Latest news with #Rituxan
Medical News Today
16-07-2025
- Health
- Medical News Today
Rituxan for rheumatoid arthritis (RA)
Rituxan (rituximab) is a brand-name intravenous (IV) infusion prescribed for RA. This article covers topics such as side effects, dosage, and how Rituxan works for is a biologic and belongs to a drug class called monoclonal antibodies. The medication is available in several biosimilar on for more information about Rituxan for has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the 'Before receiving Rituxan' section.»Learn more about Rituxan explainedRheumatoid arthritis (RA) is an autoimmune condition that typically affects the RA, your immune system mistakenly attacks healthy tissue in the joints. This can cause symptoms that affect the wrists, hands, knees, ankles, and of RASymptoms of RA may include:joint pain, stiffness, or swellingfatigueskin lumpsWho Rituxan is prescribed forRituxan is prescribed for adults with moderate to severe symptoms of RA. Doctors prescribe Rituxan when tumor necrosis factor (TNF) blocker drugs haven't worked well for managing Rituxan treats RA RA happens when the immune system mistakenly attacks healthy tissue in the works by targeting a protein called CD20, which is found on certain immune cells. This protein is thought to play a role in an overactive immune system. By blocking CD20, Rituxan helps reduce inflammation and ease RA learn more about how Rituxan works, talk with your doctor. How well Rituxan works for RAIn clinical trials, Rituxan was shown to be effective in treating learn more about how the drug performed in clinical trials, refer to Rituxan's prescribing information. You can also talk with your doctor or visit the drug manufacturer's Rituxan for RABelow is information about the dosage of Rituxan for RA in adults. Your doctor will determine the dosage that's suitable for your treating RA, the usual dosage of Rituxan is two doses of 1,000 milligrams (mg) given 2 weeks apart. This is considered one treatment course. You'll typically receive one treatment course of Rituxan every 16 to 24 is prescribed along with methotrexate (Otrexup, Rasuvo, and others) for RA. Your doctor will explain the methotrexate dosage that's right for In addition to treating RA, Rituxan has other uses. Keep in mind that the drug's dosage may differ when treating other conditions. To learn more, talk with your to receive RituxanYour doctor or another healthcare professional will give Rituxan as an IV infusion. An IV infusion is an injection into a vein that's given over a period of time. Rituxan infusions are typically given over several often Rituxan is givenFor RA, you'll receive two infusions of Rituxan 2 weeks apart. This counts as one round of on your treatment plan, you'll receive another round of treatment every 16 to 24 weeks.»Learn more about the dosing protocols for Rituxan. Rituxan side effects The use of Rituxan for RA may cause side effects that are mild or serious. Rituxan is also approved to treat several other conditions. It's important to note that side effects from Rituxan may differ depending on the condition it's used to lists below include some of the main side effects that have been reported with Rituxan. For information about other potential side effects of the drug, talk with your doctor or pharmacist. You can also refer to Rituxan's prescribing After the Food and Drug Administration (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 while receiving Rituxan and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.»Get more information about Riutxan's side side effects of RituxanThese are some mild side effects that may occur with Rituxan for RA:mild infection, such as urinary tract infection (UTI)fever or chillsindigestionitchingjoint painrunny noseThese side effects of Rituxan may be temporary, lasting a few days to weeks. But if they last longer than this, bother you, or become severe, it's important to talk with your doctor or side effects of RituxanBelow are serious side effects that can occur with Rituxan:serious infection, such as shinglesheart problems, such as ventricular fibrillation (a type of irregular heart rhythm)infusion-related reactions*severe reactions affecting the mucous membranes or skin*hepatitis B reactivation*progressive multifocal leukoencephalopathy (PML)*Call your doctor right away if you develop serious side effects while using Rituxan. If the side effects seem life threatening or you think you're having a medical emergency, call 911 or your local emergency number immediately.