Humira Pen 40mg/0.4ml Kit(2pens)cf
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat Crohn's disease.It is used to treat ankylosing spondylitis.It is used to treat plaque psoriasis.It is used to treat ulcerative colitis.It is used to treat a skin problem called hidradenitis suppurativa.It is used to treat uveitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Disease-modifying antirheumatic drug (DMARD), Immunosuppressant
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 your body. It works by blocking a protein called TNF-alpha, which can cause swelling and damage in conditions like arthritis, psoriasis, and Crohn's disease. It's given as an injection under the skin, usually every other week.
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, and follow local regulations for disposing of full boxes.
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 this 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 then return to 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, and follow local regulations for disposing of full boxes.
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 this 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 then return to 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 and for several months after stopping it.
- Report any signs of infection (fever, chills, cough, fatigue, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of tuberculosis, hepatitis B, heart failure, or any neurological problems.
- Limit sun exposure and use sunscreen, as there may be an increased risk of skin cancer.
- Maintain good hygiene to reduce the risk of infections.
- Follow your doctor's instructions for proper injection technique and storage.
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 RA, PsA, AS: 40 mg subcutaneously every other week. For CD, UC: Initial 160 mg, then 80 mg two weeks later, then 40 mg every other week. For Plaque Psoriasis: Initial 80 mg, then 40 mg every other week starting one week later. For HS: Initial 160 mg, then 80 mg two weeks later, then 40 mg weekly. For Uveitis: Initial 80 mg, then 40 mg every other week starting one week later.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 mg every other week
Psoriatic Arthritis (PsA):
40 mg every other week
Ankylosing Spondylitis (AS):
40 mg every other week
Crohn's Disease (CD):
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Ulcerative Colitis (UC):
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Plaque Psoriasis (PsO):
Initial 80 mg (Day 1), then 40 mg every other week (Day 8 onwards)
Hidradenitis Suppurativa (HS):
Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg weekly (Day 29 onwards)
Uveitis:
Initial 80 mg (Day 1), then 40 mg every other week (Day 8 onwards)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for JIA from 2 years)
Child:
Juvenile Idiopathic Arthritis (JIA, 2-17 years): 24 mg/m² up to a maximum of 40 mg every other week. Crohn's Disease (CD, 6-17 years): Weight-based induction/maintenance. Plaque Psoriasis (PsO, 4-17 years): Weight-based. Uveitis (2-17 years): Weight-based.
Adolescent:
Same as child for approved indications (JIA, CD, PsO, Uveitis). For HS, 12 years and older: Initial 160 mg (Day 1), 80 mg (Day 15), then 40 mg weekly (Day 29 onwards).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific recommendations; adalimumab is a large protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
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. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the lesions of patients with plaque psoriasis, hidradenitis suppurativa, and uveitis. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with TNF receptors, thereby reducing inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64%
Tmax:
5 to 10 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Varies by indication, typically within weeks (e.g., 2-12 weeks for RA, longer for some other indications)
PeakEffect:
Varies by indication and clinical response, often observed after several weeks to months of therapy.
DurationOfAction:
Related 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), invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis), and bacterial and viral infections. Evaluate patients for TB risk factors and test for latent infection prior to and during therapy. MALIGNANCY: Lymphoma 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 lymphoma, have been reported in adolescents and young adults treated with TNF blockers, including adalimumab, for Crohn's disease or ulcerative colitis. The majority of reported cases occurred in patients also treated 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of a 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.
Signs of 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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
A skin lump or growth, 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.
Pre-existing Heart Disease: If you have a history of heart disease, inform your doctor. Monitor your condition closely and seek medical attention if you experience any of the above symptoms.
Blood Cell Problems: If you experience any of the following symptoms, contact your doctor immediately: extreme fatigue or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of a 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.
Signs of 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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
A skin lump or growth, 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.
Pre-existing Heart Disease: If you have a history of heart disease, inform your doctor. Monitor your condition closely and seek medical attention if you experience any of the above symptoms.
Blood Cell Problems: If you experience any of the following symptoms, contact your doctor immediately: extreme fatigue or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
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, non-healing wounds.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of blood problems: easy bruising or bleeding, pale skin, unusual weakness, prolonged fever.
- 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/legs, vision changes, dizziness, seizures.
- New or changing skin lesions (potential skin cancer).
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 to determine the best course of action.
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 health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, 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 to determine the best course of action.
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 health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, 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 may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
Regularly undergo blood tests and other laboratory evaluations as directed by your doctor.
Be aware that this medication may cause high cholesterol levels. 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, or 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, planning to become pregnant, or 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 vaccinations.
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 may not be effective or may increase the risk of infection when used in conjunction with this drug.
