Monthly Archives: March 2022

Not long ago, I lost my hearingagain. As usual, I first blamed my phone for the muffled voices on the other end. Then, the loud, high-pitched ringing in my ears started, making everything even harder to hear. Finally, when I couldn't hear the TV on maximum volume, I was forced to turn on captions.

After a week of hoping it would clear up on its own, my hearing problem became intolerable, and I finally made a doctors appointment. It took ten minutes for the ENT to vacuum out the impacted earwax blocking my eardrum, and my hearing immediately returned to normal. If I sound familiar with this routine, its because Ive been through it several times. I have an underactive thyroid, hypothyroidism, which makes me more likely to develop earwax problems.

The thyroid is a small, butterfly-shaped gland located in the neck that controls energy and metabolism. My hypothyroidism is caused by Hashimoto's disease, a common autoimmune condition. Hashimoto's and hypothyroidism affect an estimated 15 to 20 million Americans. But many of those patientsand even some health care providersarent aware of the connection between thyroid conditions and hearing loss. So, let's take a look at this critical and often overlooked link.

Hearing loss falls into three primary categories:

The symptoms of hearing loss can vary and include:

Hashimotos diseasealso known as Hashimotos thyroiditisis the most common autoimmune disease in the U.S. In any autoimmune disease, the immune system produces antibodies that inappropriately target our organs, glands, tissues or cells. Several autoimmune diseases are linked to hearing loss, including Hashimoto's.

In Hashimotos, antibodies target the thyroid and gradually impair its ability to produce thyroid hormone. Over time, it usually leads to the deficiency in thyroid hormone known as hypothyroidism.

The common signs and symptoms of Hashimotos and hypothyroidism include fatigue, weight gain, hair loss, dry skin, body aches, brain fog, cold hands and feet, depression, anxiety, menstrual irregularities, and constipation, among others.

To diagnose hypothyroidism, doctors use blood tests, including Thyroid Stimulating Hormone (TSH), and available free levels of thyroid hormones Thyroxine (Free T4) and Triiodothyronine (Free T3.) Elevated TSH and low Free T4 and Free T3 levels are evidence of hypothyroidism. A positive result on the Thyroid Peroxidase Antibodies (TPOAb) test can confirm a Hashimotos diagnosis.

The treatment for hypothyroidism is thyroid hormone replacement medication, usually generic levothyroxine, a synthetic form of the T4 hormone. (Synthroid and Levoxyl are well-known brands.) Brand-name Tirosint gel cap and Tirosint-SOL liquid levothyroxine are also available. Some patients benefit from combination replacement therapy, taking generic liothyronine or Cytomel, a synthetic T3 hormone, with their levothyroxine treatment. Finally, some hypothyroid patients feel best taking a different medicationnatural desiccated thyroid (NDT)because it includes natural forms of both T4 and T3 hormones. Apart from generic tablets, currently available brands of NDT include Armour and NP Thyroid.

Hypothyroidism can actually cause sensorineural hearing loss, a connection that was first reported in medical studies all the way back in 1907. Despite this knowledge, more research is needed to determine just how common it is to have both conditions.

Regardless, there's good news for people with hearing loss who are newly diagnosed with hypothyroidism: Treating thyroid disease can help with hearing loss.

According to Sapna Shah, M.D., a board-certified endocrinologist with Paloma Health, "In the instance where thyroid dysfunction is causing hearing loss, studies find that hearing loss improves after a patient starts levothyroxine therapy. In fact, one recent study found that six to twelve months of optimal thyroid hormone replacement treatment improved hearing in nearly 50 percent of the hypothyroid patients studied. Hearing loss was completely reversed in 15 percent of the patients!

Yet, even with proper treatment for thyroid disease, there's still an increased risk of hearing loss. One study estimated that 25 percent of hypothyroid patients have evidence of some degree of mild to moderate sensorineural hearing loss. Symptoms like tinnitus are more common with hypothyroidism, and hearing loss typically develops over time.

Pat G. developed tinnitus 20 years ago when she was diagnosed with hypothyroidism. According to Pat, when she shared her tinnitus symptoms with her doctor, he told her he had tinnitus too and that there was nothing to be done.

