Amjevita 20mg/0.2ml 1 Pf Syr, 0.2ml
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; Monoclonal Antibody
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 inflammation and damage in certain diseases like rheumatoid arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, 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 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. Dispose of needles and other sharp objects in a designated container, and follow local regulations for disposing of full containers.
If you accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine whether it can still be used. If you have any questions or concerns, do not hesitate to reach out to your healthcare provider.
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 Doses
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, consult your doctor for guidance.
To ensure safe and effective use, 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 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. Dispose of needles and other sharp objects in a designated container, and follow local regulations for disposing of full containers.
If you accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine whether it can still be used. If you have any questions or concerns, do not hesitate to reach out to your healthcare provider.
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 Doses
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, consult your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while on Amjevita.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Discuss any planned surgeries or dental procedures with your doctor.
- Maintain good hygiene to reduce infection risk.
- Follow your doctor's instructions for proper injection technique and storage.
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 the initial dose. For Hidradenitis Suppurativa: Initial dose 160 mg (day 1), then 80 mg (day 15), then 40 mg weekly (day 29 onwards). For Uveitis: Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg every other week
Psoriatic Arthritis:
40 mg every other week
Ankylosing Spondylitis:
40 mg every other week
Crohn's Disease:
Initial 160 mg, then 80 mg, then 40 mg every other week
Ulcerative Colitis:
Initial 160 mg, then 80 mg, then 40 mg every other week
Plaque Psoriasis:
Initial 80 mg, then 40 mg every other week
Hidradenitis Suppurativa:
Initial 160 mg, then 80 mg, then 40 mg weekly
Uveitis:
Initial 80 mg, then 40 mg every other week
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) 2-17 years: 20 mg every other week (for 15 kg to <30 kg) or 40 mg every other week (for âĨ30 kg). Crohn's Disease 6-17 years: Weight-based dosing (e.g., 40 mg every other week for âĨ40 kg). Plaque Psoriasis 4-17 years: 0.8 mg/kg up to 40 mg every other week. Uveitis 2-17 years: 20 mg every other week (for 15 kg to <30 kg) or 40 mg every other week (for âĨ30 kg).
Adolescent:
Dosing as per child for JIA, Crohn's, Plaque Psoriasis, Uveitis, or adult dosing for other indications if weight/age appropriate.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; Adalimumab is a large protein and not expected to be removed by dialysis.
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 involved in normal inflammatory and immune responses. In autoimmune diseases, 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 cell surface receptors, leading to the down-regulation of inflammatory processes.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
5-10 days
FoodEffect:
Not applicable (subcutaneous 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:
Reticuloendothelial system (catabolism)
Unchanged:
Not applicable (protein catabolism)
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 Crohn's disease).
PeakEffect:
Varies by indication and patient response, generally within weeks to months.
DurationOfAction:
Related to half-life, allowing for bi-weekly or weekly dosing.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, blastomycosis), and other opportunistic infections. Patients should be tested for latent TB infection prior to initiating therapy 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. Cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and often fatal 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
Serious 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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.
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems that may 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 been reported 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 Failure
Heart failure, including worsening of existing heart failure, has been reported 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
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have been reported 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 taking this medication do not experience serious side effects. However, some people may experience mild or moderate side effects, including:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
* Pain, redness, swelling, or reaction at the injection site
If you experience any side effects that bother you or do not go away, 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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.
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems that may 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 been reported 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 Failure
Heart failure, including worsening of existing heart failure, has been reported 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
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have been reported 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 taking this medication do not experience serious side effects. However, some people may experience mild or moderate side effects, including:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
* Pain, redness, swelling, or reaction at the injection site
If you experience any side effects that bother you or do not go away, 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, diarrhea, painful urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
- Signs of nerve problems: numbness, tingling, weakness in arms/legs, vision changes.
- Signs of blood problems: persistent fever, easy bruising or bleeding, pale skin.
- Signs of 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 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 for clarification.
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 all your health problems with your doctor and pharmacist to determine if it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or change the dose 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 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 for clarification.
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 all your health problems with your doctor and pharmacist to determine if it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
Precautions & Cautions
Important Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Infection Risk
You may be more susceptible to infections due to this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Hepatitis B Considerations
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor before starting treatment. This medication can cause the virus to become active, leading to severe and potentially life-threatening liver problems. Your doctor will recommend hepatitis B testing, which you should undergo as directed.
Vaccination Precautions
Ensure you are up to date with all recommended vaccinations before initiating treatment with this medication. Consult your doctor before receiving any vaccines, as some may increase the risk of infection or reduce their effectiveness when used concurrently with this medication. Additionally, avoid receiving weakened bacteria, such as BCG for bladder cancer, while taking this medication.
Monitoring and Laboratory Tests
Regularly undergo blood work and other laboratory tests as advised by your doctor to monitor your condition.
