Hadlima 40mg/0.8ml Pf Syr, 1.6ml

Manufacturer ORGANON Active Ingredient Adalimumab (-bwwd, Hadlima)(a da LIM yoo mab) Pronunciation a da LIM yoo mab
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.
đŸˇī¸
Drug Class
Immunosuppressant
đŸ§Ŧ
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker
🤰
Pregnancy Category
Not available
✅
FDA Approved
Jul 2019
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

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 arthritis, psoriasis, and Crohn's disease. 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 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

  • Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
  • Avoid live vaccines while taking Hadlima.
  • Inform all healthcare providers that you are taking Hadlima before any medical procedures or vaccinations.
  • Keep all appointments with your doctor for monitoring and follow-up.
  • Store Hadlima in the refrigerator and protect from light.
  • Do not shake the syringe or pen.
  • Rotate injection sites to prevent skin reactions.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 40 mg subcutaneously every other week
Dose Range: 20 - 160 mg

Condition-Specific Dosing:

Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS): 40 mg subcutaneously every other week
Crohn's Disease (CD), Ulcerative Colitis (UC): Initial dose 160 mg (Day 1), then 80 mg (Day 15), then 40 mg every other week (Day 29 onwards)
Plaque Psoriasis (PsO), Hidradenitis Suppurativa (HS): Initial dose 80 mg, then 40 mg every other week starting one week after initial dose
Uveitis: Initial dose 80 mg, then 40 mg every other week starting one week after initial dose
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Weight-based and indication-specific (e.g., Crohn's Disease, Juvenile Idiopathic Arthritis, Uveitis, Plaque Psoriasis). Doses typically range from 20 mg to 40 mg every other week, or 40 mg every week for some indications/weights.
Adolescent: Weight-based and indication-specific, similar to child dosing or adult dosing for higher weights/indications.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not removed by dialysis; no specific adjustment needed

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

đŸ”Ŧ

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 the 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 inflammatory response in autoimmune diseases.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 64%
Tmax: 5 to 10 days
FoodEffect: No significant food effect

Distribution:

Vd: Approximately 4.7 to 6.0 L
ProteinBinding: Not applicable (monoclonal antibody)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 10 to 20 days (mean 14 days)
Clearance: Approximately 12 mL/hr
ExcretionRoute: Reticuloendothelial system (proteolytic degradation)
Unchanged: Not applicable
âąī¸

Pharmacodynamics

OnsetOfAction: Varies by indication; typically weeks to months (e.g., RA: 2-12 weeks, CD: 2-4 weeks for induction)
PeakEffect: Not directly quantifiable as a single peak effect for chronic disease modification; sustained effect with regular dosing
DurationOfAction: Related to half-life; effects persist for several weeks after discontinuation
Confidence: Medium

Safety & Warnings

âš ī¸

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 therapy and monitored for signs and symptoms of infection during and after treatment. Increased risk of malignancies, including lymphoma and other cancers, in children and adolescents treated with TNF blockers.
âš ī¸

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 discolored sputum
+ Painful urination
+ 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 or dizziness
+ Fainting
+ Changes in vision
A skin lump or growth
Pale skin
Red, scaly patches or bumps filled with pus
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
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
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart failure or worsening heart failure, including:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ Swelling in the arms or legs
Blood cell problems, such as:
+ Aplastic anemia
+ Low platelet levels
+ Low white blood cell count
+ Fatigue
+ Weakness
+ Fever
+ Chills
+ Shortness of breath
+ Unexplained bruising or bleeding
+ Purple spots on the skin

Other Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
* Pain, redness, swelling, or reaction at the injection site

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of serious infection: persistent fever, chills, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores.
  • Allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
  • Nervous system problems: numbness, tingling, weakness in arms/legs, vision changes.
  • Heart failure: new or worsening shortness of breath, sudden weight gain, swelling in ankles/feet.
  • Lupus-like syndrome: joint pain, rash on cheeks/arms (worsened by sun), fever.
  • Blood problems: persistent fever, bruising, bleeding, paleness.
  • New or worsening lumps or growths on the 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 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 for guidance.

Please note that this is not an exhaustive list of all potential drug interactions or health concerns that may affect your use of this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking, including natural products and vitamins.
* Any health problems you have, as they may impact the safety of taking this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

As this drug may increase your risk of developing an infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.

If you have a history of hepatitis B or are a carrier of the virus, consult your doctor, as medications like this one can cause the virus to reactivate, potentially leading to severe and life-threatening liver problems. Your doctor will instruct you on the necessary hepatitis B testing to monitor your condition.

Before starting treatment with this medication, ensure you are up to date with all recommended vaccinations. However, it is vital to discuss your vaccination schedule with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this drug.

Avoid receiving live vaccines, such as the BCG vaccine for bladder cancer, while using this medication, and consult your doctor for guidance.

Regularly undergo blood tests and other laboratory examinations as directed by your doctor to monitor your condition.

Be aware that this medication may cause high cholesterol levels. If you have concerns, consult your doctor for advice.

If you experience sunburn or other skin problems, inform your doctor, and schedule regular skin checks. Report any new or changing skin lesions, such as warts, sores, or moles, to your doctor, as these may require further evaluation.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor. Additionally, if you used this medication during pregnancy, inform your baby's doctor to discuss the necessary precautions and vaccination schedule for your child.
🆘

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 toxicity.

