Humira 40mg/0.8ml Kit (2prf 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
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira is a medicine that helps reduce inflammation in your body. It works by blocking a protein called TNF-alpha, which can cause swelling and damage in conditions like arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. 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 in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine if it can still be used. If you have any questions or concerns, do not hesitate to reach out to your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and then 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 use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. 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 in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you accidentally drop the device, consult the package insert or speak with your doctor or pharmacist to determine if it can still be used. If you have any questions or concerns, do not hesitate to reach out to your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and then 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
- Avoid live vaccines while on Humira.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Report any new lumps, unexplained weight loss, or persistent fever.
- Maintain good hygiene to reduce infection risk.
- Discuss any planned surgeries or dental procedures with your doctor.
- Inform all healthcare providers that you are taking Humira.
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 by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg subcutaneously every other week.
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 mg subcutaneously every other week. May increase to 40 mg weekly if not on concomitant methotrexate.
Psoriatic Arthritis (PsA):
40 mg subcutaneously every other week.
Ankylosing Spondylitis (AS):
40 mg subcutaneously every other week.
Crohn's Disease (CD):
Initial dose: 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week starting Day 29.
Ulcerative Colitis (UC):
Initial dose: 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week starting Day 29.
Plaque Psoriasis (Ps):
Initial dose: 80 mg, then 40 mg every other week starting one week after the initial dose.
Hidradenitis Suppurativa (HS):
Initial dose: 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg weekly starting Day 29.
Uveitis:
Initial dose: 80 mg, then 40 mg every other week starting one week after the 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 (CD) 6-17 years: Weight-based dosing (e.g., <40 kg: 80 mg initial, 40 mg week 2, then 20 mg every other week; ≥40 kg: 160 mg initial, 80 mg week 2, then 40 mg every other week). Ulcerative Colitis (UC) 5-17 years: Weight-based dosing (e.g., <40 kg: 80 mg initial, 40 mg week 2, then 20 mg every other week; ≥40 kg: 160 mg initial, 80 mg week 2, then 40 mg every other week). Plaque Psoriasis (Ps) 4-17 years: Weight-based dosing (e.g., <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week). Uveitis 2-17 years: Weight-based dosing (e.g., <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week).
Adolescent:
Included in child dosing for specific indications; adult dosing may apply for older adolescents based on weight/maturity for some indications.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not renally cleared.
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 and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the affected tissues of patients with Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with cell surface receptors, thereby reducing inflammation and immune responses.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
5-6 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
4.7-6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 days (mean ~14 days)
Clearance:
11-12 mL/hr
ExcretionRoute:
Reticuloendothelial system (protein degradation)
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Weeks to months (clinical effect)
PeakEffect:
Weeks to months (clinical effect)
DurationOfAction:
Approximately 2 weeks (based on dosing interval)
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 often fatal cancer, have been reported primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis treated with TNF blockers, including Humira, 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 immediately or seek medical attention:
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.
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, stomach upset or 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.
If you have a history of heart disease, inform your doctor, as this medication can worsen heart failure.
Blood Cell Problems
This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. If you experience any of the following symptoms, contact your doctor immediately: extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 potential 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 immediately or seek medical attention:
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.
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, stomach upset or 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.
If you have a history of heart disease, inform your doctor, as this medication can worsen heart failure.
Blood Cell Problems
This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. If you experience any of the following symptoms, contact your doctor immediately: extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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 potential 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, severe cough, shortness of breath, unusual skin sores, burning urination, severe diarrhea.
- Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Nervous system problems: numbness, tingling, weakness in arms/legs, vision changes, dizziness.
- Heart failure: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
- Blood problems: persistent fever, easy bruising or bleeding, pale skin.
- Lupus-like syndrome: new or worsening joint pain, rash on cheeks or arms that worsens in sun.
- Malignancy: unexplained weight loss, persistent fever, night sweats, new lumps or growths.
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 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 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 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 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.
As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding 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, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will instruct you on the necessary hepatitis B testing.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug.
Do not receive live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory examinations as directed 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.
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, reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, use this medication with caution, as you may be more susceptible 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.
As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding 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, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will instruct you on the necessary hepatitis B testing.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug.
Do not receive live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory examinations as directed 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.
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, reddish bumps that bleed or do not heal, or changes in the color or size of moles.
If you are 65 years or older, use this medication with caution, as you may be more susceptible 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 Center).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever) - due to increased risk of infection in immunosuppressed patients.
Major Interactions
- Anakinra (Kineret) - increased risk of serious infection and neutropenia.
- Abatacept (Orencia) - increased risk of serious infection.
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection and no additional clinical benefit.
- Natalizumab (Tysabri), Vedolizumab (Entyvio), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Brodalumab (Siliq), Risankizumab (Skyrizi), Guselkumab (Tremfya), Tofacitinib (Xeljanz), Baricitinib (Olumiant), Upadacitinib (Rinvoq) - increased risk of serious infection when used concomitantly with other immunosuppressants.
