Humira Pen 40mg/0.8ml Kit(2 Pens)
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?
Adalimumab (Humira) is a medicine that helps reduce inflammation in the body. It works by blocking a natural protein called TNF-alpha, which can cause inflammation and damage in conditions like arthritis, psoriasis, and Crohn's disease. 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 and other sharp objects in a designated disposal box, following local regulations for proper disposal.
Injection Site Rotation
Rotate the injection site with each use to avoid skin irritation. If you drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you have any questions or concerns, consult your doctor or pharmacist.
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 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 and other sharp objects in a designated disposal box, following local regulations for proper disposal.
Injection Site Rotation
Rotate the injection site with each use to avoid skin irritation. If you drop the device, check the package insert to determine if it can still be used. If you are unsure, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator, avoiding freezing temperatures. Do not use the medication if it has been frozen. If you have any questions or concerns, consult your doctor or pharmacist.
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
- Avoid live vaccines while on this medication.
- Report any signs of infection (fever, chills, cough, skin sores) immediately to your doctor.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
- Maintain good hygiene to reduce infection risk.
- Discuss any planned surgeries or dental procedures with your doctor, as adalimumab may need to be temporarily stopped.
- Limit alcohol intake as it can affect liver function, though not a direct interaction with adalimumab.
Available Forms & Alternatives
Available Strengths:
- Humira 40mg/0.8ml Kit (2prf Syr)
- Humira Pen 40mg/0.8ml Kit(2 Pens)
- Humira Pen 40mg Crohn Str Kit-6pen
- Humira 40mg/0.4ml Kt(2 Prf Sy) CF
- Humira 20mg/0.2ml Kit (2 Prf Syr)
- Humira 10mg/0.1ml Kit (2 Prf Syr)
- Humira Ped Cro Strt Kit (2 Prf Syr)
- Humira 80mg/0.8ml Ped Cro Str Kt CF
- Humira Pen 40mg/0.4ml Kit(2pens)cf
- Humira Pen-Cd/uc/hs Stpkcit Fr 29g
- Humira Pen-Ps/uv Starter Kit
- Humira 80mg/0.8ml Kit(2prf Pens)cf
- Humira Pediatric Uc Pen Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg subcutaneously every other week.
Dose Range:
20 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 mg SC every other week. Some patients with RA not receiving concomitant methotrexate may benefit from increasing the frequency to 40 mg SC every week or 80 mg SC every other week.
Psoriatic Arthritis (PsA):
40 mg SC every other week.
Ankylosing Spondylitis (AS):
40 mg SC every other week.
Crohn's Disease (CD):
Initial dose 160 mg SC (Day 1), followed by 80 mg SC (Day 15), then 40 mg SC every other week starting Day 29.
Ulcerative Colitis (UC):
Initial dose 160 mg SC (Day 1), followed by 80 mg SC (Day 15), then 40 mg SC every other week starting Day 29.
Plaque Psoriasis (Ps):
Initial dose 80 mg SC, then 40 mg SC every other week starting one week after the initial dose.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg SC (Day 1), followed by 80 mg SC (Day 15), then 40 mg SC every week starting Day 29.
Uveitis:
Initial dose 80 mg SC, then 40 mg SC every other week starting one week after the initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA) 2-17 years: 20 mg SC every other week (15 kg to <30 kg), 40 mg SC every other week (âĨ30 kg). Crohn's Disease (CD) 6-17 years: Weight-based dosing (e.g., <40 kg: 80 mg initial, 40 mg week 2, 20 mg every other week; âĨ40 kg: 160 mg initial, 80 mg week 2, 40 mg every other week). Uveitis 2 years and older: Weight-based dosing (e.g., <30 kg: 20 mg SC every other week; âĨ30 kg: 40 mg SC every other week).
Adolescent:
Included in child dosing for JIA, CD, Uveitis. For other indications (e.g., Ps, HS), adolescent dosing may follow adult guidelines based on weight/severity.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
Adalimumab is not expected to be removed by dialysis due to its large molecular weight. No specific dose adjustment recommended, but use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution as hepatic impairment may affect immune function and drug clearance.
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. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement and inhibits TNF-mediated cellular functions involved in inflammation, such as the expression of adhesion molecules and the production of chemokines and cytokines.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
Approximately 5 days (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Primarily via catabolism; not renally or hepatically excreted as intact drug.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical response typically seen within 2-12 weeks, depending on indication.
PeakEffect:
Varies by indication and clinical endpoint.
DurationOfAction:
Corresponds to half-life, effects persist for several weeks after discontinuation.
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: Patients treated with adalimumab 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; invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis); and bacterial, viral, and other opportunistic infections. Treatment with adalimumab should not be initiated in patients with an active infection. If a serious infection develops, adalimumab should be interrupted. MALIGNANCY: Lymphomas and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and fatal form of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. The majority of reported cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis treated with adalimumab and 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 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.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be fatal. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea 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. Seek medical attention immediately if you experience:
Shortness of breath
Sudden weight gain
Irregular 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. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, 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
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 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.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be fatal. Seek medical attention right away if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea 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. Seek medical attention immediately if you experience:
Shortness of breath
Sudden weight gain
Irregular 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. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, and some may not have any side effects at all. However, 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
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, warm/red/painful skin, open sores.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of blood problems: persistent fever, bruising, bleeding, paleness.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling of ankles/feet.
