Amjevita 40mg/0.8ml Pf Aut Inj 1pen
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), Biologic
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 protein called TNF-alpha, which plays a role in causing inflammation in conditions like rheumatoid 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, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. The medication should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button and any skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To make the injection more comfortable, 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. Throw away needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if a replacement is needed.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and then return to your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. The medication should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button and any skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To make the injection more comfortable, 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. Throw away needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if a replacement is needed.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and then return to 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 (e.g., MMR, varicella, rotavirus) while taking Amjevita and for a period after stopping, as your immune system may be weakened.
- Report any signs of infection (fever, chills, persistent cough, skin sores) to your doctor immediately.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
- Discuss any planned surgeries or dental procedures with your doctor, as Amjevita may need to be temporarily stopped.
- 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.
- Rotate injection sites (thighs or abdomen) with each dose.
Available Forms & Alternatives
Available Strengths:
- Amjevita 40mg/0.8ml Pf Aut Inj 2pen
- Amjevita 20mg/0.4ml 1 Pf Syr, 0.4ml
- Amjevita 40mg/0.8ml 1 Prf Syringe
- Amjevita 40mg/0.8ml Pf Aut Inj 1pen
- Amjevita 10mg/0.2ml Pf Syringe Inj
- Amjevita 20mg/0.2ml 1 Pf Syr, 0.2ml
- Amjevita 40mg/0.4ml 1 Pf Syr
- Amjevita 40mg/0.4ml 2 Pf Syr
- Amjevita 80mg/0.8ml 1 Aut0 Injector
- Amjevita 80mg/0.8ml 2 Auto Injector
- Amjevita 40mg/0.4ml 1 Pf Auto Inj
- Amjevita 80mg/0.8ml 2 Pf Auto Inj
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week. For Crohn's Disease, Ulcerative Colitis, Hidradenitis Suppurativa: Initial loading dose followed by 40 mg every other week or 40 mg weekly depending on response. For Plaque Psoriasis: Initial loading dose followed by 40 mg every other week. For Uveitis: Initial loading dose followed by 40 mg every other week.
Dose Range:
40 - 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 (Day 1) then 80 mg (Day 15); Maintenance: 40 mg every other week
Ulcerative Colitis:
Initial: 160 mg (Day 1) then 80 mg (Day 15); Maintenance: 40 mg every other week
Plaque Psoriasis:
Initial: 80 mg (Day 1); Maintenance: 40 mg every other week starting one week after initial dose
Hidradenitis Suppurativa:
Initial: 160 mg (Day 1) then 80 mg (Day 15); Maintenance: 40 mg weekly or 40 mg every other week
Uveitis:
Initial: 80 mg (Day 1); Maintenance: 40 mg every other week starting one week after initial dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) (2 years and older): 24 mg/m² up to a maximum single dose of 40 mg every other week. Crohn's Disease (6 years and older): Weight-based dosing, e.g., <40 kg: Initial 80 mg (Day 1) then 40 mg (Day 15), Maintenance 20 mg every other week; ≥40 kg: Initial 160 mg (Day 1) then 80 mg (Day 15), Maintenance 40 mg every other week. Ulcerative Colitis (5 years and older): Weight-based dosing similar to pediatric Crohn's Disease. Plaque Psoriasis (4 years and older): Weight-based dosing, e.g., 0.8 mg/kg up to 40 mg every other week. Uveitis (2 years and older): Weight-based dosing, e.g., 24 mg/m² up to a maximum single dose of 40 mg every other week.
Adolescent:
Dosing typically follows adult recommendations for weight-appropriate adolescents or specific pediatric guidelines for their age/weight group.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not removed by dialysis; no specific adjustment needed.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF)-alpha. It blocks TNF-alpha's interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological function of TNF-alpha. TNF-alpha is a naturally occurring cytokine involved in systemic inflammation and is a key mediator of the inflammatory response in autoimmune diseases.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
3 to 10 days (median 5 days)
FoodEffect:
Not applicable (subcutaneous injection)
Distribution:
Vd:
4.7 to 6.0 L
ProteinBinding:
Not applicable (as a monoclonal antibody, it does not bind to plasma proteins in the same manner as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
10 to 20 days (median 14 days)
Clearance:
12 mL/hr to 15 mL/hr
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Weeks to months (e.g., 2-12 weeks for RA, 8-12 weeks for CD)
PeakEffect:
Weeks to months
DurationOfAction:
Related to half-life, effects persist for several weeks after discontinuation.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to 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.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical help right away:
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 Serious Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea 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 attention right away 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, or low white blood cell count. Seek medical attention right away 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 severe side effects, and some may not experience 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
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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical help right away:
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 Serious Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea 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 attention right away 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, or low white blood cell count. Seek medical attention right away 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 severe side effects, and some may not experience 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
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. 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.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Signs of blood problems: persistent fever, bruising, bleeding, paleness.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling of ankles/feet.
- Signs of nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, dizziness.
