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Abecma side effects and how to manage them

Abecma side effects and how to manage them

As with other drugs, Abecma can cause side effects, such as fever, fatigue, and muscle and bone pain. If side effects of Abecma become difficult to tolerate, talk with your doctor or pharmacist.Abecma (idecabtagene vicleucel) is a brand-name intravenous (IV) infusion that's prescribed for adults with multiple myeloma in certain situations.If you have problems with side effects from Abecma, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment options.Abecma has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the 'Boxed warnings for Abecma' section.»Learn more about Abecma, including details about its uses.More common side effects of AbecmaAbecma 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 persist, bother you, or become severe, be sure to talk with your doctor or pharmacist. These are just a few of the more common side effects reported by people who took Abecma in clinical trials:fevernauseaheadachemusculoskeletal paindiarrheainfectionfatiguechillsdifficulty breathingcytokine release syndrome (CRS)For more information about some of these side effects, see the 'Managing side effects' section and the 'Boxed warnings for Abecma' section.Mild side effects of AbecmaMild side effects can occur with Abecma use. This list may not include all possible mild side effects of the drug. To find out more, you can refer to Abecma's prescribing information.Mild side effects that have been reported with Abecma include:fever and chillsnausea and vomitingheadachemusculoskeletal paindiarrheaconstipationmild upper respiratory infection, such as the common coldfatigueskin rashedema (swelling from fluid retention)These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, worsen, or become too difficult to tolerate, be sure to talk with your doctor or pharmacist.Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during or after treatment with Abecma and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.For more information about some of these side effects, see the 'Managing side effects' section.Serious side effects of AbecmaAbecma may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Abecma's prescribing information.If you develop serious side effects during or after Abecma treatment, 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 include:severe infectionlow levels of immunoglobulins (antibodies)CRSneurologic toxicitieshemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)prolonged cytopenia (low blood cell levels)T-cell malignancies (cancers)For more information about some of these side effects, see the 'Boxed warnings for Abecma' section.Allergic reactionFor some people, Abecma can cause an allergic reaction, but it's not clear whether this side effect occurred in the drug's studies.In general, symptoms of allergic reaction can be mild or serious.Ways to manageFor mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms.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 dimethyl sulfoxide (DMSO), your doctor may recommend treatment with a different medication instead. (Abecma contains DMSO.)Boxed warnings for AbecmaAbecma has boxed warnings. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.Abecma is a type of cancer immunotherapy called CAR T-cell therapy. These therapies, including Abecma, carry certain serious risks. If you have questions about the following warnings, you can ask your doctor to provide more information.CRSAbecma may cause CRS, which occurs when the immune system suddenly releases a large number of cytokines into the bloodstream. Cytokines are special proteins that help your immune system work. But in large amounts, cytokines cause too much inflammation in your body. CRS can be mild to severe and even life threatening.CRS was common in studies of Abecma, causing symptoms such as fever, low blood pressure, and a fast heart rate. Some participants developed more severe symptoms. Tell your doctor right away if you develop symptoms of CRS during or after your Abecma infusion. Due to the risk of this side effect, your healthcare team will monitor you closely during and after your Abecma infusion and treat CRS if it occurs. CRS is typically treated with medications that reduce inflammation, including tocilizumab (Actemra) and corticosteroids. Neurologic toxicitiesAbecma may cause neurologic toxicities, which are side effects of the drug that affect the brain and nerves. Common side effects seen in Abecma's studies include mild headache, dizziness, and tremor. In rare cases, Abecma may cause serious and life threatening neurologic toxicity, such as seizures and encephalopathy (brain damage).Due to the risk of this side effect, your care team will check for signs and symptoms of neurologic toxicity every day for at least 7 days following your Abecma infusion. Tell your doctor right away if you develop any brain- or nerve-related symptoms during or after your Abecma infusion.Treatment for neurological toxicities usually includes medications, such as antiseizure drugs, to treat or help prevent symptoms.HLH/MASHLH/MAS is a rare, potentially life threatening condition resulting from widespread inflammation