Humira 40mg/0.4ml Kt(2 Prf Sy) CF
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
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira is a medication that helps reduce inflammation in the body. It works by blocking a protein called TNF-alpha, which can cause inflammation 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 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 use, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles. Only use the medication if the solution is clear and colorless. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, and follow local regulations for disposing of full boxes.
If you accidentally drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times. Do not freeze, as this can affect the medication's potency. If the medication has been frozen, do not use it.
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 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 use, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles. Only use the medication if the solution is clear and colorless. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, and follow local regulations for disposing of full boxes.
If you accidentally drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times. Do not freeze, as this can affect the medication's potency. If the medication has been frozen, do not use it.
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
- Report any signs of infection (fever, chills, cough, skin sores) immediately to your doctor.
- Avoid live vaccines while on Humira. Discuss all vaccinations with your doctor.
- Inform all healthcare providers (including dentists) that you are taking Humira.
- Maintain good hygiene to reduce infection risk.
- Limit sun exposure and use sun protection due to increased risk of skin cancer.
- Do not stop taking Humira without consulting your doctor.
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:
40 mg subcutaneously every other week
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 mg subcutaneously every other week. Methotrexate (MTX) can be continued.
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. Some patients may benefit from 40 mg every week or 80 mg every other week.
Ulcerative Colitis (UC):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg every other week starting Day 29. Some patients may benefit from 40 mg every week or 80 mg every other week.
Plaque Psoriasis (PsO):
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 every week 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 years): 24 mg/m² up to a maximum single dose of 40 mg every other week. Crohn's Disease (CD) (≥6 years): Weight-based induction and maintenance. Plaque Psoriasis (PsO) (≥4 years): Weight-based. Uveitis (≥2 years): Weight-based.
Adolescent:
Dosing similar to adult weight-based for specific indications (e.g., CD, PsO, Uveitis) or 40 mg every other week for JIA if weight allows.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
Not expected to be removed by dialysis; no specific adjustment recommended.
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. 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 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 also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
5 to 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 and elimination by reticuloendothelial system
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full therapeutic effect may take longer (e.g., 12-16 weeks for psoriasis).
PeakEffect:
Variable depending on indication and patient response, often seen after several weeks to months of consistent dosing.
DurationOfAction:
Approximately 2 weeks (consistent with every other week dosing interval).
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients should be tested for latent TB infection before HUMIRA use and during therapy. Treatment for latent infection should be initiated prior to HUMIRA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients developing systemic fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with HUMIRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Discontinue HUMIRA if a patient develops a serious infection or sepsis. MALIGNANCY: 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 with Crohn's disease or ulcerative colitis treated with TNF blockers, including HUMIRA. For a complete list of warnings, refer to the full prescribing information.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of lupus, including:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in vision
A skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver and Heart Problems
This medication can cause liver problems, which may be fatal. Seek medical help right away if you experience:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart failure has occurred in people taking this medication, including those with pre-existing heart disease. 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
This medication can cause blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Signs of a common cold
Stomach pain
Upset stomach
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 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 symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of lupus, including:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in vision
A skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver and Heart Problems
This medication can cause liver problems, which may be fatal. Seek medical help right away if you experience:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart failure has occurred in people taking this medication, including those with pre-existing heart disease. 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
This medication can cause blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Signs of a common cold
Stomach pain
Upset stomach
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 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, diarrhea, painful urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of blood problems: persistent fever, bruising, bleeding, paleness.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of nervous system problems: numbness, tingling, weakness in arms/legs, vision changes, dizziness.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
- Signs of lupus-like syndrome: joint pain, rash on cheeks/arms (especially after sun exposure).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will likely recommend hepatitis B testing, and it is crucial to follow their instructions.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, it is crucial to discuss any vaccinations with your doctor before receiving them, as some vaccines may not be effective or may increase the risk of infection when used concurrently with this drug. Specifically, avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication.
Regular blood tests and other laboratory evaluations are necessary while taking this drug, as directed by your doctor.
High cholesterol is a potential side effect of this medication. If you have concerns, consult 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. Regular skin examinations are recommended, and you should promptly report 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 prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccinations for your child.
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, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will likely recommend hepatitis B testing, and it is crucial to follow their instructions.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, it is crucial to discuss any vaccinations with your doctor before receiving them, as some vaccines may not be effective or may increase the risk of infection when used concurrently with this drug. Specifically, avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication.
Regular blood tests and other laboratory evaluations are necessary while taking this drug, as directed by your doctor.
