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Amjevita Side Effects: What You Should Know
Amjevita can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
In clinical trials, most people took Amjevita at a dosage of 40 milligrams (mg) every other week. Here are just a few of the more common side effects reported by people who took Amjevita in clinical trials:
* For more information about this side effect, see "Side effect specifics."
Mild side effects can occur with Amjevita use. This list doesn't include all possible mild side effects of the drug. For more information, you can refer to Amjevita's prescribing information.
Mild side effects that have been reported with Amjevita include:
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while using Amjevita and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see "Side effect specifics."
Amjevita may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Amjevita's prescribing information.
If you develop serious side effects while receiving Amjevita, call your doctor right away. If the side effects seem life threatening or you think you're having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
* For more information about this side effect, see "Side effect specifics."
ALLERGIC REACTION
For some people, Amjevita injection can cause an allergic reaction.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They'll also let you know whether you should keep using the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you've had a serious allergic reaction to Amjevita injection, your doctor may recommend using a different medication instead.
Amjevita may cause several side effects. Here are some frequently asked questions about the drug's side effects and their answers.
Can Amjevita cause weight loss?
Amjevita has not been reported to cause weight loss. However, some of Amjevita's side effects, such as infections and cancer, can cause weight loss as a symptom.
If you have unintended weight loss while receiving Amjevita, talk with your doctor. They can help determine the possible cause.
Is hair loss a side effect of Amjevita?
It's not likely. Hair loss wasn't a side effect seen during clinical trials of Amjevita. There have been reports of this side effect in people using Amjevita, but it's unclear how often this has happened or if Amjevita was the cause.
If you have hair loss while using Amjevita, talk with your doctor. They can help determine the possible cause.
Learn more about some of the side effects that Amjevita may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Amjevita.
Risk of serious infections
Amjevita has a boxed warning about the risk of serious infections. A boxed warning is the most serious warning from the FDA.
Amjevita weakens your immune system and makes it harder for your body to fight infections. Because of this, Amjevita can raise your risk of serious infections. These infections may need treatment in the hospital and, on rare occasions, can be fatal. Examples include pneumonia, tuberculosis (TB), infections that spread throughout the body, and sepsis.
In clinical trials, serious infections weren't common in people using Amjevita.
Symptoms of serious infections depend on the type of infection but can include:
You may have a higher risk of serious infections if you use Amjevita with other medications that weaken your immune system. Examples include methotrexate (Trexall, Otrexup) and corticosteroids such as prednisone (Rayos). You may also have a higher risk if you have a condition that raises your risk of infections, such as diabetes.
What you can do
Before you start using Amjevita, tell your doctor if you have any active infections or infections that keep coming back. Also, talk with your doctor about infections you've had in the past. In particular, tell your doctor if you have ever had TB or hepatitis B. Your doctor may test you for these infections before prescribing Amjevita. Your doctor may prescribe medication to treat any infections you have before starting Amjevita treatment.
If you develop symptoms of an infection during Amjevita treatment, talk with your doctor right away. If you have an infection, your doctor may prescribe medication to treat it. If you develop a serious infection, your doctor will likely have you stop using Amjevita.
If you have questions or concerns about the risk of infections with Amjevita, talk with your doctor or pharmacist.
Increased risk of certain cancers
Amjevita has a boxed warning about the risk of certain cancers. A boxed warning is the most serious warning from the FDA.
Because Amjevita weakens your immune system, it can raise your risk of developing certain cancers. Examples include skin cancer, lymphoma, and leukemia.
Rare cancers, including lymphoma, have been reported in children and teenagers taking drugs similar to Amjevita. These drugs are called tumor necrosis factor (TNF) blockers. In some cases, these cancers were fatal.
Also, a rare, aggressive type of lymphoma has been reported in teenage and young adult males* receiving TNF blockers for inflammatory bowel disease. Most cases occurred in those receiving a TNF blocker with azathioprine (Azasan, Imuran) or mercaptopurine (Purinethol, Purixan). Many of these cancers were fatal.
Symptoms of cancer depend on the type of cancer but can include:
Certain factors may raise your risk of developing cancer while using Amjevita. For example, you may have a higher risk if you've ever smoked or have had cancer in the past. You may also have a higher risk if you've had past treatment with phototherapy or with other medications that weaken your immune system.
* Sex and gender exist on spectrums. Use of the term "male" in this article refers to sex assigned at birth.
