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Important Compounded Liraglutide Safety Information | WW USA

Important Compounded Liraglutide Safety Information

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of Compounded Liraglutide based on your medical evaluation.

Most Important Safety Information

  • Risk of thyroid C-Cell tumors. In studies with mice and rats, liraglutide (the active ingredient in Saxenda) caused thyroid C-cell tumors, including thyroid cancer. It is not known if Compounded Liraglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Do not use Compounded Liraglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Compounded Liraglutide if you have had a serious allergic reaction to liraglutide or any of the ingredients in liraglutide.

What is Compounded Liraglutide used for?

Compounded Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist for use in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:

  • Adults with body mass index (BMI) of 30 kg/m2 or greater (obese).
  • Adults with BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.

Limitations of Use:

  • Liraglutide should not be used in combination with other liraglutide-containing products or any other GLP-1 receptor agonist
  • It is not known if liraglutide is safe and effective when taken with other products intended for weight loss.

What should I tell my provider before using liraglutide?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • Thyroid cancer or Multiple Endocrine Neoplasia syndrome
  • Gastrointestinal disease
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Depression
  • Suicidal thoughts or behavior

Whether you are pregnant, planning to become pregnant, or breastfeeding.

  • If you are pregnant: Liraglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to liraglutide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
  • If you are a female or male of reproductive potential: Liraglutide may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
  • If you are breastfeeding: Liraglutide was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start taking liraglutide.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Insulin
  • Sulfonylureas (these can cause blood sugar levels to drop dangerously low when combined with Compounded Liraglutide)
  • Compounded Liraglutide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
  • Other GLP-1 or GLP-1/GIP receptor agonist medications such as semaglutide, dulaglutide, or tirzepatide
  • Other products for weight loss, including dietary supplements
  • Liraglutide delays gastric emptying and may impact absorption of other administered oral medications. Use with caution.

What are the most serious side effects that I or a caregiver should monitor for when taking Compounded Liraglutide?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with liraglutide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Rybelsus) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Rybelsus causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Rybelsus is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
  • Acute Gallbladder Disease: Liraglutide may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
  • Low Blood Sugar (hypoglycemia): Liraglutide lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
  • Serious Allergic Reactions: Stop using liraglutide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts and discontinue if symptoms develop.
  • Never Share a Pen: Pen-sharing poses a risk of infection.

These common side effects can occur with liraglutide.

  • Nausea
  • Diarrhea
  • Constipation
  • Vomiting
  • Injection site reactions
  • Headache
  • Hypoglycemia
  • Dyspepsia
  • Fatigue
  • Dizziness
  • Abdominal pain
  • Increased lipase
  • Pyrexia
  • Gastroenteritis

You are encouraged to report negative side effects of prescription products: