Humira Pen-Ps/uv Starter 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) alpha inhibitor; Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adalimumab 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 arthritis, psoriasis, and inflammatory bowel disease. It's given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles before use. Only use the medication if the solution is clear and colorless. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize the risk of skin irritation.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication, as this may compromise its effectiveness. 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 ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for cloudiness, leakage, or particles before use. Only use the medication if the solution is clear and colorless. Avoid injecting into skin within 2 inches (5 cm) of the belly button or into areas that are irritated, tender, bruised, red, scaly, hard, scarred, or have stretch marks. Rotate the injection site with each use to minimize the risk of skin irritation.
To reduce discomfort during injection, remove the medication from the refrigerator and let it sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. After use, discard the device and do not reuse it. Dispose of needles and other sharp objects in a designated disposal box, following local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication, as this may compromise its effectiveness. 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 (e.g., MMR, varicella, rotavirus, yellow fever) while on adalimumab and for a period after stopping. Discuss all vaccinations with your doctor.
- Report any signs of infection (fever, chills, cough, sore throat, fatigue, skin sores) to your doctor immediately.
- Inform all healthcare providers (including dentists) that you are taking adalimumab.
- Maintain good hygiene to reduce infection risk.
- Store adalimumab in the refrigerator (do not freeze) and protect from light. Allow to reach room temperature for 15-30 minutes before injecting.
- Rotate injection sites to prevent skin reactions.
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 significantly by indication. For Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS): 40 mg every other week. For Crohn's Disease (CD) and Ulcerative Colitis (UC): Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. For Plaque Psoriasis (PsO) and Hidradenitis Suppurativa (HS): Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis (RA):
40 mg every other week. Some patients with RA not receiving concomitant methotrexate may benefit from 40 mg every week or 80 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 dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. Some patients with CD may benefit from 40 mg every week or 80 mg every other week.
Ulcerative Colitis (UC):
Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every other week. Some patients with UC may benefit from 40 mg every week or 80 mg every other week.
Plaque Psoriasis (PsO):
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Hidradenitis Suppurativa (HS):
Initial dose 160 mg (Day 1) followed by 80 mg (Day 15), then 40 mg every week.
Uveitis:
Initial dose 80 mg, then 40 mg every other week starting one week after the initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for Juvenile Idiopathic Arthritis (JIA) (2 years and older), Crohn's Disease (6 years and older), Ulcerative Colitis (5 years and older), Plaque Psoriasis (4 years and older), Hidradenitis Suppurativa (12 years and older), Uveitis (2 years and older). Dosing is weight-based for most indications (e.g., JIA: 10 mg or 20 mg every other week based on weight; CD/UC: weight-based induction and maintenance).
Adolescent:
Approved for JIA, CD, UC, PsO, HS, Uveitis. Dosing is weight-based or adult dosing depending on weight and indication.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Adalimumab is a large protein and not significantly cleared 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 tumor necrosis factor (TNF)-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. In autoimmune diseases, elevated levels of TNF-alpha are found in the synovial fluid of patients with RA, PsA, and AS, and in the affected tissues of patients with CD, UC, PsO, HS, and Uveitis. Adalimumab neutralizes the biological function of TNF-alpha by blocking its interaction with cell surface receptors, thereby modulating the biological responses that are induced or regulated by TNF-alpha, including the expression of adhesion molecules responsible for leukocyte migration.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
Approximately 5 days (range 2-8 days)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 4.7 to 6.0 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10 to 20 days (mean 14 days)
Clearance:
Approximately 12 mL/hr to 15 mL/hr
ExcretionRoute:
Primarily via catabolism; not renally excreted
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for some indications (e.g., RA), but full therapeutic effect may take longer (e.g., 12-16 weeks for CD/UC).
PeakEffect:
Varies by indication and patient response.
DurationOfAction:
Maintained with every other week dosing due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis), and other opportunistic infections. Patients should be tested for latent TB before and during therapy. 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 form of lymphoma, have been reported primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis treated with TNF blockers, including adalimumab, in combination with azathioprine or 6-mercaptopurine.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Contact your doctor right away if you experience:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Contact your doctor immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
Swelling in the arms or legs that is new or worsening
Blood Cell Problems: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
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:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Lupus: Rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Skin Problems: Skin lumps or growths, pale skin, or red, scaly patches or bumps filled with pus.