What you can do
Before starting Amjevita treatment, talk with your doctor about any risk factors you may have for cancer. This can help your doctor determine whether Amjevita is safe for you.
Your doctor will monitor you closely for signs of cancer during your Amjevita treatment. See your doctor right away if you develop any changes in your skin or any other possible symptoms of cancer.
If you have questions or concerns about the risk of cancer with Amjevita, talk with your doctor or pharmacist.
Injection site reactions
You may have injection site reactions while using Amjevita. These are mild side effects that occur in the area where you inject the medication. In clinical trials, injection site reactions were the most common side effect of Amjevita.
Symptoms of injection site reactions can include:
What you can do
You should not inject Amjevita yourself unless you have received training on the correct way to inject the medication.
To help avoid injection site reactions, you should inject Amjevita in a slightly different place each time you take a dose. Always choose a healthy area of skin. Do not inject into skin that's hard, swollen, tender, red, discolored, or bruised. Also, avoid places with scars or stretch marks.
If you have an injection site reaction after injecting Amjevita, this will usually go away in a few days. To ease discomfort, it may help to apply a cool pack to the area.
If you have an injection site reaction that doesn't get better in a few days, talk with your doctor.
Below is important information you should consider before using Amjevita.
Amjevita has boxed warnings about the risk of serious infections and certain cancers. A boxed warning is the most serious warning from the FDA. For details, see the "Side effect specifics" section above.
Other precautions
Before using Amjevita, discuss your health history with your doctor. Amjevita may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
A New Kind Of Drug For Schizophrenia Promises Fewer Side Effects
For the first time in decades, the Food and Drug Administration has approved a new type of drug for schizophrenia.
The twice-a-day pill to be marketed by Bristol Myers Squibb will be called Cobenfy, though it had been referred to as KarXT during development. Its main advantage is that it appears to have fewer side effects than current medicines.
That difference has captured the attention of patients like Tiffany, a librarian in Oklahoma. She asked us to use only her first name because of the stigma associated with schizophrenia.
When she was first put on an antipsychotic drug, she says it made her feel like a zombie. Watching a video of her birthday party that year, she didn't recognize herself.
"I was opening presents — everyone was happy. And I'm just sitting there like, there's nothing going on. Like, I'm staring at a blank wall," she says. "And so I lied and I told everyone I was better."
So she stopped taking the drug and basically white-knuckled it for years until she experienced another psychotic episode.
Then, she played what she calls the "meds game," trying different pills until one worked for her. But some of the side effects were brutal. Common antipsychotic drugs can cause weight gain and increase the risk for diabetes.
One gave Tiffany a movement disorder.
"So I was pacing in my office for eight hours a day, and it is exactly 3 1/2 steps, turn, 3 1/2 steps, turn," she says. "It was a nightmare."
Decades of dopamine-focused drugsSince the first antipsychotic drug was introduced in the 1950s, the subsequent medications to treat psychosis act on the same chemical that helps the brain communicate with the rest of the body: dopamine.
"The dopamine hypothesis proposed that schizophrenia is associated with excessive dopamine neurotransmission — so too much dopamine activity," says Dr. Ann Shinn, a psychiatrist who directs clinical research on schizophrenia and bipolar disorder at McLean Hospital near Boston.
Dopamine is the neurotransmitter usually associated with reward and learning, but it actually has a lot of functions. It also plays a role in controlling movement, for example — that's why that one drug made Tiffany pace.
The new drug targets different brain receptorsCobenfy is the first new medicine for psychosis that does not act on dopamine.
"I became really interested in schizophrenia and through that work became really interested in the idea of targeting muscarinic receptors because here was a serendipitous clinical finding that suggested potential efficacy, which is really hard to come by in psychiatry," says the drug's lead inventor, Andrew Miller.
He's talking about a 1997 study in Alzheimer's patients of a drug that was shelved even though it reduced psychosis.
The muscarinic receptors got their name because they respond to muscarine, a chemical in some mushrooms. The problem for developing a drug to activate them in the brain is that they can trigger receptors in the gastrointestinal tract. Patients couldn't tolerate it.
So Miller and his team decided to add a second medicine — one already used for overactive bladder — to shut down the gastrointestinal receptors. The trick: That medication can't cross into the brain from the blood.
That means it shuts down the muscarinic receptors in the body but doesn't stop the first drug from doing its job in the brain.
"Basically Karuna kind of did this brilliant thing of putting it all together in a combination drug," Shinn says.
