Amgevita

Amgevita is an FDA-approved medication used to treat various inflammatory and autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and more. It functions as a TNF blocker, effectively reducing inflammation and managing symptoms. Available as a subcutaneous injection in multiple strengths, Amgevita offers flexible dosing options tailored to individual patient needs. It’s crucial for users to follow medical guidance to optimize treatment benefits and manage potential side effects.

Amgevita, a biosimilar to the well-known drug adalimumab, is prescribed for a range of autoimmune and inflammatory conditions, including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. This medication is particularly effective in reducing inflammation and alleviating symptoms associated with these conditions due to its mechanism as a TNF (tumor necrosis factor) blocker. Amgevita is administered through subcutaneous injections, which can be done at a healthcare facility or at home after proper instruction.

The drug comes in several dosages and forms, including prefilled syringes and autoinjectors, allowing for personalized treatment plans based on the patient’s specific health needs. The dosing regimen varies depending on the condition being treated but often starts with a higher loading dose to rapidly establish medication levels in the body, followed by a maintenance dose.

Patients using Amgevita must be aware of its potential side effects, ranging from mild, such as injection site reactions, to more severe, including increased risks of infections and possible liver issues. Regular monitoring by healthcare providers is essential to ensure the drug’s efficacy and safety. Engaging with medical professionals about potential interactions with other medications, lifestyle factors, and individual health conditions is crucial to optimizing treatment outcomes with Amgevita.

Amgevita is an FDA-approved medication used to manage a variety of chronic inflammatory conditions. It is effective in treating the following conditions:

• Rheumatoid Arthritis: Helps manage symptoms in adults.
• Juvenile Idiopathic Arthritis: Safe for children ages 2 years and older.
• Psoriatic Arthritis: Used in adults to reduce pain and swelling.
• Ankylosing Spondylitis: Helps reduce pain and maintain spine flexibility in adults.
• Crohn’s Disease: Used to manage symptoms in adults and children ages 6 years and older.
• Ulcerative Colitis: Prescribed for adults; however, there are specific limitations regarding its use.
• Plaque Psoriasis: Aids in the reduction of skin symptoms in adults.
• Hidradenitis Suppurativa: Used in adults to reduce the occurrence of painful skin nodules.
• Uveitis: Helps control inflammation of the eye in adults.

Amgevita is prescribed in specific situations, and your healthcare provider can guide you on its appropriate use based on your medical condition.

Amgevita is used to treat various inflammatory conditions, and the correct dosage depends on factors like the type of condition being treated, patient age, body weight, and other health considerations. Always follow the specific dosage plan prescribed by your doctor. Here’s a breakdown of typical dosages for various conditions:

Dosage of Amgevita for Adults

Rheumatoid Arthritis:

• Standard Dosage: 40 mg injected every other week.
• Adjustment: If symptoms persist and you are not taking methotrexate, the dosage may increase to 40 mg weekly or 80 mg every other week.

Psoriatic Arthritis & Ankylosing Spondylitis:

• Dosage: 40 mg every other week.

Crohn’s Disease:

• Initial Treatment (Loading Dose): 160 mg on Day 1 (can be split over two days), followed by 80 mg on Day 15.
• Ongoing Dosage: 40 mg every other week starting on Day 29.

Ulcerative Colitis:

• Loading Dose: 160 mg initially, followed by 80 mg two weeks later.
• Maintenance Dosage: 40 mg every other week starting from Day 29.

Plaque Psoriasis:

• Loading Dose: 80 mg on Day 1.
• Maintenance Dosage: 40 mg every other week starting from Day 8.

Hidradenitis Suppurativa:

• Loading Dose: 160 mg initially, split if necessary.
• Maintenance Dosage: 40 mg weekly or 80 mg every other week starting from Day 29.
• Uveitis:
  • Loading Dose: 80 mg initially.
  • Maintenance Dosage: 40 mg every other week starting from Day 8.

Dosage of Amgevita for Children

• Juvenile Idiopathic Arthritis (Ages 2 and older):
• 30 kg or more: 40 mg every other week.
• 15 kg to less than 30 kg: 20 mg every other week.
• 10 kg to less than 15 kg: 10 mg every other week.
• Note: Not suitable for children under 10 kg.

