3 months to expiry Ghana · FDA Ghana

ENSPRYNG 120MG/ML

SATRALIZUMAB

FDA/BL/223/05008 SATRALIZUMAB 120MG/ML INN generic

What it does

Satralizumab is a medication used to treat certain autoimmune conditions by targeting specific parts of the immune system.

Commonly used for: neuromyelitis optica spectrum disorder (NMOSD), autoimmune diseases

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/BL/223/05008
Registration date
2023-05-19
Expiry date
2026-06-01
Status
3 months to expiry
Active ingredient
SATRALIZUMAB
Dosage form
SATRALIZUMAB
Strength
120MG/ML
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Chugai Pharma
Country of origin
-
Manufacturer location
16-3 Kiyoharakōgyōdanchi, Utsunomiya, Tochigi 321-3231, Japan

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:01 · updated 2026-05-29 03:52:24

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Satralizumab is a medication used to treat certain autoimmune conditions by targeting specific parts of the immune system.

What it treats

  • neuromyelitis optica spectrum disorder (NMOSD)
  • autoimmune diseases

How it works

It works by blocking a protein that plays a key role in the immune response, helping to reduce inflammation and prevent damage to nerve cells.

Who it's for

This medication is for adults with specific autoimmune conditions, particularly NMOSD.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: satralizumab

Satralizumab is a monoclonal antibody that targets the interleukin-6 receptor (IL-6R). It is primarily used in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a condition characterized by inflammation of the optic nerves and spinal cord. By inhibiting IL-6R, satralizumab plays a crucial role in modulating immune responses associated with this autoimmune disorder.

Indications

  • Neuromyelitis optica spectrum disorder (NMOSD)
  • Recurrent neuromyelitis optica attacks

Dosage

Children: Refer to product-specific guidelines for dosing.

Adults: Refer to product-specific guidelines for dosing.

Mechanism of action

Satralizumab binds to the soluble and membrane-bound forms of the interleukin-6 receptor, preventing the binding of interleukin-6 (IL-6) to its receptor. This inhibition disrupts IL-6 mediated signaling pathways that are involved in the inflammatory process, thereby reducing inflammation and autoimmunity associated with NMOSD.

Pharmacodynamics

The pharmacodynamics of satralizumab involve the modulation of the immune system through the inhibition of IL-6 signaling. IL-6 is a pro-inflammatory cytokine that plays a significant role in the pathogenesis of various autoimmune diseases. By blocking IL-6R, satralizumab decreases the levels of inflammatory mediators and reduces the activation of immune cells, resulting in decreased disease activity and improved clinical outcomes in patients with NMOSD.

Pharmacokinetics

Satralizumab exhibits a half-life of approximately 23 days, allowing for less frequent dosing. It is administered via subcutaneous injection, with peak plasma concentrations typically reached within 3 to 7 days post-administration. The drug is predominantly eliminated via the reticuloendothelial system, with no significant renal or hepatic metabolism reported.

Contra-indications

  • Hypersensitivity to satralizumab or any of its components
  • Active infections

Adverse effects

  • Injection site reactions
  • Headache
  • Nausea
  • Fatigue
  • Increased risk of infections

Interactions

  • Immunosuppressants may increase the risk of infections
  • Live vaccines should be avoided during treatment

Precautions

  • Monitor for signs of infection during treatment
  • Use with caution in patients with a history of recurrent infections
  • Evaluate for tuberculosis prior to initiation

Pregnancy

Limited data available. Use only if clearly needed, considering potential risks and benefits.

Breast-feeding

Lactation safety not established. Caution is advised, considering potential effects on the infant.

Storage

Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.

Formulations

  • Injectable solution for subcutaneous use

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.