When To Use Ozempic
- You should use Ozempic® once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day regardless of meals.
- To help you remember to inject Ozempic® once a week only, it is recommended to note the chosen weekday on the carton. You can also write the date on the carton every time you have injected Ozempic®.
- If necessary, you can change the day of your weekly injection of Ozempic® as long as it has been at least 3 days since your last injection of Ozempic®.
Carcinogenesis Mutagenesis Impairment Of Fertility
In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day were administered to the males, and 0.1, 0.3 and 1 mg/kg/day were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at clinically relevant exposures.
- In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered . A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at 0.01 mg/kg/day, at clinically relevant exposures.
Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies .
Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests , human lymphocyte chromosome aberration, rat bone marrow micronucleus).
Combination Therapy Use Of Ozempic In Patients With Type 2 Diabetes Mellitus
Combination with metformin and/or thiazolidinediones
In a 56-week, double-blind trial , 1231 patients with type 2 diabetes mellitus were randomized to Ozempic 0.5 mg once weekly, Ozempic 1 mg once weekly, or sitagliptin 100 mg once daily, all in combination with metformin and/or thiazolidinediones . Patients had a mean age of 55 years and 51% were men. The mean duration of type 2 diabetes was 6.6 years, and the mean BMI was 32 kg/m2. Overall, 68% were White, 5% were Black or African American, and 25% were Asian 17% identified as Hispanic or Latino ethnicity.
Treatment with Ozempic 0.5 mg and 1 mg once weekly for 56 weeks resulted in a statistically significant reduction in HbA1c compared to sitagliptin .
Table 4. Results at Week 56 in a Trial of Ozempic Compared to Sitagliptin in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin and/or Thiazolidinediones
aThe intent-to-treat population includes all randomized and exposed patients. At week 56 the primary HbA1c endpoint was missing for 7%, 5% and 6% of patients and during the trial rescue medication was initiated by 5%, 2% and 19% of patients randomized to Ozempic 0.5 mg, Ozempic 1 mg and sitagliptin, respectively. Missing data were imputed using multiple imputation based on retrieved dropouts.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value and country.
cp< 0.0001 for superiority, adjusted for multiplicity.
- Figure 5. Mean HbA1c over time – baseline to week 56
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What Is Ozempic Used For
A doctor may prescribe Ozempic to:
- Help manage blood sugar levels in adults with type 2 diabetes, along with lifestyle improvements in diet and exercise.
- Lower the risk of certain heart or blood vessel problems in adults who have both heart disease and diabetes. These risks can include heart attack, stroke, and death due to heart or blood vessel issues.
With diabetes, you have elevated blood sugar levels. And over time, this can damage blood vessels in your body.
Ozempic helps lower blood sugar levels and reduce the risk of certain heart and blood vessel problems. To learn about how Ozempic works, see the What are some frequently asked questions about Ozempic? section just above.
Note: There are some limitations to how Ozempic can be used. These are as follows:
- This drug hasnt been studied in people whove had pancreatitis in the past. So, other treatments should be considered if youve had this condition.
- Ozempic isnt meant to treat type 1 diabetes or diabetic ketoacidosis .
Before starting Ozempic, talk with your doctor about all the benefits and risks of using it. You should also discuss your overall health and any health conditions you may have.
Ask your doctor if Ozempic is safe for you to take if you:
- have a family history of thyroid cancer
- have problems with your kidneys
- have diabetic retinopathy
- are pregnant or plan to become pregnant
- are breastfeeding
How Does This Medication Work What Will It Do For Me
Semaglutide belongs to a group of medications known as glucagon-like peptide-1 receptor agonists. It is used alone or with other medications to improve blood glucose levels for people with type 2 diabetes.
Diabetes medications such as semaglutide are used when diet, exercise, weight reduction and medications such as metformin, glyburide, or insulin have not been found to lower blood sugar well enough on their own. It works by helping your body make more insulin and control blood glucose levels.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
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Ozempic Interactions With Supplements
Before you start treatment with Ozempic, tell your doctor and pharmacist which supplements, herbs, and vitamins you take. By sharing this information with them, you may help prevent possible interactions.
Taking an alpha-lipoic acid supplement in combination with Ozempic may make you more likely to develop hypoglycemia . If youre taking the supplement, talk with your doctor before you begin treatment with Ozempic. They can help determine whether a supplement other than alpha-lipoic acid is right for you.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Ozempic interactions with herbs
Taking certain herbal supplements in combination with Ozempic may increase your risk of hypoglycemia . Examples of these herbs include:
If you take any of these herbal supplements, talk with your doctor before you begin using Ozempic. Your doctor can advise you on whether its safe to continue taking them.
