Monday, December 5, 2022

Alternatives To Humira For Ulcerative Colitis

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Dosage Forms & Strengths

Humira Injections for Ulcerative Colitis! (3 MONTH UPDATE & REVIEW)
  • 20mg/0.4mL
  • 40mg/0.4mL
  • 40mg/0.8mL
  • 80mg/0.8mL
  • 40mg/0.8mL
  • 80mg/0.8mL

Indicated for reduction of signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis

May be administered with methotrexate, glucocorticoids, nonsteroidal anti-inflammatory drugs , or analgesics

Humira

  • < 2 years or < 10 kg: Safety and efficacy not established
  • â¥2 years
  • 15 kg to < 30 kg: 20 mg SC q2wk
  • â¥30 kg: 40 mg SC q2wk

Cyltezo

  • < 2 years or < 10 kg: Safety and efficacy not established
  • < 15 kg: No dosage form available for weight-based dosing
  • â¥2 years
  • 15 to < 30 kg: 20 mg SC q2wk
  • â¥30 kg: 40 mg SC q2wk

Yusimry

  • â¥2 years and â¥30 kg: 40 mg SC q2wk

Amjevita, Hadlima, Hyrimoz

  • < 4 years: Safety and efficacy not established
  • â¥4 years
  • Amjevita, Hulio: 15 to < 30 kg: 20 mg SC q2wk
  • Amjevita, Hadlima, Hulio, or Hyrimoz: â¥30 kg: 40 mg SC q2wk

Patient Safety And Biosimilars

Biosimilars are thoroughly tested and analysed both in the laboratory and in clinical trials. The authorities which regulate and licence medicines in the UK and Europe are confident that biosimilar medicines are as safe and effective as the originator medicine. To be licensed by the European Medicines Agency, a biosimilar medicine must have shown it has no clinically meaningful differences from the originator biological medicine and to have met regulatory requirements in terms of quality, safety and efficacy compared to the originator medicine .

Where the National Institute for Health and Care Excellence has recommended the originator biological medicine in its guidance, they have stated that the same guidance will normally apply to a biosimilar version of that medicine.

Differences In Administration Efficacy And Conditions Treated

Robert Burakoff, MD, MPH, is board-certified in gastroentrology. He is the vice chair for ambulatory services for the department of medicine at Weill Cornell Medical College in New York, where he is also a professor. He was the founding editor and co-editor in chief of Inflammatory Bowel Diseases.

Biologics are a newer class of drugs used to treat the inflammation that is caused by inflammatory bowel disease . This is a broad range of medications that each work in slightly different ways with different standards of administration and dosing. Some are approved to treat just one form of IBD, while others are used to treat both Crohn’s disease and ulcerative colitis.

Because biologic drugs temper the immune response, people taking them are prone to certain infections. It’s important, therefore, to take steps to reduce your vulnerability. People with IBD should receive vaccinations, ideally before starting a biologic, although many immunizations can also be given while taking a biologic.

According to 2020 guidelines, a biologic drug should be used first-line for treatment in people with moderate to severe ulcerative colitis.

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Remicade Vs Humira Side By Side Comparison

Remicade and Humira are two drugs that can be used to treat similar conditions. Despite their similarities, they also have some differences to review. Their features can be compared below.

  • Tumor necrosis factor blocker
  • Monoclonal antibody
  • Tumor necrosis factor blocker
Manufacturer
  • Infusion-related reactions
  • Upper respiratory tract infection
  • Injection site reactions
  • Headache
  • No generic currently available for purchase
  • No generic currently available for purchase
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • $11,502 for a supply of 10, 100 mg vials
  • $5,773 for a supply of 2 subcutaneous kits
SingleCare Discount Price
  • Abatacept
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Remicade is in Pregnancy Category B. No fetal harm has been established in animal studies. However, fetal harm cannot be ruled out. Consult a doctor regarding steps to take if planning pregnancy or breastfeeding.
  • Humira is in Pregnancy Category B. No fetal harm has been established in animal studies. However, fetal harm cannot be ruled out. Consult a doctor regarding steps to take if planning pregnancy or breastfeeding.

Key Points About Humira

AGA Guidelines: Moderate to Severe Ulcerative Colitis ...
  • Humira is approved for both Crohn’s disease and ulcerative colitis.
  • Humira is given at home by self-injection.
  • Humira is started with 4 injections, followed by 2 injections 2 weeks later, and then 1 injection every other week.
  • Common side effects include pain or irritation at the injection site and headache, rash, and nausea.
  • If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Humira.
  • Infants born to mothers receiving Humira should not receive live vaccines for six months.
  • Humira needs to be refrigerated.

