Description
Orforglipron is used together with diet and exercise to help lose weight and keep the weight off in patients with obesity or patients with at least one weight-related medical condition.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of orforglipron in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of orforglipron in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Apalutamide
- Boceprevir
- Bosentan
- Carbamazepine
- Cenobamate
- Ceritinib
- Chlorpropamide
- Clarithromycin
- Cobicistat
- Dabrafenib
- Desogestrel
- Dienogest
- Dipyrone
- Drospirenone
- Efavirenz
- Elagolix
- Encorafenib
- Enzalutamide
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etravirine
- Fosphenytoin
- Gestodene
- Glimepiride
- Glipizide
- Glyburide
- Idelalisib
- Indinavir
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Itraconazole
- Ivosidenib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Semaglutide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergic reaction (eg, anaphylaxis, angioedema) to other GLP-1 receptor agonists, history of—Use with caution. May increase the risk of this condition occurring again.
- Dehydration or
- Diabetic retinopathy, history of or
- Digestion problems or
- Gallbladder disease or
- Kidney disease or
- Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.
- Gastroparesis (stomach does not empty food normally), severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
- Thyroid cancer, history of—Should not be used in patients with these conditions.
- Surgery or other procedures that use anesthesia or deep sedation—May increase risk of pulmonary aspiration (food or liquid getting into the lungs) during surgery or other procedures.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not take more than 1 tablet per day. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the tablet whole. Do not break, crush, or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For weight management:
- Adults—At first, 0.8 milligrams (mg) once a day for 30 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 17.2 mg per day.
- Children—Use and dose must be determined by your doctor.
- For weight management:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, and it is 7 or more days, call your doctor to talk about how to restart your treatment.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor checks your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Birth control medicines may not work while you are using this medicine. Use an effective form of birth control for 30 days after starting treatment and for 30 days after each increase of dose of this medicine to avoid getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may cause severe stomach or bowel problems. Check with your doctor right away if you have belching, bloating or full feeling, blood in stools, constipation, diarrhea, excess air or gas in the stomach, hiccups, nausea, stomach pain, uncomfortable swelling around the anus, or vomiting.
This medicine may cause serious kidney problems, including acute kidney injury. Check with your doctor right away if you have bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use orforglipron with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Check with your doctor right away if you have blurred vision or any other changes in vision. These may be symptoms of diabetic retinopathy.
Check with your doctor right away if you have stomach pain, recurrent fever, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black or tarry stools
- bloating
- diarrhea
- heartburn
- nausea
- stomach pain or burning
- vomiting
Less common
- Anxiety
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- headache
- increased hunger
- nervousness
- nightmares
- recurrent fever
- seizures
- shakiness
- slurred speech
- stomach fullness
- sweating
- unusual tiredness or weakness
- yellow eyes or skin
Rare
- Agitation
- chest tightness
- cough
- decreased urine output
- difficulty swallowing
- hives, itching, skin rash
- hostility
- irritability
- lethargy
- muscle twitching
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- stupor
- swelling of the face, ankles, or hands
- trouble breathing
Incidence not known
- Changes in vision
- constipation
- dark urine
- fever
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- excess air or gas in stomach
- passing gas
- pressure in the stomach
- stomach discomfort or upset
- swelling of the stomach area
Less common
- Hair loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80010478
