Main indications in lupus

In combination with usual treatment, in adult patients or children older than 5 years with active systemic lupus, presence of autoantibodies and high disease activity (defined for example by the presence of native anti-DNA antibodies and a low complement) despite standard treatment. It can also be used to treat adults with active lupus nephritis who are receiving standard therapy.

Not indicated in neurological lupus impairment.

Dosage

The treatment should be initiated and monitored by a physician experienced in the diagnosis and treatment of systemic lupus. Initially, belimumab infusions should be administered by a qualified healthcare professional trained in the administration of infusion therapy.

Once initial doses have been well tolerated, there will be 2 possibilities for on-going-treatment : intravenous infusion at hospital, or subcutaneous injections at home.

If the treatment is continued in the form of hospital infusions, the recommended dosage of Benlysta is 10 mg/kg on days 0, 14 and 28 of treatment and every 4 weeks thereafter.

After the initial infusions, it is possible to shift to self-subcutaneous injections at home, administered weekly. Injection pens of 200 mg should be kept in the fridge at a temperature around 4°C, and only brought to room temperature before injection.

Main side effects

- Bacterial infections, for example, bronchitis, cystitis

- Viral gastroenteritis, pharyngitis, nasopharyngitis

- Leukopenia (decrease in white blood cells)

- Hypersensitivity reactions

- Depression, insomnia

- Migraine

- Diarrhoea, nausea

- Urticaria, rash

- Pain in the extremities

- Infusion-related reactions*, fever

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Precautions for use

Benlysta has not been studied in combination with other B-cell targeting therapies or in combination with intravenous cyclophosphamide. Live vaccines should not be administered within 30 days prior to administration of Benlysta, or at the same time as Benlysta, as clinical safety has not been established.

Pregnancy

Women of childbearing age should use effective contraception during treatment with Benlysta for at least 4 months after stopping treatment.