Crohn’s Disease (Ages 6 and older):

• 40 kg or more: 160 mg initially, followed by 80 mg, then 40 mg every other week.
• 17 kg to less than 40 kg: 80 mg initially, followed by 40 mg, then 20 mg every other week.

Key Points for Dosage of Amgevita

• Make sure to receive the injections according to the schedule set by your healthcare provider.
• Your doctor may adjust the dosage based on how you respond to the treatment.
• Regular follow-up visits are important to adjust the medication as needed and to check for side effects.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

Here’s how you should use Amgevita to avoid any serious side effects and get the maximum benefit out of it:

• How Amgevita Is Injected?
  • Amgevita should be used exactly as directed by your doctor.
  • It is administered as a subcutaneous injection, which means it is injected under the skin.
  • A healthcare professional may give you the injection at their office or clinic, or they can teach you or a caregiver how to do it at home.
  • Detailed instructions for using the prefilled syringe or autoinjector are available on the Amgevita website and in the medication guide provided with your prescription.
• Injection Sites:
  • Amgevita is typically injected into the front of your thigh or your abdomen, avoiding the area near your belly button.
  • Change the injection site each time to prevent skin sensitivity or irritation.
  • Do not inject into skin that is discolored, bruised, scarred, tender, hard, or damaged.
  • Always inject directly into the skin, never through clothing.
• When to Inject:
  • Amgevita is usually injected every other week, on the same day of the week.
  • To avoid missing a dose, set reminders using an alarm, timer, or a medication reminder app.
  • Always follow your doctor’s schedule for the injections.
• Accessible Labels and Containers:
  • If you have trouble reading the medication label, some pharmacies offer options like large print, braille, or a code to scan with a smartphone that converts text to speech. If your pharmacy doesn’t provide these services, ask your doctor or pharmacist for help.

Following these steps ensures the proper use of Amgevita and helps achieve the best results from your treatment.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Amgevita is known as a TNF blocker, which stands for tumor necrosis factor blocker. This medication works by targeting and inhibiting the action of TNF, a substance in the body that causes inflammation.

By blocking TNF, Amgevita helps reduce the inflammatory responses that it triggers in the body. This reduction in inflammation can lead to a relief of symptoms associated with various inflammatory conditions, making it an effective treatment for improving the quality of life for those affected by these diseases.

Amgevita is used to treat several immune-related conditions, but like all medications, it can have side effects ranging from mild to serious. Knowing what these are will help you manage them more effectively.

Common Side Effects of Amgevita: Many people experience mild side effects that usually get better on their own within a few days or weeks. If they stick around or start to bother you, it’s a good idea to talk to your doctor. Here’s what you might see:

• Upper Respiratory Infections: Symptoms like a runny nose, sore throat, and stuffy nose are common.
• Skin Rash: You might notice red, itchy, or irritated skin.
• Headaches: These can vary from mild to severe but usually go away by themselves.
• Injection Site Reactions: You may have pain, swelling, redness, itching, or even some bleeding where the shot was given.
• Mild Allergic Reactions: These can include itching, mild redness, or swelling around the injection site.

Serious Side Effects of Amgevita: These aren’t as common, but they’re more serious and require immediate medical attention. If you notice any of these, contact your doctor right away, or in emergencies, call 911 or head to the nearest hospital:

• Lupus-like Syndrome: Look out for symptoms like trouble breathing, persistent chest pain, a rash that gets worse in sunlight, and joint pain.
• Heart Failure: Symptoms to watch for include swelling in your legs or ankles, trouble breathing, or sudden weight gain.
• Liver Problems: If you have abdominal pain, lose your appetite, or see a yellowing of your skin or eyes, these could be signs of liver trouble.
• Nerve Problems: This could show up as weakness or tingling in your limbs, dizziness, or vision issues.
• Blood Problems: You might appear paler than usual, have a fever, or find that you bruise or bleed more easily.
• Risk of Serious Infections: Amgevita can weaken your immune system, making you more likely to catch infections.
• Risk of Cancer: Like other drugs that affect the immune system, Amgevita could increase your risk of certain cancers.
• Severe Allergic Reactions: These could include extreme swelling, difficulty breathing, or a severe rash.

Always discuss any side effects with your healthcare provider, who can help you weigh the benefits of Amgevita against its potential risks and guide you on managing side effects effectively. Don’t hesitate to reach out to your doctor or pharmacist if you have any concerns about your treatment.

