Humira 20mg/0.2ml 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
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 the body. It works by blocking a natural protein called TNF-alpha, which can cause swelling and damage in conditions like rheumatoid arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper 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 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 a 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 return to 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 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 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 a 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 return to 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, cough, flu-like symptoms) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
- Discuss any planned surgeries or dental procedures with your doctor.
- Maintain good hygiene to reduce infection risk.
- Regularly monitor for new skin growths or changes in moles.
- Store Humira in the refrigerator (2°C to 8°C or 36°F to 46°F) and protect from light. Do not freeze. If needed, it can be stored at room temperature (up to 25°C or 77°F) for a maximum of 14 days, but must be discarded if not used within that time.
- Allow the prefilled syringe or pen to reach room temperature for 15-30 minutes before injecting.
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/hidradenitis suppurativa: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg every other week; some patients with RA not receiving methotrexate may benefit from 40 mg every week or 80 mg every other week.
Psoriatic Arthritis:
40 mg every other week.
Ankylosing Spondylitis:
40 mg every other week.
Crohn's Disease:
Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards).
Ulcerative Colitis:
Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards).
Plaque Psoriasis:
Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Hidradenitis Suppurativa:
Initial dose 160 mg (Day 1), then 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 initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) 2 to <4 years: 10 mg every other week. JIA 4 to <18 years: 20 mg every other week (for patients 15 kg to <30 kg) or 40 mg every other week (for patients ≥30 kg). Crohn's Disease 6 to <18 years: Weight-based dosing (e.g., <40 kg: initial 80 mg, then 40 mg; ≥40 kg: initial 160 mg, then 80 mg). Plaque Psoriasis 4 to <18 years: Weight-based dosing (e.g., 15 kg to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week). Uveitis 2 to <18 years: Weight-based dosing (e.g., 15 kg to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week).
Adolescent:
See child dosing for JIA, Crohn's, Plaque Psoriasis, Uveitis. Dosing for other indications (e.g., HS) may follow adult guidelines for adolescents weighing ≥40 kg.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Adalimumab is a large protein and not expected to be removed by dialysis.
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 intestinal mucosa of patients with Crohn's disease and ulcerative colitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
5.5 days (range 2-10 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
10 to 20 days (mean approximately 14 days)
Clearance:
11 to 15 mL/hr
ExcretionRoute:
Not applicable (catabolized into small peptides and amino acids)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within 2 weeks for some indications (e.g., RA), but full therapeutic effect may take 12-24 weeks.
PeakEffect:
Varies by indication and patient response, often seen after several weeks to months of therapy.
DurationOfAction:
Corresponds to half-life, effects persist for weeks after discontinuation.
Confidence:
High
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 type of T-cell lymphoma, have been reported in adolescents and young adults with Crohn's disease or ulcerative colitis treated with TNF blockers, including Humira. Most of these cases occurred in patients treated with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker.
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 emergency medical attention:
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 discolored sputum
+ 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 abdominal 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
+ Dizziness
+ Fainting
+ Changes in vision
Skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen gland
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following rare but serious side effects, contact your doctor immediately:
Nervous system problems, such as:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, characterized by:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ Swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet count
+ Low white blood cell count
+ Fatigue
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple spots on the skin
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects, including:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
Pain, redness, swelling, or reaction at the injection site
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for advice. 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 emergency medical attention:
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 discolored sputum
+ 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 abdominal 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
+ Dizziness
+ Fainting
+ Changes in vision
Skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen gland
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following rare but serious side effects, contact your doctor immediately:
Nervous system problems, such as:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, characterized by:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ Swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet count
+ Low white blood cell count
+ Fatigue
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple spots on the skin
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects, including:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
Pain, redness, swelling, or reaction at the injection site
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of blood problems: unusual bruising or bleeding, pale skin, extreme tiredness.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
- Signs of nervous system problems: numbness or tingling, weakness in arms or legs, vision changes, dizziness.
- Signs of new or worsening psoriasis (paradoxical psoriasis).
- Signs of lupus-like syndrome: joint pain, rash on cheeks or 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 to determine the best course of action.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) 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 change the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and ensure your safety while taking this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) 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 change the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and ensure your safety while taking this medication.
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, prior to receiving any vaccines during treatment, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when used in conjunction 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 to monitor your health while taking this medication. Adhere to the schedule recommended by your doctor.
Be aware that high cholesterol has been associated with the use of this drug. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Additionally, schedule regular skin checks and promptly report any new or changing skin lesions, such as warts, 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, exercise caution when using this medication, as you may be more prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the potential benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor, as they will need to discuss the safety and timing of certain vaccines with you.
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, prior to receiving any vaccines during treatment, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when used in conjunction 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 to monitor your health while taking this medication. Adhere to the schedule recommended by your doctor.
