Humira 80mg/0.8ml Kit(2prf Pens)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
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira (adalimumab) is a medication that helps reduce inflammation in the body. It works by blocking a protein called TNF-alpha, which plays a role in causing inflammation 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 Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particulate matter. 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 the risk of skin reactions.
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.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication, as this may compromise its effectiveness. 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 resume your regular schedule. If you are unsure about what to do in the event of a missed dose, consult your doctor for guidance.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particulate matter. 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 the risk of skin reactions.
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.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication, as this may compromise its effectiveness. 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 resume your regular schedule. If you are unsure about what to do in the event of a missed dose, consult your doctor for guidance.
Lifestyle & Tips
- Follow your doctor's instructions for dosing and administration carefully.
- Store Humira in the refrigerator (2°C to 8°C / 36°F to 46°F) and protect from light. Do not freeze.
- Allow the pen/syringe to reach room temperature for 15-30 minutes before injecting.
- Rotate injection sites to avoid skin reactions.
- Do not inject into skin that is tender, bruised, red, or hard.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Avoid live vaccines while on Humira.
- Discuss any planned surgeries or dental procedures with your doctor, as Humira may need to be temporarily stopped.
Available Forms & Alternatives
Available Strengths:
- Humira 40mg/0.8ml Kit (2prf Syr)
- Humira Pen 40mg/0.8ml Kit(2 Pens)
- Humira Pen 40mg Crohn Str Kit-6pen
- Humira 40mg/0.4ml Kt(2 Prf Sy) CF
- Humira 20mg/0.2ml Kit (2 Prf Syr)
- Humira 10mg/0.1ml Kit (2 Prf Syr)
- Humira Ped Cro Strt Kit (2 Prf Syr)
- Humira 80mg/0.8ml Ped Cro Str Kt CF
- Humira Pen 40mg/0.4ml Kit(2pens)cf
- Humira Pen-Cd/uc/hs Stpkcit Fr 29g
- Humira Pen-Ps/uv Starter Kit
- Humira 80mg/0.8ml Kit(2prf Pens)cf
- Humira Pediatric Uc Pen Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Crohn's Disease, a common maintenance dose is 40 mg every other week, or 80 mg every other week for patients who have lost response. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Plaque Psoriasis, 40 mg every other week. The 80mg/0.8ml strength is often used for specific loading doses or escalated maintenance doses for certain conditions.
Dose Range:
20 - 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 (maintenance):
40 mg every other week, or 80 mg every other week for loss of response
Ulcerative Colitis (maintenance):
40 mg every other week, or 80 mg every other week for loss of response
Plaque Psoriasis:
80 mg initial dose, then 40 mg every other week starting one week after initial dose
Hidradenitis Suppurativa:
Initial: 160 mg on Day 1, 80 mg on Day 15. Maintenance: 40 mg weekly or 80 mg every other week starting on Day 29.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 2 mg/kg (max 40 mg) every other week. Crohn's Disease: Weight-based dosing, e.g., 40 mg every other week for >=40 kg. Plaque Psoriasis: 0.8 mg/kg (max 40 mg) every other week.
Adolescent:
Dosing similar to child or adult depending on weight and indication.
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 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. It blocks TNF-alpha's interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological function of TNF-alpha. TNF-alpha is a naturally occurring cytokine involved in systemic inflammation and is a key mediator of the inflammatory response in autoimmune diseases.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
5-6 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
4.7-6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 days (mean 14 days)
Clearance:
0.25-0.30 mL/hr/kg
ExcretionRoute:
Primarily via catabolism; not renally or hepatically excreted in unchanged form.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full effect may take longer (e.g., 12-16 weeks for psoriasis).
PeakEffect:
Varies by indication and patient response, generally within weeks to months.
DurationOfAction:
Due to long half-life, effects persist for several weeks after discontinuation.
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. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with HUMIRA. 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 identified in adolescent and young adult patients treated with TNF blockers, including HUMIRA. For HUMIRA, this has occurred primarily in patients with Crohn's disease or ulcerative colitis treated with concomitant azathioprine or 6-mercaptopurine.
Side Effects
Urgent 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 notice any of the following signs or symptoms, contact your doctor or seek medical help right away:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems: Rarely, people taking this medication have experienced nervous system problems that may be permanent. If you experience any of the following, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which may be fatal. If you notice any of the following, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Contact your doctor right away 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, such as aplastic anemia, low platelet levels, and low white blood cell count. If you experience any of the following, 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 severe side effects, and many have no side effects or only minor ones. However, if you experience any of the following, contact your doctor or seek medical help:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical help right away:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems: Rarely, people taking this medication have experienced nervous system problems that may be permanent. If you experience any of the following, contact your doctor right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which may be fatal. If you notice any of the following, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Contact your doctor right away 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, such as aplastic anemia, low platelet levels, and low white blood cell count. If you experience any of the following, 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 severe side effects, and many have no side effects or only minor ones. However, if you experience any of the following, contact your doctor or seek medical help:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: persistent fever, chills, cough, shortness of breath, flu-like symptoms, skin sores, unusual fatigue.
- Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Nervous system problems: numbness or tingling, weakness in arms/legs, vision changes, dizziness, seizures.
