Velaglucerase alfa interacts in the following cases:
Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience. The majority of hypersensitivity reactions usually occur up to 12 hours post infusion. The most frequently reported symptoms of hypersensitivity include nausea, rash dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache.
An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion. Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies. An IRR often appears as a hypersensitivity reaction. The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache. Symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience. Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred. In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Due to the risk for hypersensitivity reactions including anaphylaxis appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered. If anaphylactic or other acute reactions occur, in the clinic or home setting, immediately discontinue the infusion and initiate appropriate medical treatment. For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting.
Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
There are no or limited amount of data from the use of velaglucerase alfa in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy. Caution should be exercised when prescribing to pregnant women.
There are no data from studies in breast-feeding women. It is not known whether velaglucerase alfa is excreted in human milk. Caution should be exercised when prescribing to a breast-feeding woman.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy.
Animal studies show no evidence of impaired fertility.
Velaglucerase alfa has no or negligible influence on the ability to drive or use machines.
The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week in 5 clinical studies. Fifty-four patients were naïve to ERT and 40 patients switched from imiglucerase to velaglucerase alfa. Patients were between 4 and 71 years old at the time of first treatment with velaglucerase alfa, and included 46 male and 48 female patients.
The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
The most common adverse reactions were infusion-related reactions. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased. The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Adverse reactions reported in patients with type 1 Gaucher disease are listed below. Information is presented by system organ class and frequency according to MedDRA convention. Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics.
Adverse reactions reported with velaglucerase alfa observed in patients with type 1 Gaucher disease. Italic text denotes post-marketing event:
Common: hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Very common: headache, dizziness
Uncommon: vision blurred
Common: tachycardia
Common: dyspnea
Common: hypertension, hypotension, flushing
Very common: abdominal pain/abdominal pain upper
Common: nausea
Uncommon: vomiting
Common: rash, urticaria, pruritus
Very common: bone pain, arthralgia, back pain
Very common: infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased
Common: chest discomfort
Common: activated partial thromboplastin time prolonged, neutralizing antibody positive
In some cases vomiting can be serious (reported from post-marketing experience).
The safety profile of velaglucerase alfa in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.
The safety profile of velaglucerase alfa in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
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