Amjevita 40mg/0.8ml 1 Prf Syringe
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 medicine that helps reduce inflammation in your body. It works by blocking a natural protein called TNF-alpha, which can cause swelling and damage in conditions like arthritis, Crohn's disease, and psoriasis. It's given as an injection under the skin.
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. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, 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, dispose of the device properly and do not reuse it. Discard needles in a designated sharps disposal container, and follow local regulations for disposing of full containers. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze, as this can compromise the medication's effectiveness. If the medication has been frozen, do not use it.
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. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, 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, dispose of the device properly and do not reuse it. Discard needles in a designated sharps disposal container, and follow local regulations for disposing of full containers. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze, as this can compromise the medication's effectiveness. If the medication has been frozen, do not use it.
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 on this medication.
- Report any signs of infection (fever, chills, persistent cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis or hepatitis B.
- Discuss any planned surgeries or dental procedures with your doctor.
- Maintain good hygiene to reduce infection risk.
- Limit sun exposure and use sunscreen due to increased risk of skin cancer.
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 significantly by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg subcutaneously every other week. For Crohn's Disease/Ulcerative Colitis: Initial dose 160 mg (day 1), then 80 mg (day 15), then 40 mg every other week (day 29 onwards). For Plaque Psoriasis: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg SC every other week
Psoriatic Arthritis:
40 mg SC every other week
Ankylosing Spondylitis:
40 mg SC every other week
Crohn's Disease:
Initial 160 mg, then 80 mg at week 2, then 40 mg every other week
Ulcerative Colitis:
Initial 160 mg, then 80 mg at week 2, then 40 mg every other week
Plaque Psoriasis:
Initial 80 mg, then 40 mg every other week starting one week later
Hidradenitis Suppurativa:
Initial 160 mg, then 80 mg at week 2, then 40 mg weekly starting at week 4
Uveitis:
Initial 80 mg, then 40 mg every other week starting one week later
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing varies by weight and indication (e.g., Juvenile Idiopathic Arthritis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Uveitis). Typically 20 mg or 40 mg based on weight and frequency (e.g., every other week).
Adolescent:
Dosing varies by weight and indication, often similar to adult dosing for higher weight adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not significantly removed by dialysis due to large molecular size.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF) alpha. It blocks TNF-alpha's interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological function of TNF-alpha. TNF-alpha is a naturally occurring cytokine 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 affected tissues of patients with Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
5-10 days
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
4.7-6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 days (mean ~14 days)
Clearance:
11-12 mL/hr
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Weeks to months (e.g., RA: 2-12 weeks for clinical response)
PeakEffect:
Varies by indication and individual response, typically within 12-24 weeks for full therapeutic effect.
DurationOfAction:
Maintained with regular dosing (every other week or weekly depending on indication).
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: Patients treated with adalimumab are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis), and bacterial and viral infections. Evaluate patients for TB risk factors and test for latent TB infection prior to and during therapy. Initiate treatment for latent TB prior to adalimumab use. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and often fatal T-cell lymphoma, have been reported in adolescents and young adults treated with TNF blockers, including adalimumab, for Crohn's disease or ulcerative colitis. Most of these cases occurred in patients concomitantly treated with azathioprine or 6-mercaptopurine.
Side Effects
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 or seek medical attention immediately:
Signs of an 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
Signs of 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
Signs of a 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
Signs of 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
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
A skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
If you experience any of the following nervous system problems, contact your doctor right away: burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in your arms or legs.
Liver and Heart Problems
Liver problems, which can be fatal, have been reported with this medication. Seek medical help immediately if you experience: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart failure, including worsening of existing heart failure, has been associated with this medication. If you have heart disease, inform your doctor. Contact your doctor right away if you experience: shortness of breath, sudden weight gain, irregular heartbeat, or new or worsening swelling in your arms or legs.
Blood Cell Problems
Blood cell disorders, such as aplastic anemia, low platelet count, and low white blood cell count, have been reported. If you feel extremely tired or weak, or experience fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on your skin, contact your doctor immediately.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Headache
Common cold symptoms
Stomach pain
Upset stomach
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.
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 attention immediately:
Signs of an 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
Signs of 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
Signs of a 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
Signs of 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
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
A skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
If you experience any of the following nervous system problems, contact your doctor right away: burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in your arms or legs.
Liver and Heart Problems
Liver problems, which can be fatal, have been reported with this medication. Seek medical help immediately if you experience: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart failure, including worsening of existing heart failure, has been associated with this medication. If you have heart disease, inform your doctor. Contact your doctor right away if you experience: shortness of breath, sudden weight gain, irregular heartbeat, or new or worsening swelling in your arms or legs.
Blood Cell Problems
Blood cell disorders, such as aplastic anemia, low platelet count, and low white blood cell count, have been reported. If you feel extremely tired or weak, or experience fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on your skin, contact your doctor immediately.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Headache
Common cold symptoms
Stomach pain
Upset stomach
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.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, persistent cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of blood problems: easy bruising or bleeding, pale skin, unusual weakness.
