Source: European Medicines Agency (EU) Revision Year: 2009 Publisher: Serono Europe Ltd., 56 Marsh Wall, London E14 9TP, United Kingdom
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 – Clinical Efficacy).
Treatment with Raptiva should be initiated by a physician specialised in dermatology.
An initial single dose of 0.7 mg/kg body weight is given followed by weekly injections of 1.0 mg/kg body weight (maximum single dose should not exceed a total of 200 mg). The volume to be injected should be calculated as follows:
| Dose | Volume to be injected per 10 kg body weight |
|---|---|
| Single initial dose: 0.7 mg/kg | 0.07 ml |
| Subsequent doses: 1 mg/kg | 0.1 ml |
The duration of therapy is 12 weeks. Therapy may be continued only in patients who responded to treatment (PGA good or better). For discontinuation guidance see section 4.4.
Raptiva is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
The dosage and administration schedule in the elderly should be the same as for adults (see also section 4.4).
No studies have been conducted in patients with renal or hepatic impairment. Raptiva should be used with caution in this patient population.
Raptiva is for subcutaneous injection. Injection sites should be rotated. For instructions for use see section 6.6.
After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate.
In clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/kg intravenous), one subject receiving 3 mg/kg intravenous dose experienced hypertension, chills, and fever on the day of study drug dosing, which required hospitalization. Another subject who received 10 mg/kg intravenous dose experienced severe vomiting following administration of efalizumab, which also required hospitalization. Both occurrences fully resolved without any sequelae. Doses up to 4 mg/kg/week subcutaneously for 10 weeks have been administered without any toxic effect.
There is no known antidote to Raptiva or any specific treatment for Raptiva overdose other than withholding treatment and patient observation. In case of overdose, it is recommended that the patient be monitored under close medical care and appropriate symptomatic treatment instituted immediately.
Shelf life: 4 years.
After reconstitution, an immediate use is recommended (see also section 6.4).
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
From a microbiological point of view, the product should be used immediately after first opening and reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Physico-chemical stability of the reconstituted product has been shown for 24 hours at 2°C to 8°C.
Powder: Colourless type I glass vial with a butyl rubber stopper, and aluminium seal fitted with a flip-off plastic cap.
Solvent: Type I glass pre-filled syringe.
Raptiva is available in:
Packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution and 1 needle for injection.
Packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution and 4 needles for injection.
Packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution and 12 needles for injection.
Not all pack sizes may be marketed.
Raptiva is for single use only.
One vial of Raptiva should be reconstituted with the solvent before use. Reconstitution of the singleuse vial with 1.3 ml of the supplied water for injections yields approximately 1.5 ml of solution to deliver 100 mg per 1 ml of Raptiva. The maximum retrievable dose is 125 mg per 1.25 ml of Raptiva.
The solution should reconstitute in not more than 5 minutes. The reconstituted solution is a clear to slightly opalescent, colourless to pale yellow solution, and should not be administered if it contains particles or is not clear.
Detailed instructions for use are provided in the package leaflet.
Any unused product or waste material should be disposed of in accordance with local requirements.
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