* Rituxan has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the 'Before receiving Rituxan' section. ALLERGIC REACTIONFor some people, Rituxan can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or 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. They'll also let you know whether you should continue treatment with 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 as they can become life threatening. If you've had a serious allergic reaction to Rituxan, your doctor may recommend a different medication receiving RituxanBefore you receive Rituxan, there's some important information to keep in mind. The drug may not be a safe option if you have certain medical conditions or other factors that affect your health. Some of these are mentioned warningsThis drug has several boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA).Infusion-related reactionsRituxan treatment may cause infusion-related reactions during or after your dose. In rare cases, infusion reactions may be of infusion reactions may include:swelling of your face and lipslow blood pressuredifficulty breathingYour doctor may give you medications to help reduce the risk of infusion reactions. These may include acetaminophen (Tylenol) and an antihistamine, such as diphenhydramine (Benadryl).If you have symptoms of an infusion reaction while receiving Rituxan or after, tell your doctor right away. They'll likely pause or stop your Rituxan treatment. Severe reactions affecting the mucous membranes or skinTreatment with Rituxan may cause severe reactions that affect your skin or mucous membranes (lining inside your mouth). These may include life threatening reactions such as Stevens-Johnson syndrome and toxic epidermal of these reactions may include:skin sores or blisterspeelingpain around the affected areaTell your doctor right away if you have symptoms of a mucous membrane or skin reaction. They'll likely stop your Rituxan treatment and manage your symptoms. Hepatitis B reactivation Rituxan may reactivate symptoms of hepatitis B in people who've ever had the hepatitis B virus (HBV). Reactivation of hepatitis B can lead to liver failure or be life of hepatitis B may include:jaundiceabdominal paindark urineDoctors typically test for HBV before and during Rituxan treatment. If the test shows HBV, they may treat it before prescribing Rituxan. Doctors may watch for hepatitis B reactivation for up to 2 years after the final dose of you have symptoms of hepatitis B, contact your doctor right away. They may temporarily stop Rituxan treatment until the infection is Rituxan may increase the risk of PML. This is a rare but serious brain infection that may be fatal in extreme of PML may include:weakness on one side of the bodychanges in memory, personality, or visionconfusiondifficulty speakingIf you have symptoms of PML after receiving Rituxan, tell your doctor right away. They'll likely stop your Rituxan treatment and manage your symptoms. Other warningsIn addition to boxed warnings, Rituxan has other warnings. If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before receiving Rituxan:if you have an infectionif you have a heart problemif you have a lung problemif you have a kidney problemif you're pregnant or breastfeedingif you've had an allergic reaction to Rituxan or any of its ingredientsFrequently asked questionsKeep reading for answers to some frequently asked questions about Rituxan for I receive Rituxan for RA without methotrexate?Not usually, unless your doctor recommends it. Rituxan is typically prescribed together with methotrexate (Otrexup, Rasuvo, others) for RA. If you're unable to take methotrexate for any reason, such as side effects or other health conditions, talk with your doctor. They can recommend whether Rituxan or another treatment option may be better for you. Is there anything I should avoid after a Rituxan infusion for RA?Your doctor can recommend whether to avoid anything specific after a Rituxan people feel tired or have mild body aches within a few hours of the infusion. It may be helpful to plan for rest after your appointment, especially after your first you have other questions about what to expect with Rituxan infusions, talk with your Rituxan chemotherapy or immunotherapy for RA?Rituxan is a type of immunotherapy for RA, but it isn't a works by helping to ease an overactive immune system. Rituxan does this by specifically targeting a protein called CD20 on certain immune can be used with chemotherapy to treat certain cancers. Chemotherapy works by killing all rapidly dividing cells. This includes some healthy cells along with cancer cells, which is why chemotherapy often causes widespread side you have other questions about how Rituxan works, talk with your cost and savingsThe cost of Rituxan is based on several factors. These include your prescribed treatment regimen, your insurance plan, and your location. The price also depends on the cost of the appointment to receive doses of Rituxan from a healthcare is a brand-name drug that's available in the following biosimilar versions: Riabni (rituximab-arrx)Ruxience (rituximab-pvvr)Truxima (rituximab-abbs)Brand-name drugs usually cost more than biosimilars. To learn about this drug's bioimilar versions, talk with your doctor or pharmacist.»Learn more about Rituxan and cost and 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.
