Amjevita 80mg/0.8ml 1 Aut0 Injector
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), TNF blocker
Pharmacologic Class
Monoclonal antibody, Tumor Necrosis Factor (TNF) alpha inhibitor
Pregnancy Category
Not available
FDA Approved
Jan 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Amjevita is a medicine that helps reduce inflammation in your body. It's used to treat conditions like rheumatoid arthritis, Crohn's disease, psoriasis, and others, by blocking a protein called TNF-alpha that causes inflammation. It's given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. 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 particulate matter. 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, as well as 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 adverse 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. Dispose of needles and other sharp objects in a designated disposal box, 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 a refrigerator at all times, and do not freeze. 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 accompanying information carefully. 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 particulate matter. 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, as well as 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 adverse 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. Dispose of needles and other sharp objects in a designated disposal box, 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 a refrigerator at all times, and do not freeze. 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 Amjevita and for several months after stopping it. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, cough, skin sores, fatigue) to your doctor immediately.
- Inform your doctor about any new or worsening medical conditions, especially heart problems, nerve problems, or cancer.
- Do not start any new medications, including over-the-counter drugs, supplements, or herbal remedies, without consulting your doctor.
- 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. If needed, it can be stored at room temperature (up to 25°C / 77°F) for a maximum of 14 days, but must be discarded if not used within this time.
- Allow the auto-injector 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 (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS): 40 mg every other week. For Crohn's Disease (CD) and Ulcerative Colitis (UC): Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. For Plaque Psoriasis (Ps) and Hidradenitis Suppurativa (HS): Initial dose 80 mg, then 40 mg every other week starting one week after initial dose. For Uveitis: 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 (RA):
40 mg every other week. Some patients with RA not receiving concomitant methotrexate may benefit from increasing frequency to 40 mg every week or 80 mg every other week.
Psoriatic Arthritis (PsA):
40 mg every other week.
Ankylosing Spondylitis (AS):
40 mg every other week.
Crohn's Disease (CD):
Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. Some patients may benefit from increasing frequency to 40 mg every week or 80 mg every other week.
Ulcerative Colitis (UC):
Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. Some patients may benefit from increasing frequency to 40 mg every week or 80 mg every other week.
Plaque Psoriasis (Ps):
Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every week.
Uveitis:
Initial dose 80 mg, then 40 mg every other week starting one week after initial dose. Continue concomitant corticosteroids during induction and taper per clinical practice.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 2 mg/kg (max 40 mg) every other week. Crohn's Disease (CD) (6 years and older): Weight-based dosing, e.g., <40 kg: Initial 80 mg (Day 1) then 40 mg (Day 15), then 20 mg every other week. âĨ40 kg: Initial 160 mg (Day 1) then 80 mg (Day 15), then 40 mg every other week. Ulcerative Colitis (UC) (5 years and older): Weight-based dosing, similar to CD. Plaque Psoriasis (Ps) (4 years and older): 0.8 mg/kg (max 40 mg) initial dose, then 0.4 mg/kg (max 20 mg) every other week. Uveitis (2 years and older): 20 mg every other week for patients weighing <30 kg, 40 mg every other week for patients weighing âĨ30 kg.
Adolescent:
Dosing typically follows adult or weight-based pediatric guidelines depending on indication and weight.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not removed by dialysis; no specific adjustment needed.
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 and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the 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 TNF receptors, thereby modulating the biological responses that are induced or regulated by TNF-alpha, including the expression of adhesion molecules responsible for leukocyte migration.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
Approximately 5 days (range 2-8 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the conventional sense)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Primarily via catabolism; not renally or hepatically excreted in an unchanged form.
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 CD/UC).
PeakEffect:
Varies by indication and patient response.
DurationOfAction:
Related to half-life; effects persist for several weeks after discontinuation.
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. Treat latent TB prior to use. Monitor all patients for signs and symptoms of infection during and after treatment. 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 fatal lymphoma, have been reported in adolescents and young adults with Crohn's disease or ulcerative colitis treated with TNF blockers, including adalimumab, often in combination with azathioprine or 6-mercaptopurine.
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 experience any of the following symptoms, contact your doctor or seek medical help right away:
Allergic reactions: 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.
Infections: 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 infections (UTIs): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus-like symptoms: 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.
Neurological Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you experience any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
Liver problems, including fatal cases, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Problems
Heart failure, including worsening of existing heart failure, has occurred with this medication. If you have a history of heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
Swelling in the arms or legs that is new or worsening
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience serious side effects, and many side effects are mild and temporary. However, 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
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Allergic reactions: 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.
Infections: 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 infections (UTIs): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus-like symptoms: 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.
Neurological Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you experience any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
Liver problems, including fatal cases, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Problems
Heart failure, including worsening of existing heart failure, has occurred with this medication. If you have a history of heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
Swelling in the arms or legs that is new or worsening
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience serious side effects, and many side effects are mild and temporary. However, 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
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088 or 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, diarrhea, painful urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing, dizziness.
- Signs of new or worsening heart failure: sudden weight gain, shortness of breath, swelling in ankles/feet.
- Signs of neurological problems: numbness, tingling, weakness in arms/legs, vision changes, dizziness.
