Amjevita 10mg/0.2ml Pf Syringe Inj
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), Immunosuppressant
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
Pregnancy Category
Not available
FDA Approved
Jan 2017
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 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, usually every other week. Because it affects your immune system, it's important to be careful about infections and tell your doctor if you feel sick.
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 medication 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 any 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, discard the device and do not reuse it. Properly dispose of needles and other sharp objects in a designated container, and follow local regulations for disposal when the container is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if a replacement is needed.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. 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 medication 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 any 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, discard the device and do not reuse it. Properly dispose of needles and other sharp objects in a designated container, and follow local regulations for disposal when the container is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if a replacement is needed.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. 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 taking Amjevita and for a period after stopping it. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, cough, flu-like symptoms, skin sores) to your doctor immediately.
- Inform your doctor and dentist that you are taking Amjevita before any surgeries or dental procedures.
- Store Amjevita in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze. Do not shake.
- Allow the syringe to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites (thighs or abdomen) with each dose.
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, Hidradenitis Suppurativa: Initial loading doses followed by maintenance doses (e.g., 40 mg every other week or 40 mg weekly). For Psoriasis: Initial 80 mg, then 40 mg every other week starting one week after initial dose. For Uveitis: Initial 80 mg, then 40 mg every other week starting one week after initial dose.
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg subcutaneously every other week
Psoriatic Arthritis:
40 mg subcutaneously every other week
Ankylosing Spondylitis:
40 mg subcutaneously every other week
Crohn's Disease:
Initial 160 mg (Day 1) then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Ulcerative Colitis:
Initial 160 mg (Day 1) then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Plaque Psoriasis:
Initial 80 mg, then 40 mg every other week starting one week after initial dose
Hidradenitis Suppurativa:
Initial 160 mg (Day 1) then 80 mg (Day 15), then 40 mg weekly (Day 29 onwards)
Uveitis:
Initial 80 mg, then 40 mg every other week starting one week after initial dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) 2-17 years: 10 mg (15 kg to <30 kg) or 20 mg (30 kg to <40 kg) or 40 mg (≥40 kg) every other week. Crohn's Disease 6-17 years: Weight-based dosing (e.g., 40 mg every other week for ≥40 kg). Ulcerative Colitis 5-17 years: Weight-based dosing. Plaque Psoriasis 4-17 years: Weight-based dosing. Uveitis 2-17 years: Weight-based dosing. Hidradenitis Suppurativa 12-17 years: 40 mg every other week or 40 mg weekly.
Adolescent:
See 'child' for specific conditions and dosing. Dosing often mirrors adult weight-based regimens for adolescents ≥40 kg.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
Dialysis:
No specific recommendations; adalimumab is a large protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
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 the p55 and p75 cell surface TNF receptors. 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 neutralizes the biological function of TNF-alpha by blocking its interaction with receptors, thereby modulating the inflammatory processes.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
Approximately 5 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Low (as a monoclonal antibody, it does not bind specifically to plasma proteins in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Catabolism/proteolytic degradation
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full therapeutic effect may take longer (e.g., 12-16 weeks for psoriasis).
PeakEffect:
Varies by indication and patient response; typically observed after several weeks to months of consistent dosing.
DurationOfAction:
Related to half-life; effects persist for several weeks after discontinuation due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to Amjevita use and monitored for signs and symptoms of active TB during and after treatment. 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 fatal form of lymphoma, have been reported primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis treated with TNF blockers, including adalimumab, in combination 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 immediate medical attention:
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, contact your doctor immediately:
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, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood Cell Problems: Feeling extremely tired or weak, 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 some may only have minor side effects. If you notice any of the following, contact your doctor if they bother you or do not go away:
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 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 immediate medical attention:
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, contact your doctor immediately:
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, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood Cell Problems: Feeling extremely tired or weak, 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 some may only have minor side effects. If you notice any of the following, contact your doctor if they bother you or do not go away:
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 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: persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores.
- Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, dizziness.
- Heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
- Blood problems: persistent fever, bruising, bleeding, pale skin.
- Liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
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.
