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Medicine information : RAPTIVA 100 mg/ml
| Drug class description : | Immunosuppressant |
| Generic Name : | Efalizumab |
| Drug description : | Each vial contains a retrievable amount of 125 mg of efalizumab. Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ml. Efalizumab is a recombinant humanized monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells. Efalizumab is an IgG1 kappa immunoglobulin, containing human constant region sequences and murine light- and heavychain complementary determining region sequences. |
| Presentation : | Powder and solvent for solution for injection. The powder is a white to off white cake. The solvent is a clear, colourless liquid. |
| Indications : | 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 cyclosporine, methotrexate and PUVA. |
| Adult Dosage : | 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 Special Precautions. 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. After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate. |
| Child Dosage : | The safety and efficacy of Raptiva in this age group (< 18 years old) have not been studied. Raptiva should not be used in this age group. |
| Elderly Dosage : | The dosage and administration schedule in the elderly should be the same as for adults (See Special Precautions). |
| Contra Indications : | 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. |
| Special Precautions : | Effects on the immune system a) Infections Raptiva, may affect host defenses against infections. The impact of treatment with Raptiva on the development and course of active and/or chronic infections is not fully understood. 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. b) Vaccinations No data are available on the effects of vaccination or on the secondary transmission of infection by live vaccines in patients receiving Raptiva. Patients should not receive acellular, live and live-attenuated vaccines during Raptiva treatment. Before vaccination, treatment with Raptiva should be withheld for 8 weeks and can resume 2 weeks after vaccination. c) Malignancies and lymphoproliferative disorders It is not known whether Raptiva can increase the risk of malignancies and lymphoproliferative disorders. Raptiva should be discontinued if a malignancy develops while the patient is on treatment (See Contraindications and Adverse Reactions). Raptiva has not been studied in combination with immunosuppressive systemic antipsoriasis medicinal products. Therefore, combination therapies with these products are not recommended (See Interactions). 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. If these manifestations occur, efalizumab should be stopped immediately, a platelet count should be performed and appropriate symptomatic treatment should be instituted immediately (See Adverse Reactions). Platelet counts are recommended upon initiating and periodically while receiving Raptiva treatment. It is recommended that assessments be more frequent when initiating therapy (e.g., monthly) and may decrease in frequency with continued treatment (e.g., every 3 months). Hypersensitivity and allergic reactions As with any recombinant product, Raptiva is potentially immunogenic. Consequently, if any serious hypersensitivity or allergic reaction occurs, Raptiva should be discontinued immediately and appropriate therapy initiated (See Contraindications and Adverse Reactions). Arthritis Cases of arthritis have been observed during treatment with Raptiva. In such circumstances it is recommended to discontinue Raptiva treatment. Psoriasis During treatment with Raptiva, cases of exacerbation of psoriasis, including pustular, erythrodermic, and guttate subtypes, have been observed (See Adverse Reactions). In such cases, it is recommended to discontinue treatment with Raptiva. Abrupt discontinuation of treatment may cause a recurrence or exacerbation of plaque psoriasis including erythrodermic and pustular psoriasis. Discontinuation Management of patients discontinuing Raptiva includes close observation. In case of recurrence or exacerbation of disease, the treating physician should institute the most appropriate psoriasis treatment as necessary. In case re-treatment with Raptiva is indicated the same guidance should be followed as under Posology and method of administration. Re-treatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods. Therapy may be continued only in those patients who respond adequately to treatment. Special patient populations No differences in safety or efficacy were observed between elderly ( 65 years) patients and younger patients. As there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly. Raptiva has not been studied in patients with renal or hepatic impairment and should therefore be used with caution in such patients. See Adverse Reactions regarding the effects on the hepatic function. |
| Interactions : | There have been no formal drug interaction studies performed with Raptiva. No data are available on the effects of vaccination or on the secondary transmission of infection by live vaccines in patients receiving Raptiva. Patients should not receive acellular, live and live-attenuated vaccines during Raptiva treatment. See Special Precautions. Given the mechanism of action of efalizumab, its effects on the immune system may be potentiated by systemic immunosuppressives commonly used for the treatment of psoriasis (See Special Precautions). Raptiva has been used in combination with topical corticosteroids in psoriasis patients without any untoward effects nor with any observable significant beneficial effect of the combination therapy above monotherapy with efalizumab. |
