Humira 80mg/0.8ml Ped Cro Str Kt 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)
Pharmacologic Class
Tumor necrosis factor (TNF) blocker; Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira is a medicine that 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 arthritis, Crohn's disease, and psoriasis. It's given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles before use. 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 areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize skin irritation.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you drop the device, refer to the package insert or consult your doctor or pharmacist to determine whether it can still be used.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles before use. 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 areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize skin irritation.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at all times, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you drop the device, refer to the package insert or consult your doctor or pharmacist to determine whether it can still be used.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Store Humira in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze.
- Allow the prefilled syringe or pen to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites (thighs or abdomen) with each dose.
- Do not inject into skin that is tender, bruised, red, or hard.
- Follow proper injection technique as instructed by your healthcare provider.
- Avoid live vaccines while on Humira.
- Report any signs of infection (fever, chills, persistent cough, skin sores) to your doctor immediately.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
- Discuss any planned surgeries or dental procedures with your doctor.
- Limit alcohol consumption as it may affect liver function, especially if you have underlying liver conditions.
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 example, for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg 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 starting Day 29. For Plaque Psoriasis/Hidradenitis Suppurativa: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg every other week
Psoriatic Arthritis:
40 mg every other week
Ankylosing Spondylitis:
40 mg every other week
Crohn's Disease:
Initial 160 mg, then 80 mg 2 weeks later, then 40 mg every other week
Ulcerative Colitis:
Initial 160 mg, then 80 mg 2 weeks later, then 40 mg every other week
Plaque Psoriasis:
Initial 80 mg, then 40 mg every other week starting one week later
Hidradenitis Suppurativa:
Initial 80 mg, then 40 mg every other week starting one week later
Uveitis:
Initial 80 mg, then 40 mg every other week starting one week later
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing varies by weight and indication (e.g., Juvenile Idiopathic Arthritis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Uveitis). For JIA (2 years and older, ≥15 kg to <30 kg): 20 mg every other week. For JIA (2 years and older, ≥30 kg): 40 mg every other week. For Crohn's Disease (6 years and older, <40 kg): Initial 80 mg, then 40 mg 2 weeks later, then 20 mg every other week. For Crohn's Disease (6 years and older, ≥40 kg): Initial 160 mg, then 80 mg 2 weeks later, then 40 mg every other week.
Adolescent:
Dosing varies by weight and indication, often similar to adult dosing for those ≥40 kg.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; not expected to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
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 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, and plaque psoriasis. 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:
5-10 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:
Not applicable (catabolized)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Weeks to months (e.g., 2-12 weeks for RA, 8-12 weeks for CD)
PeakEffect:
Varies by indication and individual response, often within 12-24 weeks of therapy initiation.
DurationOfAction:
Maintained with regular dosing (every other week or weekly depending on indication).
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 who develop a serious systemic fungal infection should be suspected of having an invasive fungal infection and HUMIRA should be discontinued. 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. 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 treated with TNF blockers, including HUMIRA. The majority of reported cases occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received concomitant treatment with azathioprine or 6-mercaptopurine.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary tract infections (UTIs): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus-like symptoms: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Swollen glands or other symptoms: Swollen glands, night sweats, shortness of breath, or unintended weight loss.
Neurological Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you experience any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
Liver problems, including fatal cases, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Problems
Heart failure, including worsening of existing heart failure, has occurred with this medication. If you have a history of heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
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 serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary tract infections (UTIs): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus-like symptoms: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Swollen glands or other symptoms: Swollen glands, night sweats, shortness of breath, or unintended weight loss.
Neurological Problems
Rarely, people taking this medication have experienced nervous system problems, which can be permanent. If you experience any of the following symptoms, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
Liver problems, including fatal cases, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Problems
Heart failure, including worsening of existing heart failure, has occurred with this medication. If you have a history of heart disease, inform your doctor. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
New or worsening swelling in the arms or legs
Blood Cell Problems
Blood cell problems, including aplastic anemia, low platelet levels, and low white blood cell count, have occurred with this medication. If you experience any of the following symptoms, contact your doctor right away:
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 serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Nausea
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, body aches, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores on your body, diarrhea, stomach pain, burning when you urinate.
- Signs of tuberculosis: persistent cough, weight loss, low-grade fever, night sweats.
- Signs of hepatitis B reactivation: feeling very tired, yellow skin or eyes, dark urine, clay-colored stools, muscle aches, vomiting, stomach pain.
- Signs of blood problems: fever, bruising, bleeding easily, pale skin.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling in your ankles or feet.
- Signs of nervous system problems: numbness or tingling, vision problems, weakness in your arms or legs, dizziness.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of lupus-like syndrome: joint pain, rash on cheeks or arms (worsened by sunlight).