Ozempic interactions with vitamins and minerals
Ozempic has not been reported to interact with vitamins, but the drug can interact with the mineral chromium. Using Ozempic and a chromium supplement may increase your risk of low blood sugar. Before using Ozempic, tell your doctor if youre taking chromium. They can help determine the right treatment for you.
Can Ozempic Be Used As A Weight Loss Drug In People Without Diabetes
Currently trials are under way looking at using higher doses of weekly Semaglutide as a weight loss drug in those with and without type 2 diabetes and the first of these was recently reported The Step 1 study. Based on these studies the US FDA has recently approved high dose Semaglutide 2.4mg weekly as a weight loss drug. It will be marketed a different product called Wegovy. Expect to see this available in the later part of 2021.
In this double-blind trial of 1,961 adults with a body mass index of 30 or higher, adults on high dose 2.4 mg of weekly semaglutide lost an average 14.9% of baseline body weight after 68 weeks of treatment versus only 2.4% for a group on placebo and lifestyle intervention alone. 86% of people on semaglutide lost at least 5% of their body weight and almost 70% achieved a 10% or more weight loss, and more than half were able to lose 15% of their baseline body weight.In total, adults on semaglutide treatment lost an average 15.3kg after a year, while those in the placebo/lifestyle intervention group saw only a modest 2.6 kg weight loss.In addition to weight loss, semaglutide also caused greater reductions in waist circumference, systolic and diastolic blood pressures, HbA1c, fasting plasma glucose and fasting cholesterol levels.
Whether you have diabetes, or you donât have diabetes, we all make GLP-1. It has become clear that GLP-1 is a really important hormone to help us regulate our blood sugar levels and probably our appetite and weight.
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Do I Have To Change My Diet If I Use Ozempic
If you have type 2 diabetes, making lifestyle changes, for example exercising and eating a healthier diet, is very important.
For ideas on how to reduce the carb content of some of your favourite foods, the article How to reduce carbs in your diet has many great ideas that wonât leave you missing out on flavour.
How Is It Used
- It is injected just under your skin into the fat layer in the stomach, thigh or upper arm area. Never inject into a vein or muscle. The kit contains needles that are changed with each use.
- You need to inject this medication once a week on the same day each week. Write the date on your carton each time and set a reminder. You can change this day as long as it has been three days since the last injection.
- You do not have to eat when you use it.
- If you forget a dose it can be taken within five days. If it is more than five days, skip that dose and have the usual dose on the usual day.
- The medication is stored in the refrigerator before use. It can be stored either at room temperature or the refrigerator for up to six weeks after you start using it. Never freeze this medication.
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Foods With Added Sugar
Added sugar isnt always easy to spot. Sugar is added to foods that might otherwise seem healthy, like yogurt, dried fruit, some nutrition bars, and granola.
Check the nutrition facts label and try to avoid eating foods with more than five grams of added sugar per serving often, or at least watch your portion sizes. Aim to keep your added sugar intake below 30 grams per day on an Ozempic diet.
Overview Of Clinical Studies
Ozempic has been studied as monotherapy and in combination with metformin, metformin and sulfonylureas, metformin and/or thiazolidinedione, and basal insulin in patients with type 2 diabetes mellitus. The efficacy of Ozempic was compared with placebo, sitagliptin, exenatide extended-release , and insulin glargine.
Most trials evaluated the use of Ozempic 0.5 mg, and 1 mg, with the exception of the trial comparing Ozempic and exenatide ER where only the 1 mg dose was studied. One trial evaluated the use of Ozempic 2 mg once weekly.
In patients with type 2 diabetes mellitus, Ozempic produced clinically relevant reduction from baseline in HbA1c compared with placebo.
The efficacy of Ozempic was not impacted by age, gender, race, ethnicity, BMI at baseline, body weight at baseline, diabetes duration and level of renal function impairment.
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Boxed Warning: Thyroid Cancer Risk
Ozempic has a boxed warning for the risk of thyroid cancer. A boxed warning is the most serious warning from the Food and Drug Administration .