Then, just in the last year, says Pat, I noticed that Im having trouble understanding conversations on TV, especially when they play loud background music. I know I need to see a hearing specialist soon. I had no idea any of this could be caused by my hypothyroidism!"

At least one study has indicated that people with hypothyroidismespecially those over 50also face an increased risk of sudden sensorineural hearing loss (SSNHL). With SSNHL, also known as sudden deafness, rapid hearing loss occurs immediately, or within 72 hours. SSNHL requires immediate medical attention because early diagnosis and prompt treatment can help around 85 percent of patients regain some or all of their hearing. Interestingly, optimal thyroid treatment is also a factor in recovery from SSNHL; research shows that patients with higher levels of thyroid hormones have better SSNHL treatment results.

Finally, congenital hypothyroidism (CH) is also linked to hearing loss. Before and after birth, thyroid hormone is essential for the healthy development and functioning of the entire auditory system. Babies born with CH have a life-long risk of hearing loss three times higher than the general population. Mild hearing loss occurs in around 20 percent of CH patients, and once they reach early adulthood, an estimated 17 percent of CH patients require hearing support. Hearing experts recommend that CH patients receive regular screening for early detection of any hearing problems.

Having an autoimmune disease like Hashimotos increases your risk of developing other autoimmune diseases, including several that can cause hearing loss.

Patients with autoimmune Hashimotos face a higher risk of developing autoimmune inner ear disease, or AIED. In AIED, as antibodies target the inner ear, inflammation can lead to tinnitus and later progress to fluctuating, progressive, or sudden sensorineural hearing loss in both ears. Heres a reason to seek evaluation immediately: When recognized and treated early, AIED can be reversible.

Hashimotos and hypothyroidism patients are also at higher risk of developing Menieres disease, an autoimmune disease that affects the inner ear. Menieres disease symptoms include tinnitus, vertigo, a feeling of fullness in the ear, and sensorineural hearing loss. A recent study concluded that the rates of hypothyroidism in Meniere's patients are so high that all Meniere's patients should receive thyroid screening. That same study reported that after 12 weeks of optimal hypothyroidism treatment, all the Menieres patients studied experienced improvement in their hearing.

Many different drugs can cause hearing loss. You should also be aware of other hearing-related complications of thyroid conditions, including:

According to audiologist Dr. Timothy Teague of Hearing Consultants, it's "possible to diagnose and treat thyroid issues before they impact your hearing." Familiarize yourself with the signs and symptoms of hypothyroidism, and if you have any concerns, see your health professional for thyroid blood tests. Endocrinologist Dr. Sapna Shah recommends that patients who want to get started right away order their own thyroid tests. According to Dr. Shah, "Testing for hypothyroidism is easy and affordable with an at-home thyroid test kit."

Many hearing experts recommend that patients get a hearing test and audiogram after a new diagnosis of hypothyroidism. The results can serve as a baseline to monitor hearing changes in the future.

For people already diagnosed and treated with hypothyroidism, here are three key steps to keep in mind:

Martha began noticing hearing issues around the time of her thyroid diagnosis more than a decade ago. "It wasnt profound, and I figured I could adapt." The pandemic changed things for Martha, however. Says Martha: "Wearing face masks really highlighted how much I had come to rely on lip-reading and visual facial cues when communicating! I decided to get tested when my sorority sisteran audiologisttold me not to wait until my hearing degraded too much."

As for me, the next time I notice hearing problems, I won't wait a week. Instead, I'll take Dr. Shahs advice: "If you notice that your hearing is worsening, I recommend meeting with your health care provider right away. Early diagnosis and treatment are essential."

To find a hearing healthcare professional at a clinic in your area, visit our directory of consumer-reviewed clinics. The sooner you reach out for help, the better your outcome will be.

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Hypothyroidism can cause hearing loss and tinnitus - Healthy Hearing

In this article, Dr. Sandeep Nayak, who gives one of the Best Cancer Treatments in Banglore talks about "What is a Cancer treatment & what are the types of cancer treatments?

