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ZEGALOGUE^® (dasiglucagon) injection 0.6 mg/0.6 mL is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 6 years and older. It is not known if ZEGALOGUE^® is safe and effective in children under 6 years of age.

Do not use ZEGALOGUE^® if you:

• have a tumor called pheochromocytoma in the gland on top of your kidneys (adrenal gland).
• have a tumor called insulinoma in your pancreas.

Before using ZEGALOGUE^®, tell your healthcare provider about all of your medical conditions, including if you:

• have a tumor in your pancreas.
• are allergic to dasiglucagon, or any other ingredients in ZEGALOGUE^®.
• have not had food or water for a long time (prolonged fasting or starvation).
• have adrenal insufficiency.
• have low blood sugar that does not go away (chronic hypoglycemia).
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if ZEGALOGUE^® passes into your breast milk. You and your healthcare provider should decide if you can use ZEGALOGUE^® while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Read the detailed Instructions For Use that come with ZEGALOGUE^®.
• Use ZEGALOGUE^® exactly how your healthcare provider tells you to use it.
• Make sure your caregiver knows where you keep your ZEGALOGUE^® and how to use ZEGALOGUE^® the right way before you need it.
• Your caregiver must act quickly. Having very low blood sugar for a period of time may be harmful.
• Your healthcare provider will tell you how and when to use ZEGALOGUE^®.
• After giving ZEGALOGUE^® your caregiver should call for emergency medical help right away.
• Once you are able to safely consume food or drink, your caregiver should give you a fast-acting source of sugar (such as fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
• If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.
• Tell your healthcare provider each time you use ZEGALOGUE^®. Your healthcare provider may need to change the dose of your other diabetes medicines.

ZEGALOGUE^® may cause serious side effects, including:

• high blood pressure. ZEGALOGUE^® can cause high blood pressure in certain people with tumors in their adrenal glands.
• low blood sugar. ZEGALOGUE^® can cause certain people with tumors in their pancreas called insulinomas to have low blood sugar.
• serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including: rash, difficulty breathing, low blood pressure (hypotension).

The most common side effects of ZEGALOGUE^® include: in adults: nausea, vomiting, headache, diarrhea, and injection site pain; in children: nausea, vomiting, headache, and injection site pain. These are not all the possible side effects of ZEGALOGUE^®.

Please see Prescribing Information for ZEGALOGUE^®.

Wegovy^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy^® and medicines that work like Wegovy^® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
• Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Wegovy^® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:

• to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
  
• that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.

Wegovy^® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

It is not known if Wegovy^® is safe and effective for use in children under 12 years of age.

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy^®

• have or have had problems with your pancreas or kidneys
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or mental health issues
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• are pregnant or plan to become pregnant. Wegovy^® may harm your unborn baby. You should stop using Wegovy^® 2 months before you plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Wegovy^® passes into your breast milk
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy^® may affect the way some medicines work and some medicines may affect the way Wegovy^® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Wegovy^® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Wegovy^® 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
• gallbladder problems. Wegovy^® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
• increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy^®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
• 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
• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy^®. Tell your healthcare provider if you have stomach problems that are severe or will not go away
• serious allergic reactions. Stop using Wegovy^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy^®
• increased heart rate. Wegovy^® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy^® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy^® before you are scheduled to have surgery or other procedures

The most common side effects of Wegovy^® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.

Rivfloza^® (nedosiran) injection 80 mg, 128 mg, or 160 mg is a prescription medicine used to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.

It is not known if Rivfloza^® is safe and effective in children younger than 9 years of age.

The most common side effects of Rivfloza^® include injection site reactions, such as reddening, pain, bruising, rash, or dimple at the site of injection.

Please see Rivfloza^® Prescribing Information.

Rivfloza^® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
 

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
• you have cancer or other tumors
• you are allergic to somapacitan-beco or any of the ingredients in Sogroya^®
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes
• you are a child with closed bone growth plates
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep)

• Sogroya^® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body. 
• It is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.

Before taking Sogroya^®, tell your healthcare provider about all of your medical conditions, including if you:

• have had heart or stomach surgery, trauma, or serious breathing problems
• have had cancer or any tumor
• have diabetes
• have adrenal gland problems
• are taking replacement therapy with glucocorticoids
• have thyroid gland problems
• have liver problems
• are a child with a history of worsening of curvature of the spine (scoliosis)
• are pregnant or plan to become pregnant. It is not known if Sogroya^® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Sogroya^® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya^® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya^® may affect the way some medicines work, and some medicines may affect how Sogroya^® works.

• Use Sogroya^® exactly as your healthcare provider tells you to
• Use Sogroya^® 1 time each week
• If you miss a dose of Sogroya^®, the missed dose can be taken within 3 days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day
• If more than 3 days (72 hours) have passed, skip the missed dose, and take your next dose on the regularly scheduled dosing day
• Sogroya^® pens are for use by 1 person only
• Do not share your Sogroya^® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

Sogroya^® may cause serious side effects, including:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. You or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin
• new or worsening high blood sugar or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya^®
• increase in pressure in the skull. If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider
• serious allergic reactions. Get medical help right away if you or your child have the following symptoms: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
• your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet. Tell your or your child’s healthcare provider if you or your child have any of these signs or symptoms of fluid retention
• decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child have darkening of the skin, severe fatigue, dizziness, weakness, or weight loss
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Sogroya^® works. The healthcare provider will do blood tests to check you or your child’s thyroid hormone levels
• severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain
• loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject Sogroya^®
• worsening of curvature of the spine in children (scoliosis)
• hip and knee pain or a limp in children (slipped capital femoral epiphysis)
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
• increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You or your child’s healthcare provider will do blood tests to check this

The most common side effects of Sogroya^® in children include: common cold, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya^® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please see Prescribing Information for Sogroya^®.

Sogroya^® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

• Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
• Report any unusual vaginal bleeding right away while you are using Vagifem^®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
• Using estrogen-alone may increase your chances of getting strokes or blood clots. 
• Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
• Do not use estrogens with progestogens to prevent heart disease, heart attack, strokes, or dementia. 
• Using estrogens with progestogens may increase your chances of getting blood clots, strokes, heart attacks, or breast cancer. 
• Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older
• Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. 
• Because other products and doses have not been studied in the same way, it is not known how the use of Vagifem^® will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem^®.

Vagifem^® (estradiol vaginal inserts) 10 mcg is a prescription medicine that contains estradiol (an estrogen hormone) in a vaginal insert. Vagifem^® is used after menopause to treat moderate to severe menopausal changes in and around the vagina.

Do not start using Vagifem^® if you:

• have unusual bleeding
• have been diagnosed with a bleeding disorder
• currently have or have had certain cancers
• had a stroke or heart attack
• currently have or have had blood clots
• currently have or have had liver problems
• are allergic to Vagifem^® or any of the ingredients in it

Before you use Vagifem^®, tell your healthcare provider about all of your medical conditions, including if you:

• have any unusual vaginal bleeding
• have any other medical conditions that may become worse while you are using Vagifem^®
• are going to have surgery or will be on bed rest
• are pregnant or think you may be pregnant
• are breastfeeding

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious but less common side effects include: heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high and low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, high levels of fat (triglyceride) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, cancer changes of endometriosis, enlargement of benign tumors of the uterus (fibroids), worsening of swelling of face and tongue (angioedema) in women with a history of angioedema

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• new breast lumps
• unusual vaginal bleeding
• changes in vision or speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

Common side effects of Vagifem^® include headache, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

Please see Prescribing Information for Vagifem^®.

Vagifem^® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.