She's talking about Miller's company, Karuna Therapeutics, which was acquired by pharmaceutical heavyweight Bristol Myers Squibb for $14 billion dollars earlier this year.
How much it will cost?Bristol Myers Squibb says the drug will be available starting in October at $1,850 a month, which is in line with other schizophrenia treatments. It's unclear how easy it will be for patients to get insurance coverage for Cobenfy.
"If it's like a lot of the other new medications, insurance is generally going to mandate that people try at least two generic medicines first … before they will pay for it," says Dr. Jacob Ballon, an associate professor of psychiatry at Stanford University.
Still, he has a lot of patients — and their parents — who are excited about a potential new treatment option, he says. Ballon is working on an ongoing study of how Cobenfy fits in with existing drugs and whether they can be used together.
While the new medicine isn't for everyone, it could help patients who've had trouble with existing treatments.
The FDA based its approval on 5-week double-blind, placebo-controlled studies. That means some patients received Cobenfy and others got a placebo, but neither the patients nor the clinicians knew which was which until the study was over. The short study length has prompted some experts to point out that questions remain about the drug's long-term safety and efficacy.
Common side effects with Cobenfy include nausea, constipation and rapid heartbeat.
As for Tiffany, she's interested in trying the drug down the road. Unlike previous drugs which only tackled the so-called positive symptoms of schizophrenia, like hallucinations and delusions, Cobenfy has been shown to decrease the "negative" symptoms, such as apathy and lack of motivation.
"Every time I have an episode, I lose bits of myself and bits of functionality … and that's not fair to my husband, and I hate it," she says. "So if I could have something that would help me have a little bit more initiative, that would be wonderful."
She also has some advice for people with schizophrenia who are still searching for the right treatment.
"Just keep trying," she says. "It's really hard to go on and off medications, but when you find the right one, it makes a huge difference — night and day."
Copyright 2024 NPR
Role Of Vasopressin And Hormonal Effects
Vasopressin is a naturally occurring hormone produced by a part of the brain known as the hypothalamus. It serves several essential functions, including maintaining the balance of fluids in the body, normalizing blood pressure, and regulating the sleep-wake cycle. It also influences emotions and behavior like fear, anxiety, protectiveness, and love.
In medicine, a synthetic version called Vasostrict is given in emergencies to raise blood pressure in people who have gone into shock. In addition to its approved use, Vasostrict is sometimes taken off-label to treat gastrointestinal bleeding, bleeding disorders, and other medical conditions.
Vasostrict is administered by injection, typically in a hospital or clinical setting. Sometimes, people with vasopressin deficiency self-administer it.
Kinga Krzeminska / Getty Images
Vasopressin Hormone Functions and Effects Vasopressin, also known as antidiuretic hormone (ADH), has two main functions: reducing the amount of urine released by the kidneys and helping raise blood pressure. Vasopressin is produced by the hypothalamus, the part of the brain responsible for maintaining a state of equilibrium in the body, known as homeostasis. Once made, it is stored in and secreted by the pituitary gland (also known as the "master gland"). Vasopressin is released as needed to keep key organ systems stable and balanced. Its mechanism of action—meaning the way it acts on the body—varies by the organ system. Regulation of Body Fluids Vasopressin is responsible for maintaining the normal balance of fluids around cells, referred to as tonicity. If fluid levels become low, the blood will become more concentrated. In response, the pituitary gland secretes vasopressin, causing the kidneys to reabsorb water and return it to circulation. Vasopressin does so by increasing the permeability (porousness) of renal tubules. These are millions of tiny tubes in the kidneys that filter nutrients, fluids, and other substances from your blood that your body needs to keep. The remaining fluid and waste are excreted in the form of urine. By increasing permeability, vasopressin can return the tonicity of body fluids to normal. Regulation of Blood Pressure Vasopressin is also a potent vasoconstrictor that acts on smooth muscles surrounding blood vessels, causing them to narrow (constrict). If blood pressure suddenly drops, vasopressin released by the pituitary gland will attach to receptors on the outside of blood vessels (called V1a receptors), causing vasoconstriction. By decreasing the internal volume of blood vessels, blood pressure can rise back to normal levels. Vasopressin also influences blood pressure by keeping the volume of water in your blood consistent. Too much water can increase the internal pressure within blood vessels, leading to high blood pressure, while too little water can have the opposite effect, leading to low blood pressure. The modulating effect of vasopressin can help keep blood pressure from fluctuating