Compounded Sublingual Semaglutide

This treatment plan reviews the risks and benefits of the treatment we are recommending. Please make sure to read it and the manufacturer's pamphlet that comes with the medicine. The manufacturer's pamphlet contains full information on potential medication interactions, side effects, and other important information you should know about the medicine before you start.

Instructions

You have stated that you wish to obtain treatment for weight loss management with compounded sublingual Semaglutide. Please follow the directions on your prescription and within this treatment guide for administration of your medication and your dosing titration.

GLP-1s (glucagon-like peptide-1 receptor agonists) are a class of medications used primarily for the treatment of type 2 diabetes and, more recently, for weight management. These drugs mimic the effects of a natural hormone called GLP-1, which is released in the gut after eating.

These medications work by:

• Increasing insulin secretion to help lower blood glucose after meals
• Suppress glucagon release to limit glucose release by the liver
• Slow gastric emptying to allow a more gradual absorption of glucose to reduce post-meal blood sugar spikes and to help you feel full longer
• Works on receptors in the brain to increase fullness and reduce hunger
  
  

Special Alerts:

Safety Updates

The FDA is evaluating reports of suicidal thoughts or actions in patients treated with GLP-1s. A preliminary evaluation by the FDA did not found evidence of these medications causing suicidal thoughts or actions, but further investigation is ongoing.

If you experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior please reach out to your Wisp provider right away.

Pulmonary Aspiration During Surgery or Sedation

Semaglutide products can delay stomach emptying, which may increase the risk of pulmonary aspiration (inhalation of stomach contents into the lungs) during surgeries or procedures requiring general anesthesia or deep sedation. Inform your healthcare provider if you are taking semaglutide before any planned surgeries or procedures so they can take appropriate precautions to reduce this risk.

Boxed Warning: In studies, semaglutide has been shown to cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant doses in rodents. It is unknown whether semaglutide causes C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the relevance of semaglutide-induced rodent thyroid C-cell tumors to humans has not been determined.

Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). If you experience symptoms of a mass in your neck, trouble swallowing, shortness of breath, or persistent voice hoarseness, please reach out to your Wisp provider right away.

Absorption Efficacy: This compounded sublingual semaglutide is formulated with a base that may help improve absorption through the lining of the mouth. While lab tests using human-derived tissues suggest it may begin working within 15-30 minutes, it has not yet been tested within the human body. Because of this, the effectiveness of this formulation in patients may vary.

Information on Compounded Medications

Compounded medications are specially mixed or altered by pharmacists to meet the unique needs of patients. When certain medications are on the FDA shortage list, compounded alternatives can be a safe and effective option.

Compounded drugs can be made in two types of facilities. Outsourcing facilities must follow strict manufacturing guidelines under Section 503B of the Food, Drug, & Cosmetic Act. Pharmacies that compound medications for individual patients follow different standards under Section 503A, exempt from some manufacturing requirements. Regardless of where the drug is made, both state and federal regulations ensure medications are prepared safely and not under unsanitary conditions.

Administering your Sublingual Semaglutide

Your compounded sublingual semaglutide medication should be stored at room temperature around 68-74 degrees fahrenheit in a cool, dry place away from light.

Your shipment should contain 10 syringe droppers.

Administer your medication at night after cleaning the mouth and avoid eating or drinking 30 minutes before or after.

Preparing your medication

• Double check the information on your medication including your dose, expiration date, and that the medication is clear. If not, reach out to your Wisp provider.
• Shake the medication
• Place the syringe dropper into the medication and squeeze up to the titration amount shown below for your weekly dosing
• Place your syringe dropped with your correct dosage under your tongue and fully dispense all medication to pool under your tongue
• Hold the medication under your tongue for 60 seconds before swallowing

Missed Doses

If a dose is missed within 5 days from your last dose, administer your dose as soon as possible and resume the usual schedule from that date.

If more than 5 days have passed since your missed dosage, skip the missed dose and resume your scheduling administration the following week at your normal scheduled dosing time.

If more than 2 doses are missed, reach out to your Wisp provider for further guidance and instructions on administering your treatment.

Administering Too Much Medication

• Call Poison Control at 1-800-222-1222
• Notify your Wisp provider
• Monitor for any side effects that may develop over the next several days
• If your side effects aren’t manageable after speaking to your Wisp provider or if your side effects become more severe seek treatment at an emergency care facility
• Notify your Wisp provider of your ER visit

Allergies

This medicine, like all medications, may cause an allergic reaction if you are allergic to similar medicines or components. If you are allergic to any of the following please do not take the medicine and call or message us or follow up with an in-person healthcare provider.