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

When using Amgevita, there are some important warnings to keep in mind. This medication can affect your immune system, potentially making you more vulnerable to infections, including serious or life-threatening ones. It’s essential to use this medication under close supervision from your healthcare provider.

• Increased Risk of Infections: Amgevita can make it easier for you to get infections. These infections can sometimes be severe or even fatal. Notify your doctor immediately if you experience signs of an infection, such as:
  • Fever or chills
  • Body aches or tiredness
  • Persistent cough
  • Skin sores
  • Diarrhea
  • Burning sensation when urinating
• Tuberculosis (TB) Screening: Before starting Amgevita, your doctor will likely test you for tuberculosis (TB). If you have had TB in the past, Amgevita could reactivate the infection. Your doctor will also monitor you closely for any symptoms of TB during treatment.
• Risk of Cancer: Children and adults taking TNF blockers like Amgevita may have a higher risk of developing certain types of cancer. If you have concerns about this risk, discuss them with your doctor. Your healthcare team will guide you on how to use Amgevita safely and manage potential risks. Always inform your doctor of any symptoms or concerns during treatment.

What Are the FDA Boxed Warning for Amgevita?

Amgevita comes with boxed warnings, the FDA’s most serious type of warning, to alert both doctors and patients about potential risks that could be harmful. It’s important to understand these risks before starting treatment.

• • Risk of Serious Infections: Amgevita weakens your immune system, which can increase your chances of developing serious infections. These infections may include bacterial, viral, or fungal infections, as well as tuberculosis (TB) and sepsis. These conditions could require hospitalization and may be life-threatening. Here’s what you should consider:
    • Tell your doctor if you currently have any infections or a history of recurring infections.
    • Inform your doctor if you’ve had TB in the past, as Amgevita could reactivate it. Your doctor will likely perform a TB test before starting treatment.
    • If your test is positive for TB or other infections, your doctor might treat the infection before you begin Amgevita.
• Symptoms to Watch For:
  • Fever or cough
  • Muscle aches
  • Unintentional weight loss
  • Red, hot, or swollen skin
  • Diarrhea or painful urination

If you develop a serious infection, your doctor may temporarily stop Amgevita while the infection is treated.

• Risk of Cancer: By weakening the immune system, Amgevita may increase the risk of certain cancers, including skin cancer, leukemia, and lymphoma.

• Special Concerns:
  • Children and teenagers taking TNF blockers like Amgevita have reported rare and sometimes fatal cancers, including a rare and aggressive form of lymphoma.
  • These cases have been seen more often in teenage and young adult males who were also taking medications such as azathioprine or mercaptopurine for Crohn’s disease or ulcerative colitis.
• Precautions:
  • Let your doctor know if you’ve had cancer in the past, have a family history of cancer, or if you smoke.
  • During treatment, your doctor may monitor you closely for signs of cancer through blood tests and skin exams.
• What to Look For:
  • Unusual changes in your skin
  • Any lumps or unexplained symptoms

Always have an open discussion with your doctor about the risks and benefits of Amgevita.

Before starting Amgevita, it’s important to discuss your health history with your doctor. Certain medical conditions or situations may make this medication unsuitable for you. Here are the key precautions to consider:

• Pregnancy: It’s unclear if Amgevita is safe during pregnancy, as there haven’t been enough studies in humans. In animal studies, the drug didn’t harm the fetus, but these results don’t always apply to people. Amgevita can cross the placenta, especially in the last trimester, and may temporarily weaken a newborn’s immune system.
  • If you’re pregnant or planning to become pregnant, discuss the potential risks and benefits with your doctor.
  • Untreated conditions like rheumatoid arthritis, Crohn’s disease, or ulcerative colitis during pregnancy can also harm a fetus, increasing the risk of premature delivery or low birth weight.
  • If you use Amgevita during pregnancy, your doctor might delay certain vaccines for your newborn until their immune system strengthens.
• Birth Control: Since the safety of Amgevita during pregnancy isn’t fully known, talk to your doctor about using effective birth control while taking this medication if you or your partner can become pregnant.
• Breastfeeding: Amgevita may pass into breast milk in small amounts, but it’s unclear how this might affect a breastfeeding child.
  • If you’re breastfeeding or planning to breastfeed, consult your doctor to weigh the risks and benefits.
  • If breastfeeding isn’t advised, your doctor can help you explore other feeding options for your child.
• Hepatitis B: Amgevita could reactivate hepatitis B in people who’ve had the virus before.
  • Your doctor may test for hepatitis B before starting treatment.
  • If the virus is present, your doctor will monitor you closely during Amgevita use.
  • In case of a flare-up, treatment with Amgevita may need to stop, and hepatitis B medication may be required.
• Liver Problems: If you have liver issues, such as liver failure, Amgevita could worsen your condition. Your doctor may monitor your liver function during treatment to ensure it’s safe.
• Heart Failure: Amgevita may worsen heart failure. Discuss your condition with your doctor to determine if this medication is a good option for you.
• Nerve Conditions: Amgevita could worsen nerve-related conditions like multiple sclerosis. Inform your doctor if you have any nerve disorders to evaluate if Amgevita is appropriate for you.
• Allergic Reactions: If you’ve had an allergic reaction to Amgevita or its ingredients in the past, this medication may not be safe for you. Your doctor can recommend alternative treatments that are better suited to your needs.

