COMPOUNDED SEMAGLUTIDE is a glucagon-like peptide-1 (GLP-1)
receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic
weight management in adults with an initial body mass index (BMI) of:
- >27 kg/m2 or greater (overweight or obesity)
Limitations of Use:
- Co-administration with other COMPOUNDED SEMAGLUTIDE-containing products or any GLP-1 receptor agonist is not
recommended.
- The safety and efficacy of coadministration with other products for weight management have not been
established.
- COMPOUNDED SEMAGLUTIDE has not been studied in patients with a history of pancreatitis.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
- In rodents, SEMAGLUTIDE causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether
SEMAGLUTIDE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the
human relevance of SEMAGLUTIDE-induced rodent thyroid C-cell tumors 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). Counsel patients regarding the potential risk of MTC
and symptoms of thyroid tumors.
Do not take COMPOUNDED SEMAGLUTIDE if you:
- Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple
Endocrine Neoplasia syndrome type 2 (MEN2).
- Have been diagnosed with Diabetes (Type 1 or 2)
- Have been diagnosed with pancreatitis or history of pancreatitis
- Have a diagnosis or history of gastroparesis - severe problems with your stomach, such as slowed emptying of
your stomach (gastroparesis) or problems with digesting food
- Have a known allergy to semaglutide/any other GLP-1 drug or any of the inactive ingredients in COMPOUNDED
SEMAGLUTIDE. Inactive ingredients include: di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl
alcohol, hydrochloric acid, sodium hydroxide pellets and water.
- Have a history of suicidal attempts or active suicidal ideation
WARNINGS AND PRECAUTIONS
- Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do
not restart if pancreatitis is confirmed.
- Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder
studies and clinical follow-up are indicated.
- Gastroparesis: Uncommon, but more serious, gastrointestinal adverse effect may also occur more frequently
with GLP-1 receptor agonists than with other weight loss agents.
- Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia,
including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary. Inform
all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
- Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of COMPOUNDED
SEMAGLUTIDE in patients reporting severe adverse gastrointestinal reactions or in those with renal
impairment reporting severe adverse gastrointestinal reactions.
- Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing.
Discontinue COMPOUNDED SEMAGLUTIDE if suspected and promptly seek medical advice.
- Females and males of reproductive potential: Discontinue COMPOUNDED SEMAGLUTIDE at least 2 months before a
planned pregnancy because of the long half-life of COMPOUNDED SEMAGLUTIDE.
- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue COMPOUNDED SEMAGLUTIDE
immediately
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with
COMPOUNDED SEMAGLUTIDE. Patients with a history of diabetic retinopathy should be monitored. Diabetic
retinopathy damages blood vessels in the retina and can scar your retina. As the scars get bigger, they can
pull on your retina and detach it from the back of your eye, a serious condition called retinal detachment.
- Heart Rate Increase: Monitor heart rate at regular intervals.
- Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue COMPOUNDED
SEMAGLUTIDE if symptoms develop.
- A recent study suggested there may be a connection between semaglutide use and increased risk for a blinding
eye disease called non-arteritic anterior ischemic optic neuropathy (NAION). There isn't enough data yet to
suggest patients should be concerned or should stop taking their medications. People who have diabetes are
already at risk for NAION, whether they use semaglutide or not. It is premature to conclude that the
association is a causal association. More research is necessary to test the hypothesis. Until then, patients
should be aware of this information and make a careful, informed choice based on their individual risk
profile.
Side Effects
Most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea,
diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension,
eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux
disease, and nasopharyngitis.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at
1-800-FDA-1088 or
www.fda.gov/medwatchDRUG INTERACTIONS
COMPOUNDED SEMAGLUTIDE delays gastric emptying. May impact absorption of concomitantly administered oral
medications. Use with caution.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue COMPOUNDED SEMAGLUTIDE.
- Females and Males of Reproductive Potential: Discontinue COMPOUNDED SEMAGLUTIDE at least 2 months before a
planned pregnancy because of the long half-life of COMPOUNDED SEMAGLUTIDE.
.gif)