- Signs of lupus-like syndrome: new or worsening joint pain, rash on cheeks or arms that worsens in sunlight.
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) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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. Your doctor will instruct you on the necessary hepatitis B testing to monitor your condition.
Before starting treatment with this medication, ensure you are up to date on 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.
Do not receive live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as directed 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. Additionally, schedule regular skin checks and report any new or changing skin lesions, such as warts, sores, or moles, to your doctor.
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Regular monitoring and open communication with your healthcare provider are crucial to minimize potential risks and ensure safe treatment with 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. Your doctor will instruct you on the necessary hepatitis B testing to monitor your condition.
Before starting treatment with this medication, ensure you are up to date on 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.
Do not receive live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as directed 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. Additionally, schedule regular skin checks and report any new or changing skin lesions, such as warts, sores, or moles, to your doctor.
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Regular monitoring and open communication with your healthcare provider are crucial to minimize potential risks and ensure safe treatment with this medication.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Live vaccines (during and shortly after treatment)
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection
- Immunosuppressants (e.g., azathioprine, methotrexate, corticosteroids) - increased risk of serious infection when used concurrently, though often used together in practice with careful monitoring.
Moderate Interactions
- Not available
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate latent TB.
Timing: Before initiating 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: Before initiating therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters and monitor for cytopenias.
Timing: Before initiating therapy
Liver Function Tests (LFTs) (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function and monitor for liver injury.
Timing: Before initiating therapy
Renal Function (SCr, eGFR)
Rationale: To assess baseline renal function.
Timing: Before initiating therapy
Screening for demyelinating disorders
Rationale: To identify pre-existing conditions, as TNF blockers have been associated with new onset or exacerbation of demyelinating disorders.
Timing: Before initiating therapy
Screening for heart failure
Rationale: To identify pre-existing conditions, as TNF blockers can worsen heart failure.
Timing: Before initiating therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of infection
Action Threshold: Any signs of serious infection (e.g., persistent fever, cough, dyspnea, skin lesions) require immediate medical evaluation and potential discontinuation of therapy.
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant cytopenias (e.g., persistent neutropenia, thrombocytopenia) may require 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: Persistent elevations in LFTs (e.g., >3x ULN) may require dose reduction or discontinuation.
Signs and symptoms of malignancy
Frequency: Continuously
Target: Absence of new or worsening malignancy
Action Threshold: Any suspicion of malignancy requires prompt investigation and potential discontinuation.
Signs and symptoms of new or worsening heart failure
Frequency: Continuously
Target: Stable cardiac function
Action Threshold: New onset or worsening heart failure symptoms require immediate evaluation and potential discontinuation.
Signs and symptoms of demyelinating disease
Frequency: Continuously
Target: Absence of neurological symptoms
Action Threshold: New onset neurological symptoms suggestive of demyelinating disease require immediate evaluation and discontinuation.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin lesions (e.g., rash, sores)
- Easy bruising or bleeding
- Pale skin
- Swelling of ankles/feet
- Sudden weight gain
- New or worsening shortness of breath
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Joint pain
- Muscle pain
- Rash on cheeks or other body parts (lupus-like syndrome)
Special Patient Groups
Pregnancy
Adalimumab is transferred across the placenta during the third trimester. Use during pregnancy should be considered only if clearly needed. Exposure during pregnancy may lead to increased risk of infection in the infant, particularly live vaccines, for up to 5 months after the last maternal dose.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk of major birth defects.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant. Potential for immunosuppression in the infant, affecting vaccine response.
Lactation
Adalimumab is present in human milk at low levels. The effects of local gastrointestinal exposure and systemic exposure in the breastfed infant are unknown. However, due to its large molecular weight, absorption by the infant is likely to be minimal. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the infant. Monitor for signs of infection.
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, Ulcerative Colitis in patients 5 years and older, Plaque Psoriasis in patients 4 years and older, and Uveitis in patients 2 years and older. Dosing is weight-based for most 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 a greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections was higher in patients 65 years of age and older. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira (adalimumab). It is important to ensure patients understand they are receiving a biosimilar and not the reference product.
- Thorough screening for tuberculosis (latent and active) and hepatitis B is crucial before initiating therapy due to the risk of reactivation.
- Patients should be educated on proper subcutaneous injection technique and rotation of injection sites to minimize local reactions.
- Advise patients to report any signs of infection promptly, as serious infections can occur.
- Live vaccines should be avoided during treatment and for several months after discontinuation. Consult with a healthcare provider regarding vaccination schedules.
- Monitor for new or worsening symptoms of heart failure, demyelinating disease, or lupus-like syndrome.
- Consider the increased risk of malignancy, particularly in pediatric and adolescent patients, and discuss with patients/parents.
Alternative Therapies
- Other TNF inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, tofacitinib, upadacitinib, abatacept, rituximab, vedolizumab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- Immunosuppressants (e.g., azathioprine, cyclosporine)
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (often requires prior authorization and step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.