Amjevita 40mg/0.4ml 2 Pf Syr
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat Crohn's disease.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It is used to treat ulcerative colitis.It is used to treat a skin problem called hidradenitis suppurativa.It is used to treat uveitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-Modifying Antirheumatic Drug (DMARD), Immunosuppressant
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
Pregnancy Category
Not available
FDA Approved
Sep 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Amjevita is a medicine that helps reduce inflammation in your body. It works by blocking a protein called TNF-alpha, which can cause swelling and damage in conditions like rheumatoid arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particulate matter. The solution should be colorless to faintly yellow; do not use it if the color has changed.
When selecting an injection site, avoid areas within 2 inches (5 cm) of the belly button and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated container, and follow local regulations for disposal when the container is full.
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 the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you are unsure about storage or disposal procedures, consult your doctor or pharmacist.
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, 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 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 and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize the risk of skin reactions.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated container, and follow local regulations for disposal when the container is full.
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 the refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you are unsure about storage or disposal procedures, consult your doctor or pharmacist.
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, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while taking Amjevita.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
- Maintain good hygiene to reduce infection risk.
- Store Amjevita in the refrigerator; do not freeze. Protect from light.
- Allow the syringe to reach room temperature for 15-30 minutes before injecting; do not warm it in any other way.
- Rotate injection sites (thighs, abdomen).
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 subcutaneously every other week. For Crohn's Disease, Ulcerative Colitis: Induction 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week. For Psoriasis, Hidradenitis Suppurativa: Induction 80 mg (Day 1), then 40 mg every other week. For Uveitis: Initial 80 mg, then 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:
Induction: 160 mg (Day 1), 80 mg (Day 15); Maintenance: 40 mg every other week
Ulcerative Colitis:
Induction: 160 mg (Day 1), 80 mg (Day 15); Maintenance: 40 mg every other week
Plaque Psoriasis:
Initial: 80 mg (Day 1); Maintenance: 40 mg every other week starting Day 8
Hidradenitis Suppurativa:
Initial: 160 mg (Day 1), 80 mg (Day 15); Maintenance: 40 mg weekly or 80 mg every other week
Uveitis:
Initial: 80 mg (Day 1); Maintenance: 40 mg every other week starting Day 8
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 10 mg (15 kg to <30 kg) or 20 mg (≥30 kg) every other week. Crohn's Disease (6 to 17 years): Weight-based, e.g., <40 kg: Induction 80 mg (Day 1), 40 mg (Day 15), then 20 mg every other week; ≥40 kg: Induction 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week. Ulcerative Colitis (6 to 17 years): Weight-based, similar to Crohn's. Plaque Psoriasis (4 to 17 years): Weight-based, e.g., 0.8 mg/kg up to 40 mg every other week. Uveitis (2 to 17 years): Weight-based, e.g., 20 mg (<30 kg) or 40 mg (≥30 kg) every other week. Hidradenitis Suppurativa (12 to 17 years): 80 mg (Day 1), 40 mg (Day 15), then 40 mg every other week.
Adolescent:
Dosing as per child for specific indications (JIA, CD, UC, PsO, Uveitis, HS) or adult dosing for others.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Dialysis:
Not significantly cleared by dialysis; no specific adjustment needed.
Hepatic Impairment:
Mild:
No dose adjustment necessary
Moderate:
No dose adjustment necessary
Severe:
No dose adjustment necessary
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF) alpha 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 inhibits TNF-induced expression of adhesion molecules responsible for leukocyte migration. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the lesions of patients with plaque psoriasis and hidradenitis suppurativa. In Crohn's disease and ulcerative colitis, elevated levels of TNF are found in the inflamed intestinal mucosa. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with TNF receptors, thereby reducing inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
Approximately 5 days (range 2-8 days)
FoodEffect:
Not applicable (administered subcutaneously)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein-bound in the classical sense)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Catabolism and elimination via reticuloendothelial system
Unchanged:
Not applicable (biologic)
Pharmacodynamics
OnsetOfAction:
Varies by indication; typically within 2-12 weeks for clinical response
PeakEffect:
Varies by indication; typically within 12-24 weeks for maximal response
DurationOfAction:
Related to half-life; effects persist for several weeks after discontinuation
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), invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis), and bacterial and viral infections. Evaluate patients for TB risk factors and test for latent TB infection prior to and during therapy. 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 often fatal T-cell lymphoma, have been reported in adolescents and young adults treated with TNF blockers, including adalimumab, for Crohn's disease or ulcerative colitis. The majority of reported cases occurred in patients treated with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker.
Side Effects
Serious 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 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.
Swollen Glands or Unexplained Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
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.
Other Serious Side Effects:
Heart Disease: If you have a history of heart disease, inform your doctor. This medication can cause heart failure or worsen existing heart failure.
Blood Cell Problems: Aplastic anemia, low platelet count, or low white blood cell count. If you experience extreme fatigue, weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin, contact your doctor immediately.
Common Side Effects:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 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.
Swollen Glands or Unexplained Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
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.