Dr. Nayak is a well-known Surgical Oncologist (cancer surgeon) in Bangalore and is widely regarded as one of the city's best. He is widely acknowledged as a pioneer in the field of robotic and laparoscopic cancer surgery (surgery). He is also a professor and head of the Rajiv Gandhi University of Health Science's Department of Minimal Access Surgical Oncology.Cancer therapy includes the application of surgical procedures, radiation, medications, and other modalities to cure or shrink cancer, as well as the prevention of cancer from spreading.

There are numerous cancer treatments available. Depending on the circumstances surrounding your case, you may receive a single treatment or a combination of treatments to resolve your health problem.

Cancer therapies include the following:

Treatment as the first line of defense

The basic goal of cancer treatment is to completely remove cancer from the body or to destroy all cancer cells discovered.

Although any cancer treatment can be used as the main cancer treatment, surgery is the most frequently utilized primary cancer treatment for the most prevalent types of cancer. Additionally, surgery is the most frequently used secondary cancer treatment.

Your primary treatment may be radiation therapy or chemotherapy if your cancer is highly responsive to either of these medications says Dr. Sandeep Nayak a Top Oncologist in Bangalore.

Dr. Sandeep Nayak is also mentioned in some of the top sites like Practo, Clinicspots, Lybrate as one of the top Oncologists in India.

Palliative care is a type of treatment that relieves suffering

Palliative care may be used to decrease both the side effects of cancer treatment and the signs and symptoms of cancer. Surgery, radiation, chemotherapy, and hormone therapy are all possible treatments for the illness and its symptoms.. Pain and shortness of breath are two symptoms that may be relieved by other drugs.

Palliative treatment can be used in conjunction with other cancer treatments that are meant to cure cancer.

Different Types of Cancer Treatment

Bangalore-based Dr. Sandeep Nayak a leading Oncologist notes that There are many different types of cancer treatment available. The forms of cancer therapy you receive will be determined by the type of cancer you have and how far along it has progressed.

Some cancer patients will only require a single course of treatment. However, the vast majority of patients receive a combination of therapies, including surgery along with chemotherapy and radiation therapy.

When you are diagnosed with cancer and need treatment, there is a lot to understand and consider. It is typical to feel overwhelmed and befuddled during this time. However, discussing with your doctor and learning about the different sorts of treatment you may be eligible for might help you feel more in command of your situation.

Testing for Cancer Biomarkers in the Treatment of the Disease

It is possible to test for genes, proteins, and other substances (known as biomarkers or tumor markers) that can reveal information about cancer through the use of biomarker testing. Biomarker testing can assist you and your doctor in making a treatment decision for cancer.

Chemotherapy

Chemical therapy (sometimes known as chemotherapy) is a type of cancer treatment in which medicines are used to kill cancer cells.

Hormone Replacement Therapy

Treatment with hormones can reduce or even stop the growth of breast and prostate cancers, which are known to use hormones to fuel their growth.

Hyperthermia

High-temperature treatment (hyperthermia) is a method of cancer treatment in which bodily tissue is heated to temperatures as high as 113 degrees Fahrenheit in order to destroy and kill cancer cells that cause little or no injury to normal tissue.

Photodynamic Therapy

Photodynamic therapy is a type of cancer treatment that uses a medication that is triggered by light to kill cancer and other aberrant cells.

Rife Therapy is a type of radiation treatment

In this treatment of cancer, radiation therapy is a sort of treatment that use high doses of radiation to kill cancer cells while also shrinking tumors

Transplantation of Stem Cells

Stem cell transplants are treatments that are used to replace stem cells that have been killed by heavy doses of chemotherapy or radiation therapy in persons who have lost their ability to produce blood cells

Surgery

Surgery is a method in which a surgeon removes cancer from your body when it is being used to treat cancer in patients

Therapeutic Intervention with a Specific Goal

It is also known as targeted therapy, it is a sort of cancer treatment that specifically targets the alterations in cancer cells that aid in their growth, division, and dissemination opines Dr. Sandeep Nayak one of the top Oncologists in Banglore.

Dr. Gurneet Singh Sawhney Talks About DBS Surgery in Mumbai!