- Signs of new or worsening heart failure: shortness of breath with activity or lying down, swelling of feet/ankles, sudden weight gain.
- Signs of nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, seizures.
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 allergic reaction you experienced, including any symptoms that occurred.
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 drug interactions or health concerns that may affect your use of this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as they may impact the safety and effectiveness of this medication.
Verify that it is safe to take this medication with all your other medications and health conditions before starting treatment.
* Never start, stop, or change the dose 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 allergic reaction you experienced, including any symptoms that occurred.
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 drug interactions or health concerns that may affect your use of this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as they may impact the safety and effectiveness of this medication.
Verify that it is safe to take this medication with all your other medications and health conditions before starting treatment.
* Never start, stop, or change the dose 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 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, it is vital to discuss your vaccination schedule with your doctor, as some vaccines may not be effective or may increase the risk of infection when used concurrently with this drug.
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 directed by your doctor.
Be aware that this medication may cause high cholesterol levels. If you have concerns or questions, consult 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 examinations and report any new or changing skin lesions, such as warts, sores, or 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you used this medication during pregnancy, inform your baby's doctor 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 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, it is vital to discuss your vaccination schedule with your doctor, as some vaccines may not be effective or may increase the risk of infection when used concurrently with this drug.
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 directed by your doctor.
Be aware that this medication may cause high cholesterol levels. If you have concerns or questions, consult 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 examinations and report any new or changing skin lesions, such as warts, sores, or 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you used this medication during pregnancy, inform your baby's doctor 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 toxicities.
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 immediately. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Live vaccines (during treatment)
- Anakinra (Kineret) - increased risk of serious infection and neutropenia
- Abatacept (Orencia) - increased risk of serious infection
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab) - increased risk of serious infection
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and infection (use with caution and monitor)
Moderate Interactions
- Corticosteroids - may increase risk of infection when used concurrently, but often used in combination for disease control
- Warfarin - potential for altered INR (monitor INR)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: Risk of TB reactivation; Adalimumab can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline blood counts and monitor for cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline liver function and monitor for liver injury.
Timing: Prior to initiation of therapy
Baseline disease activity assessment (e.g., DAS28, CDAI, PASI)
Rationale: To establish baseline for efficacy monitoring.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of fever, cough, malaise, localized infection signs
Action Threshold: Any new or worsening signs/symptoms of infection; prompt medical evaluation required.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant decrease in WBC, neutrophil, or platelet counts; consider holding therapy and investigate.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Significant elevation (e.g., >3x ULN); investigate and consider holding therapy.
Disease activity assessment
Frequency: Every 3-6 months or as clinically indicated
Target: Improvement or remission of disease
Action Threshold: Lack of adequate response after 12-24 weeks; consider dose adjustment or alternative therapy.
Skin examination for malignancy
Frequency: Annually or as clinically indicated
Target: Absence of suspicious lesions
Action Threshold: New or changing skin lesions; refer to dermatology.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Skin lesions (new or changing)
- Easy bruising or bleeding
- Persistent sore throat
- Unexplained weight loss
- Abdominal pain
- Jaundice
- Swelling of face/lips/tongue (allergic reaction)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Limited data from observational studies and registries suggest no increased risk of major birth defects or miscarriage. However, live vaccines should not be administered to infants exposed to adalimumab in utero for at least 5 months after the mother's last dose during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant's serum for several months after birth. Consider the risks and benefits of continuing therapy.
Lactation
Adalimumab is present in human milk at low concentrations. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. No adverse effects on breastfed infants have been reported. Considered compatible with breastfeeding by many experts.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy established for specific indications in pediatric patients (e.g., JIA, Crohn's, UC, Plaque Psoriasis, Uveitis). Dosing is weight-based. Increased risk of malignancy (lymphoma, HSTCL) reported in children and adolescents treated with TNF blockers, especially with concomitant immunosuppressants.
Geriatric Use
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. Increased incidence of serious infections and malignancies in the elderly population in general, so caution is advised.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira. Ensure patients understand this and are comfortable with the switch if applicable.
- Patients should be thoroughly screened for latent TB and HBV prior to initiation and monitored during therapy.
- Educate patients on the importance of reporting any signs of infection immediately.
- Advise patients to avoid live vaccines during treatment and for several months after stopping therapy.
- Monitor for signs of new or worsening heart failure, demyelinating disease, and hematologic reactions.
- Consider the increased risk of malignancy, particularly non-melanoma skin cancer and lymphoma, with long-term use.
- Injection site reactions are common but usually mild and transient. Proper injection technique can minimize these.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., abatacept, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, upadacitinib, tofacitinib)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Varies widely, typically several thousand USD per 40mg/0.8ml prefilled syringe
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often subject to high co-pays or co-insurance)
General Drug Facts
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 or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet 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, 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.