Other Serious Side Effects:
Heart Disease: If you have a history of heart disease, inform your doctor. This medication can cause heart failure or worsen existing heart failure.
Blood Cell Problems: Aplastic anemia, low platelet count, or low white blood cell count. If you experience extreme fatigue, weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin, contact your doctor immediately.
Common Side Effects:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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:
- Persistent fever or chills
- Unexplained weight loss
- Persistent cough or shortness of breath
- Skin sores or rashes
- Severe joint pain or swelling
- Numbness or tingling in arms/legs
- Vision changes
- Swelling of face, lips, or tongue
- Difficulty breathing or swallowing
- Easy bruising or unusual bleeding
- Yellowing of skin or eyes (jaundice)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
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 drug interactions or health concerns. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or modify the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
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 drug interactions or health concerns. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or modify the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this drug, 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 medication may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while using this drug. Consult your doctor for guidance.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been associated with 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 issues, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, exercise caution when using this drug, 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, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this drug, 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 medication may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while using this drug. Consult your doctor for guidance.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been associated with 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 issues, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, exercise caution when using this drug, 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. The highest dose administered was 10 mg/kg intravenously, which did not result in 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 for poison control.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG) during adalimumab treatment
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab) - increased risk of serious infection and neutropenia
- Anakinra - increased risk of serious infection and neutropenia
- Abatacept - increased risk of serious infection
- Rituximab - increased risk of serious infection
- Tocilizumab - increased risk of serious infection
Moderate Interactions
- Immunosuppressants (e.g., methotrexate, azathioprine, 6-mercaptopurine) - increased risk of infection, though often used in combination for synergistic effect in some conditions
- Vaccines (non-live) - may result in a diminished immune response
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection, as TNF blockers can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters and monitor for cytopenias (e.g., leukopenia, thrombocytopenia) which can occur.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function and monitor for liver enzyme elevations.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of fever, cough, malaise, localized pain/swelling
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of Amjevita.
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 <1000/mm³) may require discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Persistent or significant elevations may require discontinuation.
Signs and symptoms of malignancy
Frequency: Continuously
Target: Absence of unexplained weight loss, night sweats, persistent lymphadenopathy
Action Threshold: Prompt evaluation if suspected.
Signs and symptoms of heart failure
Frequency: Continuously
Target: Absence of new or worsening dyspnea, edema, fatigue
Action Threshold: Prompt evaluation; consider discontinuation if new or worsening heart failure.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, skin lesions, diarrhea, fatigue)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Neurological symptoms (e.g., numbness, tingling, weakness in limbs, vision changes, seizures)
- Signs of heart failure (e.g., new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Signs of lupus-like syndrome (e.g., new or worsening joint pain, rash on cheeks/nose, fever)
- Signs of blood dyscrasias (e.g., persistent fever, bruising, bleeding, pallor)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Available data from pregnancy registries and postmarketing reports have not established an association between adalimumab use and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy should be considered only if clearly needed, weighing potential benefits against potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major malformations.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant for several months post-birth. Live vaccines should be deferred in infants exposed to adalimumab in utero for at least 6 months after birth.
Lactation
Adalimumab is present in human milk at low levels. The effects of local gastrointestinal exposure and systemic exposure in a breastfed infant are unknown. However, given the large molecular weight of adalimumab, absorption by the infant is likely to be minimal. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Amjevita and any potential adverse effects on the breastfed infant from Amjevita or from the underlying maternal condition. Generally considered compatible with breastfeeding (L2).
Infant Risk:
Low risk of adverse effects due to minimal absorption by the infant.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 2 years of age and older for polyarticular juvenile idiopathic arthritis and uveitis, 6 years of age and older for Crohn's disease and ulcerative colitis, 4 years of age and older for plaque psoriasis, and 12 years of age and older for hidradenitis suppurativa. Pediatric patients treated with TNF blockers have an increased risk of malignancy, including lymphoma and hepatosplenic T-cell lymphoma.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly patients (≥65 years) and younger adult patients, but a higher incidence of serious infections has been observed in patients ≥65 years of age. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Amjevita is a biosimilar to Humira. It is important to ensure patients understand they are receiving a biosimilar and not the reference product, though the active ingredient (adalimumab) and mechanism of action are the same.
- Patients should be thoroughly screened for latent tuberculosis and hepatitis B before initiating therapy and monitored for signs of infection throughout treatment.
- Advise patients to rotate injection sites (thighs or abdomen) to minimize local reactions.
- Instruct patients to allow the prefilled syringe to reach room temperature for 15-30 minutes before injection to reduce injection site discomfort.
- Do not shake the syringe, as this can damage the protein.
- Patients should be educated on the signs and symptoms of serious infections and malignancies and instructed to seek immediate medical attention if they occur.
- Live vaccines are contraindicated during Amjevita therapy. Non-live vaccines may have a diminished response.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics for autoimmune diseases (e.g., ustekinumab, secukinumab, ixekizumab, risankizumab, guselkumab, vedolizumab, natalizumab, tofacitinib, upadacitinib, baricitinib, abatacept, rituximab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per prefilled syringe
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (Tier 4 or higher), requires prior authorization
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.