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 discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Remember, before starting, stopping, or modifying the dosage of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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 discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Remember, before starting, stopping, or modifying the dosage of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Regularly inspect your skin and report any changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
If you are 65 years or older, exercise caution when taking this medication, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Additionally, if you took this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Discuss any vaccine plans with your doctor.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Be aware that high cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin issues, consult your doctor. Regularly inspect your skin and report any changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
If you are 65 years or older, exercise caution when taking this medication, as you may be more prone to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Additionally, if you took this medication 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
Major Interactions
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
- Other TNF blockers (e.g., etanercept, infliximab - increased risk of serious infection)
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate - increased risk of infection, though often used concomitantly in some conditions with careful monitoring)
Moderate Interactions
- Vaccines (non-live: may have reduced immune response)
- Warfarin (potential for altered INR, monitor closely)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Risk of reactivation of latent TB or new active TB infection.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (surface antigen and core antibody)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: Risk of pancytopenia, leukopenia, neutropenia, thrombocytopenia, aplastic anemia.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: Risk of liver injury.
Timing: Prior to initiation of therapy
Baseline disease activity assessment
Rationale: To establish a baseline for monitoring treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: Regularly throughout therapy
Target: Absence of infection
Action Threshold: Prompt medical evaluation for any signs/symptoms of serious infection
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant decreases in cell counts (e.g., persistent neutropenia <1000/mm3, thrombocytopenia <50,000/mm3) may warrant discontinuation.
LFTs
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant elevations (e.g., >3-5x ULN) may warrant discontinuation.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: Regularly throughout therapy
Target: Absence of malignancy
Action Threshold: Prompt medical evaluation for any suspicious findings.
Signs and symptoms of new or worsening heart failure
Frequency: Regularly throughout therapy
Target: Absence of heart failure
Action Threshold: Discontinuation if new or worsening heart failure develops.
Signs and symptoms of demyelinating disease (e.g., numbness, tingling, vision changes)
Frequency: Regularly throughout therapy
Target: Absence of demyelinating disease
Action Threshold: Discontinuation if new or worsening demyelinating disorder develops.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Fatigue
- Unexplained weight loss
- Skin lesions (new or worsening)
- Numbness or tingling
- Vision changes
- Weakness in arms or legs
- Swelling in ankles/feet
- Shortness of breath with exertion
- Easy bruising or bleeding
- Pale skin
- Jaundice
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 monoclonal antibody; therefore, it is known to cross the placenta. Limited data from clinical trials and postmarketing reports suggest no increased risk of major birth defects or miscarriage. However, due to the potential for immunosuppression in the infant, live vaccines should be avoided for at least 6 months after the last maternal dose during pregnancy. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major birth defects based on available evidence.
Second Trimester:
Increased placental transfer of IgG antibodies occurs, potentially leading to higher fetal exposure.
Third Trimester:
Highest placental transfer of IgG antibodies, leading to highest fetal exposure and potential for neonatal immunosuppression.
Lactation
Adalimumab is present in human milk at low concentrations. The effects of local gastrointestinal exposure and systemic exposure in the breastfed infant are unknown. Given the large molecular weight, oral absorption by the infant is likely to be low. Consider the benefits of breastfeeding, the mother’s clinical need for Humira, and any potential adverse effects on the breastfed infant.
Infant Risk:
L3 (Moderate risk) - Low levels in milk, but potential for altered infant immune response. Monitor infant for signs of infection.
Pediatric Use
Approved for various pediatric indications including Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older, Crohn's Disease in patients 6 years and older, Ulcerative Colitis in patients 5 years and older, Plaque Psoriasis in patients 4 years and older, and Uveitis in patients 2 years and older. Dosing is weight-based for many indications. Increased risk of malignancy (lymphoma, HSTCL) reported in children and adolescents treated with TNF blockers.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increased incidence of serious infections and malignancies in the elderly population in general, so caution is advised.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic agent and requires careful screening for infections (especially TB and HBV) before and during therapy.
- Patients should be educated on proper subcutaneous injection technique and rotation of injection sites.
- The 80mg/0.8ml concentration is often used for specific maintenance doses or pediatric dosing, and patients should be carefully instructed on the correct dose and frequency.
- Biosimilars for adalimumab are available, offering potentially lower cost alternatives, but patients should be aware of the specific biosimilar name (e.g., adalimumab-atto) and not interchange without prescriber approval.
- Patients should carry an alert card indicating they are on a TNF blocker due to the risk of serious infections.
- Immunogenicity (antibody formation against adalimumab) can occur, potentially leading to loss of response; therapeutic drug monitoring may be considered in some cases of secondary loss of response.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, tofacitinib, upadacitinib, guselkumab, risankizumab, vedolizumab, natalizumab, rituximab, abatacept, tocilizumab)
- Conventional DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, azathioprine, 6-mercaptopurine)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per month per 80mg/0.8ml prefilled syringe/pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often step therapy)
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 you receive a refill of this medication. 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.