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Raptiva is a brand name for Efalizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Raptiva should be initiated by a physician specialised in dermatology. 0 mg/kg body weight (maximum single dose should not exceed a total of 200 mg). 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
The most frequent symptomatic adverse drug reactions (ADRs) observed during Raptiva therapy were mild to moderate dose-related acute flu-like symptoms including headache, fever, chills, nausea and Medicinal product no longer authorised6 myalgia.
In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva-treated patients and 24% in placebo-treated patients over 12 weeks of treatment. After initiation of therapy, these reactions were generally less frequent and occurred at similar rates to that seen in the placebo group from the third and subsequent weekly injections.
Antibodies to efalizumab were detected in only 6% of patients. In this small number of patients no differences were observed in pharmacokinetics, pharmacodynamics, clinically noteworthy adverse events or clinical efficacy. Adverse events (Preferred Terms) in the overall population studied clinically with Raptiva are listed below by frequency of occurrence and by MedDRA System Organ Class.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 1 is similar to the safety profile in the overall population treated during clinical development of Raptiva as presented above.
Additional Information Long-term exposure:
Analysis following long-term use in a cohort of 339 patients with moderate to severe psoriasis receiving Raptiva 1 mg/kg/week, of which 166 patients have been treated for more than 2 years and up to 3 years, did not show any noteworthy differences in frequency of adverse events as compared to 12 weeks of exposure to Raptiva.
Leucocytosis and lymphocytosis: in large placebo-controlled and in long-term clinical studies, between 40 and 50% of patients developed sustained asymptomatic lymphocytosis during Raptiva therapy. 5 fold the ULN (Upper Limit of Normal).
4. Medicinal product no longer authorised3 Children and adolescents (< 18 years) Raptiva is not recommended for use in children below age 18 due to a lack of data on safety and efficacy. 4). Patients with renal or hepatic impairment No studies have been conducted in patients with renal or hepatic impairment.
Raptiva should be used with caution in this patient population. Method of administration Raptiva is for subcutaneous injection. Injection sites should be rotated. 6. After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate.
3 Contraindications Hypersensitivity to efalizumab or to any of the excipients. Patients with history of malignancies. Patients with active tuberculosis and other severe infections. Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
Patients with immunodeficiencies. 4 Special warnings and precautions for use Effects on the immune system a) Infections Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
g. g. JC virus infection. Patients developing an infection during treatment with Raptiva should be monitored and according to severity Raptiva should be discontinued. In a patient with history of clinically significant recurring infections, Raptiva should be used with caution.
The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML). 8). Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML (such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes).
If PML is suspected, further dosing must be suspended until PML has been excluded. The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Hypersensitivity to efalizumab or to any of the excipients. Patients with history of malignancies. Patients with active tuberculosis and other severe infections. Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
Patients with immunodeficiencies.
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Lymphocyte count returned to baseline after therapy discontinuation. Slight elevation in absolute neutrophil count and eosinophil count were observed but in a smaller proportion of patients. 3%) of thrombocytopenia with less than 52,000 cells per μl reported.
Four of these patients had clinical signs of thrombocytopenia. Based on available platelet count measurements, the onset of platelet decline was between 8 and 12 weeks after the first dose of Raptiva in 5 patients, but occurred later in the other patients.
In one patient, thrombocytopenia occurred 3 weeks after treatment discontinuation. Over long term treatment up to 3 years, a small and gradual decrease in mean platelet counts within the normal range was observed. 4). 4% in the placebo-treated patients.
2%). Seventeen of these events occurred after discontinuation of Raptiva, while 22 occurred during treatment. In the cases occurring during treatment, most of these events (16/22) occurred in patients presenting no response to Raptiva.
Cases occurring after discontinuation were observed both in patients responding or not responding to Raptiva treatment. 8% of Raptiva-treated patients and placebo-treated patients. In these studies, the incidence of other types of arthritis-related adverse events were similar between the Raptiva and placebo groups.
Flu-like symptoms:
In large placebo-controlled clinical studies, approximately 20% of patients in excess of placebo reported flu-like symptoms including headaches, chills, fever, nausea and myalgia. The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
These symptoms diminished thereafter to a percentage comparable to that of patients treated with placebo. Headache was the most frequent of the flu-like symptoms. None of those events was serious and less than 5% were considered severe.
Overall less than 1% of patients discontinued therapy because of acute flu-like symptoms.
Hypersensitivity and allergic disorders:
In large placebo-controlled clinical studies, the percentage of patients experiencing an adverse event suggestive of hypersensitivity, including urticaria, rash […]
If any doubt exists, further evaluation, including Magnetic Resonance Imaging (MRI) scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessment, should be considered. Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
If a patient develops PML, the dosing of Raptiva must be permanently discontinued. b) Vaccinations Limited data are available on the effects of vaccination. Neo-vaccinations given during treatment with Raptiva may induce antibody levels lower than those observed in non-treated subjects, but the clinical Medicinal product no longer authorised4 significance of this is unknown.
Patients should not receive live and live-attenuated vaccines while on Raptiva therapy. Before vaccination, treatment with Raptiva should be withheld for 8 weeks and can resume 2 weeks after vaccination. 5). c) Malignancies and lymphoproliferative disorders It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
8). Raptiva has not been studied in combination with immunosuppressive systemic antipsoriasis medicinal products. 5). Immune-mediated haemolytic anaemia In post-marketing surveillance, isolated cases of severe haemolytic anaemia have been reported during treatment with Raptiva.
In such circumstances, Raptiva should be discontinued. Thrombocytopenia Thrombocytopenia may occur during Raptiva treatment and may be associated with clinical signs such as echymoses, spontaneous bruising or bleeding from muco-cutaneous tissues.
8). Platelet counts are recommended upon initiating and periodically while receiving Raptiva treatment. , every 3 months). 8). Patients have recovered after discontinuation of Raptiva, therefore Raptiva should be stopped following the diagnosis of inflammatory polyradiculoneuropathy.
Hypersensitivity and allergic reactions As with any recombinant product, Raptiva is potentially immunogenic. 8). Arthritis Cases of arthritis have been observed during treatment or after discontinuation of Raptiva. It is recommended to discontinue Raptiva if arthritis occurs during treatment.
8). In such cases, it is recommended to discontinue treatment […]