Yahoo
14-04-2025
- Business
- Yahoo
Roche Gets Nod for Expanded Use of Columvi in Lymphoma in Europe
Roche RHHBY announced that the European Commission has approved its lymphoma drug, Columvi (glofitamab), for second-line treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma ('DLBCL'). The regulatory body in Europe has now approved Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating R/R DLBCL in adult patients who are not otherwise specified or eligible for autologous stem cell transplant. The approval in the European Union was expected as the Committee for Medicinal Products for Human Use recommended approval for Columvi in the given setting in February. Columvi is also under review in the United States for a similar indication. A final decision from the FDA is expected on July 20, 2025. Year to date, shares of Roche have risen 9.3% against the industry's decline of 6.7%. Image Source: Zacks Investment Research The latest approval for the Columvi combo for second-line R/R DLBCL was based on data from the pivotal phase III STARGLO study. Data from the same showed that treatment with Columvi in combination with GemOx led to a statistically significant and clinically meaningful improvement in overall survival compared with MabThera/Rituxan (rituximab) with GemOx. This makes it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in patients whose cancer returned after first-line therapy. Treatment with Columvi plus GemOx demonstrated a 41% reduction in the risk of death versus R-GemOx. The Columvi/GemOx combo demonstrated a safety profile consistent with the individual medicines. Please note that Columvi is approved in the United States under the FDA's accelerated approval pathway as a monotherapy for treating people with R/R DLBCL after two or more lines of systemic therapy (third-line setting). The drug has also received conditional marketing authorization in the European Union and is currently approved in more than 50 countries worldwide for the same indication. Importantly, the latest nod in the European Union for Columvi (second-line setting) fulfills a condition to convert the existing marketing authorization to full approvals for third-line R/R DLBCL in the country. DLBCL is the most common form of non-Hodgkin's lymphoma ('NHL') and aggressive (fast-growing) in nature. It accounts for approximately one-third of all NHL cases. An estimated 160,000 people are diagnosed with DLBCL every year, globally. Roche is also evaluating Columvi in combination with Polivy (elotuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone in the phase III SKYGLO study to treat previously untreated DLBCL patients (first-line setting). Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Krystal Biotech, Inc. KRYS and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Jazz Pharmaceuticals' earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.35. Year to date, shares of JAZZ have lost 18.4%. JAZZ's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%. In the past 60 days, estimates for Krystal Biotech's earnings per share have increased from $5.40 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have gained 5.4%. KRYS' earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%. In the past 60 days, estimates for ADMA Biologics' earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have risen 13.2%. ADMA's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report ADMA Biologics Inc (ADMA) : Free Stock Analysis Report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
Roche's Columvi combo gains EC approval for DLBCL
Roche has secured approval from the European Commission (EC) for Columvi (glofitamab) plus gemcitabine and oxaliplatin (GemOx) combo to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This authorisation permits the use of the combo for individuals not eligible for autologous stem cell transplant. The approval of the Columvi combo, the first bispecific antibody regimen for DLBCL in Europe, follows a conditional marketing authorisation granted in July 2023 for R/R DLBCL treatment. The decision also satisfies the requirement to transition the present marketing authorisation to a standard approval. The pivotal Phase III STARGLO trial outcomes underpin the EC approval, demonstrating that Columvi plus GemOx significantly improves overall survival compared to MabThera/Rituxan (rituximab) and GemOx (R-GemOx) in R/R DLBCL patients. Columvi plus GemOx provides an off-the-shelf treatment regimen, providing a readily available option for infusion, which can help avoid delays in starting treatment. Columvi and Lunsumio (mosunetuzumab) are a part of the company's cluster of differentiation 20 (CD20)xCD3 bispecific antibody programme. Roche Global Product Development head and chief medical officer Levi Garraway stated: 'Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy. 'With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.' Roche's strategy encompasses the clinical development of allogeneic CAR T-therapies, aiming to offer tailored treatment alternatives for the diverse needs of individuals with blood cancers. Columvi's design involves a 2:1 structural format, targeting CD3 on T cells and CD20 on B cells. The company continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL. In the Phase III SKYGLO study, it is also being evaluated with Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated DLBCL, to enhance long-term outcomes and relapse prevention. In March 2025, Oxford BioTherapeutics (OBT) entered a multi-year partnership with Roche for antibody-based therapeutics to treat cancer. "Roche's Columvi combo gains EC approval for DLBCL" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
