Humira Pen-Cd/uc/hs Stpkcit Fr 29g
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 applicable (PLLR)
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 inflammation and damage in certain diseases 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. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the 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 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. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the 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
- Avoid live vaccines while taking Humira. Discuss any vaccinations with your doctor.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, or heart failure.
- Do not stop taking Humira without consulting your doctor.
- 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. Do not shake.
- Allow Humira to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Rotate injection sites to avoid skin irritation.
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:
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 subcutaneously every other week. Some patients with RA not receiving concomitant methotrexate may benefit from increasing the frequency to 40 mg every week or 80 mg every other week.
Psoriatic Arthritis (PsA):
40 mg subcutaneously every other week.
Ankylosing Spondylitis (AS):
40 mg subcutaneously every other week.
Crohn's Disease (CD):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg every other week starting Day 29.
Ulcerative Colitis (UC):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg every other week starting Day 29.
Plaque Psoriasis (Ps):
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg (Day 1), followed by 80 mg (Day 15), then 40 mg every week starting Day 29.
Uveitis:
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Juvenile Idiopathic Arthritis (JIA): 2 mg/kg (up to a maximum of 40 mg per dose) every other week. Crohn's Disease (CD) (6 years and older): Weight-based dosing, e.g., <40 kg: Initial 80 mg (Day 1), 40 mg (Day 15), then 20 mg every other week. ≥40 kg: Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week. Ulcerative Colitis (UC) (5 years and older): Weight-based dosing similar to CD. Uveitis (2 years and older): 20 mg every other week for patients weighing <30 kg, 40 mg every other week for patients weighing ≥30 kg.
Adolescent:
Dosing generally follows adult guidelines for indications approved in adolescents (e.g., JIA, CD, UC, HS, Uveitis, Ps).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not expected to be removed by dialysis due to large molecular weight; no specific recommendations.
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 normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the affected tissues of patients with Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64% (subcutaneous)
Tmax:
Approximately 5 days (range 2-10 days)
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 manner as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Primarily via catabolism; not renally excreted.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA, PsA), but full therapeutic effect may take longer (e.g., 12-16 weeks for psoriasis).
PeakEffect:
Varies by indication and individual response; generally observed after several weeks of consistent dosing.
DurationOfAction:
Related to half-life, allowing for every other week or weekly dosing.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to Humira use and monitored for signs and symptoms of TB during therapy. 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 primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis treated with TNF blockers, including Humira, in combination with azathioprine or 6-mercaptopurine.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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 unhealing wounds.
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.
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 right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
In rare cases, this medication can cause liver problems, which can be life-threatening. Seek medical help immediately if you experience:
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. Seek medical help right away 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 immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you 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
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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 unhealing wounds.
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.
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 right away:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems
In rare cases, this medication can cause liver problems, which can be life-threatening. Seek medical help immediately if you experience:
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. Seek medical help right away 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 immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you 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
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: 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 allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing.
- Signs of new or worsening heart failure: shortness of breath with activity or lying down, swelling of feet/ankles, sudden weight gain.
- Signs of nervous system problems: numbness or tingling, weakness in arms or legs, vision changes, dizziness.
- Signs of blood problems: persistent fever, bruising, bleeding, paleness.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
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 and its symptoms.
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 concerns that may affect your use of this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or adjust the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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 and its symptoms.
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 concerns that may affect your use of this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Never start, stop, or adjust the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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, you will need to undergo hepatitis B testing and discuss the results with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, it is crucial to consult your doctor before receiving any vaccines while taking this drug, as some vaccines may increase the risk of infection or reduce their effectiveness.
Do not receive live or weakened bacteria vaccines, such as the BCG vaccine for bladder cancer, while using 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 this medication can cause high cholesterol. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any new or changing skin lesions, such as warts, sores, reddish bumps that bleed or do not heal, or changes in mole color or size, 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 potential 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.
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, you will need to undergo hepatitis B testing and discuss the results with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, it is crucial to consult your doctor before receiving any vaccines while taking this drug, as some vaccines may increase the risk of infection or reduce their effectiveness.
Do not receive live or weakened bacteria vaccines, such as the BCG vaccine for bladder cancer, while using 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 this medication can cause high cholesterol. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any new or changing skin lesions, such as warts, sores, reddish bumps that bleed or do not heal, or changes in mole color or size, 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 potential 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.