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 the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on 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 a live, attenuated vaccine like BCG for bladder cancer while using this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been associated with this medication. 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 issues, consult your doctor. Regular skin examinations are crucial, and notify your doctor of any skin changes, such as new warts, sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, exercise caution when using 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 used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
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 the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on 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 a live, attenuated vaccine like BCG for bladder cancer while using this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been associated with this medication. 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 issues, consult your doctor. Regular skin examinations are crucial, and notify your doctor of any skin changes, such as new warts, sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, exercise caution when using 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 used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg 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 immediately. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (during and shortly after treatment)
Major Interactions
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
- Other biologic DMARDs (e.g., rituximab, tocilizumab, ustekinumab, secukinumab, infliximab, etanercept) - increased risk of serious infection
Moderate Interactions
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and infection (use with caution)
- Vaccines (non-live) - may result in diminished immune response
Minor Interactions
- Not specifically identified for minor interactions due to its biologic nature and mechanism of action.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD test or IGRA)
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters, as cytopenias (e.g., neutropenia, pancytopenia) can occur.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline liver function, as liver enzyme elevations can occur.
Timing: Prior to initiation of therapy
Baseline clinical assessment for signs/symptoms of infection
Rationale: To ensure patient is free of active infection before starting immunosuppressive therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: Regularly, at each clinical visit and patient self-monitoring
Target: Absence of infection
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of Amjevita.
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant cytopenias (e.g., persistent neutropenia <1000/mm³) may warrant dose reduction or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Persistent or significant elevations (e.g., >3x ULN) may warrant further investigation and potential discontinuation.
Signs and symptoms of new or worsening heart failure
Frequency: Regularly, at each clinical visit
Target: Stable cardiac status
Action Threshold: Discontinue if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease
Frequency: Regularly, at each clinical visit
Target: Absence of neurological symptoms
Action Threshold: Discontinue if new onset or exacerbation of demyelinating disorder occurs.
Skin examination for new or changing lesions
Frequency: Annually or as clinically indicated
Target: Absence of suspicious lesions
Action Threshold: Referral to dermatology for evaluation of suspicious lesions (e.g., non-melanoma skin cancer).
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Fatigue
- Unexplained weight loss
- Skin rash
- Joint pain/swelling
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Swelling of ankles/feet
- Shortness of breath with exertion
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 with adalimumab use during pregnancy. However, live vaccines should not be administered to infants exposed to adalimumab in utero until 6 months of age, as maternal antibodies may interfere with the infant's immune response.
Trimester-Specific Risks:
First Trimester:
Limited data, but no increased risk of major birth defects observed.
Second Trimester:
Limited data, but no increased risk of major birth defects observed.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant at birth. Potential for immunosuppression in the infant.
Lactation
Adalimumab is present in human milk at low levels. The effects of local gastrointestinal exposure and systemic exposure in the breastfed infant are unknown. However, due to its large molecular weight, absorption by the infant is likely to be minimal. 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.
Infant Risk:
Low risk. Monitor for signs of infection or adverse reactions in the infant.
Pediatric Use
Amjevita (adalimumab) is approved for various pediatric indications including Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older, Crohn's Disease in patients 6 years and older, Ulcerative Colitis in patients 5 years and older, Plaque Psoriasis in patients 4 years and older, Uveitis in patients 2 years and older, and Hidradenitis Suppurativa in patients 12 years and older. Dosing is weight-based for most pediatric indications. Children are at increased risk of serious infections and malignancies, including hepatosplenic T-cell lymphoma, when treated with TNF blockers.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections was higher in adalimumab-treated patients aged 65 years and older compared to younger patients. Use with caution in the elderly, and monitor closely for infections.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira (adalimumab). It is interchangeable with Humira, meaning it can be substituted for Humira without the intervention of a healthcare provider, if permitted by state law.
- Patients should be thoroughly screened for tuberculosis (latent and active) and hepatitis B before initiating Amjevita due to the risk of reactivation.
- Educate patients on the importance of reporting any signs of infection immediately, as serious infections can occur.
- Live vaccines are contraindicated during Amjevita therapy. Ensure patients are up-to-date on non-live vaccines prior to initiation.
- Monitor for signs of new or worsening heart failure or demyelinating disorders, and discontinue if these conditions develop.
- The 10mg/0.2ml prefilled syringe is particularly useful for pediatric dosing or for adult patients requiring lower or more precise doses.
Alternative Therapies
- 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)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Varies significantly; typically several thousand dollars per month per syringe/dose
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits for most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will enable healthcare professionals to provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will enable healthcare professionals to provide you with the most appropriate care and treatment.