ACTEMRA
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Package(a):
VIAL (concentrate for solution for injection): 1 x 80 mg/4 ml.
Dosage(a):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Package(b):
VIAL (concentrate for solution for injection): 4 x 80 mg/4 ml.
Dosage(b):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Package(c):
VIAL (concentrate for solution for injection): 1 x 200 mg/10 ml.
Dosage(c):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Package(d):
VIAL (concentrate for solution for injection): 4 x 200 mg/10 ml.
Dosage(d):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Package(e):
VIAL (concentrate for solution for injection): 1 x 400 mg/20 ml.
Dosage(e):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Package(f):
VIAL (concentrate for solution for injection): 4 x 400 mg/20 ml.
Dosage(f):
For IV administration.
RA: The recommended posology is 8 mg/kg body weight, given once every four weeks. For individuals whose body weight is more than 100 kg, doses exceeding 800 mg/infusion are not recommended. Doses above 1.2 g have not been evaluated in clinical studies.
sJIA: The recommended posology is 8 mg/kg body weight, once every 2 weeks in patients weighing more or equal to 30 kg, or 12 mg/kg body weight once every 2 weeks in patients weighing less than 30 kg.
See prescribing information for full details.
Prescribing Restrictions:
Indications:
Reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to one or more DMARDs or TNF antagonists or in whom DMARDs cannot be used. Can be used alone or in combination with methotrexate or other DMARDs.
Has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
Treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients. Active, severe infections.
Special Precautions:
Infections: Treatment should not be initiated in patients with active infections. Administration should be interrupted if a patient develops a serious infection until the infection is controlled. Healthcare professionals should exercise caution when considering treatment of patients with a history of recurring or chronic infections or with underlying conditions which may predispose patients to infections.
Tuberculosis: Patients should be screened for latent tuberculosis (TB) infection prior to starting therapy. Patients with latent TB should be treated with standard anti mycobacterial therapy before initiating treatment.
Complications of diverticulitis: Should be used with caution in patients with previous history of intestinal ulceration or diverticulitis. Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, hemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Hypersensitivity reactions: Serious hypersensitivity reactions have been reported in approximately 0.3% of patients. Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction.
Active hepatic disease and hepatic impairment: Treatment, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases. Therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment, as the safety in these patients has not been adequately studied.
Hepatic transaminase elevations: In clinical trials, transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with treatment, without progression to hepatic injury. An increased frequency of these elevations was observed when used in combination with potentially hepatotoxic drugs (e.g. MTX).
Hematological abnormalities: Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/kg in combination with MTX. There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Lipid parameters: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab. In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents.
Neurological disorders: Physicians should be vigilant for symptoms potentially indicative of new onset central demyelinating disorders. The potential for central demyelination is currently unknown.
Malignancy: The risk of malignancy is increased in patients with RA. Immunomodulatory medicinal products may increase the risk of malignancy.
Vaccinations: Live and live attenuated vaccines should not be given concurrently as clinical safety has not been established.
Cardiovascular risk: RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidemia) managed as part of usual standard of care..
Combination with TNF antagonists: There is no experience with the use of Actemra with TNF antagonists or other biological treatments for RA. Treatment is not recommended for use with other biological agents.
Sodium: This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1,200 mg, which should be taken into consideration by patients on a controlled sodium diet. Doses below 1,025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially sodium free.
See prescribing information for full details.
Pregnancy and lactation: There is no adequate data on the use of tocilizumab in pregnant women. A study in animals has shown an increased risk of spontaneous abortion/embryo fetal death at a high dose. The potential risk for humans is unknown. Women of childbearing potential must use effective contraception during and up to 6 months after treatment. Should not be used during pregnancy unless clearly necessary. It is unknown whether tocilizumab is excreted in human breast milk. The excretion of tocilizumab in milk has not been studied in animals. A decision on whether to continue/discontinue breast feeding or to continue/discontinue therapy should be made, taking into account the benefit of breast feeding to the child and the benefit of therapy to the woman.
Side Effects:
Very common: Upper respiratory tract infections. Common: Cellulitis, pneumonia, oral herpes simplex, herpes zoster, mouth ulceration, gastritis, rash, pruritus, headache, dizziness, hepatic transaminases increased, hypertension, leukopenia, neutropenia, hypercholesterolemia, conjunctivitis. See prescribing information for full details.
Drug Interactions:
CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced. In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression. Tocilizumab normalizes expression of these enzymes. When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. atorvastatin, calcium channel blockers, theophylline, warfarin, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect. Given its long elimination half-life (t½), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy. See prescribing information for full details.
