Praluent 75mg solution for injection in pre-filled pen

  • Name:

    Praluent 75mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    alirocumab

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/20

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Summary of Product Characteristics last updated on medicines.ie: 13/12/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 February 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 13 December 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 November 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 12 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 April 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 25 March 2019 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia

Summary of the Phase 3 Clinical Trials Program - 75 mg and/or 150 mg every 2 weeks (Q2W) dosing regimen

 

 

Evaluation of Cardiovascular (CV) events

A cardiovascular outcomes trial whose primary endpoint is adjudicated major adverse cardiovascular events (MACE, i.e. CHD death, myocardial infarction, ischemic stroke, and unstable angina requiring hospitalisation) is ongoing.

 

In pre-specified analyses of pooled phase 3 studies, treatment-emergent CV events confirmed by adjudication, consisting of coronary heart disease (CHD) death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalisation, congestive heart failure hospitalisation, and revascularisation, were reported in 110 (3.5%) patients in the alirocumab group and 53 (3.0%) patients in the control group (placebo or active control) with HR=1.08 (95% CI, 0.78 to 1.50).  Major adverse cardiovascular events (MACE-plus”, i.e.: CHD death, myocardial infarction, ischemic stroke, and unstable angina requiring hospitalisation) confirmed by adjudication were reported in 52 of 3182 (1.6%) patients in the alirocumab group and 33 of 1792 (1.8%) patients in the control group (placebo or active control); HR=0.81 (95% CI, 0.52 to 1.25).

In pre-specified final analyses of the LONG TERM study, treatment-emergent CV events confirmed by adjudication occurred in 72 of 1550 (4.6%) patients in the alirocumab group and in 40 of 788 (5.1%) patients in the placebo group; MACE-plus confirmed by adjudication were reported in 27 of 1550 (1.7%) patients in the alirocumab group and 26 of 788 (3.3%) patients in the placebo group. Hazard ratios were calculated post-hoc; for all CV events, HR=0.91 (95% CI, 0.62 to 1.34); for MACE-plus, HR=0.52 (95% CI, 0.31 to 0.90).

 

 

Clinical efficacy and safety in prevention of cardiovascular events 

 

ODYSSEY OUTCOMES study

A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years. Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT. Patients were randomized 1:1 to receive either alirocumab 75 mg once every two weeks (Q2W) or placebo Q2W. At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W. For patients who had their dose adjusted to 150 mg Q2W and who had two consecutive LDL-C values below 25 mg/dL (0.65 mmol/L), down-titration from 150 mg Q2W to 75 mg Q2W was performed. Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion. Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W. Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W. Overall, 730 (7.7%) of 9451 patients switched to placebo. A total of 99.5% of patients were followed for survival until the end of the trial. The median follow-up duration was 33 months.

The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients. Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization. The mean LDL-C value at baseline was 92.4 mg/dL (2.39 mmol/L).

Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003). Alirocumab also significantly reduced the following composite endpoints: risk of CHD event; major CHD event; cardiovascular event; and the composite of all-cause mortality, non-fatal MI, and non-fatal ischemic stroke. A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98). The results are presented in Table 3.

Updated on 19 March 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 15 March 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

approval of a Cardiovascular Risk reduction variation

Updated on 27 September 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 28 June 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Section 4.8 to add flu-like illness as follows:-

Tabulated list of adverse reactions

  • The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).
  • The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known".

Not Known column added to table

Under General disorders and administration site conditions added:-

  • Flu-like illness

 

 

 

 

 

Updated on 21 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2016 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 19 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Variation Type II  Group C.I.4 and C.I.13: update of section 4.2 of the SmPC to include a 300 mg every 4 weeks dosing regimen, based on the results of study CHOICE I (MEA 005). Section 4.8, 5.1 and 5.2 of the SmPC and the PIL have also been updated to reflect the study results.  In addition, the MAH submitted the final study report of study CHOICE II (MEA 009) and additional analysis of the two studies

Updated on 26 July 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects

Updated on 14 July 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Posology

Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.

 

3

 

 

The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg administered subcutaneously once every 2 weeks.

The dose of Praluent can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 weeks after treatment initiation or titration, when steady-state LDL-C is usually achieved, and dose adjusted accordingly (up-titration or down-titration). Patients should be treated with the lowest dose necessary to achieve the desired LDL-C reduction.

If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment two weeks from the day of the missed dose.

Special populations

Paediatric population

The safety and efficacy of Praluent in children and adolescents less than 18 years of age have not been established. No data are available.

Elderly

No dose adjustment is needed for elderly patients.

Hepatic impairment

No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment.

Renal impairment

No dose adjustment is needed for patients with mild or moderate renal impairment. Limited data are available in patients with severe renal impairment (see section 5.2).

Body weight

No dose adjustment is needed in patients based on weight.

Method of administration

Subcutaneous use.

Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.

It is recommended to rotate the injection site with each injection.

Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.

Praluent must not be co-administered with other injectable medicinal products at the same injection site.

The patient may either self-inject Praluent, or a caregiver may administer Praluent, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.

Precautions to be taken before handling

Praluent should be allowed to warm to room temperature prior to use.

 

Praluent should be used as soon as possible after it has warmed up. (Ssee section 6.6)

 

Each pre-filled pen or pre-filled syringe is for single use only.

 


6.4 Special precautions for storage

Store in a refrigerator (2°C to 8°C). Do not freeze.

Time out of refrigeration should not exceed a maximum of 24 hours at temperatures below 25°C.Praluent can be stored outside the refrigerator (below 25 °C) protected from light for a single period not exceeding 30 days. After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.

Keep the pen or syringe in the outer carton in order to protect from light

Updated on 6 October 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 October 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided