Semaglutide for Weight Loss: Information for Patients

The search for effective and safe weight loss treatments is a continuous endeavor. Semaglutide, initially developed as a medication for type 2 diabetes, has emerged as a promising option for chronic weight management. This article provides comprehensive information about semaglutide for weight loss, its mechanism of action, usage, potential side effects, and important considerations for patients.

What is Semaglutide?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics the GLP-1 hormone, which is released in the gut in response to eating. GLP-1 plays a crucial role in regulating blood sugar, appetite, and digestion.

How Semaglutide Works

Semaglutide works by:

  • Stimulating insulin production when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues for energy.
  • Lowering glucagon levels, a hormone that raises blood sugar.
  • Slowing down the emptying of the stomach, which may decrease appetite and cause weight loss.
  • Stimulating receptors in the brain that control appetite. This promotes satiety, which leads to a reduction in food intake.

FDA-Approved Semaglutide Products

There are currently three FDA-approved semaglutide products:

  • Ozempic injections and Rybelsus tablets: Approved to lower blood sugar levels in adults with type 2 diabetes. Many people use semaglutide off-label to help manage weight.
  • Wegovy: Approved for weight loss. The typical dose for weight loss is 2.4 milligrams, administered weekly as subcutaneous (under the skin) self-injections. The FDA recommends Wegovy for weight loss if you meet one of the following criteria:
    • Have a body mass index (BMI) of 27kg/m2 or greater and at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.
    • Have a BMI of 30kg/m2 or greater.

How to Use Semaglutide

Semaglutide is injected under the skin. You will be taught how to prepare and give it. It is given once every week (every 7 days). Keep taking it unless your care team tells you to stop.

Read also: Transformations with Ozempic

Instructions for Use

  • A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
  • This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.
  • It is important that you put your used needles and pens in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.
  • Wegovy® should be injected into the skin on your upper arms, thigh, or tummy (abdomen). Try to choose a different injection site for each of your injections. This will help to prevent skin problems and difficulties in injecting.
  • After each injection, remove the needle to help prevent problems with blockage, leakage or infection.
  • Wegovy® should be injected once each week, on the same day each week. Each pre-filled pen provides a single dose. The injection can be given at any time of the day, and it can be given either before or after a meal. It is best to have your doses around the same time each day.
  • There are several different strengths of semaglutide injection. You will start with a 0.25 mg dose once a week for four weeks, followed by 0.5 mg once a week for at least another four weeks. Provided you are not experiencing side-effects your dose will be increased every four weeks until you reach a maintenance dose of 2.4 mg.
  • You can change the day of your scheduled dose as long as you leave at least three days (72 hours) between doses. For example, if your dose is usually scheduled for Monday morning you could change it to Thursday morning at the earliest. Then continue each week on Thursdays.
  • Always look at the semaglutide solution before you inject it. It should be clear, colorless, and free of particles. Do not use semaglutide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the pen has passed.
  • Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Use a different site for each injection.

Dosage

Your doctor may increase your dose again after another 4 weeks based on your body's response to the medication.

What if I Miss a Dose?

If you miss a dose and the next scheduled dose is more than 2 days away, take the missed dose as soon as possible. If you miss a dose and the next scheduled dose is less than 2 days away, do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses. If you miss your dose for 2 weeks or more, take the next dose at your regular time or call your care team to talk about how to restart this medication. Inject the missed dose as soon as you remember it within 5 days after the missed dose. However, if more than 5 days have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Effectiveness of Semaglutide for Weight Loss

Semaglutide performs on a new level. An early study of 2,000 obese adults compared people using semaglutide plus a diet and exercise program with people who made the same lifestyle changes without semaglutide. After 68 weeks, half of the participants using semaglutide lost 15% of their body weight, and nearly a third lost 20%. Participants who incorporated only lifestyle changes lost about 2.4% of their weight. Since then, additional studies have shown similar results.

STEP Trials

Clinical trials have demonstrated the efficacy of semaglutide 2.4 mg for weight management. Details of these trials are shown in Table 1.

