Prescribing Information and Adverse Events Reporting
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda UK Ltd. at: AE.GBR-IRL@takeda.com. |
VPRIV® (velaglucerase alfa) 400 units powder for solution for infusion
PRESCRIBING INFORMATION FOR GREAT BRITAIN (ENGLAND, SCOTLAND, WALES) AND NORTHERN IRELAND.
Refer to Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Each vial contains 400 Units of velaglucerase alfa. Powder for solution for infusion. After reconstitution, the solution contains 100 Units of velaglucerase alfa per ml.
Indication: VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Dosage and administration: VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only over 60 minutes. VPRIV is for single-use only and must be administered through a 0.2 or 0.22 μm filter. VPRIV should be administered under the supervision of a physician experienced in the management of Gaucher disease. 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, discontinue the infusion and initiate appropriate medical treatment. Home administration, under the supervision of a healthcare professional, may be considered for patients who have received at least three infusions and are tolerating their infusions well. Posology: 60 Units/kg administered every other week as a 60-minute intravenous infusion. Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals. Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week. Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency. Renal or hepatic impairment: No dosage adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa. Elderly (≥65 years old): Elderly patients may be treated with the same dose range (15 to 60 Units/kg EOW) as other adult patients. Paediatric population: Twenty of the 94 patients who received velaglucerase alfa during clinical studies were in children and adolescents age range (4 to 17 years). The safety and efficacy profiles were similar between paediatric and adult patients. The safety and efficacy of velaglucerase alfa in children below the age of 4 years have not yet been established, no data are available.
Contraindications: Severe allergic reaction to the active substance or to any of the excipients.
Warnings and precautions: Hypersensitivity: Hypersensitivity reactions, including symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience. Infusion-related reactions were the most commonly observed adverse reactions in patients treated in clinical studies and often appear 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. In treatment naïve subjects the majority of infusion-related reactions occurred during the first six 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 medication 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, adequately trained persons in emergency measures should be readily available when velaglucerase alfa is administered. If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. For patients developing anaphylaxis in a home setting, consider continuing treatment in a clinical setting. Use velaglucerase alfa or other enzyme replacement therapy with caution in patients who have exhibited symptoms of hypersensitivity. Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in cases where symptomatic treatment was required. Immunogenicity: Development of antibodies to velaglucerase alfa may be associated with infusion-related reactions including allergic-type hypersensitivity reactions. In the clinical studies for Marketing Authorisation one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa. In this one event, the antibodies were determined to be neutralising in an in vitro assay. No patients developed IgE antibodies to velaglucerase alfa. Post Marketing Phase: During a post marketing extension study, one patient developed IgG antibodies to VPRIV. In addition, a few events of positive neutralising antibodies and lack of effect were reported post marketing. If the physician suspects a lack/loss of effect that may be related to antibody formation the patient may be tested for antibodies at the physician’s discretion. For further information on requesting antibody testing services, please contact medinfoEMEA@takeda.com. Sodium: This medicinal product contains 12.15 mg sodium per vial equivalent to 0.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Interactions: No interaction studies have been performed.
Fertility, pregnancy and lactation: Patients with Gaucher disease who become pregnant may experience increased disease activity during pregnancy and the puerperium. A risk-benefit assessment is required for women who are considering pregnancy. There are no or limited amount of data from the use of velaglucerase alfa in pregnant women. Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for individualisation of therapy. Caution should be exercised when prescribing to pregnant women. There is insufficient information on the excretion of velaglucerase alfa or its metabolites in human milk. Velaglucerase is a synthetic form of beta-glucocerebrosidase, which is a normal component of breast-milk. A risk-benefit assessment is required for women who are considering breast-feeding.
Effects on ability to drive and use machines: None.
Undesirable effects: Very common (≥1/10): headache, dizziness, abdominal pain/abdominal pain upper, bone pain, arthralgia, back pain, infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased. Common (≥1/100 to <1/10): hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions), tachycardia, dyspnoea, hypertension, hypotension, flushing, nausea, rash, urticaria, pruritus, chest discomfort, activated partial thromboplastin time prolonged, neutralising antibody positive. Other serious undesirable effects: Vomiting.
