Amjevita 80mg/0.8ml 2 Pf Auto 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
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 protein called TNF-alpha, which can cause swelling and damage in conditions like arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, either on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and do not use it if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; do not use it if the color changes.
When administering the injection, avoid injecting into skin within 2 inches (5 cm) of the belly button. Also, do not inject into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. To minimize discomfort, 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 do not heat the medication.
After use, dispose of the device properly. Do not reuse the device or any of its components, including needles. Dispose of needles in a designated needle/sharp disposal box. When the box is full, follow local regulations for disposal. 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. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and then 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, either on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and do not use it if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; do not use it if the color changes.
When administering the injection, avoid injecting into skin within 2 inches (5 cm) of the belly button. Also, do not inject into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. To minimize discomfort, 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 do not heat the medication.
After use, dispose of the device properly. Do not reuse the device or any of its components, including needles. Dispose of needles in a designated needle/sharp disposal box. When the box is full, follow local regulations for disposal. 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. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and then resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while on this medication.
- Report any signs of infection (fever, chills, cough, fatigue) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, heart failure, or any neurological problems.
- Maintain good hygiene to reduce infection risk.
- Discuss any planned surgeries or dental procedures with your doctor, as the medication may need to be temporarily stopped.
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 subcutaneously every other week. For Crohn's Disease (CD), Ulcerative Colitis (UC), Hidradenitis Suppurativa (HS), Uveitis: Initial loading doses followed by maintenance (e.g., CD initial 160 mg, then 80 mg two weeks later, then 40 mg every other week). For Plaque Psoriasis (PsO): Initial 80 mg, then 40 mg every other week starting one week after initial dose. The 80mg/0.8ml strength is often used for loading doses or specific maintenance regimens.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 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 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Ulcerative Colitis (UC):
Initial 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Plaque Psoriasis (PsO):
Initial 80 mg, then 40 mg every other week starting one week after initial dose
Hidradenitis Suppurativa (HS):
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): 10 mg to 60 mg every other week based on weight. Crohn's Disease (CD) (6 years and older): Weight-based dosing (e.g., <40 kg: 80 mg initial, 40 mg 2 weeks later, then 20 mg every other week; âĨ40 kg: 160 mg initial, 80 mg 2 weeks later, then 40 mg every other week). Ulcerative Colitis (UC) (5 years and older): Weight-based dosing similar to CD. Plaque Psoriasis (PsO) (4 years and older): 0.8 mg/kg up to 40 mg every other week. Uveitis (2 years and older): 20 mg every other week for patients âĨ30 kg, 10 mg every other week for patients <30 kg.
Adolescent:
Dosing generally follows adult or weight-based pediatric guidelines depending on indication and weight.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
Not removed by dialysis; no specific dose adjustment needed.
Hepatic Impairment:
Mild:
No specific dose adjustment necessary
Moderate:
No specific dose adjustment necessary
Severe:
No specific dose adjustment necessary
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF)-alpha. It blocks the interaction of TNF-alpha with its cell surface receptors (p55 and p75), thereby neutralizing the biological function of TNF-alpha. TNF-alpha is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the affected tissues of patients with Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64% (subcutaneous)
Tmax:
5 to 10 days
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (large protein, 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
ExcretionRoute:
Primarily via catabolism; not renally excreted as intact molecule.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Varies by indication; typically weeks to months (e.g., RA: 2-12 weeks for clinical response, CD: 2-4 weeks for induction response)
PeakEffect:
Varies by indication and clinical endpoint; generally observed after several weeks to months of therapy.
DurationOfAction:
Related to half-life; effects persist for several weeks after discontinuation due to long half-life.
Confidence:
Medium
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 therapy and monitored for signs and symptoms of infection during and after treatment. Increased risk of malignancies, including lymphoma and other cancers, in children and adolescents treated with TNF blockers. Cases of hepatosplenic T-cell lymphoma (HSTCL), a rare 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, which can be permanent. Seek medical help immediately if you experience:
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. Seek medical help immediately if you experience:
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 occurred with this medication. If you have heart disease, inform your doctor. Seek medical help immediately if you experience:
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 occurred with this medication. Seek medical help immediately if you experience:
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, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention 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 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, which can be permanent. Seek medical help immediately if you experience:
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. Seek medical help immediately if you experience:
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 occurred with this medication. If you have heart disease, inform your doctor. Seek medical help immediately if you experience:
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 occurred with this medication. Seek medical help immediately if you experience:
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, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention 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, skin sores, painful urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Signs of blood problems: easy bruising or bleeding, pale skin, unusual tiredness.
- Signs of heart failure: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
- Signs of nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, seizures.
- Signs of liver problems: yellowing of skin/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 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 to determine the best course of action.
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) medications
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 change the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure your safety while taking this medication.
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 to determine the best course of action.
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) medications
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 change the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure your safety while taking this medication.
