, or dehydration. For patients reporting severe gastrointestinal adverse events, renal function should be monitored at initiation or dose escalation .
Anaphylaxis: Severe anaphylaxis (e.g., rapid anaphylaxis, angioedema) has been reported with GLP-1 agonists. If allergic reaction occurs, this product should be discontinued; Standard treatment is given immediately and the patient is monitored until signs and symptoms subside. Do not use in patients with a past allergy to this product (see Contraindications) .
Other GLP-1 receptor agonists have been reported to cause rapid anaphylaxis and angioedema. Patients with a history of angioedema or rapid anaphylaxis to another GLP-1 receptor agonist should be treated with caution, as it is unclear whether such patients are more susceptible to rapid anaphylaxis after treatment with this product.
Sodium content: This product contains less than 1mmol (23mg) of sodium per dose, which is basically "sodium free" .
Effects on driving and mechanical ability: Semaglutide has no or negligible effect on the ability to drive a vehicle or use machinery. When used in combination with sulfonylureas or insulin, patients should be advised to take precautions to avoid hypoglycemia while driving and using machinery (see [Precautions]] .
Special notes for use and other operations:
The pen is for one person only.
This product should only be used when colorless or almost colorless and clear.
This product should not be used after freezing.
This product should be administered with a needle not exceeding 8mm in length. This injection pen should be used in conjunction with a disposable Novo needle ®.
This product does not contain needles.