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Zinbryta is a brand name for Daclizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by a physician experienced in the management of multiple sclerosis. Posology The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month. In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule.
If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule. Medicinal product no longer authorised 3 Special populations Elderly population There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
It has not been determined whether these patients respond differently compared with younger patients. Renal impairment Daclizumab beta has not been studied in patients with renal impairment. 2). Hepatic impairment Daclizumab beta has not been studied in patients with hepatic impairment.
4). Paediatric population The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established. No data are available. Method of administration Zinbryta is for subcutaneous use. It is recommended that patients should be trained in the proper technique for self-administering subcutaneous injection using the pre-filled syringe/pre-filled pen.
The usual sites for subcutaneous injection include the thigh, abdomen, and back of the upper arm. Zinbryta is provided with the needle pre-attached. Pre-filled syringes/Pre-filled pens contain a single dose only and should be discarded after use.
Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection. External heat sources such as hot water must not be used to warm Zinbryta.
This medicinal product should not be used if: • the syringe/pen is cracked or broken • the solution is cloudy or you can see particles floating in it • the solution is any other colour than colourless to slightly yellow • the pen has been dropped or is visibly damaged.
Summary of the safety profile In the placebo-controlled study (the SELECT study), 417 patients received Zinbryta (150 mg, n=208; 300 mg, n=209; every 4 weeks) for up to 1 year. In the active-controlled study (the DECIDE study), 919 patients received Zinbryta (150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular, (30 microgram weekly) for a minimum of 2 years and up to 3 years.
Medicinal product no longer authorised 7 The most common adverse reactions reported for Zinbryta were rash, increased alanine aminotransferase (ALT), depression, nasopharyngitis, upper respiratory tract infection, influenza, oropharyngeal pain, and lymphadenopathy.
Tabulated list of adverse reactions The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Order Class by frequency and incidence. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The incidence of the adverse reactions is expressed according to the following categories: • 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) Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class Adverse reaction Frequency Infections and infestations Upper respiratory tract infection† Very Common Nasopharyngitis† Very Common Pneumonia Common Respiratory tract infection Common Bronchitis Common Viral infection Common Influenza† Common Laryngitis Common Tonsillitis† Common Pharyngitis Common Folliculitis Common Rhinitis* Common Blood and lymphatic system disorders Lymphadenopathy† Common Lymphadenitis Common Anaemia* Common Autoimmune haemolytic anaemia Uncommon Immune system disorders Sarcoidosis Uncommon Psychiatric disorders Depression* Common Respiratory, thoracic and mediastinal disorders Oropharyngeal pain† Common Gastrointestinal disorders Diarrhoea Common Colitis Common Skin and subcutaneous tissue disorders Dermatitis Common Dermatitis allergic Common Eczema† Common Psoriasis Common Seborrhoeic dermatitis† Common Skin exfoliation Common Rash*† Common Rash maculopapular Common Acne† Common Erythema Common Pruritus Common Dry skin CommonMedicinal product no longer authorised 8 Exfoliative rash Uncommon Toxic skin eruption Uncommon Eczema nummular Uncommon General disorders and administration site conditions Pyrexia* Common Hepatobiliary disorders Transaminases increased Very common Autoimmune hepatitis Uncommon Fulminant hepatitis Not known Investigations Liver function test abnormal Very common Lymphocyte count decreased Common *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular) Description of selected adverse reactions Hepatic injury Serious hepatic injury, including fatal cases of autoimmune hepatitis and fulminant liver failure have occurred in patients treated with Zinbryta.
1). 8). Cases occurred early after treatment initiation, in patients having received repeated treatment courses and several months after discontinuation. Prior to treatment initiation with Zinbryta, serum transaminases (ALT and AST) and total bilirubin levels should be obtained, and patients should be screened for Hepatitis B (HBV) and C (HCV).
3). For patients who test positive for HBV or HCV infection, consultation with a physician with expertise in the treatment of HBV or HCV is recommended. Treatment initiation is not recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently as clinically indicated during treatment and up to 6 months after the last dose of Zinbryta.
