Humira Ped Cro Strt Kit (2 Prf Syr)
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat Crohn's disease.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It is used to treat ulcerative colitis.It is used to treat a skin problem called hidradenitis suppurativa.It is used to treat uveitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-modifying antirheumatic drug (DMARD)
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker; Monoclonal Antibody
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Humira is a medicine that helps reduce inflammation in the body. It works by blocking a natural protein called TNF-alpha, which can cause inflammation and damage in conditions like Crohn's disease, arthritis, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. Only use the medication if the solution is clear and colorless. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Additionally, do not inject within 2 inches (5 cm) of the belly button.
To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you drop the device, 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, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and 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 in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you drop the device, 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, but do not freeze it. If the medication has been frozen, do not use it.
Missed Dose
If you miss a dose, take it as soon as you remember and 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 Humira.
- Report any signs of infection (fever, chills, cough, flu-like symptoms) immediately to your doctor.
- Report any unusual lumps, skin changes, or persistent fatigue.
- Maintain good hygiene to reduce infection risk.
- Discuss all medications, including over-the-counter drugs, supplements, and herbal products, with your doctor.
- Inform all healthcare providers that you are taking Humira before any surgery or dental procedures.
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: Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week starting Day 29.
Condition-Specific Dosing:
Crohn's Disease:
Initial: 160 mg SC (Day 1), 80 mg SC (Day 15), then 40 mg SC every other week starting Day 29. Maintenance may be increased to 40 mg SC weekly or 80 mg SC every other week if response diminishes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Crohn's Disease (6 years to <17 years): Weight-based. <40 kg: Initial 80 mg SC (Day 1), 40 mg SC (Day 15), then 20 mg SC every other week starting Day 29. ≥40 kg: Initial 160 mg SC (Day 1), 80 mg SC (Day 15), then 40 mg SC every other week starting Day 29.
Adolescent:
For Crohn's Disease (≥17 years): Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; Adalimumab is a large protein and not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF-alpha). 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 intestinal tract of patients with Crohn's disease and ulcerative colitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
5.5 days (range 2-10 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-20 days (mean 14 days)
Clearance:
11 to 12 mL/hr
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks for most indications, but can vary.
PeakEffect:
Varies by indication and individual response.
DurationOfAction:
Approximately 2 weeks (based on dosing interval), but clinical effects can persist longer due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to initiating HUMIRA and during therapy. Treatment for latent TB should be initiated prior to HUMIRA use. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and often fatal 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
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention 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.
Swollen Glands: Night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems: Burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart Failure: Shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Other Serious Side Effects:
Blood Cell Problems: Aplastic anemia, low platelet levels, or low white blood cell count. Contact your doctor if you experience extreme fatigue or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Heart Disease: If you have a history of heart disease, inform your doctor. Seek medical attention if you experience shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Common Side Effects:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. Not all side effects are listed here. If you have questions or concerns about side effects, consult 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 experience any of the following symptoms, contact your doctor or seek medical attention 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.
Swollen Glands: Night sweats, shortness of breath, or unexplained weight loss.
Nervous System Problems: Burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart Failure: Shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Other Serious Side Effects:
Blood Cell Problems: Aplastic anemia, low platelet levels, or low white blood cell count. Contact your doctor if you experience extreme fatigue or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Heart Disease: If you have a history of heart disease, inform your doctor. Seek medical attention if you experience shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Common Side Effects:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. Not all side effects are listed here. If you have questions or concerns about side effects, consult 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: fever, chills, persistent cough, shortness of breath, flu-like symptoms, skin warmth/redness/pain, open sores.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of blood problems: persistent fever, bruising easily, bleeding, pale skin.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain.
- 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, seizures.
- Signs of malignancy: unexplained weight loss, persistent fever, night sweats, swollen glands (lymph nodes).
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.
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 any health problems you have, as they may impact the safety and effectiveness of this medication.
Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
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 any health problems you have, as they may impact the safety and effectiveness of this medication.
Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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, it is crucial to discuss this with 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.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, it is important to consult with 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 live or weakened bacteria vaccines, such as the BCG vaccine for bladder cancer, while taking this medication. Consult with your doctor for guidance.
Regular blood tests and other laboratory evaluations will be necessary, as directed by your doctor, to monitor your health while taking this medication.
High cholesterol has been reported in patients taking this drug. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event you experience sunburn or other skin problems, consult with your doctor. It is also important to have your skin regularly checked for any changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles. Report any skin changes 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. You will need to carefully weigh the potential effects on you and your baby.
If you took this medication during pregnancy, inform your baby's doctor. It will be necessary to discuss the safety and timing of certain vaccinations for your baby with the doctor.
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, it is crucial to discuss this with 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.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, it is important to consult with 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 live or weakened bacteria vaccines, such as the BCG vaccine for bladder cancer, while taking this medication. Consult with your doctor for guidance.
Regular blood tests and other laboratory evaluations will be necessary, as directed by your doctor, to monitor your health while taking this medication.
High cholesterol has been reported in patients taking this drug. If you have concerns or questions, discuss them with your doctor.
If you have a latex allergy, inform your doctor, as some products may contain latex.