• Ozempic
• Wegovy
• Rybelsus
• Semaglutide
• Hypersensitivity to GLP-1 Receptor Agonists in the past
• Macadamia nuts
• Saffron
• Apricot
  
  

Conditions

We have evaluated your health history and the specific health information you provided us, however if anything changes and you develop one of these conditions, please stop taking this medicine and call or message us immediately. This list may not be all inclusive.

• Pregnancy
• Breastfeeding
• BMI less than 27
• Personal or Family History of Medullary Thyroid Carcinoma
• Personal or Family History of Multiple Endocrine Neoplasia Type 2
• History or Active Renal disease
• Type I Diabetes
• Poorly controlled Type II Diabetes
• History of Pancreatitis
• Elevated Triglycerides
• Significant Alcohol Use
• Gallbladder disease without surgical removal
• History of Retinopathy
• History of a bowel obstruction
• History of eating disorders
• History of gastroparesis
• History of Suicidal Ideation in the past
• Recent bariatric surgery
  
  

Pregnancy and Breastfeeding

Medications for weight loss therapy are not recommended during pregnancy. Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy, however available pharmacovigilance data and data from clinical trials with WEGOVY (Semaglutide) use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Semaglutide should be discontinued for more than 2 months prior to becoming pregnant.

If you become pregnant while taking Semaglutide you should discontinue your treatment. Due to the protein binding of this medication the amount of Semaglutide in breastmilk is likely to be low. However, breastfeeding during therapy with oral semaglutide is not recommended as you should be eating an additional 340-400 calories to support your breastmilk production.

Medicines, Supplements, and Foods

We have evaluated the specific health information you provided us, however if you are taking any of the medicines, foods, or supplements listed below call or message us before you take the medicine. Some of these can cause dangerous interactions with the medicine we are prescribing you and we will help you evaluate that risk and decide on an appropriate treatment plan. Please ensure your chart is up to date with your current medications, allergies, and medical conditions so your provider can safely treat you as this list may not be all inclusive.

• Sulfonylureas
• Insulin
  
  

Emergency Side Effects

This medicine can cause dangerous and potentially life-threatening side effects. If any of the emergency side effects listed in the manufacturer’s pamphlet or those below happen to you please stop taking the medicine and call 911 or seek immediate medical help in person. This list may not be all inclusive.

• Sudden onset of chest pain
• Shortness of breath
• Difficulty or painful swallowing
• Severe skin rash and/or itching
• Facial or throat swelling
• Blurred or changes in vision
• Severe diarrhea with or without blood
• Severe vomiting
• Palpable mass in your neck
• Trouble swallowing
• Shortness of breath
• Persistent voice hoarseness
• Decreased urine output
• Pain in the right upper stomach with or without fever
• Yellowing of the skin or eyes
• Persistent gastroparesis
  
  

Other Side Effects

This medicine can also cause other side effects including (list is not all inclusive):

• Abdominal discomfort
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Decreased appetite
• Altered sensation of taste
• Fatigue
• Headache
• Belching
• Gas
• Heartburn
• Discomfort, irritation, or redness at the injection site
  
  

Risks

Accurate Information

We have evaluated your health history and your specific health information you provided and determined it is safe to proceed with this treatment at this time. If your health history changes including diagnoses or medications please message or call us before you take the medicine to ensure it's safe to proceed. Some medications and conditions can cause dangerous interactions with the medicine we are prescribing and we will help you evaluate that risk and decide on an appropriate treatment plan.

Treatment Failure

This treatment is not guaranteed to be effective. It may not work or may only partially resolve the condition for which you are seeking treatment. If the treatment is not working, or if you are experiencing new or worsening symptoms, give us a call or message us anytime. If it is an emergency, call 911 or seek immediate medical help in person. You may need to seek alternative treatment such as those listed below or in the follow up plan.

Misdiagnosis or Delayed Diagnosis

Through telehealth, there is also a risk that we misdiagnose or fail to diagnose conditions that you may have which could affect our recommendation for treatment. This risk exists with a doctor in person as well but they may have additional resources to aid their evaluation. We use evidence-based practice and guidelines as well as clinical decision-making to minimize these risks.

Accepting or Declining Our Recommendation

We have based our recommendation on your specific case and medical guidelines, but there may be alternative treatments or strategies that may be helpful to you. Some may be more or less effective than what we provide. Some treatments may require an in-person exam or procedure which we can’t provide. Message us or talk to your doctor in person to discuss alternative treatments.

Share with Your In-Person Healthcare Team

You can access your records anytime. We strongly recommend that you update your in-person doctor, pharmacist, and the rest of your healthcare team to let them know about any new medicines you are taking or other changes in your health.

You can also ask us questions anytime and we are happy to help you share any information about your health with your in-person healthcare team.