MEDICATIONS SAFETY AND DISCLAIMER

At IV MD we prescribe the FDA approved generic compounded (Semaglutide, Tirzepatide & Retatrutide) injection or other GLP-1 agonist medication. Compounding pharmacies are regulated by their state boards of pharmacy. Semaglutide and Tirzepatide are injectable prescription medicines used for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight-related medical problems to help them lose weight and keep the weight off. If you are less than BMI <27 and seek weight loss methods, the medication can be prescribed for other possible weight gain concerns which are considered “off label”. Each treatment plan will be tailored to the patient’s individual needs. GLP-1 agonist medications are not used in patients with type 1 Diabetes. 

 

SEMAGLUTIDE, TIRZEPATIDE, AND RETATRUTIDE:

  • Should be used with a reduced calorie meal plan and increased physical activity for maximum results.
  • Do not share your Semaglutide, Tirzepatide, and Retatrutide injections with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • Contain active pharmaceutical ingredients and should not be used with other semaglutide / tirzepatide / retatrutide -containing products or other GLP-1 receptor agonist medicines.
  • It is unknown if these medications are safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products.
  • It is not known if these medications can be used safely in people with a history of pancreatitis.
  • It is not known if these medications are safe and effective for use in children under 18 years of age.

Everyone loses weight at various rates. It may take 3 months to start seeing results.

Approximately 14% of participants in a large clinical study did not achieve at least 5% weight reduction.

This medication is meant for long term weight loss treatment and, at a minimum, should be on medication for at least 6 months after optimal weight loss has been achieved. 

 

Do not use Semaglutide, Tirzepatide or Retatrutide if:

  • You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • You have had a serious allergic reaction to Semaglutide, Tirzepatide, and/or Retatrutide or any of the ingredients in Semaglutide, Tirzepatide, and Retatrutide.
  • You have a history of pancreatitis.
  • If you are pregnant, nursing, or trying to become pregnant. If you are trying to conceive discontinue the GLP-1 medication. 
  • If you are a Type 1 Diabetic.

Before using Semaglutide, Tirzepatide, or Retatrutide tell your healthcare provider if you have any other medical conditions, including if you:

  • Have or have had problems with your pancreas or kidneys.
  • Have a history of diabetic retinopathy.
  • Have or have had depression, suicidal thoughts, or mental health issues.
  • Are pregnant or plan to become pregnant. Semaglutide, Tirzepatide and Retatrutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk.
  • Been diagnosed with hypoglycemia.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide, Tirzepatide, and Retatrutide may affect the way some medicines work and some medicines may affect the way Semaglutide, Tirzepatide and Retatrutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including Sulfonylureas or insulin. Semaglutide, Tirzepatide, and Retatrutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

 

Risks: Site injection reaction-such as bleeding, bruising, swelling at the site. 

 

The most common side effects of Semaglutide may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu and heartburn. Personalized treatment is geared toward preventing these side effects. 

 

More serious possible side effects of Semaglutide?


Inflammation of your pancreas (pancreatitis). Stop using Semaglutide, Tirezepatide or Retatrutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Gallbladder problems. Semaglutide, Tirzepatide and Retatrutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide, Tirzepatide or Retatrutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Serious allergic reactions. Stop using Semaglutide, Tirzepatide, or Retatrutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

Change in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Semaglutide, Tirzepatide or Retatrutide.

Increased heart rate. Semaglutide, Tirzepatide and Retatrutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse or worry you.

 

Additionally, it may cause serious side effects, including:


Possible thyroid tumors, including cancer. Tell your healthcare 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, Semaglutide, Tirzepatide, Retatrutide and medicines that work like Semaglutide, Tirzepatide and Retatrutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide, Tirzepatide or Retatrutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Semaglutide, Tirzepatide, and Retatrutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).


Benefits: 

Weight loss improves blood sugar, blood pressure, and fatty liver. Achieving a healthier weight can decrease the risk of complications associated with obesity, such as diabetes, fatty liver disease, sleep apnea, heart disease, depression, joint pain, and certain cancers. 

 

Alternatives: 

No medication for weight loss. Stimulant type medications. Bariatric surgery. Hypnosis. Reduced calorie diet. Keto. Intermittent fasting. Atkins. Do nothing. 

 

Regaining Weight Acknowledgment:

There is a risk of regaining the weight you have lost. Obesity is a chronic condition, and the majority of overweight individuals who lose weight have a tendency to regain all or some of it back over time. Factors which favor maintaining weight loss include exercise, adherence to a calorie that is low-calorie, nutritious, and full of lean proteins and vegetables, and planning a strategy for coping with weight regain before it occurs. Successful treatment may take months or even years. Utilizing medications to assist you in your weight-loss goals in addition to diet and exercise could result in the weight coming back if you do not maintain eating a healthy diet and exercising. Additionally, if you have had fluctuations in your weight in the past, it may be more difficult to maintain the weight you lose.


*****Dosing for patients new to GLP-1 medications*****

Healthy weight loss as defined by CDC is a loss of 1-2lbs per week.