In the event you experience sunburn or other skin problems, consult with your doctor. It is also important to have your skin regularly checked for any changes, such as new warts, skin sores, or reddish bumps that bleed or do not heal, or changes in the color or size of moles. Report any skin changes 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. You will need to carefully weigh the potential effects on you and your baby.
If you took this medication during pregnancy, inform your baby's doctor. It will be necessary to discuss the safety and timing of certain vaccinations for your baby with the doctor.
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 Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, typhoid)
Major Interactions
- Anakinra (Kineret)
- Abatacept (Orencia)
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection and malignancy when used concomitantly, especially in pediatric patients with Crohn's disease.
Moderate Interactions
- Corticosteroids (may increase risk of infection, but often used concomitantly for induction)
- Warfarin (potential for altered INR, monitor closely)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: Risk of TB reactivation; Adalimumab can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline cytopenias.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess for baseline hepatic impairment.
Timing: Prior to initiation of therapy
Screening for demyelinating disorders
Rationale: Adalimumab has been associated with new onset or exacerbation of central nervous system demyelinating disorders.
Timing: Prior to initiation of therapy
Screening for heart failure
Rationale: Adalimumab can worsen heart failure.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: Continuously
Target: Absence of symptoms
Action Threshold: Any new or worsening signs/symptoms of infection; prompt medical evaluation and temporary discontinuation if serious infection suspected.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: Continuously
Target: Absence of symptoms
Action Threshold: Any new or worsening signs/symptoms; prompt medical evaluation.
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); consider discontinuation.
LFTs
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant elevations (e.g., >3x ULN); consider discontinuation.
Clinical response to therapy
Frequency: Regularly (e.g., every 3-6 months)
Target: Improvement in disease activity
Action Threshold: Lack of response or loss of response; consider dose adjustment or alternative therapy.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Unusual bruising or bleeding
- Pale skin
- Fatigue
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Abdominal pain
- Swelling of ankles/feet
- New or worsening numbness/tingling
- Weakness in arms/legs
- Vision changes
- Skin lesions (e.g., new or changing moles, non-melanoma skin cancers)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. While human data suggest a low risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes, limited data exist. Use during pregnancy should be considered only if clearly needed. Live vaccines should not be administered to infants exposed to adalimumab in utero for at least 6 months after the mother's last dose.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major birth defects.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant. Potential for immunosuppression in the infant.
Lactation
Adalimumab is present in human milk at low concentrations. The effects of local gastrointestinal exposure and systemic exposure in the breastfed infant are unknown. Given the large molecular weight, absorption by the infant is likely to be minimal. 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. Generally considered compatible with breastfeeding (L3).
Infant Risk:
Low risk of adverse effects due to minimal oral absorption and low concentrations in milk. Monitor for signs of infection.
Pediatric Use
Adalimumab is approved for various pediatric indications, including Crohn's disease (≥6 years), juvenile idiopathic arthritis (≥2 years), ulcerative colitis (≥5 years), hidradenitis suppurativa (≥12 years), and uveitis (≥2 years). Dosing is weight-based for many indications. Pediatric patients, especially those with Crohn's disease treated with concomitant immunosuppressants, have an increased risk of malignancy, including hepatosplenic T-cell lymphoma (HSTCL). Close monitoring for infections and malignancies is crucial.
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. The incidence of serious infection in patients 65 years of age and older was higher than in younger patients. Use with caution in elderly patients, and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab requires refrigeration; do not freeze. Allow to reach room temperature for 15-30 minutes before injection.
- Rotate injection sites to prevent lipodystrophy.
- Patients should be thoroughly screened for latent tuberculosis (TB) and hepatitis B virus (HBV) before starting therapy and monitored during treatment.
- Advise patients to report any signs of infection immediately, as serious and sometimes fatal infections can occur.
- Patients should avoid live vaccines while on adalimumab and for a period after discontinuation.
- The risk of malignancy, particularly lymphoma and non-melanoma skin cancer, is increased with TNF blockers. Regular skin exams are recommended.
- Consider the risk of demyelinating disorders and heart failure exacerbation.
- Biosimilars are available, offering potentially lower cost alternatives. Ensure patients understand the specific product they are receiving.
- Adalimumab has a long half-life, meaning effects can persist for several weeks after the last dose.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., Infliximab, Etanercept, Golimumab, Certolizumab pegol)
- Interleukin inhibitors (e.g., Ustekinumab, Secukinumab, Ixekizumab, Guselkumab, Risankizumab)
- Janus Kinase (JAK) inhibitors (e.g., Tofacitinib, Upadacitinib, Filgotinib)
- Selective adhesion molecule inhibitors (e.g., Vedolizumab, Natalizumab)
- T-cell costimulation modulators (e.g., Abatacept)
- Corticosteroids (for acute flares)
- Immunosuppressants (e.g., Methotrexate, Azathioprine, 6-mercaptopurine, Cyclosporine)
- Aminosalicylates (e.g., Mesalamine, Sulfasalazine - for inflammatory bowel disease)
Cost & Coverage
Average Cost:
$6,000 - $8,000+ per 2 prefilled syringes/pens (40 mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the substance taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the substance taken, the amount, and the time it occurred.