Compounded Semaglutide

DEDICATION TO PATIENTS

Our Non-Negotiable Stance

Patient safety and efficacy is our top priorities. We utilize Rybelsus® tablets which are suspended in SUBMAGNA™ SL HMW base to ensure that the correct medication is being delivered to the correct administration site. All ingredients are traceable back to their source and verified for authenticity. Furthermore, we leverage peer-reviewed journals to reinforce our approach to compounding sublingual semaglutide.

AN INNOVATIVE, ANHYDROUS SUBLINGUAL BASE

What is SUBMAGNA™ SL HMW?

SUBMAGNA™ SL HMW was developed specifically to be utilized with semaglutide and other high molecular weight (HMW) substances. This sublingual base is anhydrous featuring self-emulsifying and permeation-enhancing properties. When SUBMAGNA™ SL HMW is administered under the tongue, it interacts with saliva to create an emulsion enhancing the solubility and dispersibility of semaglutide. The unique mucoadhesive properties allow for a longer contact time between the medication and mucosal tissues potentially increasing the absorption of semaglutide. Additionally, the permeation-enhancing effects promotes more efficient delivery of semaglutide into systemic circulation. These features may help better control blood glucose in patients with type 2 diabetes and support weight management in individuals with obesity without requiring needles.

BYPASS THE FIRST-PASS EFFECT

Clinical Significance of Sublingual Semaglutide

In a 2021 publication of Clinical Pharmacokinetics (60:1335-1348), Overgaard, et al., investigated the absorption, distribution, and elimination (ADE) of oral semaglutide using data from six clinical pharmacology trials. The trials utilized doses ranging from 5-mg to 10-mg with subjects including healthy volunteers, subjects with renal or hepatic impairment, and a small number with type 2 diabetes. They found that when oral semaglutide was dosed using the recommended dosing conditions (30 minutes post-dose fasting, administered with less than 120 mL of water), the resulting bioavailability was 0.8%. Bioavailability increased with longer post-dose fasting time reaching a peak of 1.4% after 120 minutes and decreased when administered with 240 mL of water. When comparing oral administration to subcutaneous/intravenous administration, oral absorption was significantly faster with lower bioavailability, however this was mitigated with frequent dosing and the long half life of semaglutide. It is important to note that, once semaglutide was absorbed, there was no difference in distribution, metabolism, or elimination when comparing routes of administration.¹

Understanding these kinetics, it appears sublingual semaglutide potentially eliminates multiple factors impacting absorption with smaller doses.

Overgaard RV, Navarria A, Ingwersen SH, Bækdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clinical Pharmacokinetics. 2021;60(10):1335-1348.

Compounded Sublingual Semaglutide 1-mg/mL

SIG: Place 0.5-mL (0.5-mg) under the tongue daily for at least 90 seconds, then swallow. May increase to 1-mL on second week if needed. Do not eat for 30 minutes after taking.

Compounded Sublingual Semaglutide

1-mg/mL OR 2-mg/mL

SIG: Place ____ mL (___ mg) under the tongue daily for at least 90 seconds, then swallow. Do not eat for 30 minutes after taking.

CUSTOMIZED DOSING

Tailored Dosing

Not every patient will require the same dose and adjustments may be need to considered. We are able to compound 1-mg/mL and 2-mg/mL concentrations to fit your patient’s needs. Smaller dose volumes (0.5-mL) may be easier to hold under the tongue.

For patients who have never taken a GLP-1 medication (GLP-1 naive), consider trialing the suggested initial dose. Lower starting doses may be warranted for patients with a history of hypoglycemia.
Suspension must be held under the tongue for a minimum of 90 seconds. Absorption is potentially increased when held for longer.

Drug Interactions

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 reduces fasting and postprandial blood glucose by stimulating insulin secretion and lowering glucagon secretion. In addition, GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. Semaglutide lowers body weight with greater fat mass loss than lean mass loss. Semaglutide decreases calorie intake, likely mediated by affecting appetite.

Severity: MAJOR

Drugs	Summary
Abiraterone actetate	Concurrent use of ABIRATERONE ACETATE and ANTIDIABETIC AGENTS may result in an increased risk of severe hypoglycemia.
Somatrogon-GHLA	Concurrent use of SOMATROGON-GHLA and ANTIDIABETIC AGENTS may result in reduced insulin sensitivity.
Chloroquine	Concurrent use of CHLOROQUINE and ANTIDIABETIC AGENTS may result in hypoglycemia.
Fluoroquinolones	Concurrent use of ANTIDIABETIC AGENTS and FLUOROQUINOLONES may result in changes in blood glucose and increased risk of hypoglycemia or hyperglycemia.
Hydroxychloroquine	Concurrent use of HYDROXYCHLOROQUINE and ANTIDIABETIC AGENTS may result in hypoglycemia.
Insulin and insulin secretagogues	Concurrent use of SEMAGLUTIDE and INSULIN AND INSULIN SECRETAGOGUES may result in an increased risk of hypoglycemia.

Drug interactions obtained from Micromedex, 2024

Severity: Moderate

Drugs	Summary
Glucagon-like Peptide-1 Receptor Agonists	Concurrent use of SEMAGLUTIDE and GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS may result in increased risk of semaglutide-related adverse effects.
Glecaprevir/pibrentasvir	Concurrent use of GLECAPREVIR/PIBRENTASVIR and ANTIDIABETIC AGENTS may result in altered glycemic control resulting in severe symptomatic hypoglycemia.
Tirzepatide	Concurrent use of SEMAGLUTIDE and TIRZEPATIDE may result in increased risk of semaglutide-related adverse effects.
Levothyroxine	Concurrent use of LEVOTHYROXINE and SEMAGLUTIDE may result in increased levothyroxine exposure and worsening of glycemic control.
Warfarin	Concurrent use of SEMAGLUTIDE and WARFARIN may result in increased warfarin exposure.
ACE Inhbitors	Concurrent use of ACE INHIBITORS and ANTIDIABETIC AGENTS may result in an increased risk of hypoglycemia.

Drug interactions obtained from Micromedex, 2024

Prescribing Made Easy

If you have examined your patient and determined they may benefit from sublingual semaglutide, prescriptions can be sent multiple ways.

E-Prescribing

E-Prescribing Instructions

Via Fax

(804) 521-7382

Via Phone

(804) 521-7384

If you choose to send in the prescription by phone, please provide patient name, date of birth, and their best contact number.

Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.

PATIENT RESOURCES

Pertinent Documents

The documents below are provided to educational purposes and outline the prescribing process, if your patient is a candidate for therapy. They should be used as a guide and not a substitute for professional judgment.