Potential Side Effects
High cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
Allergy Considerations
If you have a latex allergy, inform your doctor, as some products may contain latex.
Skin Health
If you experience sunburn or other skin problems, consult your doctor. Regularly inspect your skin and report any changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
Age-Related Precautions
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication to you and your baby. If you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Infection Risk
You may be more susceptible to infections due to this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Hepatitis B Considerations
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor before starting treatment. This medication can cause the virus to become active, leading to severe and potentially life-threatening liver problems. Your doctor will recommend hepatitis B testing, which you should undergo as directed.
Vaccination Precautions
Ensure you are up to date with all recommended vaccinations before initiating treatment with this medication. Consult your doctor before receiving any vaccines, as some may increase the risk of infection or reduce their effectiveness when used concurrently with this medication. Additionally, avoid receiving weakened bacteria, such as BCG for bladder cancer, while taking this medication.
Monitoring and Laboratory Tests
Regularly undergo blood work and other laboratory tests as advised by your doctor to monitor your condition.
Potential Side Effects
High cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
Allergy Considerations
If you have a latex allergy, inform your doctor, as some products may contain latex.
Skin Health
If you experience sunburn or other skin problems, consult your doctor. Regularly inspect your skin and report any changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
Age-Related Precautions
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication to you and your baby. If you used this medication 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 (approximately 700 mg) have been administered intravenously 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
Major Interactions
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
- Other TNF blockers (e.g., etanercept, infliximab, certolizumab, golimumab) (increased risk of serious infection)
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) (increased risk of myelosuppression and serious infection when used concurrently, especially in Crohn's disease)
Moderate Interactions
- Vaccines (may reduce immune response to inactivated vaccines)
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 latent 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 can occur.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, as liver enzyme elevations can occur.
Timing: Prior to initiation of therapy
Baseline disease activity assessment
Rationale: To establish a baseline for monitoring therapeutic response.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: At each visit and ongoing patient self-monitoring
Target: Absence of infection
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of adalimumab.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: At each visit and ongoing patient self-monitoring
Target: Absence of malignancy
Action Threshold: Prompt evaluation if malignancy suspected.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Investigate persistent cytopenias; consider discontinuation if clinically significant.
LFTs
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Investigate persistent elevations; consider discontinuation if clinically significant.
Disease activity assessment
Frequency: Every 3-6 months or as clinically indicated
Target: Reduction in disease activity/remission
Action Threshold: Consider dose adjustment or alternative therapy if inadequate response.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, skin lesions, diarrhea, dysuria)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of new or worsening heart failure (e.g., shortness of breath, swelling of ankles/feet)
- Signs of demyelinating disease (e.g., numbness, tingling, weakness, vision changes)
- Signs of lupus-like syndrome (e.g., joint pain, rash on cheeks/arms, fever)
- Signs of blood dyscrasias (e.g., persistent fever, bruising, bleeding, pallor)
- Signs of liver injury (e.g., jaundice, dark urine, abdominal pain, fatigue)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. While human data suggest that adalimumab does not increase the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, exposure during the third trimester may lead to detectable serum concentrations in the infant for several months after birth. Live vaccines should not be administered to infants exposed to adalimumab in utero until their serum adalimumab levels are undetectable or for at least 6 months after birth.
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, leading to infant exposure. Potential for immunosuppression in the infant, particularly regarding live vaccine administration.
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 the 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 adalimumab and any potential adverse effects on the breastfed infant from adalimumab or from the underlying maternal condition. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk. Monitor for signs of infection or unusual development.
Pediatric Use
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, Plaque Psoriasis in patients 4 years and older, and Uveitis in patients 2 years and older. Dosing is weight-based for many indications. Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers.
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. Use with caution due to the generally higher incidence of infections in the elderly population.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira. Ensure patients understand it is a different product but with the same active ingredient and mechanism of action.
- Always screen for latent TB and HBV before initiating therapy and monitor for reactivation during treatment.
- Educate patients on proper subcutaneous injection technique and storage (refrigeration, protect from light).
- Emphasize the importance of reporting any signs of infection immediately.
- Patients should carry an alert card indicating they are on a TNF blocker.
- Consider temporary discontinuation of adalimumab if a patient develops a serious infection.
- Monitor for new or worsening symptoms of heart failure, demyelinating disease, or lupus-like syndrome.
- Live vaccines are contraindicated; inactivated vaccines may be given but may have a reduced response.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., abatacept, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, upadacitinib, tofacitinib)
- Conventional DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Varies widely by strength and quantity (e.g., $1,500 - $7,000+) per prefilled syringe/pen
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication, including the amount taken and the time it occurred, to facilitate prompt and effective treatment.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication, including the amount taken and the time it occurred, to facilitate prompt and effective treatment.