Amjevita 20mg/0.4ml 1 Pf Syr, 0.4ml
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), Anti-inflammatory
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
Pregnancy Category
Not assigned by FDA (biologic)
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 rheumatoid 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 particulate matter. The solution should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button, as well as skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of adverse reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, 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 accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine whether it can still be used. If you have any questions or concerns, do not hesitate to reach out to your healthcare provider.
Storage and Disposal
Store this medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. When disposing of the medication, follow the same guidelines as for the device and needles.
Missed Doses
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, consult your doctor for guidance.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particulate matter. The solution should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button, as well as skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of adverse reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, 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 accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine whether it can still be used. If you have any questions or concerns, do not hesitate to reach out to your healthcare provider.
Storage and Disposal
Store this medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. When disposing of the medication, follow the same guidelines as for the device and needles.
Missed Doses
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, consult your doctor for guidance.
Lifestyle & Tips
- 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 the syringe/pen.
- Allow the syringe/pen to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites (thighs, abdomen). Do not inject into skin that is tender, bruised, red, or hard.
- Do not take live vaccines while on Amjevita.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Avoid close contact with people who are sick or have infections.
- Discuss any planned surgeries or dental procedures with your doctor, as Amjevita 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:
40 mg subcutaneously every other week (for most indications)
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS):
40 mg subcutaneously every other week. Some patients with RA not on concomitant methotrexate may benefit from 40 mg every week or 80 mg every other week.
Crohn's Disease (CD), Ulcerative Colitis (UC):
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 (Ps):
Initial dose 80 mg at Week 0, followed by 40 mg every other week starting at Week 1.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg at Week 0, followed by 80 mg at Week 2, then 40 mg every week 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): 2 mg/kg (max 40 mg) every other week. Crohn's Disease (6 years and older): Weight-based induction and maintenance. Plaque Psoriasis (4 years and older): Weight-based. Uveitis (2 years and older): Weight-based.
Adolescent:
Dosing similar to adult weight-based or standard adult dosing for specific indications (e.g., CD, UC, Ps, Uveitis, HS) if weight allows.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
Not studied; unlikely to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF)-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement and mediates antibody-dependent cell-mediated cytotoxicity. 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 play an important role in the pathologic inflammation and joint destruction that are hallmarks of these diseases. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with TNF receptors, thereby reducing inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
Approximately 5 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not extensively protein-bound (as an antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 10-14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Primarily via catabolism and elimination by reticuloendothelial system
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full effect may take longer (up to 12-24 weeks for some GI indications).
PeakEffect:
Varies by indication and patient response, generally within 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 Amjevita use and monitored for signs and symptoms of active TB during and after treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Cases of acute and chronic leukemia have been reported with TNF blocker use. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and frequently 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 products, and concomitant azathioprine or 6-mercaptopurine.
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 symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of a 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.
Signs of 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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
A skin lump or growth, pale skin, or red, scaly patches or bumps filled with pus.
Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Additional Serious Side Effects
Nervous system problems: burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart failure: shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood cell problems: extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Common Side Effects
Not everyone experiences side effects, and many people have only minor issues. However, if you notice any of the following side effects or if they bother you or persist, contact your doctor or seek medical attention:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of a 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.
Signs of 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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
A skin lump or growth, pale skin, or red, scaly patches or bumps filled with pus.
Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Additional Serious Side Effects
Nervous system problems: burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart failure: shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood cell problems: extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Common Side Effects
Not everyone experiences side effects, and many people have only minor issues. However, if you notice any of the following side effects or if they bother you or persist, contact your doctor or seek medical attention:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, skin sores, painful urination, diarrhea.
- Allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, dizziness, seizures.
- Heart failure: new or worsening shortness of breath, sudden weight gain, swelling of ankles/feet.
- Lupus-like syndrome: joint pain, rash on cheeks or arms (especially after sun exposure), fever.
- Blood problems: persistent fever, bruising, bleeding, paleness.
- Liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain.
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.
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.
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 reactivate the virus, leading to severe and potentially 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 on all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some 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 instructed by your doctor.
Be aware that this medication may cause high cholesterol. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex. Additionally, if you experience sunburn or other skin problems, consult your doctor.