Refer to the SmPC for details on full side effect profile and interactions.
UK Basic NHS price: 20 ml vial. £1410.20 per vial.
Legal Classification: POM.
Marketing authorisation (MA): GB: PLGB 54937/0018; NI: EU/1/10/646/002; EU/1/10/646/005; EU/1/10/646/006.
Business responsible for sale and supply: GB & NI: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom.
PI approval code: pi-03070.
Date of preparation: April 2024.
VPRIV is a registered trademark.
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Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda at: AE.GBR-IRL@takeda.com |
REPLAGAL® (agalsidase alfa) 1 mg/ml concentrate for solution for infusion
PRESCRIBING INFORMATION FOR GREAT BRITAIN (ENGLAND, SCOTLAND, WALES)
Refer to Summary of Product Characteristics (SmPC) before prescribing
Presentation: 1 ml contains 1 mg of agalsidase alfa. Each vial of 3.5 ml of concentrate contains 3.5mg of agalsidase alfa
Indication: Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Dosage and administration: Treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Replagal home infusion, and administration by the patient or patient’s caregiver (self-administration), may be considered for patients who are tolerating their infusions well. The decision to have a patient move to home infusion and/or self- administration should be made after evaluation and recommendation by the treating physician. Any patients experiencing adverse events during the home infusion/ self- administration need to immediately stop the infusion process and seek the attention of a healthcare professional. Posology: Replagal is administered at a dose of 0.2 mg/kg body weight by IV infusion over 40 min every other week. No dosage regimen in children aged 0-6 years or elderly patients over 65 years can presently be recommended as safety and efficacy have not yet been sufficiently established. In children aged 7-18 years, Replagal 0.2mg/kg every other week led to no unexpected safety issues. Renal and hepatic impairment: No dosage adjustment is recommended for patients with renal impairment or those on dialysis or post-kidney transplantation; however extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy. No data is available in hepatic impairment.
Contraindications: Hypersensitivity to the active substance or any of the excipients.
Warnings and precautions: 13.7% of adult patients treated with Replagal in clinical trials had idiosyncratic infusion-related reactions (generally within 2–4 months of starting treatment although later onset [after 1 year] has been reported as well). Four of 17 paediatric patients ≥7 years of age and 3 of 8 paediatric patients <7 years experienced at least one infusion reaction over a period of approximately 4 years of treatment. These effects have decreased with time. If mild or moderate acute infusion reactions occur, seek medical attention immediately. The infusion can be temporarily interrupted (for 5–10 minutes) until symptoms subside. If severe hypersensitivity or anaphylactic-type reactions occur, discontinue Replagal immediately and initiate appropriate treatment. A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease. Patients may develop IgG antibodies to the protein. A low titre antibody response was seen in approximately 24% of male patients treated with Replagal, the remaining 76% remained antibody negative throughout. In paediatric patients >7 yrs of age, 1/16 male patients tested positive for IgG anti-agalsidase alfa antibodies. No increase in the incidence of adverse events was detected for this patient. In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies. IgE antibody positivity not associated with anaphylaxis has been reported in clinical trials in a very limited number of patients. Sodium: This medicinal product contains 14.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Interactions: Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α-galactosidase activity.
Fertility, pregnancy and lactation: There is very limited data on pregnancies exposed to Replagal, therefore, caution should be exercised. Use with caution during breast-feeding.
Undesirable effects: Very common (≥1/10): peripheral oedema, headache, dizziness, neuropathic pain, tremor, hypoesthesia, paraesthesia, tinnitus, palpitations, dyspnoea, cough, nasopharyngitis, pharyngitis, vomiting, nausea, abdominal pain, diarrhoea, rash, arthralgia, pain in limb, myalgia, back pain, chest pain, rigors, pyrexia, pain, asthenia, fatigue; Common (≥1/100, <1/10): dysgeusia, hypersomnia, increased lacrimation, tinnitus aggravated, tachycardia, atrial fibrillation, hypertension, hypotension, flushing, hoarseness, throat tightness, rhinorrhoea, abdominal discomfort, urticaria, erythema, pruritus, acne, hyperhidrosis, musculoskeletal discomfort, peripheral swelling, joint swelling, hypersensitivity, chest tightness, aggravated fatigue, feeling hot, feeling cold, influenza-like illness, discomfort, malaise; Other Serious undesirable effects: anaphylactic reaction, myocardial ischaemia, heart failure.
