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  • TAKHZYRO TM
    / Takeda


    Active Ingredient
    Lanadelumab 300mg/2ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    (solution for injection): 1X2ml

    partial basket chart 55041 20934

    Related information


    Dosage

    This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).
    TAKHZYRO is intended for subcutaneous (SC) administration only. Each TAKHZYRO vial is intended for single use only.
    The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
    TAKHZYRO is not intended for treatment of acute HAE attacks. If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as possible ensuring at least 10 days between doses. No dose adjustment is required in patients above 65 years of age, or patients with renal or hepatic impairment. The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms. Rotation of the injection site is recommended. TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.


    Indications

    TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
    Hypersensitivity reactions
     have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
    General: TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.
    Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in international normalised ratio (INR) between treatment groups.
    See prescribing information for full details.


    Side Effects

    The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes. Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%).
    Immunogenicity: Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies. The development of ADA including neutralizing antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
    See prescribing information for full details.


    Drug interactions

    No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no or limited data from the use of lanadelumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
    Lactation: It is unknown whether lanadelumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breastfed child cannot be excluded during this short period. Afterwards, lanadelumab could be used during breastfeeding if clinically needed.


    Overdose

    No case of overdose has been reported. There is no available information to identify potential signs and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There is no antidote available.


    Important notes

    Storage: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep vial in the outer carton in order to protect from light.
    Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date. Do not return TAKHZYRO to refrigerated storage after storage at room temperature.


    Manufacturer
    Shire Pharmaceutical Ireland Limited, Ireland
    Licence holder
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