Amjevita 40mg/0.4ml 1 Pf Syr
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat Crohn's disease.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It is used to treat ulcerative colitis.It is used to treat a skin problem called hidradenitis suppurativa.It is used to treat uveitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-modifying antirheumatic drug (DMARD)
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
Pregnancy Category
Not available
FDA Approved
Sep 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Amjevita is a biologic medicine that works by blocking a protein in your body called TNF-alpha. This protein can cause inflammation and damage in certain autoimmune diseases like rheumatoid arthritis, Crohn's disease, and psoriasis. By blocking TNF-alpha, Amjevita helps reduce inflammation and improve symptoms.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. The solution should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If the box is full, follow local guidelines for its removal.
If you accidentally drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. The solution should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If the box is full, follow local guidelines for its removal.
If you accidentally drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while taking Amjevita and for several months after stopping.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or any other serious infections.
- Discuss any planned surgeries or dental procedures with your doctor.
- Store medication in the refrigerator; do not freeze. Protect from light.
- Allow the syringe to reach room temperature for 15-30 minutes before injection.
- Rotate injection sites.
Available Forms & Alternatives
Available Strengths:
- Amjevita 40mg/0.8ml Pf Aut Inj 2pen
- Amjevita 20mg/0.4ml 1 Pf Syr, 0.4ml
- Amjevita 40mg/0.8ml 1 Prf Syringe
- Amjevita 40mg/0.8ml Pf Aut Inj 1pen
- Amjevita 10mg/0.2ml Pf Syringe Inj
- Amjevita 20mg/0.2ml 1 Pf Syr, 0.2ml
- Amjevita 40mg/0.4ml 1 Pf Syr
- Amjevita 40mg/0.4ml 2 Pf Syr
- Amjevita 80mg/0.8ml 1 Aut0 Injector
- Amjevita 80mg/0.8ml 2 Auto Injector
- Amjevita 40mg/0.4ml 1 Pf Auto Inj
- Amjevita 80mg/0.8ml 2 Pf Auto Inj
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg subcutaneously every other week.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS):
40 mg subcutaneously every other week.
Crohn's Disease (CD), Ulcerative Colitis (UC):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg every other week starting Day 29.
Plaque Psoriasis (PsO):
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg weekly starting Day 29.
Uveitis:
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 10-30 kg: 20 mg every other week; >30 kg: 40 mg every other week. Crohn's Disease (CD): Weight-based, e.g., <40 kg: 80 mg (Day 1), 40 mg (Day 15), then 20 mg every other week; âĨ40 kg: 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week. Plaque Psoriasis (PsO) (âĨ4 years): 0.8 mg/kg (max 40 mg) every other week. Uveitis (âĨ2 years): 20 mg every other week for 10-30 kg, 40 mg every other week for >30 kg.
Adolescent:
Dosing typically follows adult or weight-based pediatric guidelines depending on indication and weight.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific recommendations; adalimumab is a large protein and not removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Pharmacology
Mechanism of Action
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. Adalimumab also lyses surface TNF-expressing cells in vitro and modulates biological responses that are induced or regulated by TNF, including the expression of adhesion molecules responsible for leukocyte migration.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64% (subcutaneous administration)
Tmax:
Approximately 5-6 days
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr
ExcretionRoute:
Reticuloendothelial system (catabolism)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Varies by indication; typically weeks to months (e.g., 2-12 weeks for RA).
PeakEffect:
Achieved after several doses, typically within 12-24 weeks depending on the indication.
DurationOfAction:
Effects persist for several weeks after discontinuation due to long half-life.
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to adalimumab therapy and monitored for signs and symptoms of active TB during and after treatment. Increased risk of malignancies, including lymphoma and other cancers, in children and adolescents treated with TNF blockers.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 or seek medical help right away:
Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, 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 nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be fatal. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Seek medical attention immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple spots on the skin
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help 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 a comprehensive list of all 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.
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 or seek medical help right away:
Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, 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 nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be fatal. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Seek medical attention immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple spots on the skin
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help 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 a comprehensive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Fever, chills, night sweats
- Persistent cough, shortness of breath
- Unusual tiredness or weakness
- Skin sores, redness, or swelling
- Unexplained weight loss
- Easy bruising or bleeding
- New lumps or growths on your body
- Numbness, tingling, or weakness in your arms or legs
- Vision changes
- Swelling in your ankles or feet, sudden weight gain, shortness of breath (signs of heart failure)
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
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 modify the dosage of any medication without first consulting 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 modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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 likely recommend hepatitis B testing, and it is vital to follow their instructions.