Be aware that high cholesterol has been associated with the use of this drug. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Additionally, schedule regular skin checks and promptly report any new or changing skin lesions, such as warts, 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, exercise caution when using this medication, as you may be more prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the potential benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor, as they will need to discuss the safety and timing of certain vaccines with you.
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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG) - due to increased risk of infection.
- 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.
- Rituximab - increased risk of serious infection.
- Tocilizumab - increased risk of serious infection.
- Natalizumab - increased risk of serious infection.
- Vedolizumab - increased risk of serious infection.
- Ustekinumab - increased risk of serious infection.
- Tofacitinib - increased risk of serious infection.
- Baricitinib - increased risk of serious infection.
- Upadacitinib - increased risk of serious infection.
Moderate Interactions
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate, corticosteroids) - increased risk of infection when used concomitantly, but often used together for synergistic effect in autoimmune diseases under close monitoring.
- Warfarin - potential for altered INR (monitor closely).
Minor Interactions
- Not specifically identified for minor interactions; most interactions are related to immunosuppression.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD test 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 and anti-HBc)
Rationale: To rule out active or chronic 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.
Baseline disease activity assessment (e.g., DAS28, CDAI, PASI, Harvey-Bradshaw Index)
Rationale: To establish a baseline for monitoring treatment efficacy.
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, dysuria, skin lesions, etc.
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; monitor for persistent cytopenias.
Action Threshold: Significant or persistent decrease in cell counts (e.g., neutropenia <1000/mm3, thrombocytopenia <50,000/mm3) may warrant dose interruption or discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Within normal limits.
Action Threshold: Significant elevation (e.g., >3-5x ULN) may warrant dose interruption or discontinuation.
Signs and symptoms of malignancy (e.g., lymphoma, skin cancer)
Frequency: At each clinical visit and patient self-monitoring.
Target: Absence of new or worsening lumps, unexplained weight loss, night sweats, persistent skin lesions.
Action Threshold: Prompt evaluation if suspected.
Signs and symptoms of new or worsening heart failure
Frequency: At each clinical visit.
Target: Absence of dyspnea, edema, rapid weight gain.
Action Threshold: Discontinue if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease
Frequency: At each clinical visit.
Target: Absence of new onset or worsening numbness, tingling, vision changes, weakness.
Action Threshold: Discontinue if new or worsening demyelinating disorder develops.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual bruising or bleeding
- Pale skin
- Extreme tiredness
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Abdominal pain
- New or worsening joint pain/swelling
- Numbness or tingling
- Vision changes
- Weakness in arms or legs
- New skin lesions or changes in existing moles
- Swollen glands
- Unexplained weight loss
- Night sweats
- Signs of allergic reaction (rash, hives, swelling, difficulty breathing)
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 surveillance suggest that Humira 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 Humira in utero for at least 6 months after the last maternal dose.
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 the infant's serum at birth. Consider the risks and benefits of continuing therapy.
Lactation
Adalimumab is present in human milk at low concentrations. 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. Given the large molecular weight, oral absorption by the infant is unlikely. Live vaccines should be avoided in breastfed infants if the mother is receiving Humira.
Infant Risk:
Low risk (L2) based on low levels in milk and poor oral absorption by infant. Monitor infant for signs of infection.
Pediatric Use
Humira 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, Plaque Psoriasis in patients 4 years and older, and Uveitis in patients 2 years and older. Dosing is weight-based for many pediatric indications. Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly patients (≥65 years) and younger adult patients, but a greater sensitivity of some older individuals cannot be ruled out. The incidence of serious infection was higher in patients ≥65 years of age. Use with caution in elderly patients, and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a subcutaneous injection; proper injection technique and site rotation are crucial to minimize injection site reactions.
- Patients should be thoroughly screened for latent tuberculosis and hepatitis B before starting therapy and monitored during treatment.
- Live vaccines are contraindicated during Humira therapy and for a period after discontinuation; consult guidelines for specific vaccine recommendations.
- Patients should be educated on the signs and symptoms of serious infections and malignancies and instructed to seek immediate medical attention if they occur.
- Humira can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
- Some patients may develop antibodies to adalimumab, which can reduce efficacy and increase the risk of injection site reactions. Therapeutic drug monitoring (TDM) may be considered in cases of secondary loss of response.
- Paradoxical reactions, such as new-onset or worsening psoriasis, can occur with TNF blockers.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Etanercept, Infliximab, Golimumab, Certolizumab pegol)
- JAK inhibitors (e.g., Tofacitinib, Baricitinib, Upadacitinib)
- IL-12/23 inhibitors (e.g., Ustekinumab, Guselkumab, Risankizumab)
- IL-17 inhibitors (e.g., Secukinumab, Ixekizumab, Brodalumab)
- Selective T-cell co-stimulation modulators (e.g., Abatacept)
- B-cell depleting agents (e.g., Rituximab)
- Integrin receptor antagonists (e.g., Vedolizumab, Natalizumab)
- Non-biologic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand dollars per 2 prefilled syringes/pens
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 your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.