throughout the body.Signs and symptoms of HLH/MAS reported from Abecma use in studies include low blood pressure, low blood cell counts, hypoxia (low oxygen), and problems with multiple organs. HLH/MAS can be fatal without early recognition and treatment.Your care team will monitor you carefully and treat the condition if it occurs. Treatment varies depending on the specific symptoms and their severity. Doctors typically give medications that reduce inflammation and manage symptoms.Prolonged cytopeniaAbecma's treatment regimen, including chemotherapy, may cause long-lasting cytopenia (low blood cell counts). Depending on the cell type, low blood cell counts can cause anemia, an increased risk of infections, and bleeding.You'll have blood tests throughout treatment so your doctor can monitor your blood cell levels. If your counts become too low, they'll prescribe treatments to raise them, such as blood transfusions.T-cell malignanciesIt's possible to develop another type of blood cancer following Abecma treatment. (Abecma is used to treat multiple myeloma, which is a type of blood cancer.) Specifically, Abecma can cause T-cell malignancies (cancers), including acute myeloid leukemia. (T cells are a type of immune system cell.) T-cell malignancies were an uncommon side effect reported in studies of Abecma.Due to this risk, you'll have regular follow-up visits with your doctor to monitor for cancers after your Abecma treatment ends. Your doctor will likely recommend lifelong monitoring. If you have questions about the monitoring process, talk with your doctor about what to expect.Managing side effectsAfter receiving Abecma, you may be able to take steps to make side effects easier to manage. If you have problems with side effects that do not go away or they become worse, talk with your doctor or pharmacist. They can discuss options for managing side effects or other available treatment options.Musculoskeletal painMusculoskeletal pain was a common side effect reported in studies of Abecma. People reported the following symptoms: joint pain and stiffnessneck or back painbone painmuscle pain, strain, and stiffnessnoncardiac chest pain (chest muscle pain not involving the heart)Steps you can take to manage symptoms of mild pain include:taking over-the-counter (OTC) pain relieversapplying warm or cold compresses to the affected areastrying alternative remedies, such as acupunctureIf you experience more significant or ongoing pain, consider talking with your doctor about treatment options, such as prescription pain relievers. DiarrheaFor some people, Abecma can cause diarrhea. This side effect was common in studies of Abecma. Most cases were mild, but some people developed more severe diarrhea. Steps you can take to manage mild diarrhea include:avoiding certain foods or drinks that may cause diarrheadrinking water with electrolytes to help prevent dehydrationtaking OTC antidiarrheal medication, such as loperamide (Imodium)If these steps don't help or your diarrhea is severe, talk with your doctor about other possible causes. For example, certain infections can also cause diarrhea, and Abecma treatment increases your risk of infection. Your doctor can help determine the cause of diarrhea and recommend suitable treatment options.»Read more: Is it normal for diarrhea to last for a week?InfectionAbecma treatment can raise your risk of infection. Mild to severe infections caused by bacteria, viruses, and other microbes were commonly reported in studies of Abecma. Examples include upper respiratory infections and pneumonia. Symptoms vary widely depending on the type of infection, but may include:fever or chillsbody acheswet or dry coughsore throatdifficulty breathingdigestive tract issues, such as vomiting or diarrheaYour doctor will monitor you for infection. If you experience symptoms of an infection or think you have one, tell your doctor. They can order certain tests to help identify the underlying cause and determine whether treatment is necessary. Steps you can take to manage your risk of infection and treat symptoms include:avoiding people who have an infectionwashing your hands with soap and water frequentlywearing a mask in public placestaking OTC medications or trying home remedies for specific symptoms, such as fever»Learn more: 8 ways to avoid colds and the flu.Precautions for AbecmaTake note of the following important information to consider before receiving Abecma.Abecma has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the 'Boxed warnings for Abecma' section.Other precautionsBefore Abecma treatment, discuss your health history with your doctor. Abecma 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:active infections or inflammatory disorderspast infection with any of these viruses: hepatitis B virus (HBV) or HCVHIVcytomegalovirusprevious allergic reaction to this or a similar drugpregnancybreastfeedingDisclaimer: 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.
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My husband of 5 months went to bed with a headache and woke up having a seizure – doctors gave him 5% chance of living
My husband of 5 months went to bed with a headache and woke up having a seizure – doctors gave him 5% chance of living