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 may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
Regular blood tests and other laboratory evaluations are necessary to monitor your health while taking this medication. Adhere to the schedule recommended by your doctor.
Be aware that this drug may cause high cholesterol levels. If you have concerns or questions, 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. Additionally, schedule regular skin checks and report any 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 potential benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccinations.
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 likely recommend hepatitis B testing, and it is vital to follow their instructions.
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 may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
Regular blood tests and other laboratory evaluations are necessary to monitor your health while taking this medication. Adhere to the schedule recommended by your doctor.
Be aware that this drug may cause high cholesterol levels. If you have concerns or questions, 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. Additionally, schedule regular skin checks and report any 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 potential benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccinations.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg (approximately 700 mg) have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (during adalimumab treatment)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol) - increased risk of serious infection.
- Anakinra - increased risk of serious infection and neutropenia.
- Abatacept - increased risk of serious infection.
Moderate Interactions
- Immunosuppressants (e.g., methotrexate, corticosteroids, azathioprine, 6-mercaptopurine) - increased risk of infection (often used concomitantly, but requires careful monitoring).
- Vaccines (non-live) - may result in a diminished immune response.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection before initiating treatment, as TNF blockers can reactivate latent TB.
Timing: Before initiating therapy.
Hepatitis B Virus (HBV) screening
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Before initiating therapy.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and monitor for cytopenias.
Timing: Before initiating therapy.
Liver Function Tests (LFTs)
Rationale: To establish baseline liver function and monitor for drug-induced liver injury.
Timing: Before initiating therapy.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue, skin lesions)
Frequency: Regularly throughout therapy and for several months after discontinuation.
Target: Absence of new or worsening signs/symptoms of infection.
Action Threshold: Prompt evaluation and potential discontinuation of adalimumab if serious infection develops.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Investigate persistent cytopenias; consider discontinuation if clinically significant.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Investigate persistent elevations; consider discontinuation if clinically significant.
Signs and symptoms of malignancy (e.g., new lumps, unexplained weight loss, persistent fever)
Frequency: Regularly throughout therapy.
Target: Absence of new or worsening signs/symptoms of malignancy.
Action Threshold: Prompt evaluation and appropriate management.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Unusual bruising or bleeding
- Pale skin
- Sore throat
- Swollen glands
- New or worsening skin lesions
- Numbness or tingling
- Vision changes
- Weakness in arms or legs
- Signs of allergic reaction (rash, hives, swelling, difficulty breathing)
- Signs of heart failure (new or worsening shortness of breath, swelling of ankles/feet)
Special Patient Groups
Pregnancy
Adalimumab crosses the placenta, particularly during the third trimester. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Infants exposed to adalimumab in utero may be at increased risk of infection; avoid administration of live vaccines to these infants for 6 months after the mother's last dose during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk of major birth defects.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant at birth. Increased risk of infection in exposed infants.
Lactation
Adalimumab is present in human milk at low concentrations. The amount ingested by a breastfed infant is very low. Given the large molecular weight, absorption by the infant is unlikely. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Approved for several pediatric indications including Juvenile Idiopathic Arthritis (JIA), Crohn's Disease, Plaque Psoriasis, and Uveitis. Dosing is weight-based. Increased risk of malignancies (e.g., lymphoma) has been reported in children and adolescents treated with TNF blockers.
Geriatric Use
Increased incidence of serious infections and malignancies has been observed in patients 65 years of age and older treated with TNF blockers. Use with caution and monitor closely for infections and malignancies.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira, offering a similar efficacy and safety profile.
- Patients must be screened for active and latent tuberculosis (TB) and hepatitis B virus (HBV) infection prior to initiating therapy.
- Live vaccines should not be administered concurrently with adalimumab. Patients should be up-to-date on all immunizations prior to starting therapy.
- Monitor patients closely for signs and symptoms of serious infections, including opportunistic infections, during and after treatment.
- Rare cases of new or worsening heart failure, demyelinating disease (e.g., multiple sclerosis), and lupus-like syndrome have been reported.
- Patients should be educated on proper subcutaneous injection technique and rotation of injection sites.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, risankizumab, guselkumab, tofacitinib, upadacitinib, baricitinib, abatacept, rituximab, vedolizumab, natalizumab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per syringe/dose
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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 about its use. 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, consult 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.