Adakveo

Treatment should be initiated by physicians experienced in the management of sickle cell disease. Posology Recommended dose The recommended dose of crizanlizumab is 5 mg/kg administered over a period of 30 minutes by intravenous infusion at week 0, week 2, and every 4 weeks thereafter.

Crizanlizumab can be given alone or with HU/HC. Delayed or missed doses If a dose is missed, the treatment should be administered as soon as possible. - If crizanlizumab is administered within 2 weeks after the missed dose, dosing should be continued according to the patient’s original schedule.

- If crizanlizumab is administered more than 2 weeks after the missed dose, dosing should be continued every 4 weeks thereafter. 8). Table 1 Recommendations for managing infusion-related reactions Severity of adverse reaction Management recommendation Mild (Grade 1) to moderate (Grade 2) infusion-related reactions Temporarily interrupt or reduce the infusion rate.

* For subsequent infusions, consider premedication and/or slower infusion rate. Severe (≥ Grade 3) infusion-related reactions Discontinue treatment with Adakveo. g. antipyretic, analgesic and/or antihistamine. g. treatment of anaphylaxis).

Special populations Elderly Crizanlizumab has not been studied in elderly patients. No dose adjustment is required as the pharmacokinetics of crizanlizumab in adults are not affected by age. 2). Data from patients with severe renal impairment are too limited to draw conclusions on this population.

Hepatic impairment The safety and efficacy of crizanlizumab in patients with hepatic impairment have not been established. e. 2). Paediatric population The safety and efficacy of crizanlizumab in paediatric patients from 6 months to 16 years have not been established.

No data are available. There is no relevant use of crizanlizumab in infants aged less than 6 months for the indication of prevention of recurrent vaso-occlusive crises. 9%) solution for injection or dextrose 5% before administration.

2 micron in-line filter by intravenous infusion over a period of 30 minutes. It must not be administered by intravenous push or bolus. 6.

Summary of the safety profile The most frequently reported adverse drug reactions (≥10% of patients) in the Adakveo 5 mg/kg group were arthralgia, nausea, back pain, pyrexia and abdominal pain. 4). 9%). Severe pain events as part of infusion-related reactions were reported post-marketing.

Medicinal product no longer authorised 6 Tabulated list of adverse reactions Table 2 lists adverse reactions based on pooled data from two studies: the pivotal study, SUSTAIN, and a single-arm, open-label pharmacokinetics/pharmacodynamics and safety study.

Use of crizanlizumab in combination with HU/HC did not result in any meaningful differences in the safety profile. Adverse reactions reported in the post-marketing setting are also presented in table 2. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

g. potential infusion related reaction). This includes but is not limited to abdominal pain, arthralgia, back pain, bone pain, chest pain, general body pain, headache, muscle spasms, musculoskeletal pain, myalgia, pain in extremity. 4.

9%) among the 111 patients who received Adakveo 5 mg/kg. There was no evidence of altered pharmacokinetics or of an altered safety profile with anti-crizanlizumab antibody development. Paediatric population Frequency, type and severity of adverse reactions in patients aged 16 and 17 years are expected to be the same as in adults.

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. 8). In the post-marketing setting, cases of infusion-related reactions were reported, including severe pain events, differing in location, severity, and/or nature from patient’s baseline and requiring hospitalisation in several cases.

The majority of these infusion-related reactions occurred during infusion or within a few hours of the completion of the first or second infusion. However, later onset of severe pain events has also been reported, following previous well-tolerated infusions.

Some patients have also experienced subsequent complications such as acute chest syndrome and fat embolism, particularly those treated with steroids. 8). 2). 2. g. treatment of anaphylaxis). Laboratory test interference: automated platelet counts Interference with automated platelet counts (platelet clumping) has been observed in patients treated with crizanlizumab in clinical studies, in particular when tubes containing EDTA (ethylenediaminetetraacetic acid) were used.

This may lead to unevaluable or falsely decreased platelet counts. There is no evidence that crizanlizumab causes a reduction in circulating platelets or has a pro-aggregant effect in vivo. To mitigate the potential for laboratory test interference, it is recommended to run the test as soon as possible (within 4 hours of blood collection) or use citrate tubes.

When needed, platelet counts can be estimated via a peripheral blood smear. Excipients with known effect This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”.

1. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products. Medicinal product no longer authorised 4