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Zypadhera is a brand name for Olanzapine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Verbatim from this product's EMA label. Tap a section to expand.
ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection. Posology Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response.
In order to identify the first ZYPADHERA dose for all patients the scheme in Table 1 should be considered. 3 Table 1 Recommended dose scheme between oral olanzapine and ZYPADHERA Target oral olanzapine dose Recommended starting dose of ZYPADHERA Maintenance dose after 2 months of ZYPADHERA treatment 10 mg/day 210 mg/2 weeks or 405 mg/4 weeks 150 mg/2 weeks or 300 mg/4 weeks 15 mg/day 300 mg/2 weeks 210 mg/2 weeks or 405 mg/4 weeks 20 mg/day 300 mg/2 weeks 300 mg/2 weeks Dose adjustment Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
During antipsychotic treatment, improvement in the patient’s clinical condition may take several days to some weeks. Patients should be closely monitored during this period. During treatment dose may subsequently be adjusted on the basis of individual clinical status.
After clinical reassessment dose may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks. (Table 1) Supplementation Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day. Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product and is considered medically appropriate.
Special populations Elderly ZYPADHERA has not been systematically studied in elderly patients (> 65 years). ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established.
4). Clinical signs and symptoms included symptoms of sedation (ranging from mild in severity up to coma) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment). Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Other adverse reactions observed in patients treated with ZYPADHERA were similar to those seen with oral olanzapine. 0%). 7% of patients. In clinical trials with ZYPADHERA the incidence of injection site related adverse reactions was approximately 8%.
The most commonly reported injection site related adverse reaction was pain (5%); some other injection site adverse reactions reported were (in decreasing frequency): nodule type reactions, erythema type reactions, non-specific injection site reactions, irritation, oedema type reactions, bruising, haemorrhage, and anaesthesia.
1% of patients. In a review of safety data from clinical trials and spontaneous postmarketing reports, injection site abscess was rarely (≥ 1/10,000 to < 1/1,000) reported. Adverse reactions seen with olanzapine The undesirable effects listed below have been observed following administration of olanzapine.
4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema. Tabulated list of adverse reactions The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency terms listed are defined as follows:
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 data available). 6) Reproductive system and breast disorders Erectile dysfunction in males Decreased libido in males and females Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/ breast enlargement in males Priapism12 12 General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10 Injection site pain Injection site abscess Investigations Elevated plasma prolactin levels8 Increased alkaline phosphatase10 High creatine phosphokinase11 High Gamma Glutamyltransfera se 10 High uric acid 10 Increased total bilirubin 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
6). Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
Post-injection syndrome During pre-marketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose, were reported in patients following an injection of ZYPADHERA. 1% of injections and approximately 2% of patients.
Most of these patients have developed symptoms of sedation (ranging from mild in severity up to coma) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment). Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
In most cases, initial signs and symptoms related to this reaction have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 – 72 hours after injection. Reactions occurred rarely (<1 in 1,000 injections) between 1 and 3 hours, and very rarely (<1 in 10,000 injections) after 3 hours.
Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered. Post-marketing reports of post-injection syndrome since the marketing authorization of ZYPADHERA are generally consistent with the experience seen in clinical studies.
After each injection, patients should be observed in a healthcare facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose. 5 Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
1. Patients with known risk of narrow-angle glaucoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Olanzapine in European Union.
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A lower starting dose (150 mg/4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant. 4). Renal and/or hepatic impairment Unless a well-tolerated and effective dose regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used.
A lower starting dose (150 mg every 4 weeks) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers. The metabolism of olanzapine may be induced by smoking. 5). When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
When indicated, dose escalation should be performed with caution in these patients. 4 Paediatric population The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established. 1 but no recommendation on a posology can be made.
Method of administration FOR INTRAMUSCULAR USE ONLY. 4) ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured.
After each injection, patients should be observed in a health care facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose. Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
). The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose. 6.
8 %). 3 % respectively). 2 Mean […]
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved. The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose.
7). 5). Injection site related adverse events The most commonly reported injection site related adverse reaction was pain. The majority of these reactions was reported to be of “mild” to “moderate” severity. 8). Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
5% vs. 5%, respectively). 4 mg) or duration of treatment. , pneumonia, with or without aspiration), or concomitant use of benzodiazepines. However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors.
, stroke, transient ischemic attack), including fatalities, were reported. 3% vs. 4%, respectively). All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors. Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
The efficacy of olanzapine was not established in these trials. Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended. 8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement. Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal products. Rare cases reported as NMS have also been received in association with oral olanzapine.
Clinical manifestations of NMS are hyperpyrexia, muscle […]