Ozempic has caused thyroid cancer in animals. Its unclear if the drug also increases thyroid cancer risk in humans. To lower the potential risk of thyroid cancer, dont use Ozempic if:
- you have a rare genetic condition called multiple endocrine neoplasia type 2
- you or a family member has had medullary thyroid cancer
For more details, see the Side effects explained section above.
Side Effects Of Metformin
Similar to Ozempic, metformin is generally considered safe. A little less than one in three people may experience gastrointestinal side effects, such as diarrhea, nausea, and vomiting. Less common side effects include :
- Chest discomfort
With long-term use of metformin, some people may develop a vitamin B12 deficiency and need to take supplements .
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What Ozempic Looks Like
Ozempic® is supplied as a clear, colourless, or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 mL of solution delivering only doses of 1 mg.
One mL solution for injection contains 1.34 mg semaglutide.
One pre-filled pen contains 4 mg semaglutide.
Ozempic® 1 mg/dose is available in a pack containing 1 pen and 4 disposable NovoFine® Plus needles .
What Is The Most Important Information I Should Know About Ozempic
Ozempic® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma in people.
- Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 .
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Can You Take Ozempic And Insulin Together
Ozempic and an insulin product may be used together if your healthcare provider determines that would be the best treatment regimen for your specific needs. Always seek medical advice from your healthcare provider to find out about possible drug interactions with prescription drugs and or supplements that you are taking. If prescribed together, the following are important considerations:
- Ozempic and insulin should not be mixed in the same syringe prior to injection.
- An injection of Ozempic and insulin may be made in the same body area , but the injections should not be made right next to each other.
- When adding Ozempic treatment in people with Type 2 diabetes already using insulin, the dose of insulin may need to be decreased to reduce the risk of hypoglycemia.
In a review of clinical trials in which a GLP-1 agonist was combined with a basal, or long-acting, insulin, similar improvements were seen in the level of blood glucose control however the added benefit was greater loss in body weight.
Looking After Your Medicine
Keep your unopened Ozempic® pens in a refrigerator . Keep away from the cooling element. Do not freeze.
While you are using your Ozempic® pen you can keep it for 6 weeks either at room temperature , or in a refrigerator , away from the cooling element. Do not freeze.
The medicine in Ozempic® must not be frozen or exposed to heat or direct sunlight.
When you are not using the pen, keep the pen cap on in order to protect from light.
Never use Ozempic® if the solution is not clear and colourless, or almost colourless.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
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Effects On Ability To Drive And Use Machines
Ozempic has no or negligible influence on the ability to drive or use machines. When it is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.Adverse effects of Ozempic include dizziness which could affect the ability to drive or use machines ).
Ozempic For Type 1 Diabetes Patients To Control Blood Glucose:
Patients with Type 1 diabetes mellitus are insulin-deficient. Ozempic lowers blood glucose by enhancing the release of insulin in a glucose-dependent mechanism.
Patients with type 1 diabetes are insulin deficient. There is absolute insulin deficiency. The Beta-cells are non-functional. Hence the beta-cells can not be stimulated to secrete insulin.
The only treatment for patients with Type 1 diabetes mellitus is insulin. Recently, an SGLT-2 inhibitor has been approved by the EMA for the treatment of diabetes mellitus type 1 who are obese and not prone to ketosis.
However, physicians are still not comfortable prescribing dapagliflozin because of the risks of Euglycemic Ketoacidosis.
To conclude, Ozempic can not lower blood glucose in type 1 diabetes patients.
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How To Use Ozempic
- Inject Ozempic® under the skin as shown to you by your doctor or diabetes education nurse. Never inject Ozempic® into a vein or muscle.
- Ozempic® may be injected into the front of your waist , the front of your thigh, or your upper arm.
- Before you use the pen for the first time, your doctor or diabetes education nurse will show you how to use it.
Are There Certain People Who Should Not Take Ozempic
Doctors typically will not prescribe Ozempic for certain people. This includes people with a personal or family history of certain thyroid cancers. It also includes people who have or have had multiple endocrine neoplasia syndrome type 2 . This is a rare endocrine condition that can increase the risk of developing thyroid cancer. Ozempic has a boxed warning about the risk of thyroid cancer. This is a serious warning from the Food and Drug Administration . To learn more, see the boxed warning at the top of this article.
Doctors also usually wont prescribe Ozempic for people who have had an allergic reaction to the drug or any of its ingredients. For details, see When to avoid Ozempic above.
Your doctor can help determine whether Ozempic is right for you.
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