Amjevita 40mg/0.8ml Pf Aut Inj 2pen
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat Crohn's disease.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It is used to treat ulcerative colitis.It is used to treat a skin problem called hidradenitis suppurativa.It is used to treat uveitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-modifying antirheumatic drug (DMARD)
Pharmacologic Class
Tumor Necrosis Factor (TNF) blocker
Pregnancy Category
Category B
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 works by blocking a protein called TNF-alpha, which can cause swelling and damage in conditions like arthritis, Crohn's disease, and psoriasis. It's given as an injection under the skin.
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 particles. The solution should be colorless to faintly yellow; if the color changes, do not use it. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, dispose of the device properly and do not reuse it. Discard needles in a designated sharps disposal container, and follow local regulations for disposing of full containers. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in 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 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 particles. The solution should be colorless to faintly yellow; if the color changes, do not use it. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, dispose of the device properly and do not reuse it. Discard needles in a designated sharps disposal container, and follow local regulations for disposing of full containers. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in 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 taking Amjevita. Discuss any vaccinations with your doctor.
- Report any signs of infection (fever, chills, persistent cough, skin sores, unusual fatigue) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or any other serious infections.
- Inform your doctor if you have or develop any new lumps, growths, or changes in moles.
- Maintain good hygiene to reduce the risk of infection.
- Store Amjevita in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze. Do not shake.
- Allow the pen to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way (e.g., microwave, hot water).
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:
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), Psoriasis (Ps), Uveitis: Dosing varies significantly by indication and may involve an initial loading dose followed by maintenance doses (e.g., 80 mg every other week or 40 mg weekly).
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg subcutaneously every other week. Some patients with RA not receiving concomitant methotrexate may benefit from increasing the frequency to 40 mg every week.
Psoriatic Arthritis:
40 mg subcutaneously every other week.
Ankylosing Spondylitis:
40 mg subcutaneously every other week.
Crohn's Disease:
Initial dose 160 mg (e.g., four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) at Week 0, followed by 80 mg at Week 2, then 40 mg every other week starting at Week 4.
Ulcerative Colitis:
Initial dose 160 mg (e.g., four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) at Week 0, followed by 80 mg at Week 2, then 40 mg every other week starting at Week 4.
Plaque Psoriasis:
Initial dose 80 mg at Week 0, followed by 40 mg every other week starting at Week 1.
Hidradenitis Suppurativa:
Initial dose 160 mg at Week 0, followed by 80 mg at Week 2, then 40 mg weekly starting at Week 4.
Uveitis:
Initial dose 80 mg at Week 0, followed by 40 mg every other week starting at Week 1.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) (2 years and older): 24 kg to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week. Crohn's Disease (6 years and older): Weight-based loading and maintenance doses. Plaque Psoriasis (4 years and older): Weight-based dosing. Uveitis (2 years and older): Weight-based dosing. Hidradenitis Suppurativa (12 years and older): Initial 80 mg at Week 0, then 40 mg every other week starting Week 1.
Adolescent:
Dosing for JIA, Crohn's Disease, Plaque Psoriasis, Uveitis, and Hidradenitis Suppurativa continues as per pediatric guidelines, often weight-based or adult dosing for older adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Adalimumab is a large protein and not significantly cleared 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). It blocks TNF-alpha's interaction with the p55 and p75 cell surface TNF receptors, thereby neutralizing the biological function of TNF-alpha. 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 intestinal tissue of patients with Crohn's disease and ulcerative colitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64% (subcutaneous)
Tmax:
Approximately 5 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks for some indications (e.g., RA), but full effect may take longer.
PeakEffect:
Varies by indication and individual response, often within 12-24 weeks.
DurationOfAction:
Approximately 2 weeks (based on dosing frequency), but biological effects may persist longer due to long half-life.
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), including reactivation of latent TB; invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis); and bacterial, viral, and other opportunistic infections. Evaluate patients for TB risk factors and test for latent TB infection prior to and during therapy. Initiate treatment for latent TB prior to adalimumab use. 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 form of lymphoma, have been reported in adolescents and young adults treated with TNF blockers, including adalimumab, for Crohn's disease or ulcerative colitis. For a complete list of warnings, refer to the full prescribing information.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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. Seek medical help immediately if you experience:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in your arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Contact your doctor right away if you notice:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. 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: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you feel:
Extremely tired or weak
Feverish
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on your skin
Other Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice 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
Upset stomach
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 any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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. Seek medical help immediately if you experience:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in your arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Contact your doctor right away if you notice:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. 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: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you feel:
Extremely tired or weak
Feverish
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on your skin
Other Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice 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
Upset stomach
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 any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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, stomach pain, burning urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing.
- Signs of new or worsening heart failure: shortness of breath with activity or lying down, swelling of feet/ankles, sudden weight gain.
- Signs of nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, dizziness, seizures.
- Signs of blood problems: persistent fever, bruising, 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 symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for guidance.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for guidance.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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 the results 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 taking 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 is a potential side effect of 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 problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, or changes in the color or size of a mole.