| Adverse Reactions : | 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 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. System Organ Class Very common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1,000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) Blood and the lymphatic system disorders Leukocytosis and lymphocytosis Thrombocytopenia Skin and subcutaneous tissue disorders Psoriasis Urticaria Musculoskeletal and connective disorders Arthralgia Psoriatic arthritis (exacerbation/flare) General disorders and administration site conditions Flu-like symptoms including, fever, headaches, chills, nausea and myalgia Hypersensitivity reactions, back pain, asthenia Injection site reactions Investigations Elevation of alkaline Phosphatase Elevation of ALT The safety profile in the target population as defined in Indications is similar to the safety profile in the overall population treated during clinical development of Raptiva as presented above. Analysis following long-term use in a cohort of 158 patients with moderate to severe psoriasis receiving Raptiva 1 mg/kg/week for 108 weeks did not show any noteworthy differences in frequency of adverse events as compared to 12 weeks of exposure to Raptiva. Safety data beyond 12 weeks in the target population are not yet available. Additional Information Leucocytosis and lymphocytosis: in large placebo-controlled clinical studies, between 40 and 50% of patients developed sustained asymptomatic lymphocytosis during Raptiva therapy. All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal). 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. Thrombocytopenia: in the combined safety database of 3291 Raptiva-treated patients, there were nine occurrences (0.3%) 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. The platelet count nadirs occurred between 12 and 72 weeks after the first dose of Raptiva. (See Special Precautions) Psoriasis: in the first 12 weeks of placebocontrolled studies, the rate of psoriasis adverse events was 3.2% in the Raptivatreated patients and 1.4% in the placebotreated patients. Among 3291 patients in the combined safety database, 39 patients presented an erythrodermic or pustular psoriasis (1.2%). 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. Psoriatic arthritis: in the first 12 weeks of placebocontrolled studies, psoriatic arthritis and exacerbation or flare of psoriatic arthritis were observed in 1.8% of Raptivatreated patients and placebotreated patients. In these studies, the incidence of other types of arthritisrelated 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 and allergic reactions was slightly higher in the Raptiva group (8%) than in the placebo group (7%). No case of anaphylaxis has been reported with the use of Raptiva. (See Special Precautions) Elevation of alkaline phosphatase: in large placebo-controlled clinical studies approximately 4.5% of patients developed sustained elevation of alkaline phosphatase throughout Raptiva therapy compared to 1% in placebo patients. All values were between 1.5 fold and 3 fold the ULN, and returned to baseline levels after therapy discontinuation. Elevation of ALT: about 5.7% of patients developed elevation in ALT during Raptiva therapy compared to 3.5% in placebo. All occurrences were asymptomatic and values above 2.5 fold ULN were not more frequent in the Raptiva group than in the placebo group. All values returned to baseline levels upon therapy discontinuation. Infections: other therapies that alter T-lymphocyte function have been associated with increased risk of developing serious infections. In placebo controlled clinical trials, infection rates in Raptiva-treated patients was approximately 27.3% versus 24.0% in placebo-treated patients. In the target population studied in study IMP24011, the infection rate in Raptiva-treated patients was approximately 25.7% versus 22.3% in placebo-treated patients. In both controlled and uncontrolled studies, the overall incidence of hospitalization for infections was 1.6 per 100 patientyears for Raptiva-treated patients compared with 1.2 per 100 patientyears for placebo- treated patients. The most frequent serious infections were pneumonia, cellulitis, infections not otherwise specified and sepsis. (See Special Precautions) Class adverse reactions Neoplasms benign and malignant: a higher rate of malignancies has been associated with therapies affecting the immune system. In placebo controlled clinical trials, the overall incidences of malignancy (the majority of which were nonmelanoma skin cancers) were similar in Raptiva-treated patients and in placebo-treated patients. In addition, the incidences of specific tumours in Raptiva patients were in line with those observed in control psoriasis populations. Among psoriasis patients who received Raptiva at any dose, the overall incidence of malignancies of any kind was 1.7 per 100 patientyears for Raptiva-treated patients compared with 1.6 per 100 patientyears for placebo-treated patients. Experience with Raptiva has not shown evidence of risk of developing malignancy exceeding that expected in the psoriasis population. (See Special Precautions) |
| Manufacturer : | Serono Ltd |
| Drug Availability : | (POM) |
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