Compounded Liraglutide

Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing liraglutide are available.

WARNING

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

• Severe nausea and/or vomiting resulting in dehydration — it is important to stay well hydrated and drink plenty of fluids while on this medication.
  
  
• Kidney problems/kidney failure — vomiting, nausea, or diarrhea can cause dehydration and worsen kidney issues, especially in individuals with pre-existing kidney disease; 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 below).
  
  
• Pancreatitis: Severe, persistent pain in your abdomen or back that does not go away.
  
  
• Acute gallbladder disease: Pain in the middle or upper right stomach, fever, yellowing of the skin or eyes (jaundice), nausea or vomiting. If gallstones or gallbladder inflammation is suspected, additional diagnostic studies are needed.
  
  
• Hepatitis/Elevated liver enzymes/Jaundice.
  
  
• Diabetic retinopathy complications: Changes in vision, especially for individuals with a history of diabetic retinopathy.
  
  
• Severe gastrointestinal disease: Liraglutide may cause or worsen gastrointestinal diseases. Do not use if you have a history of severe gastrointestinal disorders such as gastroparesis.
  
  
• Signs of low blood sugar (for example, dizziness, shakiness, jitteriness, weakness, headache, mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness).
  
  
  
  • Although rare with GLP-1 medications, if symptoms occur, seek medical care immediately. Consume sugar-containing foods or beverages (15-20 grams of sugar) — examples include juice, soda (non-diet), or hard candies to quickly raise your blood sugar.
    
    
  • If you are using insulin or insulin secretagogues (e.g., sulfonylureas like glipizide, glimepiride, glyburide), discuss with your healthcare provider if dose adjustment is needed to prevent hypoglycemia.
    
    
• Increased heart rate.
  
  
• Worsening depression, behavior changes, or suicidal thoughts.
  
  
• Never share liraglutide with other people.
  
  

Drug Interactions

As with other medications, compounded liraglutide can interact with alcohol, prescription, non-prescription medications, and herbal supplements.

• Risk of hypoglycemia increases when used with insulin or insulin secretagogues (e.g., sulfonylureas).
  
  
• Delayed gastric emptying can alter the absorption of oral medications.
  
  
  
  • If you are taking thyroid medications (e.g., levothyroxine), discuss the timing with your prescribing provider, as adjustments may be needed.
    
    
  • For medications with a narrow therapeutic window (e.g., warfarin), monitor drug levels closely while taking liraglutide.
    
    

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

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

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

Note

The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

BLACK BOX WARNING

GLP-1 receptor agonists are contraindicated in individuals with:

• A history of medullary thyroid carcinoma (MTC),
  
  
• A family history of MTC,
  
  
• Or multiple endocrine neoplasia syndrome type 2 (MEN2).
  
  

Do not take liraglutide if you have ever had thyroid cancer.
In rodent studies, GLP-1 receptor agonists caused thyroid tumors, including thyroid cancer; it is not known if liraglutide will cause thyroid tumors or cancers in humans.
Notify your doctor ASAP if you develop:

• Trouble swallowing
  
  
• Hoarseness
  
  
• A lump or swelling in your neck
  
  
• Shortness of breath
  
  

Additional Important Safety Information

• If you experience a medical emergency, call 911 or go to the nearest emergency room.
  
  
• Tell your healthcare provider about your medical history before starting liraglutide.
  
  
• Avoid alcohol while taking this medication.
  
  
• If you are taking diabetes medications, discuss them with your doctor before starting liraglutide, as dose adjustments may be necessary as you lose weight.
  
  
• Use effective contraception during treatment.
  
  
  
  • Do not take if pregnant, planning to become pregnant, or breastfeeding.
    
    
  • If planning pregnancy, stop liraglutide at least 2 months prior to trying to conceive.
    
    
• This medication may cause fetal harm.
  
  
• Notify your doctor if you have kidney, liver, or pancreas problems.
  
  
• Stop using liraglutide and call your healthcare provider immediately if you have severe stomach or abdominal pain that does not go away, with or without vomiting.
  
  
• Serious allergic reactions (e.g., swelling of face, lips, tongue, or throat; breathing difficulties; severe rash or itching; fainting; or rapid heartbeat) have been reported.
  
  
  
  • Stop using liraglutide and seek immediate medical help if any signs of an allergic reaction occur.
    
    
• Anaphylaxis and angioedema have been reported.
  
  
  
  • Discontinue liraglutide immediately if suspected.

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