Refer to the SmPC for details on full side effect profile and interactions.
UK Basic NHS price: Vials of 5 ml (containing 3.5 ml concentrate) in a pack size of 1 vial. £1049.94 for one 5 ml vial.
Legal Classification: POM.
Marketing authorisation (MA): PLGB 54937/0022.
Business responsible for sale and supply: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom.
PI approval code: pi-02315.
Date of preparation: January 2023.
Replagal is a registered trade name
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Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda UK Ltd at: AE.GBR-IRL@takeda.com |
REPLAGAL® (agalsidase alfa) 1 mg/ml concentrate for solution for infusion
PRESCRIBING INFORMATION FOR NORTHERN IRELAND
Refer to Summary of Product Characteristics (SmPC) before prescribing
Presentation: 1 ml contains 1 mg of agalsidase alfa. Each vial of 3.5 ml of concentrate contains 3.5mg of agalsidase alfa
Indication: Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Dosage and administration: Treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Replagal home infusion, and administration by the patient or patient’s caregiver (self-administration), may be considered for patients who are tolerating their infusions well. The decision to have a patient move to home infusion and/or self- administration should be made after evaluation and recommendation by the treating physician. Any patients experiencing adverse events during the home infusion/ self- administration need to immediately stop the infusion process and seek the attention of a healthcare professional. Posology: Replagal is administered at a dose of 0.2 mg/kg body weight by IV infusion over 40 min every other week. No dosage regimen in children aged 0-6 years or elderly patients over 65 years can presently be recommended as safety and efficacy have not yet been sufficiently established. In children aged 7-18 years, Replagal 0.2mg/kg every other week led to no unexpected safety issues. Renal and hepatic impairment: No dosage adjustment is recommended for patients with renal impairment or those on dialysis or post-kidney transplantation; however extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy. No data is available in hepatic impairment.
Contraindications: Hypersensitivity to the active substance or any of the excipients.
Warnings and precautions: 13.7% of adult patients treated with Replagal in clinical trials had idiosyncratic infusion-related reactions (generally within 2–4 months of starting treatment although later onset [after 1 year] has been reported as well). Four of 17 paediatric patients ≥7 years of age and 3 of 8 paediatric patients <7 years experienced at least one infusion reaction over a period of approximately 4 years of treatment. These effects have decreased with time. If mild or moderate acute infusion reactions occur, seek medical attention immediately. The infusion can be temporarily interrupted (for 5–10 minutes) until symptoms subside. If severe hypersensitivity or anaphylactic-type reactions occur, discontinue Replagal immediately and initiate appropriate treatment. A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease. Patients may develop IgG antibodies to the protein. A low titre antibody response was seen in approximately 24% of male patients treated with Replagal, the remaining 76% remained antibody negative throughout. In paediatric patients >7 yrs of age, 1/16 male patients tested positive for IgG anti-agalsidase alfa antibodies. No increase in the incidence of adverse events was detected for this patient. In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies. IgE antibody positivity not associated with anaphylaxis has been reported in clinical trials in a very limited number of patients. Sodium: This medicinal product contains 14.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Interactions: Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α-galactosidase activity.
Fertility, pregnancy and lactation: There is very limited data on pregnancies exposed to Replagal, therefore, caution should be exercised. Use with caution during breast-feeding.
Undesirable effects: Very common (≥1/10): peripheral oedema, headache, dizziness, neuropathic pain, tremor, hypoesthesia, paraesthesia, tinnitus, palpitations, dyspnoea, cough, nasopharyngitis, pharyngitis, vomiting, nausea, abdominal pain, diarrhoea, rash, arthralgia, pain in limb, myalgia, back pain, chest pain, rigors, pyrexia, pain, asthenia, fatigue; Common (≥1/100, <1/10): dysgeusia, hypersomnia, increased lacrimation, tinnitus aggravated, tachycardia, atrial fibrillation, hypertension, hypotension, flushing, hoarseness, throat tightness, rhinorrhoea, abdominal discomfort, urticaria, erythema, pruritus, acne, hyperhidrosis, musculoskeletal discomfort, peripheral swelling, joint swelling, hypersensitivity, chest tightness, aggravated fatigue, feeling hot, feeling cold, influenza-like illness, discomfort, malaise; Other Serious undesirable effects: anaphylactic reaction, myocardial ischaemia, heart failure.