High cholesterol is a potential side effect of this medication. If you have concerns, consult 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. Regular skin examinations are recommended, and you should promptly report 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 prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccinations for your child.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered without dose-limiting toxicities.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, intranasal influenza) during adalimumab treatment.
- Anakinra (Kineret) - increased risk of serious infection and neutropenia.
- Abatacept (Orencia) - increased risk of serious infection.
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab) - increased risk of serious infection.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine, corticosteroids) - increased risk of serious infection when used concomitantly, especially for prolonged periods.
Moderate Interactions
- Warfarin - potential for altered INR (monitor closely).
- Theophylline - potential for altered levels (monitor closely).
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Increased risk of TB reactivation or new infection. Must rule out active TB before starting and treat latent TB.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for cytopenias (e.g., neutropenia, pancytopenia).
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To establish baseline and monitor for liver injury.
Timing: Prior to initiation of therapy.
Vaccination status review
Rationale: Ensure all age-appropriate vaccinations are up-to-date prior to starting therapy, especially non-live vaccines.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: At each clinical visit and patient self-monitoring.
Target: Absence of fever, cough, malaise, localized pain/redness.
Action Threshold: Prompt evaluation and potential discontinuation if serious infection suspected.
Complete Blood Count (CBC) with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Within normal limits.
Action Threshold: Significant cytopenias (e.g., persistent neutropenia <1000/mm³) may require dose interruption or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Within normal limits or stable.
Action Threshold: Significant elevations (e.g., >3-5x ULN) may require dose interruption or discontinuation.
Signs and symptoms of malignancy (e.g., new lumps, unexplained weight loss, persistent fever)
Frequency: At each clinical visit and patient self-monitoring.
Target: Absence of new or worsening symptoms.
Action Threshold: Prompt evaluation if suspected.
Signs and symptoms of new or worsening heart failure
Frequency: At each clinical visit.
Target: Stable cardiac status.
Action Threshold: Discontinuation if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease
Frequency: At each clinical visit.
Target: Absence of new neurological symptoms.
Action Threshold: Discontinuation if new onset or exacerbation of demyelinating disorder occurs.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Fatigue
- Unexplained weight loss
- Night sweats
- Skin lesions (new or changing)
- Easy bruising or bleeding
- Persistent abdominal pain
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Swelling of ankles/feet
- Shortness of breath with exertion
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. However, live vaccines should be avoided in infants exposed to adalimumab in utero for at least 6 months after the last maternal dose.
Trimester-Specific Risks:
First Trimester:
Limited data, but 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, leading to detectable levels in the infant at birth. Potential for immunosuppression in the infant.
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 that is largely degraded in the infant's gastrointestinal tract. No adverse effects on breastfed infants have been reported. Considered compatible with breastfeeding by many experts.
Infant Risk:
Low
Pediatric Use
Approved for several pediatric indications (JIA, CD, PsO, Uveitis). Increased risk of malignancy (lymphoma, HSTCL) reported in children and adolescents treated with TNF blockers. Close monitoring for infections and malignancies is crucial.
Geriatric Use
Increased incidence of serious infections and malignancies in patients 65 years of age and older treated with TNF blockers. Use with caution and monitor closely for adverse events.
Clinical Information
Clinical Pearls
- Always screen for latent and active TB and HBV before initiating adalimumab and monitor during therapy.
- Avoid live vaccines during treatment and for several months after discontinuation.
- Patients should be educated on self-injection technique and proper disposal of sharps.
- Monitor for signs of serious infections, malignancy, new or worsening heart failure, and demyelinating disorders.
- Adalimumab can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
- Consider dose escalation (e.g., weekly dosing) for some patients with Crohn's disease or ulcerative colitis who lose response to every-other-week dosing.
- Biosimilars are available and may offer cost savings; ensure patients are aware of potential differences in auto-injector devices.
Alternative Therapies
- Other TNF inhibitors (e.g., Etanercept, Infliximab, Golimumab, Certolizumab pegol)
- Interleukin (IL) inhibitors (e.g., Ustekinumab, Secukinumab, Ixekizumab, Guselkumab, Risankizumab, Tildrakizumab)
- Janus Kinase (JAK) inhibitors (e.g., Tofacitinib, Baricitinib, Upadacitinib)
- Selective T-cell co-stimulation modulators (e.g., Abatacept)
- B-cell depleting agents (e.g., Rituximab)
- Phosphodiesterase 4 (PDE4) inhibitors (e.g., Apremilast)
- Traditional DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide, Azathioprine, 6-Mercaptopurine)
- Corticosteroids (e.g., Prednisone)
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 40mg/0.4ml prefilled syringe/pen
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.