Hadlima Pushtouch 40mg/0.8ml, 1.6ml
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
Pregnancy Category
Not available
FDA Approved
Jul 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hadlima is a medicine that helps reduce inflammation in your body. It works by blocking a natural protein called TNF-alpha, which can cause swelling and damage in conditions like rheumatoid arthritis, Crohn's disease, and psoriasis. It is given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not shake the solution, and inspect it for any signs of cloudiness, leakage, or particles. The solution should be colorless to pale brownish-yellow; do not use it if the color has changed to anything other than pale yellow or brown-yellow.
When administering the injection, avoid areas within 2 inches (5 cm) of the belly button and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, 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 do not heat the medication. After use, dispose of the device properly and do not reuse it. Throw away needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if you need to replace it.
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 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. The solution should be colorless to pale brownish-yellow; do not use it if the color has changed to anything other than pale yellow or brown-yellow.
When administering the injection, avoid areas within 2 inches (5 cm) of the belly button and skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Rotate the injection site with each use to minimize discomfort and reduce the risk of skin reactions.
To make the injection more comfortable, 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 do not heat the medication. After use, dispose of the device properly and do not reuse it. Throw away needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
If you have any questions or concerns, consult your doctor or pharmacist. If you accidentally drop the device, check the package insert to determine if it can still be used or if you need to replace it.
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 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 taking Hadlima.
- Report any signs of infection (fever, chills, cough, flu-like symptoms) to your doctor immediately.
- Report any unusual lumps, skin changes, or unexplained weight loss.
- Maintain good hygiene to reduce infection risk.
- Discuss any planned surgeries or dental procedures with your doctor.
- Inform all healthcare providers that you are taking Hadlima.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication. For Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week. For Crohn's Disease/Ulcerative Colitis: Initial 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards).
Dose Range:
40 - 160 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
40 mg SC every other week. Some patients with RA not receiving methotrexate may benefit from 40 mg SC every week or 80 mg SC every other week.
Psoriatic Arthritis:
40 mg SC every other week.
Ankylosing Spondylitis:
40 mg SC every other week.
Crohn's Disease:
Initial dose 160 mg SC (given as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg SC two weeks later (Day 15), then 40 mg SC every other week starting on Day 29. Some patients may benefit from 40 mg SC every week or 80 mg SC every other week.
Ulcerative Colitis:
Initial dose 160 mg SC (given as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg SC two weeks later (Day 15), then 40 mg SC every other week starting on Day 29. Some patients may benefit from 40 mg SC every week or 80 mg SC every other week.
Plaque Psoriasis:
Initial dose 80 mg SC, then 40 mg SC every other week starting one week after the initial dose.
Hidradenitis Suppurativa:
Initial dose 160 mg SC (given as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg SC two weeks later (Day 15), then 40 mg SC every week starting on Day 29.
Uveitis:
Initial dose 80 mg SC, then 40 mg SC every other week starting one week after the initial dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing established for Juvenile Idiopathic Arthritis (JIA), Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Uveitis, and Hidradenitis Suppurativa based on weight. For JIA (2 years and older, 10 kg to <15 kg: 10 mg every other week; 15 kg to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week).
Adolescent:
Dosing established for JIA, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Uveitis, and Hidradenitis Suppurativa based on weight (typically 40 mg every other week for those ≥30 kg).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; adalimumab is a large protein and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF-alpha). It blocks TNF-alpha's interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological function of TNF-alpha. TNF-alpha is a naturally occurring cytokine involved in systemic inflammation and is a key mediator of the pathological inflammation in autoimmune diseases.
Pharmacokinetics
Absorption:
Bioavailability:
64% (subcutaneous)
Tmax:
5-10 days
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
4.7-6.0 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 days (mean approximately 14 days)
Clearance:
11-12 mL/hr
ExcretionRoute:
Primarily via catabolism; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks for some indications (e.g., RA), but full therapeutic effect may take longer (up to 12-24 weeks).
PeakEffect:
Varies by indication and clinical endpoint.
DurationOfAction:
Corresponds to half-life, allowing for bi-weekly or weekly dosing.
Safety & Warnings
BLACK BOX WARNING
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. Patients should be tested for latent TB infection prior to initiating Hadlima and during therapy. Treatment for latent TB should be initiated prior to Hadlima. 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 notice any of the following signs or symptoms, contact your doctor immediately or seek medical attention:
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, contact your doctor right away:
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, sudden weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood Cell Problems: Extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Common Side Effects
Most people do not experience severe side effects, and many have no side effects or only mild ones. However, if you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Nausea
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 signs or symptoms, contact your doctor immediately or seek medical attention:
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, contact your doctor right away:
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, sudden weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.
Blood Cell Problems: Extreme tiredness or weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin.
Common Side Effects
Most people do not experience severe side effects, and many have no side effects or only mild ones. However, if you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Common cold symptoms
Stomach pain
Nausea
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, severe cough, shortness of breath, flu-like symptoms, warm/red/painful skin, diarrhea, painful urination.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of blood problems: persistent fever, bruising, bleeding easily, pale skin.
- 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 liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Signs of lupus-like syndrome: joint pain, rash on cheeks/arms (especially after sun exposure).
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.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe use and potential interactions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the 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.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe use and potential interactions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, it is crucial to discuss this with your doctor. Medications like this one can cause the hepatitis B virus to become active, potentially leading to severe and life-threatening liver problems. As directed by your doctor, you will need to undergo hepatitis B testing.
Before starting treatment with this drug, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this medication.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while using this drug. Consult your doctor for guidance.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Use of this medication has been associated with high cholesterol. If you have concerns, discuss them with your doctor.