Treatment discontinuation is recommended in patients who reach ALT or AST >3 times the ULN regardless of bilirubin levels. Patients should be informed about the risk of hepatic injury, the need for periodic monitoring and warned about signs or symptoms suggestive of hepatic dysfunction.
g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist.
Treatment discontinuation should be considered if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring. 5). Refer to section below, ‘Educational Guidance’, for details of the Hepatic Risk Management Guide for Physicians and Patient Card that are recommended for use with this medicine.
Educational guidance All physicians who intend to prescribe Zinbryta must ensure they are familiar with the Hepatic Risk Management Guide for Physicians for this medicinal product. The physician should discuss the risk of hepatic injury with patients and provide them with a Patient Card.
g. 1). Medicinal product no longer authorised 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Daclizumab in European Union.
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7% of patients in clinical trials. In clinical studies, serum transaminase elevations occurred at any time during treatment and up to 6 months after the last dose of Zinbryta. Most patients had mild elevations that were below or up to 3 x ULN and resolved spontaneously.
In clinical trials, an increased incidence of elevations of ALT or AST was reported more frequently in Zinbryta-treated patients compared to placebo or interferon beta- 1a (intramuscular). The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular).
Table 2. Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials Skin reactions In clinical studies Zinbryta increased the incidence of skin reactions [18% vs 13% (placebo); 37% vs 19% (interferon beta-1a (intramuscular))] and serious skin reactions [<1% vs 0% (placebo); 2% vs <1% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
The most common skin reactions were rash, dermatitis, and eczema. The majority of patients had skin reactions that were mild or moderate in severity. Discontinuation due to skin reactions was 4% in Zinbryta-treated patients. 5%Medicinal product no longer authorised 9 Depression In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was <1% with Zinbryta.
Infections In clinical studies, Zinbryta increased the incidence of infections [50% vs 44% (placebo) and 65% vs 57% (interferon beta-1a (intramuscular))] and serious infections [3% vs 0% (placebo); 4% vs 2% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
The most common types of infections were upper respiratory tract infections and viral infections. The median duration was similar between the treatment groups. The rate of infections and serious infections did not increase over time.
The majority of patients with infections continued on treatment with Zinbryta. Discontinuation of Zinbryta due to infections was <1%. Autoimmune haemolytic anaemia Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Gastrointestinal disorders An increased incidence of […]
The Card informs patients of the risk of serious hepatic injury, and its possible symptoms, so that they are aware of situations in which they should contact a healthcare professional in a timely manner. In addition, the Card explains the need for monitoring of liver function and educates the patient on the importance of adherence to their monthly blood tests.
g. exfoliative rash or dermatitis, toxic skin eruption), have been reported with Zinbryta. Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids. Medicinal product no longer authorised 5 Depression Zinbryta should be administered with caution to patients with previous or current depressive disorders.
Patients treated with Zinbryta should be advised to report any symptoms of new or worsening depression, and/or suicidal ideation immediately to the prescribing physician. 8). g. pneumonia and bronchitis), have been reported with Zinbryta.
If serious infection develops, it could be necessary to withhold treatment with Zinbryta until the infection resolves. Tuberculosis infections have been reported in patients treated with Zinbryta. In patients who have had tuberculosis or who live in endemic areas of the disease, screening for active tuberculosis should be performed before starting treatment, and patients should be monitored during treatment.
8). Zinbryta has not been studied in patients with immunodeficiency syndromes. Autoimmune haemolytic anaemia Autoimmune haemolytic anaemia has been reported in patients treated with Zinbryta which resolved with standard treatment and discontinuation of Zinbryta.
g. 8). Gastrointestinal disorders Colitis has been reported with Zinbryta. The colitis improved with discontinuation of Zinbryta and standard treatment. g. 8). Lymphopenia When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3).
Sustained severe lymphopenia (< 500/mm3), was not observed in clinical studies with Zinbryta. However, as a precaution, monitoring of complete blood count is recommended every 3 months. The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Excipient related considerations This medicinal product […]