SOLIRIS 300mg - $1800/Vial

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Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body). ... Eculizumab injection is in a group of medications called monoclonal antibodies.

1. Name of the medicinal product

Soliris 300 mg concentrate for solution for infusion

2. Qualitative and quantitative composition

Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology.

One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).

After dilution, the final concentration of the solution to be infused is 5 mg/ml.

Excipients with known effect: Sodium (5 mmol per vial)

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Concentrate for solution for infusion.

Clear, colorless, pH 7.0 solution.

4. Clinical particulars

4.1 Therapeutic indications

Soliris is indicated in adults and children for the treatment of:

- Paroxysmal nocturnal haemoglobinuria (PNH).

Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).

- Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).

Soliris is indicated in adults for the treatment of:

- Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).

4.2 Posology and method of administration

Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal or neuromuscular disorders.

Posology

Adult Patients:

In Paroxysmal Nocturnal Haemoglobinuria (PNH):

The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase:

• Initial phase: 600 mg of Soliris administered via a 25 – 45 minute intravenous infusion every week for the first 4 weeks.

• Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 – 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).

In atypical Haemolytic Uremic Syndrome (aHUS) and refractory generalized Myasthenia Gravis (gMG):

The aHUS and refractory gMG dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:

• Initial phase: 900 mg of Soliris administered via a 25 – 45 minute intravenous infusion every week for the first 4 weeks.

• Maintenance phase: 1,200 mg of Soliris administered via a 25 – 45 minute intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25 – 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).


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