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, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine-related concerns with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that this medication may cause high cholesterol. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. 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.
If you are 65 years or older, exercise caution when taking 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 took this medication 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 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, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine-related concerns with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that this medication may cause high cholesterol. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. 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.
If you are 65 years or older, exercise caution when taking 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 took 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 due to the nature of the drug. Doses up to 10 mg/kg have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Provide supportive care and monitor for any adverse reactions. Call 1-800-222-1222 for poison control.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) - due to risk of infection.
Major Interactions
- Anakinra (Kineret) - increased risk of serious infection and neutropenia.
- Abatacept (Orencia) - increased risk of serious infection.
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection and no added benefit.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection when used concomitantly, especially in certain populations (e.g., pediatric CD).
Moderate Interactions
- Warfarin - potential for altered INR; monitor closely.
- Cyclosporine - potential for altered levels; monitor closely.
- Theophylline - potential for altered levels; monitor closely.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection, which can be reactivated by TNF blockers.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: To rule out active or latent HBV infection, which can be reactivated by TNF blockers.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
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, fatigue, skin lesions)
Frequency: Regularly throughout therapy, at each visit
Target: Absence of new or worsening infection
Action Threshold: Prompt evaluation and potential discontinuation if serious infection suspected.
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits; monitor for cytopenias
Action Threshold: Significant decrease in cell counts (e.g., persistent neutropenia, thrombocytopenia) 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
Action Threshold: Significant elevation (e.g., >3x ULN) may warrant further investigation and potential discontinuation.
Signs and symptoms of new or worsening heart failure
Frequency: Regularly throughout therapy
Target: Stable cardiac status
Action Threshold: Worsening symptoms may require discontinuation.
Signs and symptoms of demyelinating disease (e.g., numbness, tingling, vision changes)
Frequency: Regularly throughout therapy
Target: Absence of new neurological symptoms
Action Threshold: New onset or worsening symptoms may require discontinuation.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin lesions (e.g., rash, sores)
- Painful urination
- Numbness or tingling
- Vision changes
- Weakness in arms or legs
- Swelling of ankles/feet
- Sudden weight gain
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, due to its immunosuppressive effects, infants exposed to adalimumab in utero may have an increased risk of infection, particularly if live vaccines are administered within 6 months of birth. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with increased risk of major birth defects.
Second Trimester:
Limited data, but generally not associated with increased risk of major birth defects.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant. Potential for immunosuppression in the infant; live vaccines should be deferred for at least 6 months after birth.
Lactation
Adalimumab is present in human milk at low levels. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein that is largely degraded in the infant's gastrointestinal tract. No adverse effects on breastfed infants have been reported. Considered compatible with breastfeeding, but monitor infant for signs of infection.
Infant Risk:
Low risk of adverse effects; monitor for signs of infection.
Pediatric Use
Approved for various indications including JIA, CD, UC, PsO, HS, and Uveitis in specific age groups. Increased risk of malignancies, including lymphoma, has been reported in children and adolescents treated with TNF blockers. Careful risk-benefit assessment is crucial.
Geriatric Use
Increased incidence of serious infections (including fatal infections) has been observed in patients 65 years of age and older treated with adalimumab. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Prior to initiating Amjevita, thoroughly screen patients for latent or active tuberculosis (TB) and hepatitis B virus (HBV) infection. Treatment for latent TB should be initiated before starting Amjevita.
- Counsel patients extensively on the risk of serious infections and malignancies, and instruct them to report any signs or symptoms of infection immediately.
- Amjevita is a biosimilar to Humira. Ensure patients understand that it is a highly similar and interchangeable product (if designated as such by FDA) with no clinically meaningful differences.
- Patients should avoid live vaccines while on Amjevita and for a period after discontinuation. Consult current guidelines for specific vaccine recommendations.
- Monitor patients for new or worsening symptoms of heart failure or demyelinating disorders, and discontinue Amjevita if these conditions develop.
- The 80mg/0.8ml strength is often used for specific loading doses or maintenance regimens, particularly in conditions like psoriasis or certain phases of Crohn's/ulcerative colitis treatment.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Etanercept, Infliximab, Golimumab, Certolizumab pegol)
- Interleukin (IL) inhibitors (e.g., Ustekinumab, Secukinumab, Ixekizumab, Guselkumab, Risankizumab, Tildrakizumab)
- Janus Kinase (JAK) inhibitors (e.g., Tofacitinib, Upadacitinib, Filgotinib)
- Selective T-cell co-stimulation modulators (e.g., Abatacept)
- Selective adhesion molecule inhibitors (e.g., Vedolizumab, Natalizumab)
- Phosphodiesterase 4 (PDE4) inhibitors (e.g., Apremilast)
- Conventional synthetic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids (e.g., Prednisone)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per 80mg/0.8ml prefilled auto-injector
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's essential to contact your doctor promptly. 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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.