Drug: Zepbound


Medication disclaimers


BLACK BOX WARNING:

Tirzepatide, the active ingredient in Zepbound, is contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome Type 2. Do not take it if you have ever had thyroid cancer. In studies with rodents, tirzepatide caused thyroid tumors, including thyroid cancer; it is not known if it will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.

If you experience a medical emergency, call 911 or go to the nearest emergency room.

Tell your health care provider about your medical history prior to taking Zepbound.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Zepbound, as your diabetes medications may need to be adjusted as you lose weight.

People of childbearing age should use reliable birth control while taking this medication. Use a non-oral contraceptive method (instead of an oral contraceptive). If you use oral contraception, add a barrier method of contraception during the first four weeks after initiation and for four weeks after dose escalation.

This medication may cause fetal harm. Do not take this medication if pregnant, trying to get pregnant, or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least two months before trying. Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Zepbound and call your health care provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or a very rapid heartbeat.

Severe hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Zepbound if suspected and promptly seek medical advice.

WARNING

Please get in touch with 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, and diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; it may sometimes lead to the need for hemodialysis.
  • Severe stomach problems, including abdominal bloating or pain, acid reflux, a feeling of fullness after eating just a few bites of food, nausea, and vomiting, including vomiting undigested food eaten a few hours earlier. This may be a symptom of gastroparesis. Also tell your health care provider if you have stomach problems that will not go away.
  • An inability to pass gas or stool is a symptom of possible bowel obstruction. Other symptoms may include severe abdominal pain, nausea, and vomiting.
  • 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 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 or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder are suspected, further studies are needed.
  • Hepatitis, elevated liver enzymes/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 it 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 GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams)—drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (e.g., sulfonylurea), it is best to talk to your health care provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
  • 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 who will be performing the procedure that you’re taking a GLP-1 so they can give you instructions to avoid this.
  • Increasing heart rate.
  • Worsening depression, behavior changes, or suicidality.
  • Note: Never share your Zepbound pen with other people.

SIDE EFFECTS INFORMATION

Many people experience no side effects. 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. For a complete list of side effects, review the medication packaging inserts.

DRUG INTERACTIONS

As with other medications, Zepbound can interact with alcohol and some prescription and non-prescription drugs and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Zepbound delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, before starting Zepbound please review the timing of taking it with your prescribing doctor as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (e.g., warfarin) should be monitored closely while on Zepbound.

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

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

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