- Signs of blood problems: easy bruising or bleeding, persistent fever, pale skin.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
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 and its symptoms.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, inform them about any existing health problems. This information will help your healthcare team determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, inform them about any existing health problems. This information will help your healthcare team determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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 hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive 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 reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Additionally, schedule regular skin checks and promptly report 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.
If you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines for your child.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive 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 reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Additionally, schedule regular skin checks and promptly report 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.
If you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines for your child.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered intravenously without dose-limiting toxicities.
What to Do:
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Live vaccines (during and for at least 5 months after adalimumab treatment)
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection
- Other biologic DMARDs (e.g., rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab) - increased risk of serious infection
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and serious infection when used concomitantly, especially in certain populations (e.g., CD/UC)
- Vaccines (live attenuated) - risk of infection from vaccine strain
Moderate Interactions
- Non-live vaccines - may result in a diminished immune response to vaccination
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate latent TB.
Timing: Before initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Before initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters and monitor for cytopenias.
Timing: Before initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline hepatic function and monitor for drug-induced liver injury.
Timing: Before initiation of therapy
Renal Function (SCr, eGFR)
Rationale: To assess baseline renal function, though adalimumab is not renally cleared.
Timing: Before initiation of therapy
Baseline clinical assessment for signs/symptoms of infection, malignancy, demyelinating disease, heart failure
Rationale: To establish baseline health status and identify contraindications or precautions.
Timing: Before initiation of therapy
Routine Monitoring
Clinical assessment for signs/symptoms of infection (e.g., fever, cough, fatigue)
Frequency: Regularly, at each patient visit
Target: Absence of new or worsening infection symptoms
Action Threshold: Prompt evaluation and potential interruption of therapy if serious infection suspected.
Clinical assessment for signs/symptoms of malignancy (e.g., new lumps, unexplained weight loss)
Frequency: Regularly, at each patient visit
Target: Absence of new or worsening malignancy symptoms
Action Threshold: Prompt evaluation and potential discontinuation if malignancy diagnosed.
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, thrombocytopenia) may require dose reduction or discontinuation.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Significant elevations (e.g., >3x ULN) may require dose reduction or discontinuation.
Clinical assessment for new or worsening heart failure symptoms
Frequency: Regularly, at each patient visit
Target: Stable cardiac status
Action Threshold: Worsening heart failure may require discontinuation.
Clinical assessment for new or worsening neurological symptoms (e.g., numbness, tingling, vision changes)
Frequency: Regularly, at each patient visit
Target: Stable neurological status
Action Threshold: New onset or worsening demyelinating disease symptoms may require discontinuation.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, shortness of breath, skin lesions, painful urination)
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of new or worsening heart failure (shortness of breath, swelling of ankles/feet, sudden weight gain)
- Signs of neurological problems (numbness, tingling, weakness in arms/legs, vision changes, dizziness)
- Signs of blood disorders (easy bruising, bleeding, persistent fever, pallor)
- Signs of liver problems (yellowing of skin/eyes, dark urine, severe stomach pain, nausea, vomiting)
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 6 months after the mother's last dose during pregnancy, due to potential immunosuppression in the infant. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.
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.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant's serum for several months after birth. This may affect the infant's immune response, particularly to live vaccines.
Lactation
Adalimumab is present in human milk at low concentrations. The amount ingested by a breastfed infant is very low and unlikely to cause systemic effects due to its large molecular weight and susceptibility to degradation in the infant's gastrointestinal tract. Breastfeeding is generally considered compatible with adalimumab use, but the decision should weigh the developmental and health benefits of breastfeeding against the mother's clinical need for adalimumab and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk (L3 - Moderate risk by some classifications due to theoretical concerns, but generally considered compatible by LactMed and clinical guidelines).
Pediatric Use
Adalimumab is approved for several pediatric indications including Juvenile Idiopathic Arthritis (JIA), Crohn's Disease (CD), Ulcerative Colitis (UC), Plaque Psoriasis (Ps), and Uveitis. Dosing is weight-based for most pediatric indications. Children and adolescents treated with TNF blockers, including adalimumab, have an increased risk of malignancy, including lymphoma and hepatosplenic T-cell lymphoma (HSTCL). Close monitoring for signs of infection and malignancy is crucial.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but the greater sensitivity of some older individuals cannot be ruled out. Elderly patients have a higher incidence of infections in general, and caution should be exercised when treating the elderly. Close monitoring for infections is particularly important in this population.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira, meaning it is highly similar to and has no clinically meaningful differences from the reference product.
- Patients should be thoroughly screened for tuberculosis (latent and active) and hepatitis B virus before starting Amjevita and monitored during therapy.
- Patients should be advised to report any signs of infection immediately, as serious and sometimes fatal infections can occur.
- Live vaccines are contraindicated during Amjevita therapy and for a period after discontinuation. Discuss vaccination status with patients.
- The 80mg/0.8ml auto-injector is a convenient formulation, often used for induction doses or specific maintenance regimens depending on the indication.
- Adalimumab can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
- Patients should be educated on proper injection technique and rotation of injection sites to minimize local reactions.
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, tofacitinib, upadacitinib, guselkumab, risankizumab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids (for acute flares)
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine)
Cost & Coverage
Average Cost:
Highly variable, typically $6,000 - $8,000+ per 80mg/0.8ml auto-injector (or 2x40mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
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 provides crucial information for patients. 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 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 incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.