Hadlima 40mg/0.8ml Pf Syr, 1.6ml
Overview
What is this medicine?
How to Use This Medicine
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
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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
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.
Precautions & Cautions
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
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.
Minor Interactions
- Not well-defined for specific minor interactions.
Monitoring
Baseline Monitoring
Rationale: To rule out latent or active TB infection before initiating therapy, as TNF blockers can reactivate TB.
Timing: Prior to initiation of therapy
Rationale: To rule out active or chronic HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Rationale: To assess baseline hematologic status and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Rationale: To ensure patient is free of active infection before starting immunosuppressive therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
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
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
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
Frequency: At each clinical visit
Target: Stable cardiac status
Action Threshold: Worsening heart failure symptoms may require discontinuation
Frequency: At each clinical visit
Target: Absence of new neurological symptoms
Action Threshold: New onset or worsening demyelinating symptoms may require discontinuation
Frequency: Annually or as clinically indicated
Target: Absence of suspicious lesions
Action Threshold: Suspicious lesions require biopsy and appropriate management
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:
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.
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)