Due to a rare disease, the leg had become 50 kg, the operation went on for 90 hours

Moderna seeks to apply FDA for clearance to vaccinate children under the age of 6

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What is a Cancer treatment & what are the types of cancer treatments? - News Track English

The need for mental health services on campuses across the country has intensified during the pandemic. With it has come an increased awareness among college counselors and administrators about the importance of meeting the needs of every student especially those who hold marginalized identities and may have experienced extraordinary hardship over the past two years.

While grappling with pandemic-related challenges and typical college student woes, Black students may be dealing with increased public attention on police brutality and distress in their communities, for example. Latino students may be grappling with heated debates on immigration policy that affect their loved ones, or the challenges of straddling two different cultures. LGBTQ+ students may face questions about gender, sexuality, identity and acceptance.

Kelsey Moran is a counselor and coordinator of LGBTQIA+ counseling services and programming at the College of the Holy Cross in Massachusetts. When were working with them, were not just working with them and their anxiety, she said of the LGBTQIA+ students she serves. Were working with them and their full background and identity as an understanding of self.

Related: Students to administrators: Lets talk about mental health on campus

Research shows mental health treatment is more effective when its in line with the clients culture and when clients perceive their therapist to be culturally competent. But many colleges are still figuring out how exactly to care for students from underserved groups.

Others, like College of the Holy Cross, have been able to rely on systems they built before the pandemic to help students through a particularly difficult time.

Moran started as Holy Crosss first LGBTQIA+ coordinator in 2018. Alongside a multicultural services coordinator and a coordinator who works specifically with student athletes, Moran works across campus to make sure that queer and transgender students are able to get the mental health care they need. She provides individual therapy and also runs three support groups for queer and trans students on campus.

The resources have become even more relevant as queer and trans students suffered particular challenges during the pandemic.

Two years ago, when the coronavirus first caused the college to shut down, some students were excited to spend time at home and be reunited with family. But for many queer and trans students, particularly those whose families werent accepting of their gender or sexuality, it was a terrifying shift, Moran said.

Related: Nations skeletal school mental health network will be severely tested

Politics have also presented a challenge for LGBTQ+ students, they said. The wave of bills to limit the mention of LGBTQ+ topics, ban certain books and categorize gender affirming care for trans children as abuse is targeting peoples existence and their ability to feel safe and supported, Moran said.

Keygan Miller, advocacy manager at The Trevor Project, a nonprofit focused on suicide prevention for LGBTQ+ youth, said that a therapist doesnt have to identify as queer or trans to help a student who does. Instead, therapists need to be well versed on what Miller called 101-level issues in the LGBTQ community and affirm the students identity.

Queer and trans students may come to therapy with extra layers of concern and distrust, they said. Students may have fears that the therapist will disclose information about their identity to their family, or that they will be asked to change who they are.Trans students also often need therapists to help them access gender affirming care, like surgery and hormone replacement therapy, with letters and other documentation, Miller said.

In addition to recognizing and affirming the identities of LGBTQ+ students, counselors also need to be sensitive to students race, ethnicity, socioeconomic status, immigration status, religion and disability status, among other identities, therapists and administrators said. That hasnt always been easy for college campus center staff, some 70 percent of whom are white.

Reyna Smith, a doctoral candidate at the University of the Cumberlands in Kentucky, was working in a college counseling center in 2020 when George Floyd was murdered by a former Minneapolis police officer. When she felt the center didnt handle it appropriately for students or staff, she left her position.

Especially as enrollment increases, and diversity increases on campus, you need to be able to support the needs of all students.

There are students here on campus that are affected by this, are you going to do something about it? Smith said she remembers thinking.

Now, she is studying the experiences of Black students seeking mental health care on predominantly white college campuses.

Related: Anxiety, depression hit students in underrepresented groups

She said that when someone is part of a minority group and feels isolated or misunderstood, it can contribute to anxiety and depression and produce other social and academic harms. And when students dont see themselves reflected in counseling staff, they can be discouraged from seeking treatment or end treatment early if they dont feel their therapist understands them.

She said campus counseling centers should aim to hire more Black staff and people from other underrepresented groups. But like Miller, she believes they can improve services by training the staff they already have on the best ways to counsel people of different identity groups.

