Drug: Oral Semaglutide Dissolving Tablets

Compounded medications are not FDA-approved or evaluated for safety or efficacy but include active ingredients sourced from FDA-registered facilities. If you notice any changes in the appearance, color, or consistency of the medication, please contact your prescriber immediately before using it.

Do not use this medication if you are or suspect you may be allergic to any of the ingredients in the compounded product. Other ingredients include: 

• vitamin B-6 (Pyridoxine HCL), 10 mg per tablet 
• sucralose

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience any of the following:

• Severe nausea and/or vomiting resulting in dehydration: It is important to stay well hydrated and drink plenty of fluids while on this medication. Dehydration may lead to low blood pressure or kidney problems. 
• Kidney problems/kidney failure: Vomiting, nausea, and diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis.
• Thyroid C-cell tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see “Black Box Warning” above).
• Pancreatitis: Severe pain in your abdomen or back that will not go away.
• Acute gallbladder disease: Pain in the middle or right upper stomach, fever, white parts of your eyes or skin turning yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected, further study is needed.
• Hepatitis, elevated liver enzymes, or jaundice.
• Diabetic retinopathy problems: Changes in vision in those with type 2 diabetes, particularly vision problems, may worsen in those with a history of diabetic retinopathy.
• Severe gastrointestinal disease: May cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease.
• Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness): While this is rare with semaglutide, if it occurs, please seek in-person care immediately. Do not drive if your blood sugar has been low. There is a greater chance of you having a crash. Very low blood sugar can lead to seizures, passing out, long-lasting brain damage, and sometimes death. It may be harder to control blood sugar during stress, such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar. If you have symptoms of low blood sugar, try having liquid or food containing sugar (around 15-20 grams)—drink juice or regular soda, or eat some hard candies right away, as this will help raise your blood sugar quickly. Contact your care provider for instructions on how to manage low blood sugar. If compounded semaglutide is taken with insulin or an insulin secretagogue (i.e., sulfonylureas), it is best to talk to your health care provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
• Increasing heart rate.
• Worsening depression, behavior changes, or suicidality.
• If you are going under general anesthesia or deep sedation, GLP-1s may make you accidentally breathe food or liquid into your lungs (pulmonary aspiration). Tell the providers performing the procedure that you’re taking a GLP-1 so they can give you instructions to avoid this.

SIDE EFFECTS

Many people experience no side effects while taking semaglutide. Some of the most common or potential side effects include:

• Nausea
• Constipation
• Vomiting
• Diarrhea
• Abdominal pain
• Headache
• Indigestion
• Injection site reactions
• Dizziness
• Back pain
• Increased lipase or amylase
• Altered taste
• Nasopharyngitis (common cold)
• Passing gas
• Bloating
• Belching
• Gastroenteritis
• Decreased appetite
• Fatigue
• Gastroesophageal reflux disease
• Low blood sugar (hypoglycemia) in those with type 2 diabetes
• Upset stomach

These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. 

Too much vitamin B-6 taken for a year or longer can cause disease of the nervous system (neuropathy) and loss of control of voluntary body movements (ataxia). Symptoms usually stop if you stop taking B-6 as soon as symptoms appear. Too much vitamin B-6 can also cause painful skin lesions, sensitivity to light, nausea, and heartburn. 

For a complete list of side effects, review the medication packaging inserts.

DRUG INTERACTIONS

This drug may prevent other drugs taken by mount from getting into the body. If you take other medications by mouth, you may need to stagger the timing with this drug.

As with other medications, semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with other drugs that may lower blood sugar, such as insulin or insulin secretagogues, such as sulfonylureas. Semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, before starting semaglutide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it, as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on semaglutide. If you are taking levothyroxine, talk to your health care provider before starting semaglutide. 

Vitamin B-6 can interact with some medications, including cycloserine, antiepileptic drugs, and theophylline. 

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions, and additional information.

To report suspected adverse reactions to compounded semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go to the nearest emergency room.