Medication info

Wegovy Prefilled Pen 1.0 (Semaglutide)

Prescription medication근육 · 정맥 · 피하
Ingredient · strength
Semaglutide›4mg
Manufacturer / importer
노보노디스크제약(주)
Appearance
A colorless or almost colorless transparent liquid contained in a colorless transparent cartridge equipped with a dose-adjustable prefilled pen.
Packaging
1 prefilled pen/box [prefilled pen (3 mL)]
Approval status
Active

MFDS item code 202301386 · Approved 2023.04.27

Summary

Main use
Weight loss and maintenance for patients with obesity and overweight (including weight-related comorbidities), and treatment for reducing the risk of cardiovascular events.
Who receives it
Adults · Children
Adult administration
Adults start with a dose of 0.25 mg once weekly, escalating to a maintenance dose of 2.4 mg once weekly over 16 weeks. The stepwise escalation schedule is as follows: Weeks 1-4: 0.25 mg Weeks 5-8: 0.5 mg Weeks 9-12: 1 mg Weeks 13-16: 1.7 mg Maintenance dose: 2.4 mg Administered once weekly, can be taken at any time of the day regardless of meals.
Child administration
Adolescents aged 12 years and older should follow the same dose escalation schedule as adults. The dose should be increased until reaching a maintenance dose of 2.4 mg or the maximum tolerated dose, not exceeding 2.4 mg once weekly.

Ingredients

Importer
노보노디스크제약(주)

Efficacy & effects

Weight loss and maintenance for patients with obesity and overweight (including weight-related comorbidities), and treatment for reducing the risk of cardiovascular events.

  • Obesity
  • abnormal blood sugar levels
  • prediabetes
  • type 2 diabetes
  • hypertension
  • dyslipidemia
  • obstructive sleep apnea
  • cardiovascular disease
  • overweight
View approved original text

This medication is primarily used to assist with weight management. For adults, it is administered as an adjunct to a reduced-calorie diet and increased physical activity in obese patients with a body mass index (BMI) of 30 or greater, or in overweight patients with a BMI of 27 or greater but less than 30 who have weight-related comorbidities such as prediabetes, hypertension, or dyslipidemia. It is also used to lower the risk of major cardiovascular events in individuals with established cardiovascular disease. Adolescents aged 12 years and older are prescribed it as an adjunct to weight management if they are obese with a weight greater than 60 kg in accordance with the adult BMI criteria. If a teenager does not achieve a BMI decrease of at least 5% within 12 weeks of starting treatment, therapy should be discontinued and re-evaluated. This medication is effectively used for weight control and improving cardiovascular health.

How it is given

Adult administration

Adults start with a dose of 0.25 mg once weekly, escalating to a maintenance dose of 2.4 mg once weekly over 16 weeks. The stepwise escalation schedule is as follows: Weeks 1-4: 0.25 mg Weeks 5-8: 0.5 mg Weeks 9-12: 1 mg Weeks 13-16: 1.7 mg Maintenance dose: 2.4 mg Administered once weekly, can be taken at any time of the day regardless of meals.

Child administration

Adolescents aged 12 years and older should follow the same dose escalation schedule as adults. The dose should be increased until reaching a maintenance dose of 2.4 mg or the maximum tolerated dose, not exceeding 2.4 mg once weekly.

Precautions

This medication should not be used in patients who have an allergy to the active ingredient or any excipients. Caution is advised for patients in a dehydrated state, as this medication may exacerbate dehydration due to gastrointestinal side effects. Patients should take preventive measures such as adequate fluid intake to prevent fluid loss. If there is a history of acute pancreatitis or suspicion of acute pancreatitis symptoms, use of this medication should be discontinued, and it should not be readministered if pancreatitis is confirmed. This medication should not be used as a substitute for insulin in patients with type 2 diabetes and should not be used in combination with other GLP-1 receptor agonists. When used alongside sulfonylureas or insulin, the risk of hypoglycemia increases, so patients should be educated about hypoglycemia symptoms and doses of concomitant medications should be adjusted as necessary. Patients with diabetic retinopathy should be monitored closely, as this medication may worsen retinopathy, so regular eye examinations are necessary. This medication is not recommended for patients with severe renal or hepatic impairment, type 1 diabetes, or certain heart conditions, as safety and efficacy have not been adequately studied in these populations. Women who are pregnant or planning to become pregnant should not use this medication. If using it, treatment should be discontinued and at least 2 months should be waited before trying to conceive. Breastfeeding women should also avoid using this medication. This medication may delay gastric emptying due to gastrointestinal side effects, thus caution is needed when general anesthesia or deep sedation is required. Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, etc.) may occur frequently, and treatment may be discontinued due to these symptoms. Overdose may lead to dehydration; thus, care must be taken not to exceed the prescribed dose, and if adverse symptoms occur, seek medical consultation immediately. This medication does not significantly affect driving or the operation of machinery, but caution is required as dizziness may occur during dose escalation periods. Patients should receive adequate education from healthcare professionals on the correct injection techniques before administration and dispose of the used needles safely afterwards. This medication should be stored in a refrigerator and protected from freezing. Once opened, it should be used within 6 weeks, kept away from direct sunlight, and stored out of reach of children.

Side effects

  • Nausea
  • diarrhea
  • constipation
  • vomiting
  • headache
  • dizziness
  • taste disturbance
  • paresthesia
  • hypotension
  • orthostatic hypotension
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  • increased heart rate
  • abdominal pain
  • gastritis
  • gastroesophageal reflux disease
  • dyspepsia
  • belching
  • gastrointestinal gas retention
  • abdominal distension
  • acute pancreatitis
  • delayed gastric emptying
  • intestinal obstruction
  • cholelithiasis
  • hair loss
  • angioedema
  • fatigue
  • injection site reaction
  • increased amylase
  • increased lipase
  • nasopharyngitis
  • gastroenteritis
  • sinusitis
  • urinary tract infection
  • ligament sprain
  • anxiety
  • influenza
  • rash
  • urticaria
  • fracture
  • nephrolithiasis
  • liver enzyme abnormalities
  • sensory disturbances
  • skin pain
  • sensitive skin
  • skin burning sensation

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container, refrigerated at temperatures between 2°C and 8°C, ensuring it does not freeze. It is also advisable to keep it in a dark place away from direct sunlight.

Appearance and packaging

Appearance

A colorless or almost colorless transparent liquid contained in a colorless transparent cartridge equipped with a dose-adjustable prefilled pen.

Package unit

1 prefilled pen/box [prefilled pen (3 mL)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.