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Remember Tell Your Doctor Right Away If You Have An Infection Or Symptoms Of An Infection Including:

  • Fever, sweats, or chills
  • Warm, red, or painful skin or sores on your body
  • Diarrhea or stomach pain
  • Urinating more often than normal
  • Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis in adults.
  • Moderate to severe hidradenitis suppurativa in people 12 years and older.
  • To treat moderate to severe Crohns disease in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • US-HUM-210186

    US-HUM-210262

    What Does This Mean For Me

    Any switching to a new medicine from adalimumab should involve a conversation between you and your clinical team and should take into account your needs, preferences and values as well as all the available clinical evidence.

    In a discussion with your clinical team you can understand your options and agree on the most appropriate medicine. In some cases, it may continue to be the originator biological medicine. It is important to note that there may be differences with the biosimilar, for example in the pen used to inject the medicine and homecare arrangements for delivery. If you have concerns you should raise these with your IBD team.

    We understand that switching to a new medicine can be an unsettling time, and therefore it is crucial that you are fully informed about the new biosimilars. To find out more about what the changes mean for you please read the NHS Patient FAQs.

    The Department of Health, Social Services and Public Safety in Northern Ireland and the Scottish Medical Consortium in Scotland have yet to indicate when they plan to review the biosimilar for adalimumab, but when they do we will communicate this fact to members and supporters. Read the All-Wales Medicine Strategy Group AWMSGs position statement on biosimilars .

    Please visit the publications section of our website to find out more information about adalimumab and biological drugs.

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    Does Stelara Have A Black Box Warning

    No, Stelara doesnt have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.

    Stelara can cause serious side effects. But the Food and Drug Administration hasnt required the manufacturers of Stelara to include a black box warning with this medication.

    How Effective Are Stelara And Humira

    Adalimumab (Humira) – IBD treatments explained by the experts

    You may wonder whether Stelara and Humira are effective at treating your autoimmune or inflammatory condition.

    Both drugs are used to treat certain active forms of plaque psoriasis, psoriatic arthritis, Crohns disease, and ulcerative colitis in adults. Active means you have inflammation and symptoms. See the sections below for information on the drugs effectiveness for these conditions.

    To find out the effectiveness of Stelara and Humira for treating conditions in children, talk with your childs doctor. And to learn about the effectiveness of Humira for uses other than those listed below, see this in-depth article.

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    If I Take Stelara For A Long Time Will I Have Withdrawal Symptoms When I Stop Using It

    Its possible that your condition may return or worsen if you stop taking Stelara. This can lead to symptoms that may be confused with withdrawal symptoms.

    Dont stop taking Stelara unless your doctor recommends that you stop treatment. Once you stop taking Stelara, your doctor will monitor you closely to determine if you can safely remain off the medication.

    Key Points About Entyvio

    • Entyvio is approved for ulcerative colitis and Crohn’s disease.
    • Entyvio is given by infusion in three starting doses, and then every eight weeks.
    • Common side effects include infections pain in the joints, back, throat or extremities symptoms of nausea, fever, fatigue, cough, or itching and a rash.
    • If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Entyvio.
    • It’s not currently known if Entyvio passes into breastmilk.

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    How To Use Stelara

    You should use Stelara according to your doctor or healthcare professionals instructions.

    Stelara is given as a subcutaneous injection. Your healthcare professional will give you your first dose. They may also show you how to self-inject the drug at home for your future doses.

    If you are taking Stelara to treat Crohns disease or ulcerative colitis, your first dose will be given as an intravenous infusion . This infusion usually lasts at least 1 hour. Youll get the infusion in a healthcare office or clinic. The rest of your doses will be given as subcutaneous injections, which can be given by either your healthcare professional or yourself.

    The manufacturer of Stelara provides step-by-step instructions for self-injections. They also provide instructional videos that review how to use Stelara.

    What Are The Side Effects Of Stelara And Humira

    AGA Guidelines: Moderate to Severe Ulcerative Colitis ...

    Like many drugs, Stelara and Humira may cause side effects. These side effects may vary depending on the condition each drug is being used to treat. Overall, most common side effects of both drugs are mild, and serious side effects are rare.

    Note: For more information about possible side effects, see this article on Stelara side effects and the side effects section of this Humira article.

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    What Should I Ask My Doctor

    If you have psoriasis or an inflammatory bowel disease, Stelara and Humira may help treat your condition. They have some similar serious side effects and warnings.

    A main difference between these drugs is how often you use them. Once youre on a maintenance dose, youll receive Stelara once every 8 or 12 weeks. Humiras maintenance dose is one injection every other week.

    Also, Stelara and Humira arent in the same exact drug class. So one may be a better fit than the other based on your condition, overall health, past or current treatments, and medical history.

    If you have questions about these drugs for your condition, talk with your doctor or pharmacist. Ask about any concerns you have. Here are a few examples to get you started.

    • I take other medications. Do either Stelara or Humira interact with them?
    • I have cardiomyopathy . Is Stelara or Humira a better option for my psoriatic arthritis?
    • How long does it take each drug to start working? Will one drug improve my symptoms faster than the other?
    • Would Stelara or Humira be a better fit for me based on my health and medical history?
    • Are there any side effects that happen from using either drug long term?
    • How long have Stelara and Humira been used for my condition?