  • STEP 1: In a 68-week trial, semaglutide 2.4 mg resulted in a significant reduction in body weight when compared with either placebo or liraglutide. Patients treated with semaglutide 2.4 mg experienced a -14.9% weight loss vs. 2.4% with placebo. 86.4% of patients treated with semaglutide 2.4 mg vs. 31.5% with placebo achieved a weight loss of 5% or more.
  • STEP 2: In a 68-week trial involving adults with overweight or obesity and type 2 diabetes, semaglutide resulted in a -9.6% weight loss vs. -3.4% with placebo. 68.8% of patients treated with semaglutide 2.4 mg vs. 28.5% with placebo achieved a weight loss of 5% or more.
  • STEP 3: In a 68-week trial, semaglutide resulted in a -16.0% weight loss vs. -5.7% with placebo. 86.6% of patients treated with semaglutide vs. 47.6% with placebo achieved a weight loss of 5% or more.
  • STEP 4: In a trial assessing weight loss after discontinuation of semaglutide, patients initially treated with semaglutide experienced a -17.4% weight loss with continued semaglutide vs. -5.6% with placebo.
  • STEP 5: In a 104-week trial, semaglutide resulted in a -15.2% weight loss vs. -2.6% with placebo. 77.1% of patients treated with semaglutide vs. 34.4% with placebo achieved a weight loss of 5% or more.

Lifestyle Changes

Semaglutide should only be used as an addition to a calorie-controlled diet and increased physical activity. Ask your doctor for advice on maintaining a healthy lifestyle.

Read also: Comprehensive guide: Tirzepatide and Semaglutide for weight management

  • It is important for you to drink plenty of fluids while you are using semaglutide. Adults should aim to drink at least two litres (about 8-10 cups) of fluid per day. Most sorts of drink will do but as a start, try just drinking a glass of water 3-4 times a day in addition to what you normally drink.
  • Try to eat a balanced diet containing high-fibre foods such as wholemeal and wholegrain breads and cereals, fruit and vegetables, brown rice and wholemeal pasta. If you are not used to a high-fibre diet, it may be best to increase the amount of fibre you eat gradually.
  • The NHS recommends 150 minutes of physical activity per week - that's 30 minutes, five days a week. Ask your doctor or a pharmacist for advice about increasing your physical activity. It is best to start slowly and build up your level of activity over a period of a few weeks.

Potential Side Effects

The side effects of semaglutide are typically mild - especially when compared to the complications associated with overweight and obesity.

  • Gastrointestinal issues are the most common complaint among people just starting semaglutide. But you may be able to reduce the side effects by beginning on a lower dose and then slowly increasing the amount you take.

Side Effects That You Should Report to Your Care Team as Soon as Possible

  • Allergic reactions-skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Change in vision
  • Dehydration-increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
  • Fast or irregular heartbeat
  • Gallbladder problems-severe stomach pain, nausea, vomiting, fever
  • Kidney injury-decrease in the amount of urine, swelling of the ankles, hands, or feet
  • Pancreatitis-severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
  • Thoughts of suicide or self-harm, worsening mood, feelings of depression
  • Thyroid cancer-new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness

Side Effects That Usually Do Not Require Medical Attention

  • Constipation
  • Diarrhea
  • Loss of appetite
  • Nausea
  • Upset stomach

Very Common Semaglutide Side-Effects (These Affect More Than 1 in 10 People)

  • Feeling sick (nausea), tummy (abdominal) pain: Stick to simple foods - avoid rich or spicy meals
  • Diarrhoea: Drink plenty of water to replace lost fluids
  • Constipation: Drink plenty of water and eat a balanced diet including lots of fruit and vegetables
  • Being sick (vomiting): Stick to simple foods - avoid rich or spicy meals. Drink plenty of water to replace lost fluids
  • Headache: Drink plenty of water and ask a pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
  • Tiredness, fatigue: This should pass once you get used to the medicine

Common Semaglutide Side-Effects (These Affect Fewer Than 1 in 10 People)

  • Indigestion, bloating, wind, gallstones: Stick to simple foods - avoid rich or spicy meals
  • Increased heart rate, hair loss, changes to the way you taste or feel things: Let your doctor know if these become troublesome
  • Feeling dizzy: Do not drive and do not use tools or machines until you feel better
  • Redness or swelling at the injection site: Use a different injection site each week