I think theres a need to adjust to the population, Smith said. Especially as enrollment increases, and diversity increases on campus, you need to be able to support the needs of all students.

This story about LGBTQ+ student counseling was produced by The Hechinger Report, a nonprofit, independent news organization focused on inequality and innovation in education . Sign up for the higher education newsletter.

The Hechinger Report provides in-depth, fact-based, unbiased reporting on education that is free to all readers. But that doesn't mean it's free to produce. Our work keeps educators and the public informed about pressing issues at schools and on campuses throughout the country. We tell the whole story, even when the details are inconvenient. Help us keep doing that.

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Rethinking campus mental health to better serve LGBTQ+ students and others - The Hechinger Report

CONTRIBUTED CONTENT Have you felt worse after CBD or cannabis use? If so, what were your reactions?

CBD (cannabidiol) and cannabis have been shown to help with conditions such as epilepsy, seizures, muscle stiffness, arthritis, autoimmunity, Parkinsons, ALS, anxiety, OCD, PTSD, depression, inflammation, bacterial infection, pain, depression, GI ulcers, and mood.

However, either CBD or cannabis makes some of our patients feel worse. This led us down a rabbit hole of research and we found two main reasons CBD or cannabis can have a negative effect.

Of the more than 1,000 strains of cannabis and CBD, some stimulate this immune response and can worsen autoimmunity.

Although the identification of the immune properties of various strains of cannabis is improving, at this time theres no way to know which ones are immune stimulating. Just be aware of this prior to use in case you have a negative reaction.

Boosting the immune response isnt inherently bad. For those who do not have autoimmunity it can actually be beneficial to improve immune resilience.

But for the autoimmune patient, it can be like pouring gasoline onto a fire.

When you have an autoimmune disease such as Hashimotos low thyroid, you want to balance the immune system, not boost it. Some people with autoimmunity already have over-zealous immune systems that hyper react to things, including foods, chemicals, and their own bodies.

In these people, using herbs or compounds that stimulate immunity will make their symptoms and condition worse.

Typically, the best strains for pain and inflammation are those that have higher amounts of CBD to THC. CBD is the compound best known for fighting pain and inflammation.

Im not saying *not* to use CBD. In fact, I have become a regular user of and advocate for CBD for back pain after fracturing my back and becoming paralyzed for a few days.

Im simply sharing this information so you arent caught off guard if you have a reaction.

To learn more about our services and to schedule a free consultation, please visitredriverhealthandwellness.com. We work with your prescribing physician for optimal results. Do not discontinue medication or hormone replacement therapy without consulting your prescribing physician.

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CBD and cannabis have many proven health benefits, but if you have an autoimmune disease or Hashimoto's low thyroid, proceed cautiously - Cache Valley...

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that OpdualagTM (nivolumab and relatlimab-rmbw), a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2

The trial met its primary endpoint, progression-free survival (PFS), and Opdualag more than doubled the median PFS when compared to nivolumab monotherapy, 10.1 months (95% Confidence Interval [CI]: 6.4 to 15.7) versus 4.6 months (95% CI: 3.4 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 to 0.92, P=0.0055).1 The Opdualag safety profile was similar to that previously reported for nivolumab.1,2 No new safety events were identified with the combination when compared to nivolumab monotherapy.1,2 Grade 3/4 drug-related adverse events were 18.9% in the Opdualag arm compared to 9.7% in the nivolumab arm.2 Drug-related adverse events leading to discontinuation were 14.6% in the Opdualag arm compared to 6.7% in the nivolumab arm.2

Since the approval of the first immune checkpoint inhibitor more than 10 years ago, weve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma, said F. Stephen Hodi, M.D., director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute.3 Todays approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints LAG-3 and PD-1.1,2

Opdualag is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions (IMARs) including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, myocarditis and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); and embryo-fetal toxicity.1 Please see Important Safety Information below.

While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients, said Samit Hirawat, chief medical officer, global drug development, Bristol Myers Squibb.3 Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients. The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.

