Advixa 0.8ml Pre-Filled Syringe

✔️ Advixa, a tumor necrosis factor (TNF) inhibitor, is used for treating a range of autoimmune and inflammatory conditions:

• Rheumatoid Arthritis (RA): In adult patients with moderate to severe active RA, it alleviates symptoms, helps achieve significant clinical response, slows joint damage progression, and improves functional ability.
• Juvenile Idiopathic Arthritis (JIA): Reduces symptoms of moderate to severe polyarticular JIA in children aged 2 years and older.
• Psoriatic Arthritis (PsA): Used in adults to ease symptoms, halt joint damage, and enhance physical function.
• Ankylosing Spondylitis (AS): Targets symptom relief in adult patients with active AS.
• Adult Crohn’s Disease (CD): Induces and maintains clinical remission and reduces signs in moderate to severe CD in adults unresponsive to standard treatments, or intolerant/lost response to infliximab.
• Pediatric Crohn’s Disease: Effective for children (6 years and older) with moderate to severe CD, especially in those unresponsive to corticosteroids or immunosuppressants like azathioprine, 6-mercaptopurine, or methotrexate.
• Ulcerative Colitis (UC): Used in moderate to severe UC in adults not responding adequately to corticosteroids, azathioprine, or 6-MP. Continuation beyond 8 weeks is advised only if clinical remission is observed.
• Plaque Psoriasis (Ps): Treats moderate to severe chronic plaque psoriasis in adults who are suitable for systemic or phototherapy and not responsive to other systemic therapies.
• Hidradenitis Suppurativa (HS): Manages moderate to severe cases in adult patients.

✔️ Adverse Effects

Common side effects:

Injection site reactions (redness, pain, swelling, itching)

Frequent causes of discontinuation in RA patients:

Rash, pneumonia, disease flare

Other notable reactions:

Gastrointestinal: Perforations, diverticulitis, pancreatitis

Liver: Hepatitis, liver failure

Immune: Sarcoidosis, anaphylaxis

Nervous system: Demyelinating disorders like optic neuritis or Guillain-Barré syndrome

Cardiovascular: Deep vein thrombosis, systemic vasculitis

Skin: Stevens-Johnson Syndrome, worsening psoriasis, alopecia, erythema multiforme

Lung: Pulmonary fibrosis, interstitial lung disease, embolism

Neoplasms: Rare tumors like Merkel Cell Carcinoma

✔️ Dosage & Administration

Route: Subcutaneous injection

Adults

RA, PsA, AS: 40 mg every other week. If not on methotrexate, some RA patients may benefit from weekly 40 mg dosing.

Plaque Psoriasis: Start with 80 mg, followed by 40 mg every other week starting a week later.

HS:

Day 1: 160 mg (either 4 x 40 mg injections or split over two days)

Day 15: 80 mg

From Day 29: 40 mg every week

Crohn’s Disease & Ulcerative Colitis:

Day 1: 160 mg

Day 15: 80 mg

Day 29 and onwards: 40 mg every other week

For UC, continue only if remission is evident by week 8 (Day 57)

✔️ Pediatric Dosing:

Juvenile Idiopathic Arthritis (JIA):

10 to <15 kg: 10 mg every other week

15 to <30 kg: 20 mg every other week

≥30 kg: 40 mg every other week

Pediatric Crohn’s Disease:

17 to <40 kg:

Day 1: 80 mg (2 injections)

Day 15: 40 mg

Day 29 onwards: 20 mg every other week

≥40 kg:

Day 1: 160 mg (4 injections or 2 per day over 2 days)

Day 15: 80 mg (2 injections)

Day 29 onwards: 40 mg every other week

✔️ Drug Interactions

Abatacept / Anakinra: Increases the risk of severe infections—concurrent use should be avoided.

Live vaccines: Contraindicated while on Advixa due to the risk of infection.

✔️ Contraindications

Known allergy or hypersensitivity to adalimumab or its formulation components.

✔️ Pregnancy & Lactation

Pregnancy: Classified as Category B. Animal studies haven’t shown harm, but there are no adequate studies in humans. As an IgG1 antibody, adalimumab crosses the placenta, especially in the third trimester.

Lactation: Small amounts may pass into breast milk, but absorption by the infant is unlikely. Use caution in nursing mothers

✔️ Precautions

• Infections: Avoid initiating therapy during active infections. Monitor closely if infection develops during treatment.
• Fungal Infections: Consider antifungal therapy if symptoms occur in patients exposed to endemic mycoses.
• Cancer: Slightly higher incidence in treated patients; monitor for signs.
• Neurological: May worsen or induce demyelinating disorders.
• Hepatitis B Reactivation: Screen before therapy; discontinue if reactivation occurs.
• Cytopenias: Monitor blood counts; discontinue if severe.
• Heart Failure: May worsen or newly develop; monitor accordingly.
• Autoimmune Events: Lupus-like syndrome can occur—discontinue if symptoms arise.

✔️ Therapeutic Class

• Disease-Modifying Antirheumatic Drugs (DMARDs)
• Immunosuppressants

✔️ Storage

• Store between 2°C and 8°C (refrigerated).
• Do not freeze.
• Keep in the original packaging to protect from light until use.
• Do not use beyond the printed expiration date.