If you experience sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, skin sores, 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 drug, 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. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccines.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have a history of hepatitis B or are a carrier of the virus, it is crucial to discuss this with your doctor. Medications like this one can cause the hepatitis B virus to become active, potentially leading to severe and life-threatening liver problems. As directed by your doctor, you will need to undergo hepatitis B testing.
Before starting treatment with this drug, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction with this medication.
Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while using this drug. Consult your doctor for guidance.
Regularly undergo blood tests and other laboratory evaluations as instructed by your doctor.
Use of this medication has been associated with high cholesterol. If you have concerns, discuss them with your doctor.
If you experience sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any skin changes, such as new warts, skin sores, 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 drug, 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. If you used this drug during pregnancy, inform your baby's doctor, as you will need to discuss the safety and timing of certain vaccines.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 10 mg/kg have been administered without dose-limiting toxicities.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (during treatment)
- Anakinra (Kineret)
- Abatacept (Orencia)
Major Interactions
- Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol) - increased risk of serious infections and neutropenia.
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and serious infections when used concomitantly, especially in Crohn's disease.
Moderate Interactions
- Vaccines (non-live) - may result in a diminished immune response.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Adalimumab increases the risk of reactivation of latent TB and new onset TB. Must rule out active TB before initiation and treat latent TB.
Timing: Prior to initiating therapy.
Hepatitis B Virus (HBV) screening (HBsAg and anti-HBc)
Rationale: Risk of HBV reactivation in chronic carriers.
Timing: Prior to initiating therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic parameters; TNF blockers can cause cytopenias.
Timing: Prior to initiating therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function; TNF blockers can cause liver enzyme elevations.
Timing: Prior to initiating therapy.
Baseline clinical assessment for signs/symptoms of infection or malignancy
Rationale: To establish baseline health status given increased risks with therapy.
Timing: Prior to initiating therapy.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, fatigue)
Frequency: Regularly throughout therapy and for several months after discontinuation.
Target: Absence of signs/symptoms.
Action Threshold: Prompt medical evaluation for any new or worsening signs/symptoms of infection.
Signs and symptoms of malignancy (e.g., unexplained weight loss, persistent fever, lymphadenopathy)
Frequency: Regularly throughout therapy.
Target: Absence of signs/symptoms.
Action Threshold: Prompt medical evaluation for any new or worsening signs/symptoms of malignancy.
CBC with differential
Frequency: Periodically, or if signs/symptoms of cytopenias develop.
Target: Within normal limits.
Action Threshold: Investigate persistent abnormalities; consider discontinuation if clinically significant cytopenias occur.
LFTs
Frequency: Periodically, or if signs/symptoms of liver injury develop.
Target: Within normal limits.
Action Threshold: Investigate persistent elevations; consider discontinuation if significant liver injury occurs.
Screening for demyelinating disease symptoms (e.g., numbness, tingling, vision changes)
Frequency: Regularly throughout therapy.
Target: Absence of symptoms.
Action Threshold: Discontinue adalimumab if new or worsening demyelinating disorder develops.
Signs and symptoms of heart failure (e.g., dyspnea, edema)
Frequency: Regularly throughout therapy.
Target: Absence of symptoms.
Action Threshold: Discontinue adalimumab if new or worsening heart failure develops.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Persistent cough
- Shortness of breath
- Fatigue
- Unexplained weight loss
- Skin lesions (new or changing)
- Easy bruising or bleeding
- Pale skin
- Numbness or tingling
- Vision changes
- Weakness in limbs
- Swelling in ankles/feet
- New or worsening joint pain/swelling
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 of major birth defects.
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 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 Hadlima and any potential adverse effects on the breastfed infant from Hadlima or from the underlying maternal condition. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Safety and efficacy established for specific indications and age groups (e.g., JIA in patients 2 years and older, Crohn's disease in patients 6 years and older, Ulcerative Colitis in patients 5 years and older, Plaque Psoriasis in patients 4 years and older, Uveitis in patients 2 years and older, Hidradenitis Suppurativa in adolescents 12 years and older). Increased risk of malignancy (lymphoma, HSTCL) in children and adolescents, particularly with concomitant immunosuppressants.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increased incidence of serious infections and malignancies in the elderly population in general, so caution is advised.
Clinical Information
Clinical Pearls
- Hadlima is a biosimilar to Humira, meaning it is highly similar and has no clinically meaningful differences in terms of safety, purity, and potency.
- Patients should be thoroughly screened for TB and HBV before starting therapy and monitored for signs of infection throughout treatment.
- Patients should be educated on proper injection technique and storage of the medication.
- Emphasize the importance of reporting any new or worsening symptoms, especially those related to infection or malignancy.
- Live vaccines are contraindicated during adalimumab therapy. Non-live vaccines may be less effective.
- Consider discontinuing adalimumab if a patient develops new onset or worsening heart failure, demyelinating disease, or significant cytopenias.
- The Pushtouch pen is designed for ease of use, but patients should still receive training.
Alternative Therapies
- Other TNF-alpha blockers (e.g., etanercept, infliximab, golimumab, certolizumab pegol)
- Other biologics with different mechanisms of action (e.g., abatacept, rituximab, tocilizumab, ustekinumab, secukinumab, ixekizumab, guselkumab, risankizumab, upadacitinib, tofacitinib)
- Conventional DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
- Corticosteroids
- Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, cyclosporine)
Cost & Coverage
Average Cost:
Varies widely, typically several thousand dollars per month. per 40mg/0.8ml syringe/pen
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits for most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.