- Heart failure: new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain.
- Blood problems: persistent fever, bruising, bleeding easily, pale skin.
- Liver problems: persistent nausea, vomiting, abdominal pain, dark urine, yellowing of skin/eyes.
- 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 allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking, including natural products and vitamins.
* Any existing health problems or concerns.
To ensure your safety, it is vital to verify that it is safe to take this medication with all of your current medications and health conditions. Do not initiate, discontinue, 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 allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking, including natural products and vitamins.
* Any existing health problems or concerns.
To ensure your safety, it is vital to verify that it is safe to take this medication with all of your current medications and health conditions. Do not initiate, discontinue, 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. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss the results with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug. Additionally, avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor. Be aware that this medication may cause high cholesterol levels. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex. Also, if you experience sunburn or other skin problems, consult your doctor. It is crucial to have your skin regularly examined by a healthcare professional. 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, to your doctor.
If you are 65 years or older, use this medication with caution, 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. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccines 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. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo hepatitis B testing and discuss the results with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this drug. Additionally, avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor. Be aware that this medication may cause high cholesterol levels. If you have concerns, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex. Also, if you experience sunburn or other skin problems, consult your doctor. It is crucial to have your skin regularly examined by a healthcare professional. 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, to your doctor.
If you are 65 years or older, use this medication with caution, 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. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccines 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab) - increased risk of serious infection
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection (often used concomitantly, but requires careful monitoring)
Moderate Interactions
- Not available
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Baseline clinical assessment for signs/symptoms of infection, demyelinating disease, heart failure, malignancy.
Rationale: To establish baseline status and identify contraindications or precautions.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment for signs/symptoms of infection (e.g., fever, cough, malaise)
Frequency: Regularly, at each visit and patient self-monitoring
Target: Absence of infection
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of adalimumab.
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, thrombocytopenia) may warrant dose reduction or discontinuation.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Significant elevation (e.g., >3x ULN) may warrant investigation and potential discontinuation.
Clinical assessment for new or worsening signs/symptoms of heart failure
Frequency: Regularly, at each visit
Target: Stable cardiac function
Action Threshold: Worsening heart failure symptoms may require discontinuation.
Clinical assessment for new or worsening neurological symptoms (e.g., numbness, tingling, vision changes)
Frequency: Regularly, at each visit
Target: Absence of new neurological symptoms
Action Threshold: New onset or worsening demyelinating disease symptoms may require discontinuation.
Skin examination for new or changing lesions
Frequency: Annually or as clinically indicated
Target: Absence of suspicious lesions
Action Threshold: Suspicious lesions should be evaluated for malignancy.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, diarrhea, dysuria)
- Allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Neurological symptoms (e.g., numbness, tingling, weakness in limbs, vision changes, seizures)
- Signs of heart failure (e.g., new or worsening shortness of breath, swelling of ankles/feet, sudden weight gain)
- Blood dyscrasias (e.g., persistent fever, bruising, bleeding, pallor)
- Liver problems (e.g., persistent nausea, vomiting, abdominal pain, dark urine, yellowing of skin/eyes)
- Lupus-like syndrome (e.g., joint pain, rash on cheeks/nose, fever)
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 not be administered to infants exposed to adalimumab in utero for at least 6 months after birth.
Trimester-Specific Risks:
First Trimester:
Limited data, no increased risk of major birth defects observed.
Second Trimester:
Limited data, no increased risk of major birth defects observed.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant for several months after birth. Live vaccines should be delayed in exposed infants.
Lactation
Adalimumab is present in human milk at low levels. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. No adverse effects have been reported in breastfed infants. Considered compatible with breastfeeding by most experts.
Infant Risk:
Low risk
Pediatric Use
Approved for various pediatric indications including JIA, pediatric Crohn's disease, pediatric plaque psoriasis, and pediatric ulcerative colitis. Dosing is weight-based. Increased risk of malignancy (lymphoma, including HSTCL) has been reported in children and adolescents treated with TNF blockers, particularly with concomitant immunosuppressants.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increased incidence of serious infections and malignancies in the elderly population in general should be considered.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic, meaning it is a protein-based medication. It must be injected and cannot be taken orally.
- Patients should be thoroughly screened for tuberculosis (latent and active) and hepatitis B before starting therapy due to the risk of reactivation.
- Live vaccines are contraindicated during adalimumab therapy. Patients should be up-to-date on all recommended vaccinations prior to initiation.
- Patients should be educated on proper injection technique and rotation of injection sites to minimize local reactions.
- Close monitoring for signs of infection is crucial, as adalimumab suppresses the immune system.
- The 80mg/0.8ml strength is often used for specific loading doses (e.g., psoriasis) or escalated maintenance doses (e.g., Crohn's disease) where higher concentrations are needed.
- Biosimilars of adalimumab are available, offering potentially lower cost alternatives, but patients should be aware of specific brand names and interchangeability.
Alternative Therapies
- Other TNF inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, tofacitinib, upadacitinib, risankizumab, vedolizumab, natalizumab, abatacept, rituximab)
- Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- NSAIDs
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 2 prefilled pens (80mg/0.8ml)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, do not 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 refill your prescription. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.