Humira Pediatric Uc Pen Kit
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?
Adalimumab (Humira) is a medicine that helps reduce inflammation in your body. It works by blocking a natural protein called TNF-alpha, which can cause inflammation and damage in conditions like ulcerative colitis. 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 cloudiness, leakage, or particles before use. 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 accidentally 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 at all times. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and then 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 cloudiness, leakage, or particles before use. 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 accidentally 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 at all times. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you miss a dose, take it as soon as you remember and then resume your regular schedule. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid live vaccines while on this medication and for several months after stopping it. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, cough, flu-like symptoms, skin sores) to your doctor immediately.
- Limit exposure to people who are sick or have infections.
- Maintain good hygiene to reduce infection risk.
- Inform your doctor about any new or changing skin growths.
- Inform all healthcare providers (including dentists) that you are taking adalimumab.
Available Forms & Alternatives
Available Strengths:
- Humira 40mg/0.8ml Kit (2prf Syr)
- Humira Pen 40mg/0.8ml Kit(2 Pens)
- Humira Pen 40mg Crohn Str Kit-6pen
- Humira 40mg/0.4ml Kt(2 Prf Sy) CF
- Humira 20mg/0.2ml Kit (2 Prf Syr)
- Humira 10mg/0.1ml Kit (2 Prf Syr)
- Humira Ped Cro Strt Kit (2 Prf Syr)
- Humira 80mg/0.8ml Ped Cro Str Kt CF
- Humira Pen 40mg/0.4ml Kit(2pens)cf
- Humira Pen-Cd/uc/hs Stpkcit Fr 29g
- Humira Pen-Ps/uv Starter Kit
- Humira 80mg/0.8ml Kit(2prf Pens)cf
- Humira Pediatric Uc Pen Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week starting Day 29 for Ulcerative Colitis.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Ulcerative Colitis (Maintenance):
40 mg every other week. Some patients with inadequate response may benefit from 40 mg every week or 80 mg every other week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Ulcerative Colitis (4 years and older): Initial dose 2.4 mg/kg (max 160 mg) at Week 0, then 1.2 mg/kg (max 80 mg) at Week 2. Maintenance dose 0.6 mg/kg (max 40 mg) every other week starting Week 4. For patients with inadequate response, dose may be increased to 0.6 mg/kg (max 40 mg) every week.
Adolescent:
For Ulcerative Colitis (4 years and older): Initial dose 2.4 mg/kg (max 160 mg) at Week 0, then 1.2 mg/kg (max 80 mg) at Week 2. Maintenance dose 0.6 mg/kg (max 40 mg) every other week starting Week 4. For patients with inadequate response, dose may be increased to 0.6 mg/kg (max 40 mg) every week.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not removed by dialysis; no adjustment needed
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 and blocks its interaction with the p55 and p75 cell surface TNF receptors. It 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 intestinal mucosa of patients with Crohn's disease and ulcerative colitis. Adalimumab neutralizes the biological function of TNF by blocking its interaction with TNF receptors, thereby reducing inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
5-10 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
4.7-6.0 L
ProteinBinding:
Not applicable (as it is a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 days (mean 14 days)
Clearance:
11-15 mL/hr
ExcretionRoute:
Not specifically characterized; catabolized and eliminated as amino acids
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Weeks to months (clinical response)
PeakEffect:
Weeks to months (clinical response)
DurationOfAction:
Variable, maintained with continued dosing (half-life supports every other week or weekly dosing)
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients should be tested for latent TB infection before HUMIRA use and during therapy. Treatment for latent infection should be initiated prior to HUMIRA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients developing systemic fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with HUMIRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and fatal form of lymphoma, have been reported in adolescent and young adult patients treated with TNF blockers, including HUMIRA, for Crohn's disease or ulcerative colitis. Almost all of these patients had received concomitant treatment with azathioprine or 6-mercaptopurine. See full prescribing information for additional information.
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of lupus, including:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen gland
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following rare but serious side effects, contact your doctor immediately:
Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, including:
+ Shortness of breath
+ Sudden weight gain
+ Irregular heartbeat
+ New or worsening swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet levels
+ Low white blood cell count
+ Feeling extremely tired or weak
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple "splotches" 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, contact your doctor if they bother you or do not go away:
Headache
Signs of a common cold
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of lupus, including:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen gland
Night sweats
Shortness of breath
Unintentional weight loss
If you experience any of the following rare but serious side effects, contact your doctor immediately:
Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in vision
+ Dizziness
+ Seizures
+ Weakness in the arms or legs
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, including:
+ Shortness of breath
+ Sudden weight gain
+ Irregular heartbeat
+ New or worsening swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet levels
+ Low white blood cell count
+ Feeling extremely tired or weak
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple "splotches" 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, contact your doctor if they bother you or do not go away:
Headache
Signs of a common cold
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: persistent fever, chills, cough, shortness of breath, unusual tiredness, skin sores, burning urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Signs of malignancy: unexplained weight loss, persistent fever, night sweats, swollen glands.
- Signs of nerve problems: numbness, tingling, weakness in arms/legs, vision changes.