Avoid receiving live or weakened bacteria vaccines, such as BCG for bladder cancer, while taking this medication, and discuss any concerns with your doctor.
Regularly undergo blood tests and other laboratory evaluations as directed by your doctor.
Be aware that this medication may cause high cholesterol levels. 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, or 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, planning to become pregnant, or 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 vaccinations.
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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG, oral polio, typhoid)
Major Interactions
- Abatacept (Orencia)
- Anakinra (Kineret)
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection and malignancy
Moderate Interactions
- Warfarin (potential for altered INR, monitor closely)
- Theophylline (potential for altered levels, monitor closely)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection, as TNF blockers can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening
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 establish baseline and monitor for cytopenias (e.g., leukopenia, thrombocytopenia, pancytopenia).
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for hepatic events.
Timing: Prior to initiation of therapy
Assessment for demyelinating disease
Rationale: To identify pre-existing neurological conditions.
Timing: Prior to initiation of therapy
Assessment for heart failure
Rationale: To identify pre-existing heart failure, as TNF blockers can worsen or cause new-onset heart failure.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue, skin lesions)
Frequency: Regularly throughout therapy and for several months after discontinuation
Target: Absence of signs/symptoms
Action Threshold: Prompt evaluation and treatment if infection suspected; consider holding adalimumab.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or as clinically indicated
Target: Within normal limits
Action Threshold: If significant cytopenias develop, consider discontinuing adalimumab.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated
Target: Within normal limits
Action Threshold: If persistent elevations or signs of liver injury, consider discontinuing adalimumab.
Skin examination for malignancy
Frequency: Periodically
Target: Absence of suspicious lesions
Action Threshold: Referral to dermatologist for suspicious lesions.
Signs and symptoms of new or worsening heart failure
Frequency: Regularly
Target: Absence of new or worsening symptoms
Action Threshold: Prompt evaluation; consider discontinuing adalimumab.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Unusual fatigue
- Skin lesions (e.g., rash, nodules, non-healing sores)
- Weight loss
- Night sweats
- Diarrhea
- Abdominal pain
- Joint pain/swelling (if not primary indication)
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Swelling of ankles/feet
- Sudden weight gain
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta. Limited data from human pregnancies 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 the mother's last dose.
Trimester-Specific Risks:
First Trimester:
Low risk based on available data.
Second Trimester:
Low risk based on available data; placental transfer increases in the second and third trimesters.
Third Trimester:
Low risk based on available data; highest placental transfer occurs in the third trimester, leading to detectable levels in infant serum at birth.
Lactation
Adalimumab is present in human milk at low levels. Systemic exposure in a breastfed infant is expected to be low because adalimumab is a large protein and is likely to be degraded in the infant's gastrointestinal tract. No adverse effects have been reported in breastfed infants. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Approved for several pediatric indications (JIA, CD, PsO, Uveitis, HS). Increased risk of malignancy, including hepatosplenic T-cell lymphoma, has been reported in children and adolescents treated with TNF blockers. Careful monitoring for infections and malignancies is crucial.
Geriatric Use
Increased incidence of serious infections (including fatal infections) has been observed in patients 65 years of age and older treated with TNF blockers. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab requires careful screening for latent or active tuberculosis and hepatitis B before initiation and ongoing monitoring.
- Patients should be educated on the signs and symptoms of serious infections and malignancies, and instructed to report them immediately.
- Live vaccines are contraindicated during adalimumab therapy and for several months after discontinuation. Infants exposed in utero should also avoid live vaccines for at least 6 months.
- Consider holding adalimumab therapy if a patient develops a serious infection or requires surgery.
- Biosimilars are available and may offer cost savings; ensure patients are aware of potential differences in auto-injector devices.
- Patients with pre-existing demyelinating disorders or heart failure should be carefully evaluated before starting adalimumab, as it can exacerbate these conditions.
Alternative Therapies
- Other TNF blockers (e.g., Etanercept, Infliximab, Golimumab, Certolizumab pegol)
- Interleukin inhibitors (e.g., Ustekinumab, Secukinumab, Ixekizumab, Guselkumab, Risankizumab, Tildrakizumab)
- JAK inhibitors (e.g., Tofacitinib, Baricitinib, Upadacitinib)
- Selective co-stimulation modulators (e.g., Abatacept)
- B-cell depleting agents (e.g., Rituximab)
- Phosphodiesterase 4 (PDE4) inhibitors (e.g., Apremilast)
- Conventional DMARDs (e.g., Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide)
- Corticosteroids
- Immunosuppressants (e.g., Azathioprine, 6-mercaptopurine, Cyclosporine)
Cost & Coverage
Average Cost:
$6,000 - $8,000+ per 2 pens (40mg/0.4ml)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.