Important Considerations

  • This medicine can cause persistent and severe tummy (abdominal) pain with sickness (nausea and/or vomiting) in a few people. If this happens to you, you should speak with your doctor as soon as possible as these can be symptoms of an inflamed pancreas (pancreatitis).
  • Semaglutide injections can cause low blood sugar (hypoglycaemia). Signs include feeling shaky or anxious, sweating, looking pale, feeling hungry, a feeling that your heart is pounding (palpitations), and feeling dizzy. If this happens to you, eat or drink something sugary and then follow this up with a snack such as a sandwich or a piece of fruit.

Who Should Not Take Semaglutide?

Avoid semaglutide if you have:

  • History of medullary thyroid cancer
  • History of gallbladder disease
  • History of pancreatitis
  • Multiple endocrine neoplasia syndrome type 2 (MEN2)

Important Precautions

  • Semaglutide injection caused thyroid tumors in rats. It is not known if this medication increases the risk of tumors in humans. Tell your doctor if you or anyone in your family has or has ever had thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to use semaglutide injection. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath.
  • If you are going to need surgery or a procedure, tell your care team that you are taking this medication.
  • Do not take this medication without first talking to your care team if you may be or could become pregnant. Your care team can help you find the option that works for you. Weight loss is not recommended during pregnancy. Women and girls of childbearing potential must use effective contraception during treatment and for two months after stopping.
  • Talk to your care team if you are breastfeeding. When recommended, this medication may be taken. Its use during breastfeeding has not been well studied. Your care team may suggest other options.
  • Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant.
  • This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
  • Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
  • Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
  • This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.
  • This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use semaglutide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
  • This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
  • This medicine may cause severe stomach or bowel problems. Check with your doctor right away if you have belching, bloated or full feeling, blood in stools, constipation, diarrhea, excess air or gas in the stomach, hiccups, nausea, stomach pain, uncomfortable swelling around the anus, or vomiting.
  • This medicine may increase your heart rate while you are at rest. Check with your doctor right away if you have fast or pounding heart beat.
  • This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Drug Interactions

Insulin and other medications for diabetes may interact with semaglutide. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine. Do not take other medicines during the time you are using semaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Storage

Store unopened packs of pre-filled pens in a fridge. Do not freeze the pens and do not use them if you think they have been accidentally frozen.Once in use you can keep the pre-filled pen at room temperature for up to six weeks. Keep the cap on the pen to protect the medicine from light. Semaglutide pens may also be stored at room temperature for certain amount of time. Talk to your doctor or pharmacist about how long you can store semaglutide pens at room temperature.

Compounded Semaglutide

FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.

Read also: Semaglutide Without Diet Changes

FDA Recommendations for Health Care Professionals and Patients

Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy. Visit FDA’s BeSafeRx campaign for resources to safely buy prescription medicines online. Talk to your doctor if you have questions about your medicines.

Concerns with Compounded Versions of These Drugs

A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed. The agency has identified some areas of concern for compounded GLP-1 drugs. FDA is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns.

Injectable GLP-1 drugs require refrigeration as indicated in their package inserts. FDA has received complaints that certain compounded GLP-1 drugs have arrived warm or with inadequate ice packs to keep the drug at recommended storage temperatures.

Recommendations for Consumers

The agency encourages patients to be vigilant and know the source of their medicine. Carefully check labels of compounded GLP-1 drugs for warning signs such as spelling errors or incorrect addresses and ensure your medicine is provided by a licensed pharmacy and prescribed by a licensed health care provider. If you receive a product with a licensed pharmacy name on the label that you think might be fraudulent, contact the pharmacy to ask if it is their product. Talk to your doctor if you have questions about your medicines.

General Advice

  • Keep all medicines out of the reach and sight of children. Always lock safety caps.
  • Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
  • This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
  • Do not keep out-of-date or unwanted medicines. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:
    • Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
    • If you cannot return the medication, follow the directions in the MedGuide.
  • Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
  • Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body’s response to semaglutide.
  • Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
  • Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital.

tags: #semaglutide #for #weight #loss #information #for