Refer to the SmPC for details on full side effect profile and interactions.
UK Basic NHS price: Vials of 5 ml (containing 3.5 ml concentrate) in a pack size of 1 vial. £1049.94 for one 5 ml vial.
Legal Classification: POM.
Marketing authorisation (MA): EU/1/01/189/001-003.
Business responsible for sale and supply: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom.
PI approval code: pi 02117.
Date of preparation: December 2022.
Replagal is a registered trade name
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Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda UK Ltd at: AE.GBR-IRL@takeda.com |
Elaprase▼ (idursulfase) 2mg/ml concentrate for solution for infusion
PRESCRIBING INFORMATION FOR GREAT BRITAIN.
Refer to Summary of Product Characteristics (SmPC) before prescribing.
Presentation: 1 ml Elaprase concentrate contains 2 mg of idursulfase.
Indication: For the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Dosage and administration: Children, adolescents and adults 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period. The infusion may be gradually reduced to 1 hour if no infusion associated reactions observed. Treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with inherited metabolic disorders. Infusion of Elaprase at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional.
Contraindications: Severe or life threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable.
Warnings and precautions: Infusion-related reactions: In clinical trials infusion-related reactions were treated or ameliorated by slowing infusion rate, interrupting infusion, or by administration of medicinal products such as antihistamines, antipyretics, low-dose corticosteroids or beta-agonist nebulisation. No patient discontinued treatment due to an infusion reaction during clinical studies. Patients with severe underlying airway disease should be closely monitored during infusion in an appropriate clinical setting. This is particularly important for patients on antihistamines or other sedative medicinal product. Use of these medicinal products in patients with severe underlying airway disease should be limited where possible. Institution of positive airway pressure may be necessary in some cases. Consider delaying infusion in patients with acute febrile respiratory illness. Patients using supplementary oxygen should have this readily available during infusion, in the event of an infusion-related reaction. Anaphylactoid/anaphylactic reactions: These have the potential to be life-threatening and have been observed in some patients treated with Elaprase up to several years after initiating treatment. Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction. If an anaphylactoid/anaphylactic reaction occurs, the infusion should be immediately suspended and appropriate treatment and observation initiated. The current medical standards for emergency treatment should be observed. Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring and should be treated with caution when re-administering Elaprase, with appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) available during infusions. Patients with the complete deletion/large rearrangement genotype: Paediatric patients with this genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to idursulfase and have a higher probability of developing infusion related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume. Sodium: This medicinal product contains 0.482 mmol of sodium (or 11.1 mg) per vial. This should be taken into consideration for patients on a controlled sodium diet.
Interactions: No formal medicinal product interaction studies have been conducted. Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Fertility, pregnancy and lactation: As a precautionary measure, it is preferable to avoid the use of Elaprase during pregnancy. Use of Elaprase during breastfeeding should only be undertaken when the potential benefit is judged by the physician to justify the risk.
Effects on ability to drive and use machines: No or negligible influence.
Undesirable effects: Very common (≥1/10): headache, flushing, wheezing, dyspnoea, abdominal pain, nausea, diarrhoea, vomiting, urticaria, rash, pruritus, erythema, pyrexia, chest pain, infusion-related reaction. Common (≥1/100 to <1/10): dizziness, tremor, cyanosis, arrhythmia, tachycardia, hypertension, hypotension, hypoxia, bronchospasm, cough, swollen tongue, dyspepsia, arthralgia, infusion-site swelling, face oedema, peripheral oedema. Other Serious undesirable effects: anaphylactoid/anaphylactic reaction.
Refer to the SmPC for details on full side effect profile and interactions.
