ACTEMRA 162mg Injection/Solution for

What is ACTEMRA 162mg

ACTEMRA 162mg is a prescription biologic medication containing the active ingredient Tocilizumab, an interleukin-6 (IL-6) receptor antagonist. It is available in a pre-filled syringe formulation (0.9ml) designed for subcutaneous injection.

• Therapeutic class: Immunosuppressive agent / Biologic Disease-Modifying Antirheumatic Drug (bDMARD)
• Indications: Used in the management of:
  • Rheumatoid Arthritis (RA) in adults
  • Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Systemic JIA (sJIA) in pediatric patients
  • Giant Cell Arteritis (GCA)
  • Cytokine Release Syndrome (CRS) associated with CAR T-cell therapy
  • Severe COVID-19 pneumonia in specific clinical settings
• Formulation: 162mg/0.9ml pre-filled syringe for subcutaneous use, packaged in sets of four
• Mechanism: By targeting IL-6 receptors, it dampens the immune response and inflammation contributing to autoimmune disease pathology.

ACTEMRA offers an effective option for patients not responding well to traditional DMARDs or other biologic therapies. Its subcutaneous administration enables at-home treatment, improving convenience and compliance.

How to use ACTEMRA 162mg

ACTEMRA 162mg should be used exactly as prescribed by your healthcare provider. It is administered as a subcutaneous injection using the pre-filled syringe.

• Preparation:
  • Allow the pre-filled syringe to sit at room temperature for 30 minutes before injection (do not warm by any other means).
  • Inspect the solution visually for particulate matter or discoloration; it should be clear to pale yellow and free from particles.
• Injection technique:
  • Choose an injection site: typically the abdomen (except for 2 inches around the navel), upper thigh, or upper arm.
  • Rotate injection sites to avoid irritation or skin reactions.
  • Clean the site with an alcohol swab before injecting.
  • Inject the full contents of the syringe subcutaneously as instructed.
• Dosage frequency: Usually administered once weekly or every other week depending on the indication and patient’s clinical response.
• After administration:
  • Dispose of the used syringe in a puncture-resistant sharps container.
  • Monitor for immediate allergic reactions such as rash, dizziness, or difficulty breathing.

Patients should be trained in proper injection techniques or receive assistance from a caregiver or healthcare professional. Consistent use as directed is essential for maintaining disease control.

Mode of Action ACTEMRA 162mg

ACTEMRA (Tocilizumab) works by selectively inhibiting the activity of interleukin-6 (IL-6), a pro-inflammatory cytokine involved in numerous immune-mediated processes.

• Target: IL-6 receptor (both soluble and membrane-bound forms)
• Mechanism:
  • IL-6 plays a central role in inflammation and the progression of autoimmune diseases.
  • ACTEMRA binds to the IL-6 receptor, blocking IL-6 from exerting its effects on target cells.
  • This leads to reduced activation of inflammatory pathways including C-reactive protein (CRP) production, T-cell activation, and B-cell proliferation.
• Clinical benefits:
  • Reduces joint inflammation and damage in rheumatoid arthritis.
  • Improves physical function and quality of life in autoimmune disorders.
  • Controls systemic inflammation in severe cytokine storms (e.g., CRS or COVID-19).

The inhibition of IL-6 by ACTEMRA helps restore immune balance and prevent the progression of inflammatory and autoimmune diseases. However, IL-6 also has protective roles in infection defense, which is why infection risk increases with this treatment.

ACTEMRA 162mg Interactions ACTEMRA 162mg

Tocilizumab (ACTEMRA) can interact with various drugs by altering the metabolism of medications processed by the liver enzyme CYP450, particularly CYP3A4, CYP2C9, and CYP1A2.

• Immunosuppressive agents:
  • Concurrent use with other biologics or immunosuppressants (e.g., TNF inhibitors, cyclosporine) increases the risk of infections.
• CYP450 substrate drugs: ACTEMRA may increase the metabolism of these drugs, potentially lowering their effectiveness:
  • Warfarin – monitor INR levels closely.
  • Cyclosporine – monitor serum levels for reduced efficacy.
  • Oral contraceptives – efficacy may be reduced; consider alternative contraception.
  • Theophylline, Atorvastatin, Omeprazole – may require dose adjustments.
• Vaccines:
  • Avoid live vaccines during treatment (e.g., MMR, BCG, Yellow fever).
  • Inactivated vaccines may be less effective due to suppressed immune response.

