Orforglipron

Orforglipron may increase the risk that you will develop thyroid gland tumors, including thyroid cancer. Orforglipron caused tumors in rats. It is not known if this medication increases the risk in humans. Tell your doctor if you or anyone in your family has or has ever had thyroid tumors, thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to take orforglipron. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of taking orforglipron.

Orforglipron is used to assist with weight loss and maintenance in certain people who are obese or overweight and have weight-related medical problems. Orforglipron is in a class of medications called incretin mimetics. It works by slowing the emptying of the stomach and may decrease appetite and cause weight loss.

Orforglipron comes as a tablet to take by mouth. Take once a day, with or without food. Take orforglipron at around the same time every day.

Take orforglipron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of orforglipron and gradually increase your dose, not more than once every 30 days.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking orforglipron,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know some medications should not be taken with orforglipron. Other medications may cause dosing changes or extra monitoring when taken with orforglipron. Make sure you have discussed any medications you are currently taking or plan to take before starting orforglipron with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking orforglipron, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with orforglipron: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking orforglipron. Do not start any of these medications while taking orforglipron without discussing with your healthcare provider.
• you should know that orforglipron may decrease the effectiveness of oral hormonal contraceptives (birth control pills). You will need to use another method of birth control to prevent pregnancy for 30 days after you start treatment. You will also need to use another method of birth control for 30 days after each increase in your dose of orforglipron. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• tell your doctor if you have or have ever had pancreatitis (inflammation of the pancreas); diabetes; diabetic retinopathy (damage to the eyes caused by diabetes); severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine) or other problems digesting food; or gall bladder, liver, or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking orforglipron, call your doctor.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking orforglipron.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking orforglipron.
• this medication may cause changes in your blood sugar. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, irritability, sweating, hunger, drowsiness, shakiness, weakness, headache, slurred speech, blurred vision, fast heart rate and feeling jittery. You should know the symptoms of low blood sugar and what to do if you have these symptoms.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss 7 or more daily doses in a row, call your doctor.

Orforglipron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• heartburn
• stomach pain
• gas
• burping
• unusual tiredness
• hair loss
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking orforglipron and call your doctor immediately or get emergency medical treatment:

• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
• rash; hives; itching; swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; dizziness; fainting; or fast heartbeat
• vision changes
• pain in the right or upper middle stomach area, fever, clay-colored stools, or yellowing of skin or eyes

Orforglipron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to orforglipron.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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