- Signs of heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
- Signs of blood problems: easy bruising or bleeding, persistent fever, pale skin.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Remember, before starting, stopping, or modifying the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Remember, before starting, stopping, or modifying the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a live, attenuated vaccine like BCG 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, undergo the necessary hepatitis B testing and discuss any concerns with your healthcare provider.
Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, prior to receiving any vaccines during treatment, consult your doctor. The use of certain vaccines in conjunction with this drug may increase the risk of infection or reduce the vaccine's effectiveness.
Do not receive a live, attenuated vaccine like BCG 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more prone to side effects.
Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
Overdose Information
Overdose Symptoms:
- Limited clinical experience with overdose. No dose-limiting toxicity observed in clinical trials.
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. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG) during adalimumab treatment and for at least 3 months after the last dose.
- Concurrent use with other TNF blockers (e.g., infliximab, etanercept) due to increased risk of serious infection and no added benefit.
Major Interactions
- Anakinra (Kineret): Increased risk of serious infection and neutropenia; concomitant use not recommended.
- Abatacept (Orencia): Increased risk of serious infection; concomitant use not recommended.
- Rituximab (Rituxan): Potential for increased immunosuppression and infection risk.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate): Increased risk of serious infection and lymphoproliferative disorders, especially in pediatric patients with Crohn's disease or ulcerative colitis.
Moderate Interactions
- Vaccines (non-live): May result in a diminished immune response to vaccination.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection, as TNF blockers can reactivate TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or latent HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline cytopenias (e.g., leukopenia, thrombocytopenia, pancytopenia).
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess for baseline hepatic impairment.
Timing: Prior to initiation of therapy
Baseline skin examination
Rationale: To screen for skin cancer, especially non-melanoma skin cancer.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: At each visit and instruct patient to report immediately
Target: Absence of fever, cough, malaise, localized pain/redness
Action Threshold: Any new or worsening signs/symptoms of infection warrant immediate evaluation and potential treatment interruption.
CBC with differential
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant cytopenias (e.g., persistent neutropenia, thrombocytopenia) may require dose interruption or discontinuation.
LFTs (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits
Action Threshold: Persistent elevations >3x ULN may require dose interruption or discontinuation.
Skin examination
Frequency: Annually or as clinically indicated
Target: Absence of suspicious lesions
Action Threshold: Any new or changing skin lesions should be evaluated for malignancy.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, diarrhea, dysuria)
- Symptoms of malignancy (e.g., unexplained weight loss, persistent fever, night sweats, swollen lymph nodes)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of new or worsening heart failure (e.g., shortness of breath, swelling of ankles/feet)
- Symptoms of demyelinating disease (e.g., numbness, tingling, weakness, vision changes)
- Symptoms of lupus-like syndrome (e.g., rash, joint pain, fever)
- Symptoms of pancytopenia (e.g., persistent fever, bruising, bleeding, pallor)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, particularly 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 (or longer if maternal adalimumab levels are detectable).
Trimester-Specific Risks:
First Trimester:
Limited data, no clear increased risk of major birth defects.
Second Trimester:
Limited data, no clear increased risk of major birth defects.
Third Trimester:
Significant placental transfer occurs, potentially leading to detectable levels in the infant at birth. Increased risk of infection in the infant is theoretical but not definitively proven in studies. Avoid live vaccines in exposed infants.
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 adalimumab and any potential adverse effects on the breastfed infant from adalimumab or from the underlying maternal condition. Live vaccines should be avoided in breastfed infants if there is concern about significant systemic absorption.
Infant Risk:
Low risk (L3)
Pediatric Use
Adalimumab is approved for pediatric ulcerative colitis in patients 4 years of age and older. Pediatric patients treated with TNF blockers, including adalimumab, are at an increased risk for serious infections and malignancies, including hepatosplenic T-cell lymphoma (HSTCL), especially when used in combination with azathioprine or 6-mercaptopurine. Close monitoring for signs of infection and malignancy is crucial.
Geriatric Use
The incidence of serious infections and malignancies was higher in adalimumab-treated patients aged 65 years and older compared to younger patients. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic agent requiring careful patient selection and monitoring due to risks of serious infections and malignancies.
- Patients should be thoroughly screened for latent TB and HBV before initiation and monitored during therapy.
- Live vaccines are contraindicated during treatment and for a period after discontinuation.
- The 'Pediatric Uc Pen Kit' specifically refers to the formulation and delivery device for pediatric use in ulcerative colitis, emphasizing the importance of correct weight-based dosing.
- Biosimilars of adalimumab are available, offering alternative treatment options and potentially lower costs.
- Patients should be educated on proper injection technique and storage of the pens/syringes.
Alternative Therapies
- Other TNF blockers (e.g., infliximab, golimumab)
- Integrin receptor antagonists (e.g., vedolizumab)
- Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)
- Interleukin-12/23 inhibitors (e.g., ustekinumab)
- Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
- Corticosteroids (e.g., prednisone, budesonide)
- Aminosalicylates (e.g., mesalamine)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per month (e.g., 2 pens/syringes)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.