Humira 10mg/0.1ml Kit (2 Prf 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)
Pharmacologic Class
Tumor necrosis factor (TNF) blocker; Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira is a medicine that works by blocking a protein in your body called TNF-alpha. This protein can cause inflammation and damage in certain diseases like arthritis, Crohn's disease, and psoriasis. By blocking TNF-alpha, Humira helps reduce inflammation and improve symptoms.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. Only use the medication if the solution is clear and colorless. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Additionally, do not inject within 2 inches (5 cm) of the belly button.
To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal.
Storage and Disposal
Store the medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you have any questions or concerns about storage or disposal, consult your doctor or pharmacist.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. Only use the medication if the solution is clear and colorless. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Additionally, do not inject within 2 inches (5 cm) of the belly button.
To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal.
Storage and Disposal
Store the medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you have any questions or concerns about storage or disposal, consult your doctor or pharmacist.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while on Humira.
- Report any signs of infection (fever, chills, persistent 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.
- Discuss any planned surgeries with your doctor, as Humira may need to be temporarily stopped.
- Store Humira in the refrigerator (2°C to 8°C / 36°F to 46°F) and protect from light. Do not freeze.
Available Forms & Alternatives
Available Strengths:
- Humira 40mg/0.8ml Kit (2prf Syr)
- Humira Pen 40mg/0.8ml Kit(2 Pens)
- Humira Pen 40mg Crohn Str Kit-6pen
- Humira 40mg/0.4ml Kt(2 Prf Sy) CF
- Humira 20mg/0.2ml Kit (2 Prf Syr)
- Humira 10mg/0.1ml Kit (2 Prf Syr)
- Humira Ped Cro Strt Kit (2 Prf Syr)
- Humira 80mg/0.8ml Ped Cro Str Kt CF
- Humira Pen 40mg/0.4ml Kit(2pens)cf
- Humira Pen-Cd/uc/hs Stpkcit Fr 29g
- Humira Pen-Ps/uv Starter Kit
- Humira 80mg/0.8ml Kit(2prf Pens)cf
- Humira Pediatric Uc Pen Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg subcutaneously every other week. For Crohn's Disease/Ulcerative Colitis: Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards). For Plaque Psoriasis: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose. For Hidradenitis Suppurativa: Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg weekly (Day 29 onwards). For Uveitis: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Dose Range:
10 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg every other week; some patients with RA not on concomitant methotrexate may benefit from 40 mg every week.
Psoriatic Arthritis:
40 mg every other week.
Ankylosing Spondylitis:
40 mg every other week.
Crohn's Disease:
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week (Day 29 onwards).
Ulcerative Colitis:
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week (Day 29 onwards).
Plaque Psoriasis:
Initial 80 mg, then 40 mg every other week starting one week after initial dose.
Hidradenitis Suppurativa:
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg weekly (Day 29 onwards).
Uveitis:
Initial 80 mg, then 40 mg every other week starting one week after initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) 2-17 years: 24 mg/m² up to a maximum single dose of 40 mg every other week. Crohn's Disease 6-17 years: Weight-based dosing (e.g., <40 kg: 40 mg initial, 20 mg week 2, then 20 mg every other week; ≥40 kg: 80 mg initial, 40 mg week 2, then 40 mg every other week). Ulcerative Colitis 5-17 years: Weight-based dosing (e.g., <40 kg: 80 mg initial, 40 mg week 2, then 40 mg every other week; ≥40 kg: 160 mg initial, 80 mg week 2, then 80 mg every other week). Plaque Psoriasis 4-17 years: 0.8 mg/kg up to 40 mg initial, then 0.4 mg/kg up to 20 mg weekly. Uveitis 2-17 years: 24 mg/m² up to a maximum single dose of 40 mg every other week.
Adolescent:
Dosing as per child for JIA, Crohn's, UC, Plaque Psoriasis, Uveitis, or adult dosing if appropriate for weight/age.
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 pathological immune response in autoimmune diseases.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
Approximately 5 days (range 2-10 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks for some indications (e.g., RA), but full therapeutic effect may take longer.
PeakEffect:
Varies by indication and individual response.
DurationOfAction:
Corresponds 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 Humira therapy 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 Humira. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and fatal form of lymphoma, have been reported in adolescents and young adults treated with TNF blockers, including Humira, for Crohn's disease or ulcerative colitis.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems that may be permanent. If you experience any of the following, 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
Liver problems, including fatal cases, have been reported with this medication. Seek medical help 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 may cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Seek medical help immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count, have been reported. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following, contact your doctor or seek medical help 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 any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems
Rarely, people taking this medication have experienced nervous system problems that may be permanent. If you experience any of the following, 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
Liver problems, including fatal cases, have been reported with this medication. Seek medical help 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 may cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Seek medical help immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count, have been reported. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following, contact your doctor or seek medical help 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 any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores.
- Signs of allergic reaction: rash, hives, swelling of face/lips/mouth/tongue, difficulty breathing or swallowing.
- Signs of blood problems: persistent fever, bruising, bleeding, paleness.
- Signs of nervous system problems: numbness or tingling, weakness in arms/legs, vision changes (double vision, blurred vision).
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling of ankles/feet.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- New or worsening psoriasis (paradoxical psoriasis).
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 you experienced, including any symptoms that occurred.
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 that may affect your use of this medication. 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 any health problems you have, as they may impact the safety and effectiveness of this medication.
