Amjevita 40mg/0.4ml 1 Pf Auto Inj

Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF) alpha and neutralizes its biological function by blocking its interaction with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF 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 and hidradenitis suppurativa. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.

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:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower abdominal pain
+ Pelvic pain
Signs of lupus, including:
+ Rash on the cheeks or other body parts
+ Easy sunburning
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen gland
Night sweats
Shortness of breath
Unintentional weight loss

If you experience any of the following rare but serious side effects, contact your doctor immediately:

Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, including:
+ Shortness of breath
+ Sudden weight gain
+ Irregular heartbeat
+ Swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet count
+ Low white blood cell count
+ Fatigue
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple spots on the skin

Other Possible Side Effects

Most people taking this medication will not experience serious side effects. However, some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor if they bother you or do not go away:

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

This is not an exhaustive list of possible 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 allergic reaction and its symptoms.
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 to determine the best course of action.

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) medications
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. This precaution will help prevent potential interactions and ensure your safety while taking this medication.

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

While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid 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. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.

Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.

Do not receive live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Consult your doctor for guidance.

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

Be aware that high cholesterol has been reported in patients taking this medication. 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. Regularly examine your skin and report any changes, such as new warts, skin sores, 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, exercise caution when taking this medication, as you may be more prone 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 took this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccinations.

• Live vaccines (during and for at least 6 months after treatment)
• Anakinra (increased risk of serious infection and neutropenia)
• Abatacept (increased risk of serious infection)

• Other biologic DMARDs (e.g., etanercept, infliximab, golimumab, certolizumab, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, upadacitinib, tofacitinib, baricitinib) - increased risk of serious infection.
• Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, oral polio, BCG, live attenuated influenza vaccine) - risk of vaccine-induced infection.

• Immunosuppressants (e.g., methotrexate, azathioprine, 6-mercaptopurine, corticosteroids) - increased risk of infection when used concomitantly, though often used together in certain conditions (e.g., RA, CD).
• Warfarin (potential for altered INR, monitor closely)

• Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, flu-like symptoms, skin warmth/redness/pain, diarrhea, painful urination)
• Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
• New or worsening neurological symptoms (e.g., numbness, tingling, weakness in limbs, vision changes, dizziness)
• Signs of heart failure (e.g., shortness of breath, swelling of ankles/feet, sudden weight gain)
• Signs of lupus-like syndrome (e.g., joint pain, rash on cheeks/nose, fever)
• New or unusual lumps/growths, unexplained weight loss, night sweats (potential malignancy)
• Easy bruising or bleeding, persistent fever, pallor (potential cytopenias)

Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Available data from clinical trials and postmarketing experience with adalimumab use in pregnant women have not established an association between adalimumab and major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, live vaccines should be avoided in infants exposed to adalimumab in utero for at least 6 months following the mother's last dose during pregnancy.

Adalimumab is present in human milk. Published data suggest that infant exposure to adalimumab through breast milk is low. The effects of local gastrointestinal exposure and systemic exposure in the breastfed infant are unknown. Consider the benefits of breastfeeding 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.

Approved for various pediatric indications including Juvenile Idiopathic Arthritis (JIA), Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis. Dosing is weight-based. Increased risk of malignancy (lymphoma, including hepatosplenic T-cell lymphoma) has been reported in children and adolescents treated with TNF blockers.

No overall differences in effectiveness or safety were observed between elderly and younger patients, but a higher incidence of serious infections has been observed in patients 65 years of age and older. Use with caution and monitor closely for infections.

• Amjevita is a biosimilar to Humira (adalimumab). Biosimilars are highly similar to the reference product with no clinically meaningful differences in terms of safety, purity, and potency.
• Patients should be thoroughly screened for tuberculosis (latent and active) and hepatitis B virus prior to initiating therapy due to the risk of reactivation.
• Patients should be educated on the signs and symptoms of serious infections and instructed to seek immediate medical attention if they occur.
• Injection site reactions (pain, redness, swelling, itching) are common but usually mild and transient. Proper injection technique can help minimize these.
• Adalimumab can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs, depending on the indication.
• Due to its immunosuppressive effects, patients should avoid live vaccines during treatment and for a period after discontinuation.

• Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
• Other biologic DMARDs with different mechanisms of action (e.g., abatacept, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, tildrakizumab)
• Janus Kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, upadacitinib)
• Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
• Corticosteroids (for acute flares, not long-term maintenance)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (for symptomatic relief)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.