- Signs of nervous system problems: numbness, tingling, weakness in arms/legs, vision changes (double vision, blurred vision).
- Signs of lupus-like syndrome: joint pain, rash on cheeks/arms (especially after sun exposure).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to 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 changing the dose 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 changing the dose 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.
As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will likely recommend hepatitis B testing, and it is vital to follow their instructions.
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.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Instead, discuss alternative options with your doctor.
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 is a potential side effect of this drug. If you have concerns or questions, consult your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks 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, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will likely recommend hepatitis B testing, and it is vital to follow their instructions.
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.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this medication. Instead, discuss alternative options with your doctor.
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 is a potential side effect of this drug. If you have concerns or questions, consult your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks 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, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg (approximately 700 mg) have been administered without dose-limiting toxicity.
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 risk of infection in immunosuppressed patients.
- Anakinra (Kineret) - increased risk of serious infection and neutropenia.
- Abatacept (Orencia) - increased risk of serious infection.
Major Interactions
- Other biologic DMARDs (e.g., etanercept, infliximab, golimumab, certolizumab, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, tildrakizumab) - increased risk of serious infection.
- Cyclophosphamide - increased risk of malignancy (e.g., lymphoma) when used in combination with TNF blockers.
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 certain conditions.
- Vaccines (non-live) - may result in a diminished immune response to vaccination.
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 latent TB.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters and monitor for cytopenias.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess baseline liver function and monitor for drug-induced liver injury.
Timing: Prior to initiation of therapy.
Baseline clinical assessment for signs/symptoms of infection or malignancy
Rationale: To establish a baseline and identify any pre-existing conditions that may be exacerbated.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue, skin lesions)
Frequency: At each clinical visit and patient self-monitoring.
Target: Absence of new or worsening infection.
Action Threshold: Prompt evaluation and treatment of any suspected serious infection; consider temporary or permanent discontinuation of adalimumab.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: At each clinical visit.
Target: Absence of new or worsening malignancy.
Action Threshold: Prompt evaluation of any suspected malignancy; consider discontinuation of adalimumab.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or as clinically indicated (e.g., if patient develops signs of cytopenia).
Target: Within normal limits.
Action Threshold: Significant or persistent cytopenias (e.g., neutropenia, thrombocytopenia, pancytopenia) may warrant discontinuation.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated (e.g., if patient develops signs of liver injury).
Target: Within normal limits or stable.
Action Threshold: Significant or persistent elevations may warrant discontinuation.
Signs and symptoms of new or worsening heart failure
Frequency: At each clinical visit.
Target: Stable cardiac function.
Action Threshold: Worsening heart failure may warrant discontinuation.
Signs and symptoms of demyelinating disease (e.g., numbness, tingling, vision changes, weakness)
Frequency: At each clinical visit.
Target: Absence of new or worsening neurological symptoms.
Action Threshold: Development of new or worsening demyelinating symptoms may warrant discontinuation.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin rash or lesions
- Painful urination
- Diarrhea
- Abdominal pain
- Unexplained weight loss
- Swollen glands
- Easy bruising or bleeding
- Pale skin
- Numbness or tingling
- Vision changes
- Weakness in arms or legs
- Swelling in ankles/feet
- Sudden weight gain
Special Patient Groups
Pregnancy
Adalimumab is transferred across the placenta 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 clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in infant serum at birth. Potential for immunosuppression in the infant.
Lactation
Adalimumab is present in human milk at low levels. The amount ingested by a breastfed infant is very low and unlikely to cause adverse effects. Breastfeeding is generally considered compatible with adalimumab use, but monitor the infant for signs of infection.
Infant Risk:
Low risk (L3 - Moderately Safe).
Pediatric Use
Adalimumab is approved for several pediatric indications (JIA, CD, Uveitis) in specific age groups and weight-based dosing. Children are at increased risk for serious infections and malignancies (including hepatosplenic T-cell lymphoma) compared to adults. Close monitoring is essential.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly (âĨ65 years) and younger patients, but the incidence of serious infections was higher in patients âĨ65 years of age. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a potent immunosuppressant; thorough screening for latent infections (TB, HBV) is critical before initiation.
- Patients should be educated on the signs and symptoms of serious infections and instructed to seek immediate medical attention if they occur.
- Live vaccines are contraindicated during treatment and for a period after discontinuation. Non-live vaccines may have a diminished response.
- Risk of malignancy, particularly lymphoma, is increased, especially in young males with IBD on concomitant thiopurines.
- Monitor for new or worsening heart failure symptoms and neurological symptoms suggestive of demyelinating disease.
- Injection site reactions are common but usually mild and transient. Proper injection technique can minimize discomfort.
- Biosimilars are now available, offering potentially lower-cost alternatives, but ensure patients are aware of the specific product they are receiving.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Etanercept, Infliximab, Golimumab, Certolizumab pegol)
- Other biologic DMARDs with different mechanisms of action (e.g., Abatacept, Rituximab, Tocilizumab, Ustekinumab, Secukinumab, Tofacitinib, Upadacitinib, Filgotinib)
- Conventional synthetic DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids (for acute flares, not long-term maintenance)
- Non-steroidal anti-inflammatory drugs (NSAIDs) (for symptomatic relief)
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $7,000 per 40mg/0.8ml pen (single pen)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits for most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, 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.