Never start, stop, or change the dose 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 allergic reaction you experienced, including any symptoms that occurred.
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 that may affect your use of this medication. 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 any health problems you have, as they may impact the safety and effectiveness of this medication.
Never start, stop, or change the dose 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. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a live, weakened bacteria vaccine, such as BCG for bladder cancer, while using this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and notify your doctor of any skin changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, as well as any changes in the color or size of moles.
If you are 65 years or older, exercise caution when using this medication, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. You will need to weigh the potential advantages and disadvantages for both you and your baby.
If you used this medication during pregnancy, inform your baby's doctor. You will need to discuss the safety and timing of certain vaccines with the doctor to ensure your baby's well-being.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a live, weakened bacteria vaccine, such as BCG for bladder cancer, while using this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and notify your doctor of any skin changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, as well as any changes in the color or size of moles.
If you are 65 years or older, exercise caution when using this medication, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. You will need to weigh the potential advantages and disadvantages for both you and your baby.
If you used this medication during pregnancy, inform your baby's doctor. You will need to discuss the safety and timing of certain vaccines with the doctor to ensure your baby's well-being.
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 Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
- 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 and other adverse events.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and serious infection when used concomitantly, especially in certain populations (e.g., Crohn's disease).
Moderate Interactions
- Vaccines (non-live) - may result in a diminished immune response to vaccination.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD test or IGRA)
Rationale: To rule out latent or active TB infection before initiating therapy, 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 status, as cytopenias (e.g., leukopenia, neutropenia, thrombocytopenia, pancytopenia) can occur.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, as liver enzyme elevations can occur.
Timing: Prior to initiation of therapy.
Screening for other infections (e.g., fungal, opportunistic)
Rationale: To identify and treat any existing infections before starting immunosuppressive therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout therapy and for several months after discontinuation.
Target: Absence of fever, chills, cough, shortness of breath, skin lesions, dysuria, etc.
Action Threshold: Prompt evaluation and treatment for any suspected serious infection.
CBC with differential
Frequency: Periodically, or as clinically indicated, especially if cytopenias are suspected.
Target: Within normal limits; monitor for significant decreases.
Action Threshold: Discontinue adalimumab if significant cytopenias develop.
LFTs
Frequency: Periodically, or as clinically indicated.
Target: Within normal limits; monitor for significant elevations.
Action Threshold: Consider discontinuation if significant liver injury occurs.
Signs and symptoms of malignancy (e.g., lymphoma, skin cancer)
Frequency: Regularly throughout therapy.
Target: Absence of new or worsening lumps, unexplained weight loss, night sweats, persistent fever, changes in moles.
Action Threshold: Prompt evaluation for any suspected malignancy.
Signs and symptoms of new or worsening heart failure
Frequency: Regularly throughout therapy.
Target: Absence of dyspnea, edema, rapid weight gain.
Action Threshold: Discontinue adalimumab if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease
Frequency: Regularly throughout therapy.
Target: Absence of new onset or worsening numbness, tingling, weakness, vision changes.
Action Threshold: Discontinue adalimumab if new or worsening demyelinating disorder develops.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Unexplained weight loss
- Night sweats
- Skin lesions (new or changing)
- Pain or swelling in joints
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Signs of allergic reaction (rash, hives, swelling, difficulty breathing)
- Symptoms of heart failure (swelling of ankles/feet, sudden weight gain, shortness of breath)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Available data from clinical trials and postmarketing reports suggest that adalimumab use during pregnancy does not increase the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, live vaccines should not be administered to infants exposed to adalimumab in utero for at least 6 months after birth.
Trimester-Specific Risks:
First Trimester:
Limited data, but no increased risk of major birth defects observed.
Second Trimester:
Limited data, but no increased risk of major birth defects observed.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in infant serum at birth. Consider discontinuing adalimumab during the third trimester if clinically appropriate to minimize infant exposure, especially if live vaccines are planned for the infant.
Lactation
Adalimumab is present in human milk at low concentrations. The relative infant dose is very low (estimated <0.1%). Given its large molecular weight, oral absorption by the infant is unlikely. No adverse effects have been reported in breastfed infants. Considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Adalimumab is approved for several 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 many 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 greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infections was higher in adalimumab-treated patients aged 65 years and older compared to younger patients. Use with caution in elderly patients, and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic agent requiring careful patient selection and monitoring due to potential for serious infections and malignancies.
- Patients must be screened for latent TB and HBV prior to initiation and monitored during therapy.
- Patients should be educated on signs of infection and instructed to seek immediate medical attention if they occur.
- Live vaccines are contraindicated during adalimumab therapy. Non-live vaccines may have a diminished response.
- The 10mg/0.1ml concentration is often used for pediatric dosing or specific titration schedules where lower doses are required.
- Consider temporary discontinuation of adalimumab before major surgery to reduce infection risk, based on individual patient assessment and surgeon's recommendation.
- Paradoxical reactions, such as new onset or worsening psoriasis, can occur.
- Rare cases of new onset or exacerbation of demyelinating disorders have been reported; discontinue if these occur.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, tofacitinib, upadacitinib, guselkumab, risankizumab, vedolizumab, natalizumab, rituximab, abatacept, anakinra)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month per 2 prefilled syringes (40mg/0.8ml or 10mg/0.1ml)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
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 safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide 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 for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide 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 for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.