Always share your complete medical history and any concerns with your doctor before starting Amgevita. This will help ensure the safest and most effective treatment for your condition.

Missing a dose of Amgevita can happen, but it’s important to handle it correctly to maintain your treatment schedule. Here’s what you should do:

• If you forget to take your Amgevita injection and remember it soon after, go ahead and take it as soon as you can. After that, continue with your next dose at its regular time to keep on track. But, if it’s nearly time for your next planned dose when you remember the missed one, it’s best to get in touch with your doctor to figure out the right action.
• If you usually get your Amgevita shots at a doctor’s office or clinic and you miss an appointment, call them immediately to arrange another visit as soon as possible.
• To avoid missing doses in the future, you might find it helpful to set up reminders. You can use an alarm, leave a note in a place you frequently check like your bathroom mirror or bedside table, or even use a smartphone app designed for medication reminders.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Using more Amgevita than your doctor has prescribed can be risky. Here’s how to handle it if you think you’ve used too much:

• Always stick to the dosage your doctor recommends for Amgevita. Taking more can cause serious side effects or even lead to an overdose. If you believe you’ve administered too much Amgevita, it’s important to act quickly.
• First, call your doctor for advice. If you can’t reach your doctor right away, you can also contact America’s Poison Centers at 800-222-1222 for immediate guidance, or use their online tool for assistance.
• In cases where you experience severe symptoms or feel extremely unwell after taking too much Amgevita, don’t wait—call 911 or your local emergency number immediately, or get to the nearest emergency room. Quick action is essential.

[Note: If you consumed more than the recommended dose, get medical help right away, or call the Poison Help line at 1-800-222-1222.]

Proper storage of your medication is crucial for its effectiveness. Here’s how to store Amgevita correctly:

• Amgevita must be kept in the refrigerator at temperatures between 36–46°F (2–8°C).
• Always keep it in its original carton to protect it from light.
• Make sure it doesn’t freeze. If Amgevita does freeze, do not use it, even if it thaws.
• If you need to take Amgevita out of the refrigerator, for example when traveling, you can store it at room temperature for up to 14 days, as long as it doesn’t get warmer than 77°F (25°C).
• Just like in the fridge, keep it in its original carton to shield it from light and avoid placing it in hot spots like a car’s glove box.
• Make a note of the date when you take Amgevita out of the refrigerator, so you don’t forget.
• If you haven’t used it within those 14 days, it should be thrown away properly.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Amgevita can interact with many other medications, which might affect how well those drugs work or increase your risk of side effects. It’s crucial to manage these interactions to ensure your treatment is safe and effective.

Interactions with Other Medications: Amgevita might not work well, or could become risky, when used with certain other medications. Here’s a simplified breakdown of potential interactions:

Tumor Necrosis Factor (TNF) Blockers: Amgevita itself is a TNF blocker, and using it with similar drugs also increases the risk of serious infections. Examples of other TNF blockers include:

• Cimzia (certolizumab)
• Humira (adalimumab)
• Simponi (golimumab)
• Enbrel (etanercept)
• Remicade (infliximab)

Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): These are drugs used to treat conditions like arthritis. Combining Amgevita with other biologic DMARDs could greatly increase your risk of serious infections. Common examples include:

• Kineret (anakinra)
• Orencia (abatacept)
• Rituxan (rituximab)