The Sun

time40 minutes ago

  • The Sun

My husband of 5 months went to bed with a headache and woke up having a seizure – doctors gave him 5% chance of living

CAMI and Jake Bartel had been married just five months when their world was turned upside down. Just before bed one night in 2019, Jake, then 27, complained of a headache, nothing Cami, 23 at the time, thought much of. 8 8 8 The couple went to sleep as normal at their home in Chicago, and both hoped it would pass by morning. But at 4am on October 1, Cami woke to find Jake having a seizure right beside her in bed. 'I called 911 immediately. It was surreal, almost like watching someone else's life unravel,' said Cami, now 28. 'One moment we were planning our future, and the next I was rushing my 27-year-old husband to hospital without knowing if he'd survive.' What started as a simple headache had spiralled into a full-blown medical emergency overnight. By the time Jake was admitted, doctors were completely baffled. 'He didn't just have a seizure,' said Cami. 'There was also swelling on his brain, and that really scared everyone.' Medics initially suspected a severe viral or bacterial infection and ran urgent tests for everything from meningitis to West Nile virus. 'They told me they were checking for all kinds of infections,' she said. 'But every single test came back negative. It was like watching them search in the dark while Jake got worse.' With no clear answers and Jake's condition deteriorating rapidly, doctors prepared Cami for the worst. 'That's when they gave me the five per cent survival rate,' she says. 'They assumed it had to be some virus they just couldn't identify, but they weren't even considering anything beyond that. 'I was 22, sitting there, trying to process that my husband, who had been healthy just hours earlier, might not make it through the night.' But Jake, now 32, defied the odds and was discharged from hospital just two weeks later. However, the nightmare was far from over, as no one could explain what had happened or why. 8 8 'We went home with no diagnosis, just this overwhelming sense of fear mixed with relief,' said Cami. During the hospital stay, one resident doctor had mentioned MELAS, a rare mitochondrial disorder that usually appears in childhood. At 27, Jake didn't fit the profile so most doctors brushed it off, but the couple agreed to genetic testing, just in case. Then, at the end of 2019, they got the call that would change everything: Jake tested positive for MELAS - Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes. 'It felt like someone had pulled the rug from under our lives,' Cami said. 'We had no idea what MELAS even was, and suddenly it became the defining factor in every decision we made.' MELAS is a rare, incurable genetic disorder that affects the mitochondria, organelles responsible for producing energy in the cells. Loss of youth For Jake, a large portion of those mitochondria simply don't work. 'It means his body can't generate enough energy,' Cami said. 'He can look fine on the outside, but inside his cells are starving.' The diagnosis forced them to overhaul every part of their life. Jake had to leave his position as an attorney and wine date nights stopped. He began a strict low-stress lifestyle, new medications, and a specialist diet to avoid triggering further episodes. 'We were in our 20s, and suddenly everything was about survival,' said Cami. 'The hardest part wasn't just the physical toll, it was the loss of that youthful certainty. 'That sense that the future was ours.' Looking back, Cami believes that moment reflects a wider issue. 'Mitochondrial diseases like MELAS are so often overlooked, especially in adults. "If that one resident hadn't mentioned it weeks later, we might never have found out.' 'They were convinced it was some unknown infection they couldn't identify,' said Cami. 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'I can't put into words what it's like to watch the person you love struggle to speak,' she says. 'I knew he was still Jake, but I also knew we were starting all over again.' It took Jake two years of recovery and rehabilitation to regain his speech and strength. Today he's back working as an attorney, and he and Cami now share their story on TikTok to raise awareness of MELAS and support others navigating chronic illness. Their TikTok page, has become a place of education, vulnerability, and hope. In one emotional clip, Jake thanked viewers for their support. 'We didn't expect this kind of response, and we're genuinely grateful,' he said. 'It's been incredibly hard to come to terms with having MELAS. Every day is a balancing act, managing my health while trying to live a full life.' What is MELAS syndrome? MELAS syndrome is a rare genetic condition that affects how the body produces energy. 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Source: National Orgainsation for Rare Disorders 'You never know what's coming next' The couple frequently answer questions from followers, especially about MELAS being hereditary. 'It is maternally inherited,' says Cami explained. 'But we've been told any children we may have won't be affected.' More than anything, Cami and Jake want others in similar situations, particularly young couples, to know they're not alone. 'If your partner has a medical condition, you learn quickly that love is more than romance," she said. "It's about being in the trenches together." "Love so hard," she added. "Never go to bed angry. Be grateful, even on the hard days. Because you never know what's coming next.' 8

Horrifying ancient meal loved by Neanderthals is a dieter's dream – but would YOU eat sickening dish?
Horrifying ancient meal loved by Neanderthals is a dieter's dream – but would YOU eat sickening dish?