excessively. Effects on the Brain Vasopressin is also a central neurotransmitter, meaning a chemical messenger that acts on the central nervous system (comprised of the brain and spinal cord). Its action on the brain is centered around a part of the hypothalamus, called the suprachiasmatic nucleus, that regulates circadian rhythms in the body. Circadian rhythms are part of the body's internal clock, running in the background so that biological processes occur at the correct time, day or night, to keep the body functioning. Chief among these is the body's sleep-wake cycle. Without circadian rhythms, the body's ability to maintain homeostasis—including functions like sleep, appetite, digestion, body temperature, and hormone release—would be severely compromised. Effect on Mood and Behaviors Vasopressin also acts on parts of the brain called the prefrontal cortex (the brain's "personality center") and amygdala (which processes emotion), where it is thought to influence social and emotional states, including fear, anxiety, and aggression. This seems especially true in males. Some scientists even contend that vasopressin—and a related hormone also produced by the hypothalamus called oxytocin—may be directly or indirectly involved with anxiety disorders and autism. With that said, vasopressin is also thought to promote vigilance and protective instincts that can increase emotional bonding and social attachment. In tandem with oxytocin, which provokes feelings of contentment and security, the effect of vasopressin on social behavior is regarded by some as the biological metaphor for "love." Other Effects Vasopressin is also associated with nausea and may serve to trigger the vomiting reflex (emesis) when there is a gastrointestinal illness or poisoning. Vasopressin is also known to act on the pancreas and increase the production of insulin, the hormone that helps regulate blood sugar. Persistently high levels of vasopressin are associated with an increased risk of diabetes. Normal vs. Abnormal Vasopressin Release The underproduction or overproduction of vasopressin can have serious health consequences. Chief among these is the disruption of sodium levels in the blood. Abnormally high or low sodium levels cause fluid retention and also disrupt vital functions like heart rhythms and muscle contractions. Low Vasopressin Large amounts of diluted urine and excessive thirst (polydipsia) are characteristic of a group of conditions formerly known as diabetes insipidus. This included "central diabetes insipidus" associated with vasopressin production and "nephrogenic diabetes insipidus" associated with vasopressin response. Today, these conditions are respectively described as: Arginine vasopressin deficiency (AVD): This is when the hypothalamus or pituitary gland is damaged by a head injury, brain tumor, surgery, or other diseases or conditions, preventing the production or secretion of vasopressin. Arginine vasopressin resistance (AVR): This is when the kidneys do not respond to the effects of vasopressin. This may be caused by an inherited disorder or a disease or medication that makes renal tubules insensitive to vasopressin, even when there is plenty of vasopressin. Both AVD and AVR cause excessive urination, which can lead to abnormally high blood sodium levels, known as hypernatremia. Symptoms of hyponatremia include nausea, vomiting, thirst, restlessness, muscle twitches, spasms, confusion, and, in severe cases, intracranial bleeding. High Vasopressin Overstimulation of the hypothalamus can lead to a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which excessive amounts of vasopressin are produced, leading to decreased urination. Many different things can cause SIADH, some of which include: Disorders of the brain, such as head injury, infection, or stroke Brain surgery in the area of the hypothalamus Exposure to general anesthesia Diseases like tuberculosis, cancer, and HIV Substance use disorder Certain drugs, including anticonvulsants, antidepressants, and chemotherapy The overproduction of vasopressin dilutes sodium levels as excessive amounts of water are retained, leading to hyponatremia. Symptoms of hyponatremia include nausea, vomiting, headaches, loss of appetite, balance problems, mental changes, and, in severe cases, seizures and coma. Persistently high vasopressin levels can also increase insulin production. Over time, this can reduce the body's sensitivity to insulin, resulting in glucose intolerance and type 2 diabetes. Complications Certain progressive kidney and heart diseases can lead to organ damage or failure due to SIADH and the overproduction of vasopressin. These include: Polycystic kidney disease (PKD): This is a condition characterized by frequent urination and progressive kidney injury. To compensate for the fluid loss, the pituitary gland will release more vasopressin. However, as kidney damage mounts, the reabsorbed fluid can start to accumulate in the kidneys themselves, causing irreversible kidney damage and kidney failure. Congestive heart failure (CHF): This is when the heart cannot pump enough blood to service the body's needs. To compensate for the loss of circulating blood, the body will release two to three times more vasopressin than normal. The ensuing rise in blood pressure can cause cardiomyopathy (stiffening of