    If you have psoriasis, subscribe to our newsletter for the latest guidance on treatment options, dealing with flare-ups, and more.

    Dosage For Psoriatic Arthritis

    The usual dose of Stelara for adults with psoriatic arthritis is 45 mg for each injection.

    Stelara is given as one subcutaneous injection on each of the following days:

    • your first dose is given on day 1
    • your second dose is given 4 weeks later
    • your third dose is given 12 weeks after your second dose
    • the rest of your doses are given every 12 weeks

    If you have psoriatic arthritis with plaque psoriasis, your doctor may prescribe a higher dosage of Stelara for you.

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    Drug Forms And Strengths

    Stelara comes as a liquid solution that contains the active drug ustekinumab.

    Its available as:

    • a single-dose, prefilled syringe that holds 0.5 mL of solution and contains 45 mg of ustekinumab
    • a single-dose, prefilled syringe that holds 1 mL of solution and contains 90 mg of ustekinumab
    • a single-dose vial that holds 0.5 mL of solution and contains 45 mg of ustekinumab

    Stelara is given as a subcutaneous injection. It can be given in your upper arms, thighs, belly, or buttocks.

    Your healthcare professional may give you Stelara injections at a medical clinic. They may also show you how to self-inject Stelara at home.

    Note: Stelara also comes in a vial that contains 130 mg of ustekinumab. This vial is used for a one-time intravenous infusion of Stelara. Its used to give the first dose of the drug to people with Crohns disease or ulcerative colitis. This one-time infusion is called a loading dose or an induction dose. This IV infusion will take place over at least 1 hour. Each dose of Stelara after the IV infusion is given as a subcutaneous injection.

    Stelara And Other Medications Or Therapies

    Humira injection | Ulcerative Colitis

    Below are lists of medications and therapies that can interact with Stelara. These lists do not contain all the drugs that may interact with Stelara.

    Before taking Stelara, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

    If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

    Stelara and vaccines

    You shouldnt get a live vaccine when youre using Stelara. Getting a live vaccine during Stelara treatment increases your risk of getting the condition the vaccine is meant to prevent.

    This is because Stelara suppresses your immune systems ability to fight infections. Receiving a live vaccine during Stelara treatment increases your risk of serious infections.

    Examples of live vaccines that you should avoid during Stelara treatment include:

    You should also avoid getting the Bacillus Calmette-Guérin vaccine for 1 year before you start using Stelara, during your Stelara treatment, and for 1 year after you stop using Stelara. The BCG vaccine is meant to prevent tuberculosis . Its more commonly given to people who live outside of the United States.

    Stelara and allergy shots

    Stelara and warfarin

    If youre taking these drugs together, your doctor may need to adjust your dosage of either Stelara or warfarin.

    • everolimus
    • sirolimus

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    Can I Use Stelara And Humira Together

    Most likely not.

    In general, biologic disease-modifying antirheumatic drugs , such as Stelara and Humira, shouldnt be used together. Doing so increases the risk of serious side effects from these drugs.

    Biologic DMARDs are newer, more targeted treatments that help reduce inflammation by suppressing specific parts of your immune system.

    Even though biologic DMARDs arent prescribed together, sometimes doctors prescribe a biologic DMARD with a traditional DMARD. Methotrexate is an example of a traditional DMARD. Traditional DMARDs are older, less targeted drugs used to reduce inflammation in your body.

    Also, if your condition isnt controlled with your current biologic DMARD, your doctor may switch your treatment to another biologic DMARD. But this depends on many factors, such as:

    • your condition
    • past treatments or other current medications
    • any side effects youve experienced
    • your overall health

    What Should I Watch For After Starting Humira

    HUMIRA can cause serious side effects, including:

    Common side effects of HUMIRA include injection site reactions , upper respiratory infections , headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

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    Dose Optimization Of Infliximab

    In addition to a dose increase, higher levels of drug may be obtained through the addition of an immunomodulator. In the SONIC trial of infliximab alone, azathioprine alone, or the combination for the treatment of CD, median trough levels of infliximab at week 30 were 1.6 mcg/mL in patients in the infliximab group and 3.5 mcg/mL for those in the combination therapy group . Corticosteroid-free remission rates were higher in patients with higher trough levels, although rates were still high among patients with lower trough levels. The UC-SUCCESS trial evaluated infliximab, azathioprine, or the combination for the treatment of UC and found that a higher percentage of patients on combination therapy achieved corticosteroid-free remission at week 16 compared with patients on infliximab alone or azathioprine alone . This study did not report whether this increase in remission rates was related to a difference in infliximab levels between the combination and infliximab groups.

    An algorithm for the evaluation and dose adjustment of infliximab in an inflammatory bowel disease patient with continued inflammation.

    ATI, antibodies to infliximab TNF, tumor necrosis factor.

    Aliment Pharmacol Ther.

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