The Sun

time2 hours ago

  • The Sun

Horrifying ancient meal loved by Neanderthals is a dieter's dream – but would YOU eat sickening dish?

NEANDERTHALS may have feasted on maggot-infested meat as a core part of their diet, according to a new study. But the pungent delicacy was more than simply "starvation rations", said Melanie Beasley, assistant professor of anthropology at Purdue University, Indiana. 2 A number of Indigenous communities have viewed putrefied - or fermented - meat as highly desirable. It is easier to digest, meaning the body can better and more quickly absorb nutrients without cooking. Experts have long known that Neanderthals - our extinct human ancestor - were omnivores, eating meat and vegetables like most modern people. But chemical signatures found in Neanderthal remains suggest they ate as much meat as lions. Analysis of their bones found too much nitrogen than what a classic omnivore would have. But hominins simply cannot tolerate eating the high levels of protein that large predators can. When humans eat as much protein as Earth's apex predators – or hypercarnivores – over long periods of time, without consuming enough other nutrients they can develop protein poisoning. Also known as "rabbit starvation", protein poisoning can lead to malnutrition and death. Research from Beasley and her team suggests that Neanderthals had a hidden delicacy: maggots. Similar to the historical diets of some indigenous communities, Neanderthals too may have dined on decaying meat. Stunningly lifelike face of 75,000-year-old Neanderthal woman in her 40s recreated after 'best-preserved' skull found It is this that would have boosted their internal nitrogen levels to hypercarnivore-levels, according to the study. Maggots, which are fly larvae, can be a fat-rich source of food. They are unavoidable after you kill another animal, easily collectible in large numbers and nutritionally beneficial. Melanie Beasley, assistant professor of anthropology at Purdue University, Indiana "We suspected that maggots could have been a different potential source of enriched nitrogen-15 in the Neanderthal diet," Beasley explained in a recent article published in The Conversation. "Maggots, which are fly larvae, can be a fat-rich source of food. "They are unavoidable after you kill another animal, easily collectible in large numbers and nutritionally beneficial." Beasley and her colleagues used data from a forensic anthropology project focused on how nitrogen might help estimate time since death to investigate the possibility. "I had originally collected modern muscle tissue samples and associated maggots at the Forensic Anthropology Center at University of Tennessee, Knoxville, to understand how nitrogen values change during decomposition after death," she said. "While the data can assist modern forensic death investigations, in our current study we repurposed it to test a very different hypothesis. "We found that stable nitrogen isotope values increase modestly as muscle tissue decomposes, ranging from -0.6 permil to 7.7 permil." The researchers found that maggots found in dried, frozen or cached animal foods would have inflated the nitrogen levels in ancient humans during the Late Pleistocene era. Research shows that [nitrogen-15] values are higher for cooked foods, putrid muscle tissue from terrestrial and aquatic species, and, with our study, for fly larvae feeding on decaying tissue. "Neanderthals' cultural practices, similar to those of Indigenous peoples, might be the answer to the mystery of their high [nitrogen-15] values. "Ancient hominins were butchering, storing, preserving, cooking and cultivating a variety of items. "All these practices enriched their paleo menu with foods in forms that nonhominin carnivores do not consume. "Research shows that [nitrogen-15] values are higher for cooked foods, putrid muscle tissue from terrestrial and aquatic species, and, with our study, for fly larvae feeding on decaying tissue." Although maggots may not solely explain the lion-like nitrogen levels in Neanderthals, according to the researchers. It is still unclear how many maggots an ancient human would need to eat to account for so much nitrogen. More research is needed on changes in nitrogen-15 values of foods processed, stored and cooked following Indigenous traditional practices to "help us better understand the dietary practices of our ancient relatives," said Beasley. 2

Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study
Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study

Reuters

time2 hours ago

  • Reuters

Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study

July 28 (Reuters) - Celcuity (CELC.O), opens new tab said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading. The drug, gedatolisib, in combination with Pfizer's (PFE.N), opens new tab Ibrance and AstraZeneca's (AZN.L), opens new tab endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients in a late-stage study. HR+/HER2- breast cancer accounts for about 70% of all breast cancers. The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' (NOVN.S), opens new tab Afinitor and AstraZeneca's Truqap. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.

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