Compounded Tirzepatide (Active Pharmaceutical Ingredient in Mounjaro®)

Please see: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf and https://www.drugs.com/tirzepatide.html

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 Compound Tirzepatide based on your medical evaluation.

Tirzepatide (tir-ZEP-a-tide)

Indications and Use:
Compound Tirzepatide is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.
Tirzepatide is a glucagon-like-peptide-1 (GLP-1) receptor agonist and a glucose-dependent insulinotropic polypeptide (GIP) agonist.
• It may be used for weight management in overweight or obese patients.
• It may be used for blood sugar management in overweight or obese patients.
• Tirzepatide is not for patients with type 1 diabetes.
• It may slow gastric emptying.
• It may also be used for other conditions as determined by your doctor.
Compounded Drug Forms: Subcutaneous injection
Compound Tirzepatide should not be used with other Tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Tirzepatide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Tirzepatide can be used in people who have had pancreatitis. It is not known if Tirzepatide is safe and effective for use in children under 18 years of age.
Important Safety Information for Tirzepatide injection

What products are available?
Tirzepatide 10 mg/mL injectable solution
• 1 mL fill volume in 5 mL amber vial
• 4 mL fill volume in 10 mL amber vial

What should the injectable product look like?
Upon visual inspection, the vial contents should appear as a clear solution with no visible particles.

What should I tell my health care provider before I take this medicine?
• Allergy to Tirzepatide
• History of medullary thyroid cancer or other thyroid C-cell cancer
• History of pancreas or kidney problems
• History of tachyarrhythmias
• History of depression, suicidal thoughts or actions
• History of diabetic retinopathy
• History of severe stomach problems, like gastroparesis
• Pregnant or breastfeeding

How should I use this medicine?
Follow the package directions provided by the pharmacy and by your prescriber. Your dosage is based on your medical condition and response to therapy. Follow the dosing schedule provided carefully.
Injectable medications should be given subcutaneously or intramuscularly as indicated by your healthcare provider. See recommended administration guide for further instruction.
• For Injectable — This medication should be given by subcutaneous injection. A subcutaneous injection (SQ) delivers medicine into the fatty layer between skin and muscle, used to give a small quantity of certain kinds of medications.
• Rotating your injection site is recommended. Commonly used injection sites include: the outer area of the upper arm, the abdomen (avoiding a 2-inch circle around the navel), or the front of the thigh.
• Wash hands and sanitize the injection site with alcohol prior to administration. Do not use the solution if it becomes cloudy, has particles, or changes color. Dispose of used needles in a Sharps container. Do not use past the beyond use date indicated on the prescription label.
• Discard 28-days after initial puncture.

What if I miss a dose?
• If you miss a dose within 4 days of the scheduled dose, administer it as soon as possible.
• If more than 4 days have passed since the missed dose, skip the missed dose, and continue with your regular dosing schedule.
• Do not take double the dose at once.
• If it is necessary to change weekly administration day, allow 72 hours (about 3 days) between two doses. Do not take 2 doses of Tirzepatide within 3 days of each other.

What should I watch for while using this medicine?
• Signs of an allergic reaction: hives blistering, swelling of the mouth, face, lips tongue throat, trouble breathing.
• Signs of injection site reaction: redness or itching around the administration site.
• Signs of new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior
• Signs of hypoglycemia
• Notify health care provider if taking diabetes medications like insulin or sulfonylureas. These drugs in combination with Tirzepatide may increase the risk for low blood sugar.
• Regular check-ups with your provider are recommended.

What may interact with this medicine?
• Due to the nature of the medication, Tirzepatide may slow gastric emptying. This could interfere with the breakdown of other medications.
• Drug interactions exist with this medication.
• Of note: Tirzepatide may delay absorption of oral contraception; decreased efficacy possible.
• Discuss your medication regimen with your health care provider to determine the best therapy for you.

What side effects may I notice from receiving this medicine?
Side effects that may occur and may go away as your body gets used to the medication include:
• Gastrointestinal issues, such as:
• Decreased appetite
• Increases in serum amylase and serum lipase
• Abdominal pain or stomach upset
• Constipation or diarrhea
• Nausea or vomiting
• Dyspepsia
• Sinus tachycardia

What serious side effects prompt immediate attention?
Contact your doctor immediately or seek medical attention if you experience:
• Neck mass
• Trouble breathing or swallowing
• Vocal hoarseness that will not go away
• Kidney problems or urinary complications
• Gallbladder problems
• Very rapid heart rate
• 15 beats or more per minute from baseline may occur within 4 weeks of therapy onset
• Eyesight changes
• Severe dizziness
• Signs of low blood sugar
• Inflammation of the pancreas
• Worsening behavioral or mood changes like depression or thoughts of self-harm You may experience side effects not listed. Contact your doctor with questions.
An allergic reaction to this medication is unlikely but seek medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, and/or trouble breathing.

Contraindications:
Hypersensitivity to Tirzepatide, or any component of the formulation. Tirzepatide is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia, type 2 (MEN 2).

Where should I keep my medicine?
• Follow the storage recommendations found on your prescription label.
• Store injectables at refrigeration, between 36 to 46 degrees F, unless otherwise specified on the packaging.
• Protect injectables from light.

Additional Information:
• Do not share this medication with others to whom it was not prescribed.
• Keep out of reach of children and pets.
• If an overdose is suspected contact your local poison control center at 1-800-222-1222 or go to the nearest emergency room.

If you have any questions concerning this or any of your medications, contact your doctor or the pharmacy during normal business hours to answer your questions.
You may report side effects to the FDA at 1-800-FDA-1088.

**Patient Education Resources**
Understanding Obesity:
– CDC on Obesity (https://www.cdc.gov/obesity/)
– National Institute of Diabetes and Digestive and Kidney Diseases (https://www.niddk.nih.gov/health-information/weight-management)

Healthy Lifestyle Tips:
– ChooseMyPlate (https://www.choosemyplate.gov/)
– American Heart Association (https://www.heart.org/en/healthy-living)

Weight Loss Support:
– Choosing a Safe & Successful Weight loss Program ( https://www.niddk.nih.gov/health-information/weight-management/choosing-a-safe-successful-weight-loss-program)
– Obesity Action Coalition (https://www.obesityaction.org/)

**Prescriber/Doctor Information**
Melanie Maltese, NP: Extensive experience in managing chronic conditions like obesity. Committed to providing personalized and evidence-based care to each patient.

**Contact Information**
For any questions or concerns, please reach out to us:
– Phone: 208-887-4872
– Email: info@healthyhabitswc.com
– Physical Address: 14 S Baltic Pl, Meridian, ID 83642

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medication or any other medication. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does not include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. For questions about the source of any of the information provided herein, pharmacists at Belmar Pharmacy are available. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of this medicine.

NIOSH Drug: Observe special handling and disposal requirements.
Do not flush down a toilet or pour down a drain. Check with your pharmacist if you have questions about the best way to dispose of medications. There may be a drug take-back program in your area.

References:
1. Clinical Resource, Comparison of GLP-1 Agonists. Pharmacist’s Letter/Prescriber’s Letter. August 2019.
• Tirzepatide. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.lexi.com. Accessed April 2023.