UK basic NHS price: Vials of 5 ml (containing 3 ml concentrate) in a pack size of 1 vial. £1985 for one 5 ml vial.
Legal classification: POM.
Marketing authorisation (MA) number: PLGB 54937/0021.
Business responsible for sale and supply: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom.
PI approval code: pi-02301.
Date of preparation: January 2023.
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▼This medicinal product is subject to additional monitoring. Adverse events should be reported to the Medicines and Healthcare products Regulatory Agency. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda at: AE.GBR-IRL@takeda.com. |
Elaprase▼ (idursulfase) 2mg/ml concentrate for solution for infusion
PRESCRIBING INFORMATION FOR NORTHERN IRELAND.
Refer to Summary of Product Characteristics (SmPC) before prescribing.
Presentation: 1 ml Elaprase concentrate contains 2 mg of idursulfase.
Indication: For the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Dosage and administration: Children, adolescents and adults 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period. The infusion may be gradually reduced to 1 hour if no infusion associated reactions observed. Treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with inherited metabolic disorders. Infusion of Elaprase at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional.
Contraindications: Severe or life threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable.
Warnings and precautions: Infusion-related reactions: In clinical trials infusion-related reactions were treated or ameliorated by slowing infusion rate, interrupting infusion, or by administration of medicinal products such as antihistamines, antipyretics, low-dose corticosteroids or beta-agonist nebulisation. No patient discontinued treatment due to an infusion reaction during clinical studies. Patients with severe underlying airway disease should be closely monitored during infusion in an appropriate clinical setting. This is particularly important for patients on antihistamines or other sedative medicinal product. Use of these medicinal products in patients with severe underlying airway disease should be limited where possible. Institution of positive airway pressure may be necessary in some cases. Consider delaying infusion in patients with acute febrile respiratory illness. Patients using supplementary oxygen should have this readily available during infusion, in the event of an infusion-related reaction. Anaphylactoid/anaphylactic reactions: These have the potential to be life-threatening and have been observed in some patients treated with Elaprase up to several years after initiating treatment. Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction. If an anaphylactoid/anaphylactic reaction occurs, the infusion should be immediately suspended and appropriate treatment and observation initiated. The current medical standards for emergency treatment should be observed. Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring and should be treated with caution when re-administering Elaprase, with appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) available during infusions. Patients with the complete deletion/large rearrangement genotype: Paediatric patients with this genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to idursulfase and have a higher probability of developing infusion related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume. Sodium: This medicinal product contains 0.482 mmol of sodium (or 11.1 mg) per vial. This should be taken into consideration for patients on a controlled sodium diet.
Interactions: No formal medicinal product interaction studies have been conducted. Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Fertility, pregnancy and lactation: As a precautionary measure, it is preferable to avoid the use of Elaprase during pregnancy. Use of Elaprase during breastfeeding should only be undertaken when the potential benefit is judged by the physician to justify the risk.
Effects on ability to drive and use machines: No or negligible influence.
Undesirable effects: Very common (≥1/10): headache, flushing, wheezing, dyspnoea, abdominal pain, nausea, diarrhoea, vomiting, urticaria, rash, pruritus, erythema, pyrexia, chest pain, infusion-related reaction. Common (≥1/100 to <1/10): dizziness, tremor, cyanosis, arrhythmia, tachycardia, hypertension, hypotension, hypoxia, bronchospasm, cough, swollen tongue, dyspepsia, arthralgia, infusion-site swelling, face oedema, peripheral oedema. Other Serious undesirable effects: anaphylactoid/anaphylactic reaction.
Refer to the SmPC for details on full side effect profile and interactions.
UK basic NHS price: Vials of 5 ml (containing 3 ml concentrate) in a pack size of 1 vial. £1985 for one 5 ml vial.
Legal classification: POM.
Marketing authorisation (MA) number(s): EU/1/06/365/001-003.
Business responsible for sale and supply: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom.
PI approval code: pi-02168.
Date of preparation: October 2022
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▼This medicinal product is subject to additional monitoring. Adverse events should be reported to the Medicines and Healthcare products Regulatory Agency. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard Adverse events should also be reported to Takeda at: AE.GBR-IRL@takeda.com. |
