Important Safety Information for Tizaro® (tirzepatide) Injection
Warning: Risk of Thyroid C-Cell Tumors
In animal studies, Tizaro caused thyroid tumors, including thyroid cancer. It is not known whether Tizaro causes thyroid C-cell tumors or medullary thyroid carcinoma (MTC) in humans. Inform your healthcare provider if you experience symptoms such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath. These could be signs of thyroid cancer.
Do not use Tizaro if you or your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is Tizaro Used For?
Tizaro is used in combination with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or in adults with overweight and a weight-related condition, such as type 2 diabetes, high blood pressure, or high cholesterol.
Limitations of Use:
- Tizaro should not be used in combination with other tirzepatide-containing medications or GLP-1 receptor agonists.
- Tizaro is not indicated for use in individuals with a BMI below 27 kg/m² or for other weight-loss purposes beyond its approved indication.
Who Should Not Use Tizaro?
Do not use Tizaro if:
- You or your family have a history of MTC or MEN 2.
- You have had a severe allergic reaction to tirzepatide or any of its components.
How Should I Take Tizaro?
- Administer Tizaro as a subcutaneous injection once weekly in the abdomen, thigh, or upper arm, preferably on the same day each week.
- Tizaro can be taken with or without food.
- Follow your provider’s instructions regarding dose adjustments, typically every four weeks, until reaching the maintenance dose.
- Do not share pens or needles to avoid the risk of infection.
What Should I Tell My Provider Before Using Tizaro?
Inform your healthcare provider about your medical history, including:
- Thyroid cancer or endocrine system conditions
- Type 1 or type 2 diabetes
- Pancreatitis or gastrointestinal disease
- Kidney disease
- Gallbladder disease
- Depression or suicidal thoughts
- Any surgeries requiring sedation
- Pregnancy, plans to become pregnant, or breastfeeding
If you are pregnant or planning to become pregnant:
- Tizaro should not be used during pregnancy, as weight loss may harm the unborn baby and offers no benefit during pregnancy.
If you are breastfeeding:
- It is not known if Tizaro passes into breast milk. Consult your provider to evaluate the risks and benefits.
What Are the Most Serious Side Effects of Tizaro?
Seek immediate medical attention if you experience:
- Thyroid C-Cell Tumors: Report any lump or swelling in the neck, hoarseness, or difficulty swallowing immediately.
- Acute Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting, should be reported promptly.
- Gallbladder Issues: Symptoms such as severe upper abdominal pain, yellowing of the skin or eyes (jaundice), fever, or pale stools may indicate gallbladder disease.
- Kidney Problems: Severe dehydration caused by nausea, vomiting, or diarrhea can lead to kidney issues. Drink plenty of fluids to stay hydrated.
- Severe Allergic Reactions: Stop using Tizaro and seek help if you experience swelling of the face or throat, severe rash, difficulty breathing, or rapid heartbeat.
- Mental Health Changes: Notify your provider immediately if you experience mood changes, depression, or suicidal thoughts.
What Are the Most Common Side Effects of Tizaro?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Fatigue
- Injection site reactions
- Headache
Important Considerations
- Tizaro may delay gastric emptying, affecting the absorption of oral medications. Inform your provider about all medications, supplements, and vitamins you take.
- If you use oral hormonal contraceptives, Tizaro may reduce their effectiveness during dose escalation. Use a barrier contraceptive method for four weeks after each dose adjustment until the maintenance dose is achieved.
- Before surgeries requiring fasting or sedation, consult your provider, as Tizaro may increase the risk of aspiration due to delayed gastric emptying.
Pregnancy Registry:
A pregnancy registry monitors outcomes in individuals exposed to Tizaro during pregnancy. Pregnant patients or healthcare providers are encouraged to contact the registry at [manufacturer contact details].
This document provides essential safety information but is not comprehensive. Consult your healthcare provider and the full Prescribing Information for more details.
To report side effects: Contact your local health authority or report them to the manufacturer at [manufacturer contact details].