Lymphocyte activation gene-3 (LAG-3) and programmed death-1 (PD-1) are two distinct inhibitory immune checkpoints that are often co-expressed on tumor-infiltrating lymphocytes, thus contributing to tumor-mediated T-cell exhaustion.2 The combination of nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) results in increased T-cell activation compared to the activity of either antibody alone.1 Relatlimab (in combination with nivolumab) is the first LAG-3-blocking antibody to demonstrate a benefit in a Phase 3 study.1 It is the third checkpoint inhibitor (along with anti-PD-1 and anti-CTLA-4) for Bristol Myers Squibb.

Todays approval is exciting news and offers new hope to the melanoma community. The availability of this treatment combination may enable patients to potentially benefit from a new, first-in-class dual immunotherapy, said Michael Kaplan, president and CEO, Melanoma Research Alliance.

The FDA-approved dosing for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every four weeks.1 The recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age, has not been established.1

This application was approved under the FDAs Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.4 The review was also conducted under the FDAs Project Orbis initiative, which enabled concurrent review by the health authorities in Australia, Brazil and Switzerland, where the application remains under review.

About RELATIVITY-047

RELATIVITY-047 is a global, randomized, double-blind Phase 2/3 study evaluating the fixed-dose combination of nivolumab and relatlimab versus nivolumab alone in patients with previously untreated metastatic or unresectable melanoma.1,2 The trial excluded patients with active autoimmune disease, medical conditions requiring systemic treatment with moderate or high dose corticosteroids or immunosuppressive medications, uveal melanoma, and active or untreated brain or leptomeningeal metastases.1 The primary endpoint of the trial is progression-free survival (PFS) determined by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).1 The secondary endpoints are overall survival (OS) and objective response rate (ORR).1 A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of nivolumab (480 mg) and relatlimab (160 mg) or nivolumab (480 mg) by intravenous infusion every four weeks until disease progression or unacceptable toxicity.1

Select Safety Profile From RELATIVITY-047

Adverse reactions leading to permanent discontinuation of Opdualag occurred in 18% of patients.1 Opdualag was interrupted due to an adverse reaction in 43% of patients.1 Serious adverse reactions occurred in 36% of patients treated with Opdualag.1 The most frequent (1%) serious adverse reactions were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%).1 Fatal adverse reactions occurred in three (0.8%) patients treated with Opdualag and included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis.1 The most common (20%) adverse reactions were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%).1 The Opdualag safety profile was similar to that previously reported for nivolumab.1,2 No new safety events were identified with the combination when compared to nivolumab monotherapy.1,2 Grade 3/4 drug-related adverse events were 18.9% in the Opdualag arm compared to 9.7% in the nivolumab arm.2 Drug-related adverse events leading to discontinuation were 14.6% in the Opdualag arm compared to 6.7% in the nivolumab arm.2

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.5 Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs.5,6 The incidence of melanoma has been increasing steadily for the last 30 years.5,6 In the United States, approximately 99,780 new diagnoses of melanoma and about 7,650 related deaths are estimated for 2022.5 Melanoma can be mostly treatable when caught in its very early stages; however, survival rates can decrease as the disease progresses.6

OPDUALAG INDICATION

OpdualagTM (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

OPDUALAG IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions (IMARs) listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

IMARs which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, they can also occur after discontinuation of Opdualag. Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if Opdualag requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

Opdualag can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.7% (13/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (2.3%) adverse reactions. Pneumonitis led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 1.4% of patients.

Immune-Mediated Colitis

Opdualag can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

Immune-mediated diarrhea or colitis occurred in 7% (24/355) of patients receiving Opdualag, including Grade 3 (1.1%) and Grade 2 (4.5%) adverse reactions. Colitis led to permanent discontinuation of Opdualag in 2% and withholding of Opdualag in 2.8% of patients.

Immune-Mediated Hepatitis

Opdualag can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.

Immune-mediated hepatitis occurred in 6% (20/355) of patients receiving Opdualag, including Grade 4 (0.6%), Grade 3 (3.4%), and Grade 2 (1.4%) adverse reactions. Hepatitis led to permanent discontinuation of Opdualag in 1.7% and withholding of Opdualag in 2.3% of patients.

