Amjevita 80mg/0.8ml 2 Auto Injector

Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human Tumor Necrosis Factor (TNF) alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the lesions of patients with plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with receptors, thereby reducing inflammation and immune responses.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.

If you experience any of the following, contact your doctor right away:

Nervous System Problems: Burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart Failure: Shortness of breath, sudden weight gain, irregular heartbeat, or swelling in the arms or legs (new or worsening).
Blood Cell Problems: Extreme fatigue or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.

Common Side Effects

Most people do not experience severe side effects, and many have no side effects or only mild ones. However, if you notice any of the following, contact your doctor or seek medical attention if they bother you or persist:

Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site

Reporting Side Effects

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.

If you have a history of hepatitis B or are a carrier of the virus, consult your doctor, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will instruct you on the necessary hepatitis B testing.

Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug.

Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Discuss any concerns with your doctor.

Regularly undergo blood tests and other laboratory evaluations as directed by your doctor.

Be aware that this medication may cause high cholesterol. If you have concerns, discuss them with your doctor.

If you have a latex allergy, inform your doctor, as some products may contain latex.

In the event of sunburn or other skin problems, consult your doctor. Regular skin checks are recommended, and you should report any skin changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Additionally, if you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.

• Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) during adalimumab therapy.
• Concurrent use with other TNF blockers (e.g., etanercept, infliximab) or other biologic DMARDs (e.g., anakinra, abatacept) due to increased risk of serious infections and neutropenia.

• Immunosuppressants (e.g., methotrexate, corticosteroids): Increased risk of serious infections.
• Vaccines (non-live): May result in a diminished immune response to vaccination.

• Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, skin lesions, diarrhea, dysuria)
• Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of new or worsening heart failure (e.g., shortness of breath, swelling of ankles/feet, sudden weight gain)
• Signs of neurological problems (e.g., numbness, tingling, weakness in limbs, vision changes)
• Signs of blood disorders (e.g., persistent fever, bruising, bleeding, pallor)
• Signs of liver problems (e.g., persistent nausea, vomiting, dark urine, yellowing of skin/eyes, abdominal pain)
• Signs of malignancy (e.g., new lumps, unexplained weight loss, night sweats, persistent fatigue)
• Injection site reactions (e.g., redness, swelling, itching, pain at injection site)

Adalimumab is a human IgG1 antibody, which is known to cross the placenta. While animal studies have not shown direct harm, human data are limited. It is generally considered for use during pregnancy only if clearly needed, with careful consideration of risks vs. benefits. Exposure during the third trimester may lead to detectable levels in the infant for several months post-birth, potentially affecting the infant's immune response to live vaccines.

Adalimumab is present in human milk at low concentrations. Due to its large molecular weight, absorption by the infant is unlikely. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Amjevita and any potential adverse effects on the breastfed infant from Amjevita or from the underlying maternal condition. Generally considered compatible with breastfeeding by many expert groups.

Safety and efficacy have been established for specific pediatric indications (e.g., JIA, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis). Dosing is weight-based. Children and adolescents treated with TNF blockers have an increased risk of malignancy, including hepatosplenic T-cell lymphoma (HSTCL). Live vaccines should be avoided.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections in patients 65 years of age and older was higher than in younger patients. Use with caution and monitor closely for infections.

• Amjevita is a biosimilar to Humira; it is not an interchangeable biosimilar at this time, meaning pharmacists cannot substitute it without prescriber approval.
• Patients should be thoroughly screened for latent tuberculosis and hepatitis B before starting therapy and monitored throughout treatment.
• Educate patients on the importance of reporting any signs of infection immediately, as serious infections can occur.
• Advise patients to avoid live vaccines during treatment and for several months after discontinuation, especially for infants exposed in utero.
• Injection site reactions are common but usually mild and transient. Proper injection technique and rotating injection sites can help.
• Consider the risk of malignancy, particularly in pediatric and young adult males with IBD, and discuss with patients.
• Patients with pre-existing demyelinating disorders or heart failure should be monitored closely, as TNF blockers can exacerbate these conditions.

• Other TNF-alpha inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
• Other biologic DMARDs with different mechanisms of action (e.g., abatacept, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, upadacitinib, tofacitinib, baricitinib)
• Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
• Corticosteroids (for acute flares, not long-term maintenance)
• Immunosuppressants (e.g., azathioprine, cyclosporine)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.