Moderate Interactions
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine, corticosteroids) - increased risk of infection, but often used concomitantly in specific indications (e.g., IBD) with careful monitoring.
- Warfarin - potential for altered INR (monitor closely).
Minor Interactions
- Not specifically identified for minor interactions with adalimumab.
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 for baseline cytopenias (e.g., neutropenia, thrombocytopenia, pancytopenia).
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess for baseline hepatic impairment.
Timing: Prior to initiation of therapy.
Renal Function Tests (RFTs) - SCr, eGFR
Rationale: To assess for baseline renal function.
Timing: Prior to initiation of therapy.
Baseline clinical assessment for signs/symptoms of infection or malignancy
Rationale: To establish a baseline and identify pre-existing conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment for signs/symptoms of infection (e.g., fever, cough, malaise)
Frequency: At each visit, or as clinically indicated.
Target: Absence of infection
Action Threshold: Prompt evaluation and treatment if infection suspected; consider holding adalimumab.
Clinical assessment for signs/symptoms of malignancy (e.g., new lumps, unexplained weight loss, persistent fever)
Frequency: At each visit, or as clinically indicated.
Target: Absence of malignancy
Action Threshold: Prompt evaluation if malignancy suspected; consider discontinuing adalimumab.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially if cytopenias develop.
Target: Within normal limits
Action Threshold: Investigate persistent cytopenias; consider holding/discontinuing adalimumab if significant.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially if liver injury suspected.
Target: Within normal limits or stable
Action Threshold: Investigate elevated LFTs; consider holding/discontinuing adalimumab if significant.
Screening for demyelinating disease symptoms (e.g., numbness, tingling, vision changes)
Frequency: At each visit, or as clinically indicated.
Target: Absence of new neurological symptoms
Action Threshold: Prompt neurological evaluation if new symptoms develop; consider discontinuing adalimumab.
Screening for new or worsening heart failure symptoms
Frequency: At each visit, or as clinically indicated.
Target: Stable cardiac status
Action Threshold: Prompt cardiac evaluation if new/worsening symptoms; consider discontinuing adalimumab.
Symptom Monitoring
- Signs of serious infection (persistent fever, chills, severe cough, shortness of breath, skin lesions, diarrhea, dysuria)
- Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of new or worsening heart failure (shortness of breath, swelling of ankles/feet, sudden weight gain)
- Symptoms of demyelinating disease (numbness, tingling, weakness in limbs, vision changes, dizziness)
- Symptoms of lupus-like syndrome (new or worsening joint pain, rash on cheeks/arms, fever)
- Symptoms of blood dyscrasias (persistent fever, bruising, bleeding, pallor)
- Symptoms of malignancy (unexplained weight loss, persistent fever, night sweats, new lumps/growths)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Limited data from observational studies and registries suggest no increased risk of major birth defects or miscarriage with adalimumab use during pregnancy. However, due to potential for immunosuppression in the infant, live vaccines should be deferred for at least 6 months after birth if the mother received adalimumab during pregnancy.
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 infant exposure and transient immunosuppression.
Lactation
Adalimumab is present in human milk at low concentrations. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Humira and any potential adverse effects on the breastfed infant from Humira or from the underlying maternal condition. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects due to low systemic absorption and degradation in infant GI tract. Monitor for signs of infection.
Pediatric Use
Approved for multiple pediatric indications including JIA, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis. Dosing is weight-based for most indications. Increased risk of malignancy (lymphoma, HSTCL) has been reported in children and adolescents treated with TNF blockers, particularly with concomitant immunosuppressants.
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. Increased incidence of serious infections and malignancies in the elderly population in general should be considered.
Clinical Information
Clinical Pearls
- Adalimumab requires careful screening for latent TB and HBV before initiation due to the risk of reactivation.
- Patients should be educated on the signs and symptoms of serious infections and malignancies and instructed to report them immediately.
- Live vaccines are contraindicated during adalimumab therapy and for a period after discontinuation.
- Adalimumab can be used as monotherapy or in combination with methotrexate for RA.
- The 40mg/0.8ml prefilled syringe/pen is a common formulation, but other strengths and formulations exist (e.g., 80mg/0.8ml, 20mg/0.4ml).
- Patients should be trained on proper subcutaneous injection technique.
- Consider holding adalimumab temporarily during active serious infections or before major surgeries.
Alternative Therapies
- Conventional synthetic DMARDs (csDMARDs) like Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide
- Targeted synthetic DMARDs (tsDMARDs) like JAK inhibitors (Tofacitinib, Baricitinib, Upadacitinib)
- Corticosteroids (for acute flares, not long-term monotherapy)
- NSAIDs (for symptomatic relief)
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per 40mg/0.8ml prefilled syringe/pen
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often limited to specific indications)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for patients. Please 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. 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.