Immune-Mediated Endocrinopathies

Opdualag can cause primary or secondary adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus, which can be present with diabetic ketoacidosis. Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. In patients receiving Opdualag, adrenal insufficiency occurred in 4.2% (15/355) of patients receiving Opdualag, including Grade 3 (1.4%) and Grade 2 (2.5%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of Opdualag in 1.1% and withholding of Opdualag in 0.8% of patients.

Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Hypophysitis occurred in 2.5% (9/355) of patients receiving Opdualag, including Grade 3 (0.3%) and Grade 2 (1.4%) adverse reactions. Hypophysitis led to permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 0.6% of patients.

Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Thyroiditis occurred in 2.8% (10/355) of patients receiving Opdualag, including Grade 2 (1.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of Opdualag. Thyroiditis led to withholding of Opdualag in 0.3% of patients. Hyperthyroidism occurred in 6% (22/355) of patients receiving Opdualag, including Grade 2 (1.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of Opdualag. Hyperthyroidism led to withholding of Opdualag in 0.3% of patients. Hypothyroidism occurred in 17% (59/355) of patients receiving Opdualag, including Grade 2 (11%) adverse reactions. Hypothyroidism led to the permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 2.5% of patients.

Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. Diabetes occurred in 0.3% (1/355) of patients receiving Opdualag, a Grade 3 (0.3%) adverse reaction, and no cases of diabetic ketoacidosis. Diabetes did not lead to the permanent discontinuation or withholding of Opdualag in any patient.

Immune-Mediated Nephritis with Renal Dysfunction

Opdualag can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear etiology. In patients receiving Opdualag, immune-mediated nephritis and renal dysfunction occurred in 2% (7/355) of patients, including Grade 3 (1.1%) and Grade 2 (0.8%) adverse reactions. Immune-mediated nephritis and renal dysfunction led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 0.6% of patients.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

Immune-Mediated Dermatologic Adverse Reactions

Opdualag can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Rash with eosinophilia and systemic symptoms has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

Immune-mediated rash occurred in 9% (33/355) of patients, including Grade 3 (0.6%) and Grade 2 (3.4%) adverse reactions. Immune-mediated rash did not lead to permanent discontinuation of Opdualag. Immune-mediated rash led to withholding of Opdualag in 1.4% of patients.

Immune-Mediated Myocarditis

Opdualag can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology. The diagnosis of immune-mediated myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. If clinically confirmed, permanently discontinue Opdualag for Grade 2-4 myocarditis.

Myocarditis occurred in 1.7% (6/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (1.1%) adverse reactions. Myocarditis led to permanent discontinuation of Opdualag in 1.7% of patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant IMARs occurred at an incidence of <1% (unless otherwise noted) in patients who received Opdualag or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: Cardiac/Vascular: pericarditis, vasculitis; Nervous System: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other IMARs, consider a Vogt-Koyanagi-Haradalike syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Other (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

Opdualag can cause severe infusion-related reactions. Discontinue Opdualag in patients with severe or life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions. In patients who received Opdualag as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23/355) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, Opdualag can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Opdualag for at least 5 months after the last dose of Opdualag.

Lactation

There are no data on the presence of Opdualag in human milk, the effects on the breastfed child, or the effect on milk production. Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Opdualag and for at least 5 months after the last dose.

Serious Adverse Reactions

In Relativity-047, fatal adverse reaction occurred in 3 (0.8%) patients who were treated with Opdualag; these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis. Serious adverse reactions occurred in 36% of patients treated with Opdualag. The most frequent serious adverse reactions reported in 1% of patients treated with Opdualag were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%).

Common Adverse Reactions and Laboratory Abnormalities

The most common adverse reactions reported in 20% of the patients treated with Opdualag were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%).

The most common laboratory abnormalities that occurred in 20% of patients treated with Opdualag were decreased hemoglobin (37%), decreased lymphocytes (32%), increased AST (30%), increased ALT (26%), and decreased sodium (24%).

Please see U.S. Full Prescribing Information for Opdualag.

OPDIVO + YERVOY INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO + YERVOY IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%).

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis.

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Haradalike syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions.

In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

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U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag (nivolumab and relatlimab-rmbw), as Treatment for...