Semaglutide:

Month 1: Inject 0.25mg subcutaneously every week for 4 weeks.

Month 2: Inject 0.5mg subcutaneously every week for 4 weeks.
Month 3: Inject 0.5mg subcutaneously every week for 4 weeks.


Tirzepatide:

Month 1: Inject 2.5mg subcutaneously every week for 4 weeks.
Month 2: Inject 5mg subcutaneously every week for 4 weeks.
Month 3: Inject 5mg subcutaneously every week for 4 weeks. 


Retatrutide:
Month 1: Inject 2mg subcutaneously every week for 4 weeks.
Month 2: Inject 4mg subcutaneously every week for 4 weeks.
Month 3: Inject 4mg subcutaneously every week for 4 weeks.

*The above is recommend guidelines for dosing of GLP-1 medications, however, if weight loss is consistent at a lower dose then increasing is not necessary.*

AFTER MONTH 3: It is the patients responsibility to contact the clinic and arrange a 3 month follow-up medical consultation to discuss re-ordering dosing. 
RE-ORDEREING: Patient may call clinic or submit a refill request online via iv-md.com.

I’ve met my goal…what do I do now?

Contact the IV MD Clinic office to discuss with a clinician the best solution to maintain your new weight loss success. Options include titrating down or spacing out your injections every 10-14 days to assess tolerance without weight gain and then titrate down as tolerated.

Notes for patients beginning semaglutide or tirzepatide:
Not every patient will achieve the same results at the same speed.
Raising the dose too quickly can have adverse effects and rapid weight loss that is unhealthy.
There WILL be periods of stalls or greater weight loss attainment. Calorie restriction due to the mechanism of action of the medicine will cause diet naïve patients to lose weight faster than patients who have dieted consistently without results.
It is not advised to go back and forth between medications just to attain rapid results.
The medication prescribed is intended for the patient whose name appears on the label. IV MD Clinic does not condone or tolerate sharing of medications between patients.
Patients are responsible for reviewing the packaging and labeling with every new RX order.
IV MD will use several pharmacies during any week to efficiently fill prescriptions. Each compounding pharmacy provides a different concentration of medication.
Patients should understand the MILLIGRAM dose they are injecting, not only the “units” (Milligrams are different than units which are also different than milliliters). 
Rapidly increasing the dose or not following the instructions of IV MD Clinic clinicians and staff can lead to severe dehydration, constipation, nausea, and flu-like symptoms.
Follow all package instructions, do not self-medicate and adjust the dose on your own.
If you have a history of depression and/or suicidal thoughts while taking these medicines, call 911 immediately or go to the nearest Emergency Department.
Female Patients: If you miss your menstrual cycle, you must discontinue semaglutide/tirzepatide immediately.

Are Compounding Medications / Pharmacies Safe?
Compounding pharmacy quality assurance can be monitored by the FDA, state Boards of Pharmacy, and the United States Pharmacopeial (USP) Convention.
There are regulatory standards in place to make sure that compounded medications are safe. Only certain healthcare professionals, like licensed pharmacists or physicians, can compound medications.  IV MD, LLC uses compounded medications that are prepared by state-licensed 503A compounding pharmacies and 503B outsourcing facilities.  These pharmacies include: ProRx, MedRx, Empower, and Hallandale.
USP also created standards to ensure compounded medications are high quality. USP guidelines set quality standards for ingredients used in compounds. They also establish standards for how compounds are made, tested, and verified. Most states require compounding pharmacies to fully comply with USP standards.
Compounding pharmacies are regulated by the state Board of Pharmacy. Compounding pharmacies are also subject to inspections to make sure that they’re meeting all expectations. If a compounding pharmacy doesn’t follow these quality standards, corrective action may take place. IV MD Clinic partners with a network of high-quality, large-scale compounding pharmacies to guarantee on time delivery of medications used.


*****Updated FDA Warning Regarding GLP-1 Medications September 2023*****


The FDA warns semaglutide (Ozempic) users of increased ileus risk and hypoglycemia with insulin secretagogues.
The US Food and Drug Administration has provided safety-related labeling changes for semaglutide (Ozempic) products, warning users of the potential for increased risk of ileus, a blockage that keeps food or liquid from passing through the colon.1
In the labeling change, which was announced on September 20, 2023, the FDA pointed out the change was based on voluntarily reported events from a population of uncertain size and, as a result, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. On the same day, the FDA issued an additional label update highlighting those using semaglutide in combination with an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia, with new labeling information suggesting those initiating semaglutide use should consider reducing the dose of concomitantly administered insulin secretagogue, such as sulfonylureas or insulin, to reduce the risk of hypoglycemia.1
According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.
Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of the agent, with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.
References:
1. Drug safety-related labeling changes (SRLC). Drug Safety-related Labeling Changes (SrLC). September 22, 2023. Accessed September 28, 2023. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2183.
2. Campbell P. SEMAGLUTIDE shortage prompts FDA warning to patients, providers. HCP Live. June 7, 2023. Accessed September 28, 2023. https://www.hcplive.com/view/semaglutide-shortage-prompts-fda-warning-to-patients-providers.