Adalimumab Application Scope

Adalimumab is a biologic medication used to treat various autoimmune and inflammatory conditions by inhibiting tumor necrosis factor-alpha (TNF-α). It is indicated for:

Rheumatoid Arthritis (RA): Moderate to severe cases in adults.
Polyarticular Juvenile Idiopathic Arthritis (JIA): Moderate to severe cases in children aged 2 years and older.
Psoriatic Arthritis: Moderate to severe cases in adults.
Ankylosing Spondylitis: Active cases in adults.
Crohn’s Disease: Moderate to severe cases in adults and pediatric patients aged 6 years and older.
Ulcerative Colitis: Moderate to severe cases in adults and pediatric patients aged 6 years and older.
Plaque Psoriasis: Moderate to severe chronic cases in adults who are candidates for systemic therapy.
Hidradenitis Suppurativa: Moderate to severe cases in patients aged 12 years and older.
Uveitis: Non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients aged 2 years and older.
Enthesitis-Related Arthritis: Active cases in patients aged 6 years and older.
Axial Spondyloarthritis: Active cases in adults.

Adalimumab Characteristics

Ingredients
- Active Ingredient: Adalimumab
- Formulation: Solution for injection
Active Ingredient: Adalimumab
Formulation: Solution for injection
Properties:
- Mechanism of Action: Monoclonal antibody that binds to TNF-α, inhibiting its interaction with cell surface TNF receptors.
- Administration Route: Subcutaneous injection

Dosage Forms:
- Prefilled syringe: 40 mg/0.4 mL, 40 mg/0.8 mL
- Pen injector: 40 mg/0.4 mL
- Vial: 40 mg/0.8 mL
Packaging Specification:
Prefilled Syringe: Single-use, 1 mL prefilled glass syringe with a fixed ½ inch needle.
Pen Injector: Single-use, prefilled pen injector.
Vial: Single-use vial for institutional use.
Storage:
Unopened: Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
After Removal from Refrigerator: May be stored at room temperature (not exceeding 25°C or 77°F) for up to 14 days. Do not return to the refrigerator once removed.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Complies with applicable pharmacopeial standards and regulatory requirements.
Approval Number: For specific approval numbers, refer to the regulatory authority’s database (e.g., FDA, EMA).
Date of Revision: Refer to the latest prescribing information for the most recent revision date.
Manufacturer: AbbVie Inc.

Guidelines for the Use of Adalimumab

Dosage and Administration:
- Rheumatoid Arthritis: 40 mg every other week.
- Polyarticular JIA: 10 mg/kg every other week.
- Psoriatic Arthritis: 40 mg every other week.
- Ankylosing Spondylitis: 40 mg every other week.
- Crohn’s Disease: Induction: 160 mg initially, 80 mg at week 2, 40 mg at week 4. Maintenance: 40 mg every other week.
- Ulcerative Colitis: Induction: 160 mg initially, 80 mg at week 2, 40 mg at week 4. Maintenance: 40 mg every other week.
- Plaque Psoriasis: Induction: 80 mg initially, 40 mg at week 1, 40 mg at week 2. Maintenance: 40 mg every other week.
- Hidradenitis Suppurativa: Induction: 160 mg initially, 80 mg at week 2, 40 mg at week 4. Maintenance: 40 mg every other week.
- Uveitis: Induction: 80 mg initially, 40 mg at week 1, 40 mg at week 2. Maintenance: 40 mg every other week.
- Enthesitis-Related Arthritis: 10 mg/kg every other week.
- Axial Spondyloarthritis: 40 mg every other week.
- Recommended Dose: As per the indications listed above.
- Administration:
  - Administered via subcutaneous injection.
  - Rotate injection sites to minimize tissue irritation.
  - Do not inject into areas where the skin is tender, bruised, red, or hard.
- Missed Dose:
  - If a dose is missed, administer as soon as possible.
  - Resume the regular dosing schedule thereafter.
  - If the next dose is near, skip the missed dose.
  - Do not administer two doses at the same time
Adverse Reactions:
- Common Adverse Reactions:
  - Injection site reactions (pain, redness, swelling).
  - Upper respiratory infections.
  - Headache.
  - Rash.
- Serious Adverse Reactions:
  - Serious infections (e.g., tuberculosis, bacterial, fungal, or viral infections).
  - Malignancies, including lymphoma.
  - Hepatitis B reactivation.
  - Neurological events (e.g., multiple sclerosis).
  - Hematologic reactions (e.g., pancytopenia).
Contraindications:
- Active infections.
- Known hypersensitivity to adalimumab or any of its components.
- Severe heart failure.
Precautions:
- Screen for tuberculosis prior to initiation.
- Monitor for signs of infection during treatment.
- Use caution in patients with a history of demyelinating disease.
- Vaccinations: Ensure up-to-date immunizations before starting therapy.

Adalimumab Interactions

Immunosuppressive Agents: Concurrent use may increase the risk of infections.
Live Vaccines: Avoid concurrent use due to potential for reduced efficacy and increased risk of infection.
Other TNF Inhibitors: Concurrent use not recommended due to increased risk of serious infections and malignancies.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.