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MEPACT® Prescribing Information

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MEPACT® Prescribing Information MEPACT® (mifamurtide) Prescribing Information discontinued. Monitor for signs of allergic reactions. (Refer to Summary of Product Characteristics (SmPC) before Gastrointestinal toxicity may be exacerbated when Mepact is prescribing). used in combination with high dose, multi-agent chemotherapy and was associated with an increased use of Mifamurtide 4mg vial. Presentation: 4 mg powder for parenteral nutrition. Interactions: There is no evidence of concentrate for dispersion for infusion. Single vial in outer any interactions between Mepact and the anti-tumour effects carton. Indication: Treatment of high-grade resectable non- of chemotherapy and vice versa. It’s recommended to metastatic osteosarcoma after macroscopically complete separate the administration times of Mepact and doxorubicin surgical resection in children, adolescents and young adults. or other lipophilic medicinal products. Chronic or routine use Mepact is used in combination with post-operative multi- of corticosteroids should be avoided. Mifamurtide is not agent chemotherapy. Safety and efficacy have been assessed expected to interact with the metabolism of substances that in patients aged 2- 30 years at initial diagnosis. are hepatic cytochrome P450 substrates. In a large controlled Dosage & Administration: Should be initiated and randomised study, Mepact used at the recommended dose supervised by specialist physicians. Children, adolescents & 2 and schedule did not exacerbate the renal toxicities of young adults: 2 mg/m body surface area. It should be cisplatin and ifosfamide or the hepatic toxicities of administered as adjuvant therapy following resection: twice methotrexate and ifosfamide. Pregnancy & breastfeeding: No weekly at least 3 days apart for 12 weeks, followed by once- data available. Adverse Effects: Very common (≥10%): weekly treatments for an additional 24 weeks for a total of 48 Anaemia, anorexia, headache, dizziness, tachycardia, infusions in 36 weeks. Paediatric patients (<2 yrs): Safety and hypertension, hypotension, dyspnoea, tachypnoea, cough, efficacy not established; No data available. Patients aged >30 vomiting, diarrhoea, constipation, abdominal pain, nausea, years: Not recommended; No data available. Patients with hyperhidrosis, myalgia, arthralgia, back pain, pain in renal or hepatic impairment: There are no clinically extremity, fever, chills, fatigue, hypothermia, pain, malaise, meaningful effects of mild to moderate renal (creatinine asthenia, chest pain. Common (≥1/100 to <1/10): Sepsis, clearance (CrCL) ≥ 30ml/min) or mild hepatic impairment cellulitis, nasopharyngitis, catheter site infection, upper (Child-Pugh class A or B) on the pharmacokinetics of respiratory tract infection, urinary tract infection, pharyngitis, mifamurtide: dose adjustments are not necessary for these Herpes simplex infection, cancer pain, leukopenia, patients. However, due to the greater pharmacokinetic thrombocytopenia, granulocytopenia, febrile neutropenia, variability of Mepact, caution is recommended in patients dehydration, hypokalaemia, decreased appetite, confusional with moderate hepatic impairment. As no pharmacokinetic state, depression, insomnia, anxiety, paraesthesia, data for Mepact are available in patients with severe renal or hypoaesthesia, tremor, somnolence, lethargy, blurred vision, hepatic impairment, caution should be used in these patients. vertigo, tinnitus, hearing loss, cyanosis, palpitations, phlebitis, Continued monitoring of kidney and liver function is flushing, pallor, pleural effusion, exacerbated dyspnoea, recommended if Mepact is used beyond completion of productive cough, haemoptysis, wheezing, epistaxis, chemotherapy until all therapy is completed. Powder for exertional dyspnoea, sinus congestion, nasal congestion, concentrate for dispersion for infusion: Mepact must be pharyngolaryngeal pain, upper abdominal pain, dyspepsia, reconstituted, filtered using the filter provided and further abdominal distension, lower abdominal pain, hepatic pain, diluted prior to administration. Mepact should be rash, pruritis, erythema, alopecia, dry skin, muscle spasms, reconstituted with 50mL sodium chloride 9mg/mL (0.9%) and neck pain, groin pain, bone pain, shoulder pain, chest wall the appropriate dose volume withdrawn and added back to pain, musculoskeletal stiffness, haematuria, dysuria, the sodium chloride 9mg/mL (0.9%) infusion bag for pollakiuria, dysmenorrhoea, peripheral oedema, oedema, intravenous administration over 1 hour (see SmPC). mucosal inflammation, infusion site erythema, infusion site Contraindications, Warnings and Precautions: reaction, catheter site pain, chest discomfort, feeling cold, Contraindications: Hypersensitivity to mifamurtide or weight decreased, Post procedural pain. Other Serious excipients. Concurrent administration with ciclosporin, other Adverse Effects, Frequency not known: seizure, thrombosis calcineurin inhibitors and high-dose non-steroidal anti- Pharmaceutical Precautions: Store the unopened, inflammatory agents (NSAIDs, cyclooxygenase inhibitors). unreconstituted vial in a refrigerator (2-8°C), protected from Precautions: In patients with asthma or other chronic light. Reconstituted Mepact is stable for up to 6 hours at 25°C. obstructive pulmonary disease, consider administration of Reconstituted Mepact suspension should not be stored in a prophylactic bronchodilators. If a severe respiratory reaction refrigerator or frozen. PI Date: January 2015. PI Code: occurs, administration should be discontinued and UK/MEP/1501/0001. POM. appropriate treatment initiated. Monitor and manage Legal category: Basic NHS Price episodes of neutropenic fever. Fever or chills persisting more & Marketing Authorisation: £2,375 for each Mepact 4mg than 8 hours after administration of Mepact should be vial (EU/1/08/502/001). Further information is available evaluated for possible sepsis. Use Mepact with caution in from: Takeda UK Ltd. Building 3, Glory Park, Glory Park patients with a history of autoimmune, inflammatory or other Avenue, Wooburn Green, Buckinghamshire, HP10 0DF. Tel: collagen diseases. Monitor for signs or symptoms of arthritis 01628 537 900 Fax: 01628 526 617. or synovitis. If symptoms persist or worsen in patients with a Mepact® is a registered trademark. history of thrombosis, vasculitis or unstable cardiovascular disorders, Mepact administration should be delayed or Please refer to the Summary of Product Characteristics for details on the full side-effect profile and drug interactions of Mepact. Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Takeda UK Ltd on 01628 537 900 .
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