Regular skin checks are crucial. Inform your doctor of 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, use this medication with caution, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you used this drug 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 reactivate the virus, leading to severe and potentially 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 on all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some 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 instructed by your doctor.
Be aware that this medication may cause high cholesterol. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex. Additionally, if you experience sunburn or other skin problems, consult your doctor.
Regular skin checks are crucial. Inform your doctor of 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, use this medication with caution, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered without dose-limiting toxicities.
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) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG)
- Anakinra (Kineret)
- Abatacept (Orencia)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab) - increased risk of serious infection and neutropenia.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine) - increased risk of myelosuppression and serious infection (especially in CD/UC).
Moderate Interactions
- Warfarin (potential for altered INR, monitor closely)
- Theophylline (potential for altered levels, monitor closely)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate TB.
Timing: Before initiation of therapy
Hepatitis B Virus (HBV) screening
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Before initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters and identify pre-existing cytopenias.
Timing: Before initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function.
Timing: Before initiation of therapy
Renal Function Tests (e.g., creatinine)
Rationale: To assess baseline renal function.
Timing: Before initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue)
Frequency: At each visit and instruct patient to self-monitor
Target: Absence of new or worsening 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 cytopenias (e.g., persistent neutropenia, thrombocytopenia) may warrant discontinuation.
LFTs
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Significant elevation (e.g., >3x ULN) may warrant investigation and potential discontinuation.
Signs and symptoms of malignancy (e.g., new lumps, unexplained weight loss)
Frequency: At each visit
Target: Absence of new or worsening malignancy
Action Threshold: Prompt evaluation if suspected.
Signs and symptoms of new or worsening heart failure
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Discontinuation if new or worsening heart failure occurs.
Signs and symptoms of demyelinating disease (e.g., numbness, tingling, vision changes)
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Discontinuation if new or worsening CNS demyelinating disorder occurs.
Symptom Monitoring
- Signs of serious infection (persistent fever, chills, cough, shortness of breath, skin lesions, diarrhea, dysuria)
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- Neurological symptoms (numbness, tingling, weakness in limbs, vision changes, seizures)
- Signs of heart failure (new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Lupus-like syndrome (joint pain, rash on cheeks/nose, fever, chest pain)
- Injection site reactions (redness, swelling, itching, pain at injection site)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Limited data from human pregnancies suggest no increased risk of major birth defects or miscarriage. However, live vaccines should not be administered to infants exposed to adalimumab in utero for at least 6 months after birth, as their immune response may be impaired. Use during pregnancy only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, no clear evidence of increased risk.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant for several months after birth. Consider delaying live vaccines in exposed infants.
Lactation
Adalimumab is present in human milk at very low concentrations. Systemic exposure in a breastfed infant is expected to be very low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. Therefore, adverse effects on the breastfed infant are considered unlikely. Breastfeeding is generally considered compatible with adalimumab use.
Infant Risk:
Low risk
Pediatric Use
Approved for various pediatric indications including JIA (âĨ2 years), Crohn's disease (âĨ6 years), Ulcerative Colitis (âĨ5 years), Plaque Psoriasis (âĨ4 years), and Uveitis (âĨ2 years). Dosing is often weight-based. Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly and younger patients, but the greater frequency of infections and malignancies in the elderly population should be considered. 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 and active tuberculosis (TB) and Hepatitis B Virus (HBV) before starting Amjevita and monitored during treatment.
- Live vaccines are contraindicated during Amjevita therapy and for several months after discontinuation.
- Patients should be educated on proper injection technique, storage, and disposal of syringes/pens.
- Monitor for signs of serious infections, malignancy, new or worsening heart failure, and neurological symptoms.
- Injection site reactions are common but usually mild and transient. Rotate injection sites to minimize discomfort.
Alternative Therapies
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, tofacitinib, upadacitinib, guselkumab, risankizumab, vedolizumab, natalizumab, abatacept, rituximab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine)
- Corticosteroids
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine)
Cost & Coverage
Average Cost:
Varies widely, typically several thousand dollars per month per 40mg syringe/pen
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 amount, and the time it occurred.