Other Symptoms: Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
If you experience any of the following nervous system problems, contact your doctor immediately:
Burning, numbness, or tingling sensations that are not normal
Changes in vision
Dizziness
Seizures
Weakness in the arms or legs
Liver Problems: This medication can cause liver problems, which can be life-threatening. Contact your doctor right away if you experience:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Heart Failure: This medication can cause heart failure or worsen existing heart failure. If you have heart disease, inform your doctor. Contact your doctor immediately if you experience:
Shortness of breath
Sudden weight gain
Abnormal heartbeat
Swelling in the arms or legs that is new or worsening
Blood Cell Problems: This medication can cause blood cell problems, such as aplastic anemia, low platelet levels, and low white blood cell count. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fever
Chills
Shortness of breath
Unexplained bruising or bleeding
Purple "splotches" on the skin
Other Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site
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, extreme fatigue, skin lesions, painful urination.
- Allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing, dizziness.
- New or worsening heart failure: sudden weight gain, swelling in ankles/feet, shortness of breath, especially when lying down.
- Neurological problems: numbness, tingling, weakness in arms/legs, vision changes, dizziness.
- Blood problems: persistent fever, easy bruising or bleeding, pale skin.
- Liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Lupus-like syndrome: joint pain, rash on cheeks or arms that worsens in sun, fever, chest pain.
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 that occurred.
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 safety of concurrent use.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that all your medications and health conditions are compatible with this drug to minimize potential interactions and adverse effects.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 safety of concurrent use.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that all your medications and health conditions are compatible with this drug to minimize potential interactions and adverse effects.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, you will need to undergo hepatitis B testing and discuss the results with your doctor.
Before starting treatment with this medication, ensure you are up to date on 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 taking 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 high cholesterol has been associated with this medication. If you have concerns, 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 issues, consult your doctor. Regular skin examinations are recommended. Notify your doctor immediately if you notice any skin 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.
If you are 65 years or older, exercise caution when using this medication, 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. Additionally, if you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccinations.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, consult your doctor. Medications like this one can cause the hepatitis B virus to reactivate, potentially leading to severe and life-threatening liver problems. As directed by your doctor, you will need to undergo hepatitis B testing and discuss the results with your doctor.
Before starting treatment with this medication, ensure you are up to date on 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 taking 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 high cholesterol has been associated with this medication. If you have concerns, 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 issues, consult your doctor. Regular skin examinations are recommended. Notify your doctor immediately if you notice any skin 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.
If you are 65 years or older, exercise caution when using this medication, 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. Additionally, if you used this medication during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccinations.
Overdose Information
Overdose Symptoms:
- Limited clinical experience with overdose. Doses up to 10 mg/kg have been administered intravenously 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (during and for a period after treatment)
- Anakinra (Kineret)
- Abatacept (Orencia)
Major Interactions
- Other TNF-alpha inhibitors (e.g., etanercept, infliximab, golimumab, certolizumab pegol) - increased risk of serious infection and neutropenia.
- Rituximab (Rituxan) - increased risk of serious infection.
- Tocilizumab (Actemra) - increased risk of serious infection.
- Natalizumab (Tysabri) - increased risk of serious infection.
- Vedolizumab (Entyvio) - increased risk of serious infection.
- Ustekinumab (Stelara) - increased risk of serious infection.
Moderate Interactions
- Immunosuppressants (e.g., methotrexate, azathioprine, 6-mercaptopurine, corticosteroids) - increased risk of infection, but often used concomitantly for synergistic effect in some conditions.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Increased risk of reactivation of latent TB or new TB infection. Must rule out active TB before starting and treat latent TB.
Timing: Before initiating therapy
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: Increased risk of HBV reactivation in chronic carriers.
Timing: Before initiating therapy
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for cytopenias (e.g., neutropenia, thrombocytopenia, pancytopenia).
Timing: Before initiating therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To establish baseline and monitor for liver injury.
Timing: Before initiating therapy
Baseline clinical assessment for signs/symptoms of infection, heart failure, demyelinating disease, malignancy.