Patients should inform their doctor of all medications, supplements, and herbal products they use. Close monitoring is essential when starting or stopping ACTEMRA in patients using CYP450-metabolized drugs.

Dosage of ACTEMRA 162mg

The dosage of ACTEMRA 162mg depends on the indication, body weight, and route of administration. It should be prescribed and monitored by a qualified healthcare provider.

• For Rheumatoid Arthritis (Adults):
  • 162mg subcutaneously once weekly or every other week depending on clinical response.
• Giant Cell Arteritis:
  • 162mg once weekly in combination with a tapering course of glucocorticoids.
• Systemic Juvenile Idiopathic Arthritis (sJIA):
  • Dose and frequency vary based on body weight:
    • For ≥30kg: 162mg every week
    • For <30kg: 162mg every other week
• Cytokine Release Syndrome:
  • Generally treated with intravenous ACTEMRA; subcutaneous use is not typical in this setting.

ACTEMRA dosage may be adjusted based on lab results (e.g., liver enzymes, neutrophil count, platelet count). Treatment should be paused or modified in case of elevated liver function tests or significant hematologic abnormalities.

Possible side effects of ACTEMRA 162mg

Like all biologic medications, ACTEMRA can cause side effects, some of which may be serious. Monitoring is essential during treatment.

• Common side effects:
  • Injection site reactions (redness, pain, swelling)
  • Headache, dizziness
  • Upper respiratory tract infections
  • Elevated liver enzymes (AST/ALT)
  • Increased cholesterol levels
• Serious side effects:
  • Severe infections (e.g., tuberculosis, bacterial sepsis, fungal infections)
  • Gastrointestinal perforation (especially in patients with diverticulitis)
  • Hepatotoxicity (elevated transaminases, liver injury)
  • Hypersensitivity or anaphylaxis
  • Neutropenia and thrombocytopenia

Patients should immediately report symptoms such as fever, persistent cough, abdominal pain, yellowing of the skin/eyes, or signs of allergic reactions. Regular lab monitoring helps detect adverse effects early and ensures safe use.

ACTEMRA 162mg Contraindications ACTEMRA 162mg

ACTEMRA is contraindicated in certain clinical situations where the risks outweigh potential benefits.

• Known hypersensitivity:
  • Patients with a history of hypersensitivity to Tocilizumab or any of the formulation’s excipients (e.g., polysorbate 80).
• Active severe infections:
  • Including tuberculosis, sepsis, or opportunistic infections.
• Liver impairment:
  • Do not initiate ACTEMRA in patients with elevated liver enzymes (ALT/AST >1.5x ULN).
• Hematological abnormalities:
  • ANC < 2,000/mm³
  • Platelet count < 100,000/mm³
• Pregnancy and breastfeeding:
  • Use only if clearly needed. Animal studies show risk; human data is limited.

All patients should be screened for latent tuberculosis and other infections before starting therapy. Vaccinations should be up to date, and live vaccines should be avoided during treatment.

Storage of ACTEMRA 162mg

Proper storage of ACTEMRA 162mg ensures stability, potency, and patient safety.

• Temperature:
  • Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • Do not freeze.
• Handling:
  • Protect from light—keep in original carton until time of use.
  • If needed, the syringe can be kept at room temperature (below 30°C/86°F) for up to 14 days. Do not return it to the refrigerator once it reaches room temperature.
• Do not use if:
  • The solution is cloudy, discolored, or contains particles.
  • The expiration date has passed.
• Disposal:
  • Dispose of used syringes in a designated sharps container.
  • Follow local regulations for medication and sharps disposal.

Correct storage practices are crucial for maintaining the effectiveness of ACTEMRA. Patients should receive education on handling, temperature limits, and disposal.