What important information is included in the package insert for adalimumab?

Adalimumab is a fully humanized monoclonal antibody drug that belongs to the tumor necrosis factor α (TNF-α) inhibitor class and is widely used in the treatment of a variety of chronic inflammatory diseases. Its clinical application covers multiple fields of systemic diseases, such as rheumatology and immunity, digestive system, dermatology and ophthalmology.

1. Basic information about drugs

Drug name: Adalimumab (Adalimumab),

Drug category: humanized anti-TNF-α monoclonal antibody

Preparation form: subcutaneous injection, common specifications are40mg/0.8ml syringe

Mode of administration: subcutaneous injection, patients can inject themselves under the guidance of a doctor

2. Introduction to main indications (keywords cover a wide range of diseases)

Due to its good anti-inflammatory properties, adalimumab is approved for the treatment of the following diseases, covering children to adult patients:

1. Rheumatoid Arthritis (RA): Applicable to adult patients, with or without methotrexate, it can reduce symptoms, delay the progression of joint damage, and improve quality of life.

2. Juvenile idiopathic arthritis (JIA): Suitable for children over 2 years old to relieve arthritis symptoms and limited activity.

3. Psoriatic arthritis (PsA): not only controls arthritis symptoms, but also slows down the progression of joint destruction and improves functional impairment.

4. Ankylosing spondylitis (AS): Relieve spinal pain and stiffness, and reduce fluctuations in the condition.

5. Crohn's disease (CD): used for patients with moderate to severe active Crohn's disease aged 6 years and above to control intestinal inflammation.

6. Ulcerative colitis (UC): For adults and children over 5 years old with moderate to severe UC, it helps induce and maintain remission.

7. Chronic plaque psoriasis (Ps): Provide effective treatment alternatives for patients who are ineffective, contraindicated or intolerant to traditional systemic treatments or phototherapy.

8. Hidradenitis suppurativa (HS): Relieve the number of skin lesions and degree of inflammation for moderate to severe patients over 12 years old.

9. Non-infectious uveitis (UV): treatment of intermediate, posterior or panuveitis, suitable for adults and children over 2 years old.

3. Recommended usage and dosage (rich entries and diverse keywords)

The dose setting of adalimumab is formulated according to different disease types and patient weight to ensure a balance between efficacy and safety:

1. Adult patients with RA, PsA, and AS: The usual dose is 40 mg subcutaneously every 2 weeks. For those not taking methotrexate, the dose can be increased to 40 mg weekly or 80 mg every other week.

2. JIA or pediatric uveitis: Weight 10-15kg: 10mg once every 2 weeks; 15-30kg: 20mg once every 2 weeks; ≥30kg: 40mg once every 2 weeks

3. Initial treatment of Crohn’s disease (CD):

Adults:Start with 160mg (on a single day or two consecutive days), 80mg on the 15th day, and maintain 40mg every 2 weeks from the 29th day

Children (17kg-40kg): 80mg starting, 40mg on the 15th day, 20mg every 2 weeks starting on the 29th day

≥40kg: Same dosage regimen as adults

4. Ulcerative colitis (UC):

Adults: Same asCD regimen, if ineffective after 8 weeks, discontinue the drug

Children:20-40kg: 80mg initially, then 40mg × 2 times, 40mg every 2 weeks or 20mg every week

≥40kg: 160mg initially, 80mg on day 8, 80mg on day 15, maintain 80mg/2 weeks or 40mg/week

5. Plaque psoriasis and adult uveitis:

The starting dose is80mg, and the maintenance phase will enter after one week, 40mg once every 2 weeks

6. Hidradenitis suppurativa (HS):

Adults:Start at 160mg, 80mg on day 15, 80mg every 2 weeks or 40mg per week from day 29

Adolescents (over 12 years old): 30-60kg: 80mg initially, 40mg every 2 weeks from the 8th day; ≥60kg: adult standard dose

4. Usage restrictions and precautions (SEO keywords include "side effects" and "intolerance")

The effect of this product on patients who are unresponsive or intolerant to TNF inhibitors is unknown and needs to be carefully evaluated.

Potential side effects include injection site reactions, infection risks (such as tuberculosis, fungal infections, etc.), allergic reactions, and malignant tumor risks.

Tuberculosis screening and liver function assessment are required before use.

Pregnant and lactating women should consult a doctor before use and weigh the pros and cons.

Combination use with other biologics such as abatacept, etanercept, and rituximab is not recommended.

5. Summary

The instructions for adalimumab provide detailed indications and medication guidance, covering multi-system chronic inflammatory diseases. It is a highly versatile and clinically proven TNF blocker.TNF blocker. Its dosage is flexible and its treatment range is wide, providing an effective immunosuppressive solution for patients with various rheumatic diseases, gastrointestinal autoimmune diseases, skin diseases and ophthalmic immune diseases. Patients should strictly follow the instructions or medical advice during use, paying special attention to the initial dose and maintenance treatment time points to ensure the sustainability and safety of the drug.

Reference materials:https://www.drugs.com/adalimumab.html