Rationale: To identify pre-existing conditions that may be exacerbated or contraindicate therapy.
Timing: Before initiating therapy
Routine Monitoring
Clinical assessment for signs/symptoms of infection (e.g., fever, cough, fatigue, skin lesions)
Frequency: At each clinical visit (e.g., every 3-6 months or as clinically indicated)
Target: Absence of new or worsening infection
Action Threshold: Prompt evaluation and potential discontinuation if serious infection suspected.
Complete Blood Count (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 <1000/mm3, thrombocytopenia <50,000/mm3) may require dose interruption or discontinuation.
Liver Function Tests (LFTs) - ALT, AST
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Persistent elevations >3-5x ULN may require dose interruption or discontinuation.
Clinical assessment for new or worsening heart failure symptoms
Frequency: At each clinical visit
Target: Stable cardiac status
Action Threshold: New onset or worsening heart failure requires discontinuation.
Clinical assessment for new neurological symptoms (e.g., numbness, tingling, vision changes, weakness)
Frequency: At each clinical visit
Target: Absence of new neurological deficits
Action Threshold: New onset of demyelinating disease symptoms requires discontinuation.
Symptom Monitoring
- Signs of serious infection (persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, painful urination)
- Allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- New or worsening heart failure (shortness of breath, swelling of ankles/feet, sudden weight gain)
- Neurological symptoms (numbness, tingling, weakness in limbs, vision changes, dizziness)
- Blood dyscrasias (persistent fever, bruising, bleeding, pallor)
- Liver problems (jaundice, dark urine, abdominal pain, fatigue)
- Lupus-like syndrome (joint pain, rash on cheeks/nose, fever, chest pain)
Special Patient Groups
Pregnancy
Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Limited data from observational studies and registries suggest no increased risk of major birth defects or miscarriage. However, live vaccines should not be administered to infants exposed to adalimumab in utero for at least 6 months after birth due to potential immunosuppression.
Trimester-Specific Risks:
First Trimester:
Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester:
Limited data, no clear evidence of increased risk.
Third Trimester:
Significant placental transfer occurs, leading to detectable levels in the infant's serum at birth. Potential for immunosuppression in the infant.
Lactation
Adalimumab is present in human milk at low levels. Systemic absorption in the infant is unlikely due to the large molecular weight and degradation in the infant's gastrointestinal tract. Generally considered compatible with breastfeeding by expert organizations.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Approved for multiple pediatric indications (JIA, CD, UC, PsO, HS, Uveitis) down to specific age cutoffs (e.g., 2 years for JIA/Uveitis, 4 years for PsO, 5 years for UC, 6 years for CD, 12 years for HS). Dosing is often weight-based. Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers, particularly in combination with other immunosuppressants.
Geriatric Use
Increased incidence of serious infections in patients 65 years of age and older treated with adalimumab. Use with caution and monitor closely for infections.
Clinical Information
Clinical Pearls
- Adalimumab is a biologic, meaning it's a protein-based medication. It must be injected and cannot be taken orally.
- Patients should be thoroughly screened for latent tuberculosis and hepatitis B before starting therapy and monitored during treatment.
- Live vaccines are contraindicated during adalimumab therapy. Inactivated vaccines may be given, but the immune response may be blunted.
- Patients should be educated on proper injection technique and rotation of injection sites.
- The 'Starter Kit' typically contains the initial higher loading doses for certain indications (e.g., Crohn's, UC, HS) or the first few maintenance doses.
- Patients should be advised to report any signs of infection, new or worsening heart failure, or neurological symptoms immediately.
- Biosimilars to Humira are available and may offer cost savings, but patients should discuss switching with their healthcare provider.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., ustekinumab, vedolizumab, natalizumab, secukinumab, ixekizumab, risankizumab, guselkumab, tofacitinib, upadacitinib, baricitinib, abatacept, rituximab, tocilizumab)
- Conventional synthetic DMARDs (csDMARDs) (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine)
Cost & Coverage
Average Cost:
$6,000 - $8,000+ per 2-pen/syringe pack (40 mg/0.8 mL)
Insurance Coverage:
Specialty Tier (requires prior authorization and often 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 and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.