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. You will need to weigh the potential advantages and disadvantages to both you and your baby.
If you used this medication during pregnancy, inform your baby's doctor. You will need to discuss the safety and timing of certain vaccines with the doctor to ensure your baby receives the necessary vaccinations.
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 the results 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 taking 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 is a potential side effect of 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 problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, or changes in the color or size of a mole.
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. You will need to weigh the potential advantages and disadvantages to both you and your baby.
If you used this medication during pregnancy, inform your baby's doctor. You will need to discuss the safety and timing of certain vaccines with the doctor to ensure your baby receives the necessary vaccinations.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered without dose-limiting toxicity.
What to Do:
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (during treatment)
- Anakinra (Kineret)
- Abatacept (Orencia)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection and neutropenia
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection (use with caution)
Moderate Interactions
- Vaccines (non-live): May result in a diminished immune response to vaccination.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Risk of TB reactivation or new infection; Adalimumab can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status; risk of cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) including ALT, AST, bilirubin
Rationale: To assess baseline hepatic function; rare reports of liver injury.
Timing: Prior to initiation of therapy
Baseline clinical assessment for signs/symptoms of infection
Rationale: To ensure patient is free of active infection before starting therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment for signs/symptoms of infection (e.g., fever, cough, malaise)
Frequency: At each visit, or as clinically indicated
Target: Absence of infection
Action Threshold: Prompt evaluation and potential discontinuation if serious infection suspected.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant decreases in cell counts (e.g., persistent neutropenia, thrombocytopenia) may warrant 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 warrant further investigation or discontinuation.
Screening for malignancy (e.g., skin exams, age-appropriate cancer screening)
Frequency: Annually or as clinically indicated
Target: Absence of new or worsening malignancy
Action Threshold: New or worsening malignancy may require discontinuation.
Signs/symptoms of heart failure (e.g., dyspnea, edema)
Frequency: At each visit
Target: Absence of new or worsening heart failure
Action Threshold: New or worsening heart failure may require discontinuation.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, skin lesions, fatigue, weight loss)
- Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Neurological symptoms (new onset or worsening numbness, tingling, weakness in limbs, vision changes, seizures)
- Symptoms of heart failure (shortness of breath, swelling of ankles/feet, sudden weight gain)
- Symptoms of lupus-like syndrome (joint pain, rash, fever, fatigue)
- New or worsening skin lesions (especially for psoriasis patients, or signs of non-melanoma skin cancer)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, particularly during the third trimester. While available data from clinical trials and postmarketing experience have not established a clear association with major birth defects, miscarriage, or adverse maternal or fetal outcomes, it should be used during pregnancy only if clearly needed. Consider the potential for immunosuppression in infants exposed to adalimumab in utero, and avoid administering live vaccines to these infants for at least 6 months after the mother's last dose during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major birth defects.
Second Trimester:
Limited data, but placental transfer increases in the second and third trimesters.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant's serum at birth. Potential for transient immunosuppression in the infant.
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 and is likely to be partially degraded in the infant's gastrointestinal tract. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Amjevita and any potential adverse effects on the breastfed infant from Amjevita or from the underlying maternal condition. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects due to low systemic absorption and degradation in the infant's GI tract. Monitor for signs of infection.
Pediatric Use
Adalimumab is approved for various pediatric indications including Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older, Crohn's Disease in patients 6 years and older, Plaque Psoriasis in patients 4 years and older, Uveitis in patients 2 years and older, and Hidradenitis Suppurativa in patients 12 years and older. Dosing is typically weight-based. Children and adolescents treated with TNF blockers, including adalimumab, have an increased risk of malignancy, including lymphoma and other cancers.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly and younger patients, but a higher incidence of serious infections has been observed in patients 65 years of age and older treated with adalimumab compared to younger patients. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira, meaning it is highly similar and has no clinically meaningful differences in terms of safety, purity, and potency.
- Patients should be thoroughly screened for latent tuberculosis and hepatitis B before initiating Amjevita and monitored during therapy.
- Patients should be educated on proper injection technique and storage, emphasizing refrigeration and allowing the pen to warm to room temperature before use.
- Due to immunosuppression, patients should avoid live vaccines and report any signs of infection promptly.
- The black box warning for serious infections and malignancy is critical and should be discussed with patients.
- Adalimumab has a long half-life, so effects and potential side effects can persist for several weeks after discontinuation.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., IL-12/23 inhibitors like ustekinumab, IL-17 inhibitors like secukinumab/ixekizumab, IL-6 inhibitors like tocilizumab, T-cell costimulation modulators like abatacept, JAK inhibitors like tofacitinib/upadacib/filgotinib)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids (for acute flares, not long-term maintenance)
- Non-steroidal anti-inflammatory drugs (NSAIDs) (for symptomatic relief)
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per pen/dose (e.g., $3,000 - $7,000+ per 40mg pen) per 40mg/0.8ml prefilled autoinjector pen
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 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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to 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 taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to 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 taken, the quantity, and the time it occurred.