the heart muscle), contributing to end-stage heart failure. When to Consider Vasopressin Injections A synthetic version of the hormone can replicate the effects of natural vasopressin and be prescribed for different medical purposes. The synthetic version has been taken for more than 100 years and was initially released under the brand name Pitressin. The U.S. Food and Drug Administration (FDA) has licensed it under the brand name Vasostrict. Vasostrict has one approved use: treating vasodilatory shock. This is a form of shock, also known as distributive shock, which is characterized by excessive vasodilation (widening of blood vessels). As with other types of shock, vasodilatory shock causes a reduction of circulating blood, which deprives organs of the oxygen they need to survive. If not treated aggressively, vasodilatory shock can lead to multi-organ failure and death. Several types of shock fall under the umbrella of vasodilatory shock, including: Vasostrict treats vasodilatory shock by triggering rapid vasoconstriction, quickly restoring blood pressure before permanent organ damage can occur. Off-Label Uses Vasostrict has many off-label uses (applications not licensed by the FDA). These include managing vasopressin deficiency and treating or preventing severe bleeding conditions. Examples include: Surgeons will sometimes use Vasostrict to reduce the risk of bleeding during and after surgery. This is especially true for people with bleeding disorders who lack platelets or clotting factors to stem bleeding. Vasostrict is also sometimes used by nephrologists (kidney specialists) and endocrinologists (hormone specialists) to manage people with AVP. That said, an updated version of the drug molecule called DDVAP (desmopressin) is generally preferred as it has a longer drug half-life (12 hours versus six hours) and can also be taken as a tablet or nasal spray. DDVAP is currently licensed to treat central diabetes insipidus, hemophilia, and von Willebrand disease. Similarly, gastroenterologists or hepatologists (liver specialists) sometimes use Vasostrict to treat esophageal varices but tend to prefer a drug called Sandostatin (octreotide), which has fewer serious side effects. How to Administer Vasopressin Injections Vasostrict is typically given intravenously (into a vein) but is also sometimes delivered subcutaneously (under the skin) for the management of AVD. The method of administration varies by the condition: Vasodilatory shock: Vasostrict is diluted with saline or dextrose water and delivered via an intravenous (IV) drip. Esophageal variceal bleeding: Vasostrict is delivered for this condition similarly to shock, albeit at a higher dose. Nitroglycerin delivered by IV is taken to help lower the risk of side effects. Cardiac arrest: Vasostrict is typically combined with epinephrine (adrenaline) to restart a heart that has stopped entirely. Bleeding disorders: To reduce the risk of bleeding during or after surgery, Vasostrict is diluted with saline and delivered by IV drip, typically at a lower dose than for shock. Vasopressin deficiency: Vasostrict can be self-administered with daily subcutaneous injections or given intravenously in a clinic to manage AVD. Though it's useful in people with AVD, it is not used for those with AVR because their kidneys are nonresponsive to vasopressin. Side Effects to Monitor As with all medications, Vasostrict can cause side effects, some of which may be severe. Given that the drug is frequently used in emergencies, the benefits tend to outweigh the risks. If used for the management of AVD, speak with a specialist to make an informed choice. Side effects commonly seen with intravenous Vasostrict include: Headaches Fatigue Shortness of breath Abdominal pain Nausea or vomiting Dizziness or balance problems Easy bruising or nosebleeds Abnormally slowed breathing Heart palpitations Irregular or rapid heartbeats Swelling of the lower legs and feet Confusion or mental changes Skin lesions Seizures In addition, people may experience temporary AVD, leading to hypernatremia. Tapering the dose after the blood pressure is normalized may help reduce the risk. The only absolute contraindication to Vasostrict is a known severe allergy to synthetic vasopressin or chlorobutanol (a preservative used in the Vasostrict formulation). Though Vasostrict's effect on a fetus during pregnancy is unknown, studies suggest that it may induce uterine contractions, potentially leading to miscarriage or preterm birth. Its safety in children, nursing babies, and older adults has also not been established. Summary Vasopressin is a hormone that the hypothalamus produces and the pituitary gland secretes. It slows down urine output and causes blood vessels to constrict. By doing so, it can maintain the normal balance of fluids in the body, regulate blood pressure, and maintain circadian rhythm and overall homeostasis. It also influences behaviors and emotions like fear, vigilance, and love. Vasopressin is also manufactured as an injectable drug called Vasostrict, which can treat vasodilatory shock. It can also be prescribed off-label to manage vasopressin deficiency, prevent postoperative or intraoperative bleeding, and treat bleeding disorders, esophageal variceal bleeding, or cardiac arrest.
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