Description
Drug Info: ApoThera Drug Disease Clinical Support App
Storage
– Refrigerate at 2-8ºC (36-46ºF)
– If needed, each single-dose pen can be stored unrefrigerated at temperatures not to exceed 30ºC (86ºF) for up to 21 days
– Do not freeze
– Protect from light
– If needed, each single-dose pen can be stored unrefrigerated at temperatures not to exceed 30ºC (86ºF) for up to 21 days
– Do not freeze
– Protect from light
Missed Dose
<4 Days (96 hr)
– Administer as soon as possible after missed dose
– Administer as soon as possible after missed dose
>4 days
– Skip missed dose and administer next dose on regularly scheduled day
– In each case, patients can resume their regular once weekly dosing schedule
– Skip missed dose and administer next dose on regularly scheduled day
– In each case, patients can resume their regular once weekly dosing schedule
How Zepbound Works
SC Administration
– Administer SC in abdomen, thigh, or upper arm
– Rotate injection site with each dose
– Administer once weekly, at any time of day, with or without meals
– Change day of weekly administration: May be changed, if necessary, as long as time between the 2 doses is at least 3 days (72 hr)
– Rotate injection site with each dose
– Administer once weekly, at any time of day, with or without meals
– Change day of weekly administration: May be changed, if necessary, as long as time between the 2 doses is at least 3 days (72 hr)
SC Preparation
– Inspect visually before use
– Solution should appear clear and colorless to slightly yellow; discard if particulate matter or discoloration observed
– Solution should appear clear and colorless to slightly yellow; discard if particulate matter or discoloration observed
The Most Common Side Effects
– Nausea
– Diarrhea
– Decreased appetite
– Vomiting
– Constipation
– Indigestion
– Stomach (abdominal) pain
– The most common adverse reactions reported in ≥5% of Zepbound-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Kidney Problems (Kidney Failure)
– In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse
– It is important for you to drink fluids to help reduce your chance of dehydration
– Zepbound has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which if severe could cause acute kidney injury. In patients treated with GLP-1 receptor agonists, there have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Zepbound in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Severe Stomach Problems
– Stomach problems, sometimes severe, have been reported in people who use Zepbound
– Tell your healthcare provider if you have stomach problems that are severe or will not go away
Changes in Vision
– Tell your healthcare provider if you have changes in vision during treatment with Zepbound.
– Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.
– Zepbound has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema
– Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Gallbladder Problems
– Gallbladder problems have happened in some people who use Zepbound
– In clinical trials, acute gallbladder disease was reported by 0.6% of Zepbound-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated
– Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
- pain in your upper stomach (abdomen)
- fever
- yellowing of skin or eyes (jaundice)
- clay-colored stools
Low Blood Sugar (Hypoglycemia)
– Your risk for getting low blood sugar may be higher if you use Zepbound with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin
– Signs and symptoms of low blood sugar may include:
- dizziness or light-headedness
- sweating
- confusion or drowsiness
- headache
- blurred vision
- slurred speech
- shakiness
- fast heartbeat
- anxiety, irritability, or mood changes
- hunger
- weakness
- feeling jittery
– Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia
– The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin.
– Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Inflammation of Pancreas (Pancreatitis)
– Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Zepbound clinical trials. Zepbound has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Zepbound. Observe patients for signs and symptoms, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Zepbound and initiate appropriate management.
Pregnancy
– Tell your healthcare provider if you are pregnant or plan to become pregnant
– Tell your healthcare provider if you become pregnant while using Zepbound
– Limited data on Zepbound use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
– Based on animal reproduction studies, there may be risks to the fetus from exposure to Zepbound
– Use only if potential benefit justifies the potential risk to the fetus
- Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).
Lactation
– It is not known if Zepbound passes into your breast milk
– Talk to your healthcare provider about the best way to feed your baby while using Zepbound
– There are no data on the presence of Zepbound in human milk, the effects on the breastfed infant, or the effects on milk production.
– The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zepbound and any potential adverse effects on the breastfed infant from MOUNJARO or from the underlying maternal condition
Females of Reproductive Potential
– Birth control pills by mouth may not work as well while using Zepbound
– If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound
– Talk to your healthcare provider about birth control methods that may be right for you while using Zepbound
– Advise females using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.
Active Ingredient
– Tirzepatide (Zepbound)
Inactive Ingredients
Inactive Ingredients
– Sodium chloride
– Sodium phosphate dibasic heptahydrate
– Water for injection
– Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH
Contraindications
– A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
– Known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Zepbound
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