Medications with a Narrow Safe Range: Amgevita can affect how your liver processes certain drugs, which could either diminish their effectiveness or enhance side effects. For these drugs, your doctor may monitor you more closely. These include:

• Neoral (cyclosporine)
• Elixophyllin (theophylline)
• Sandimmune (cyclosporine)
• Jantoven (warfarin)
• Theo-24 (theophylline)

Drugs That Weaken the Immune System: These drugs can further elevate your risk of getting infections when used with Amgevita. Such drugs include:

• Azasan (azathioprine)
• Rayos (prednisone)
• Purixan (mercaptopurine)
• Imuran (azathioprine)
• Purinethol (mercaptopurine)
• Trexall (methotrexate)
• Otrexup (methotrexate)

What to Do: Always discuss your entire medication list with your doctor, including all prescription, over-the-counter drugs, as well as any supplements or vitamins you are taking. This discussion will help prevent harmful interactions. If you have any concerns about drug interactions, be sure to ask your healthcare provider for advice.

What Are the Other Amgevita Interactions?

While taking Amgevita, it’s important to be aware of how different substances can interact with this medication. Let’s go over how it interacts with herbs, supplements, foods, vaccines, and alcohol.

• Herbs and Supplements: Currently, there are no specific herbs or supplements known to interact with Amgevita. However, it’s always a good idea to talk to your doctor or pharmacist before starting any new herbal or supplement regimen while on Amgevita.
• Foods: No specific food interactions with Amgevita have been identified. If you’re concerned about how certain foods might affect your treatment, don’t hesitate to discuss these concerns with your doctor.
• Vaccines: While on Amgevita, you should avoid live vaccines. Usually, these vaccines are safe for people with healthy immune systems, but because Amgevita can weaken your immune system, there’s a risk of developing serious infections from these vaccines. Make sure to discuss your vaccination history with your doctor before starting Amgevita, as you may need to receive some vaccines beforehand. Live vaccines contain weakened versions of viruses or bacteria, such as:
  • Measles, mumps, and rubella vaccine (M-M-R II, Priorix)
  • Chickenpox vaccine (Varivax)
  • Nasal spray flu vaccine (FluMist)
  • Oral typhoid vaccine (Vivotif)
  • Oral rotavirus vaccine (Rotarix, RotaTeq)
  • Shingles vaccine (Shingrix)
• Alcohol: There’s no reported interaction between Amgevita and alcohol, but drinking alcohol can increase some side effects of Amgevita like headaches. Moreover, heavy drinking can lead to liver issues, which might be exacerbated by Amgevita, as it can also affect liver health. If you have conditions like ulcerative colitis or plaque psoriasis that Amgevita treats, you might notice that alcohol triggers or worsens your symptoms.

If you enjoy alcoholic beverages, discuss this with your doctor or pharmacist to understand the potential risks while being treated with Amgevita. They can provide personalized advice and support, ensuring that your treatment plan considers all aspects of your lifestyle and health.

[Note: This isn’t a complete list, and there could be other drugs that interact with Amgevita. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

When considering treatment for autoimmune conditions, there are several alternatives to Amgevita that you might discuss with your healthcare provider. These alternatives include both biologic medications and traditional treatments known as disease-modifying antirheumatic drugs (DMARDs).

• Simlandi (adalimumab-ryvk)
• Methotrexate (generic, no brand listed)
• Orencia (abatacept)
• Rinvoq (upadacitinib)
• Taltz (ixekizumab)
• Enbrel (etanercept)
• Benlysta (belimumab)
• Kevzara (sarilimumab)
• Cimzia (certolizumab pegol)
• Actemra (tocilizumab)
• Remicade (infliximab)
• Kineret (anakinra)
• Neoral (cyclosporine)
• Rituxan (rituximab)
• Plaquenil (hydroxychloroquine)
• Cyltezo (adalimumab-adbm)
• Azulfidine (sulfasalazine)
• Humira (adalimumab)
• Simponi (golimumab)
• Olumiant (baricitinib)
• Abrilada (adalimumab-afzb)
• Arava (leflunomide)
• Imuran (azathioprine)

These alternative medications can be useful for different reasons, such as varying effectiveness, side effects, or how the drug is administered. It’s important to have a conversation with your doctor about which medication might be best for your specific condition and personal health needs. Your doctor will consider your medical history, current health, and treatment goals when suggesting alternatives to Amgevita.

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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