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 be instituted. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Live vaccines (during treatment)
  • Anakinra (increased risk of serious infection and neutropenia)
  • Abatacept (increased risk of serious infection)
🔴

Major Interactions

  • Other TNF blockers (e.g., etanercept, infliximab, golimumab, certolizumab) - increased risk of serious infection
  • Other potent immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of serious infection (use with caution and monitor closely)
🟡

Moderate Interactions

  • Not well-defined for specific moderate interactions beyond additive immunosuppression.
đŸŸĸ

Minor Interactions

  • Not well-defined for specific minor interactions.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Tuberculosis (TB) screening (PPD or IGRA)

Rationale: To rule out latent or active TB infection before initiating therapy, 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 chronic HBV infection, as TNF blockers can reactivate HBV.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status and identify pre-existing cytopenias.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function.

Timing: Prior to initiation of therapy

Assessment for signs/symptoms of infection

Rationale: To ensure patient is free of active infection before starting immunosuppressive therapy.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Signs and symptoms of infection (e.g., fever, cough, fatigue, skin lesions)

Frequency: At each clinical visit and patient self-monitoring

Target: Absence of new or worsening infection

Action Threshold: Prompt evaluation and potential interruption of therapy if serious infection develops

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, thrombocytopenia) may require dose reduction or discontinuation

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits or stable

Action Threshold: Significant elevations (e.g., >3x ULN) may require further investigation and potential interruption of therapy

Signs and symptoms of new or worsening heart failure

Frequency: At each clinical visit

Target: Stable cardiac status

Action Threshold: Worsening heart failure symptoms may require discontinuation

Signs and symptoms of demyelinating disease

Frequency: At each clinical visit

Target: Absence of new neurological symptoms

Action Threshold: New onset or worsening demyelinating symptoms may require discontinuation

Skin examination for malignancy (especially non-melanoma skin cancer)

Frequency: Annually or as clinically indicated

Target: Absence of suspicious lesions

Action Threshold: Suspicious lesions require biopsy and appropriate management

đŸ‘ī¸

Symptom Monitoring

  • Fever
  • Chills
  • Sore throat
  • Persistent cough
  • Shortness of breath
  • Unusual fatigue
  • Skin rash or lesions
  • Joint pain or swelling
  • Numbness or tingling
  • Weakness in limbs
  • Vision changes
  • Swelling of ankles/feet
  • Weight loss
  • Easy bruising or bleeding
  • Persistent abdominal pain

Special Patient Groups

🤰

Pregnancy

Adalimumab is an IgG1 antibody and is known to cross the placenta, particularly during the second and third trimesters. While available data from registries and post-marketing reports have not established a clear association with major birth defects or miscarriage, potential risks to the fetus (e.g., immunosuppression) cannot be entirely excluded. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Live vaccines should not be administered to infants exposed to adalimumab in utero for at least 6 months after the mother's last dose.

Trimester-Specific Risks:

First Trimester: Limited placental transfer; theoretical risk of early pregnancy loss or major birth defects not clearly established.
Second Trimester: Increased placental transfer; potential for fetal exposure and theoretical risk of immunosuppression.
Third Trimester: Highest placental transfer; increased risk of fetal exposure and potential for neonatal immunosuppression.
🤱

Lactation

Adalimumab is present in human milk at low concentrations. Systemic exposure in a breastfed infant is expected to be low due to the large molecular weight of adalimumab, which limits transfer into milk, and its degradation 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.

Infant Risk: Low risk of systemic effects in the breastfed infant.
đŸ‘ļ

Pediatric Use

Approved for various pediatric indications including Juvenile Idiopathic Arthritis (JIA), Crohn's Disease (CD), Ulcerative Colitis (UC), Plaque Psoriasis (PsO), and Uveitis. Dosing is weight-based and indication-specific. Children are at increased risk of serious infections and malignancies (lymphoma) compared to adults.

👴

Geriatric Use

No overall differences in effectiveness or safety were observed between elderly and younger patients, but the greater sensitivity of some older individuals cannot be ruled out. Elderly patients have a higher incidence of infections in general, and caution should be exercised when treating the elderly.

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 educated on proper subcutaneous injection technique and rotation of injection sites to minimize local reactions.
  • Adalimumab can cause injection site reactions (pain, redness, swelling, itching), which are usually mild and transient.
  • Patients should be advised to report any new or worsening symptoms, especially those related to infection, malignancy, or neurological changes.
  • Regular monitoring for tuberculosis, hepatitis B, and signs of infection is crucial due to the immunosuppressive nature of the drug.
  • The onset of action can be slow, and patients should be counseled on the importance of adherence to the prescribed dosing regimen even if immediate improvement is not seen.
🔄

Alternative Therapies

  • Other TNF blockers (e.g., infliximab, etanercept, golimumab, certolizumab pegol)
  • Other biologics with different mechanisms of action (e.g., ustekinumab, secukinumab, ixekizumab, risankizumab, guselkumab, tofacitinib, upadacitinib, baricitinib, vedolizumab, natalizumab, rituximab, abatacept, anakinra)
  • Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide)
  • Corticosteroids
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
💰

Cost & Coverage

Average Cost: Expensive per syringe
Generic Available: Yes
Insurance Coverage: Specialty Tier (requires prior authorization)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.