- Higher doses may increase the risk of adverse effects, particularly infections.
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 (during adalimumab treatment)
- 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 and other adverse events.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and infection when used concomitantly, though often used together in practice with careful monitoring.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Risk of TB reactivation or new infection. Adalimumab can reactivate latent TB.
Timing: Before initiating therapy
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Before initiating therapy
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for cytopenias (e.g., neutropenia, pancytopenia).
Timing: Before initiating therapy
Liver Function Tests (LFTs) (ALT, AST, bilirubin)
Rationale: To establish baseline and monitor for liver injury.
Timing: Before initiating therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: At each visit and ongoing patient education
Target: Absence of fever, cough, malaise, skin lesions, etc.
Action Threshold: Prompt evaluation and potential interruption of therapy if serious infection suspected.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Investigate significant decreases in cell counts; consider therapy interruption.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Investigate significant elevations; consider therapy interruption.
Signs and symptoms of malignancy
Frequency: Ongoing patient education and clinical assessment
Target: Absence of new or worsening symptoms
Action Threshold: Prompt evaluation of any suspicious findings.
Signs and symptoms of new or worsening heart failure
Frequency: Ongoing patient education and clinical assessment
Target: Absence of dyspnea, edema, rapid weight gain
Action Threshold: Prompt evaluation; consider discontinuation if new or worsening HF occurs.
Signs and symptoms of demyelinating disease
Frequency: Ongoing patient education and clinical assessment
Target: Absence of new or worsening neurological symptoms
Action Threshold: Prompt evaluation; consider discontinuation if new onset or exacerbation occurs.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin rash or lesions
- Joint pain or swelling (new or worsening)
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Hives
- Chest pain
- New or worsening symptoms of heart failure (e.g., dyspnea, edema, rapid weight gain)
- Easy bruising or bleeding
- Persistent sore throat or fever
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 monoclonal 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, as adalimumab may interfere with the infant's immune response to the vaccine. The clinical significance of this exposure is not fully established.
Trimester-Specific Risks:
First Trimester:
Limited data, no clear evidence of increased risk of major birth defects or miscarriage.
Second Trimester:
Limited data, no clear evidence of increased risk.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant's serum at birth. Potential for immunosuppression in the infant.
Lactation
Adalimumab is present in human milk at low concentrations. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Humira and any potential adverse effects on the breastfed infant from Humira or from the underlying maternal condition. Live vaccines should be avoided in breastfed infants if the mother is receiving adalimumab.
Infant Risk:
Low risk of adverse effects to the breastfed infant. Monitor for signs of infection.
Pediatric Use
Humira is approved for several pediatric indications, including Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older, Crohn's Disease (CD) in patients 6 years and older, Ulcerative Colitis (UC) in patients 5 years and older, Hidradenitis Suppurativa (HS) in adolescents 12 years and older, and Uveitis in patients 2 years and older. Dosing is weight-based for many pediatric indications. Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly and younger patients, but a higher incidence of serious infections has been observed in patients 65 years of age and older treated with TNF blockers. Use with caution in elderly patients, and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic agent that requires careful screening for infections (especially TB and HBV) before initiation and ongoing monitoring during therapy.
- Patients should be educated on self-injection technique and proper storage of the medication.
- Due to its immunosuppressive effects, patients should avoid live vaccines during treatment and for a period after discontinuation.
- The black box warning for serious infections and malignancies is critical and must be discussed with patients.
- Biosimilars of adalimumab are available, offering potential cost savings, but specific product names and interchangeability should be confirmed with the prescribing physician and pharmacist.
- Patients should be advised to report any new or worsening symptoms, particularly those related to infection, neurological changes, or heart failure.
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, vedolizumab, tofacitinib, upadacitinib, guselkumab, risankizumab, abatacept, rituximab)
- Conventional synthetic DMARDs (csDMARDs) (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Targeted synthetic DMARDs (tsDMARDs) (e.g., JAK inhibitors like tofacitinib, upadacitinib, filgotinib)
Cost & Coverage
Average Cost:
$6,000 - $8,000+ per 2 prefilled pens/syringes (40 mg each)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often high co-pays/coinsurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.