Prescribing Information can be found through the links in the Product Cards at the bottom of the page

<h3>Toujeo® versus degludec 100 U/mL in people with T1DM8</h3>
One Care study8
The first real-world study to compare 2nd-generation basal insulin analogues, Toujeo® and degludec 100 U/mL, in people with T1DM, using continuous glucose monitoring.8
The primary endpoint of the One Care study was effectiveness of Toujeo® versus insulin degludec 100 U/mL in terms of percentage of time in the predetermined glucose range (70-180 mg/dL). Time in range over the course of a full day was similar in both groups (52.4% for those receiving Toujeo® versus 49.3% for the insulin degludec group. At night the time in range was significantly higher in the Toujeo® group (52.4% versus 46.2%, p=0.0209).8
One Care was an observational, retrospective cohort, cross‑sectional, multicentre study of continuous glucose monitoring data in 199 adults with T1DM in Spain comparing the effectiveness (using percentage of time‑in‑range 70‑180 mg/dL over 14 consecutive days within a 4‑week period) and safety of Toujeo® (insulin glargine 300 units/mL) versus degludec using continuous glucose monitoring in routine clinical practice.8

Limitations of the One Care study:8
<ul>
 <li>No randomisation</li>
 <li>No centralised laboratory</li>
 <li>No intensive control and monitoring of clinical practice</li>
 <li>The degludec 100 U/mL group presented a more severe course of disease (higher rates of retinopathy) compared with the Toujeo® group</li>
</ul>

Safety Profile

Abbreviations

References

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>
 <a href="${link:{uuid:{acd7760d-f31d-4d7e-8b21-2cdf496d1cc2},repository:{dam},path:{/Portal/UK/Prescribing-links/Lantus_GB_NI.pdf}}}">Prescribing Information&nbsp;UK</a> 
 &nbsp;
 &nbsp;</td>
 </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>
 <a href="${link:{uuid:{8cd02cf2-bd72-495f-b720-698ef8d3f0da},repository:{dam},path:{/Portal/UK/Prescribing-links/Toujeo.pdf}}}" target="_blank">Prescribing Information UK</a> 
 &nbsp;
 &nbsp;</td>
 </tr>
 </tbody>
</table>

Lantus® (insulin glargine 100 units/mL) Prescribing Information GB

Lantus® (insulin glargine 100 units/mL) Prescribing Information NI

Toujeo® (insulin glargine 300 units/mL) Prescribing Information UK

TYPE-1-DIABETES

DIABETES

Toujeo (insulin glargine 300 Units/mL) Versus insulin degludec 100 units/mL in T1DM

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A case study presented by Dr Sarah Lawless of an 81 year old RRMM patient who receives SARCLISA® + Pd at 4th Line. The case study demonstrates that elderly patients can tolerate triplet-based therapy and that egh Isa Pd should be considered for all eligible patients at 4th line.

MULTIPLE-MYELOMA

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A Real World Case Study:

Presented by Dr Sarah Lawless

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<a href="${link:{uuid:{5dabc6e6-c2fb-4d0b-a7a7-fe7742c3375f},repository:{dam},path:{/Portal/UK/Products/sarclisa/Sarclisa-PI-GB-May-2024_campus.pdf}}}">Prescribing information GB</a>

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SARCLISA®▼ (isatuximab) Prescribing Information GB

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
Prescribing Information for SARCLISA®▼&nbsp;(isatuximab) can be found via the Product Card at the bottom of the page.
<h2>In this video, you'll learn about</h2>
A case study presented by Christine Skeet of an 84 year old RRMM patient who receives SARCLISA® + Pd at 4th Line. The case study examines the practical considerations of managing an elderly patient with lytic bone disease and renal impairment.

A Real World Case Study:

Presented by Christine Skeet

Get in touch with 
 
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<a href="${link:{uuid:{55f30477-c7e2-49c0-8cfc-16966f28d4c2},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-GB-October-2022.pdf}}}" target="_blank">Prescribing Information(GB)</a>

<a href="${link:{uuid:{9e0d6f97-2ebb-4422-92ab-569b89c7dfe0},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-NI.pdf}}}" target="_blank">Prescribing Information(NI)</a>

Praluent®&nbsp;can be injected subcutaneously into the thigh, abdomen or upper arm. Patients should rotate the injection site with each injection.1
<h2>Ease of use assessed as ≥9.8 out of 10 in all assessments for both devices*2</h2>

*Study of 69 patients who randomly received unsupervised, self-administered alirocumab 300 mg via 1 x 300 mg injection with the SYDNEY device (n=35) or 2 x 150 mg injections with the currently approved auto-injector (n=34). Possible answers ranged from 1 (very dissatisfied) to 10 (very satisfied). 
 **Evaluated in a cross-sectional, non-interventional study involving 151 patients enrolled in Praluent® phase 3 trials. 
 SmPC=summary of product characteristics.
<h3>Up to 30 days out of the fridge1</h3>
<ul>
 <li>Store in a refrigerator (2°C to 8°C). Do not freeze</li>
 <li>PRALUENT®&nbsp;can be kept outside a refrigerator below 25°C and protected from light for a single period not exceeding 30 days</li>
 <li>After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.</li>
</ul>
Although many patients requiring lipid lowering therapies are not experienced with self-injected medication, in a real world study, results indicated that the pre-filled pen was well-accepted by patients.6

<table border="1" cellpadding="1" cellspacing="1" style="width: 100%;">
 <tbody>
 <tr>
 <td>
 <h3>Dosage information</h3>
 The usual starting dose for PRALUENT®&nbsp;is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (&gt;60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously. The dose of PRALUENT®&nbsp;can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks. If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.</td>
 </tr>
 </tbody>
</table>

<a href="/uk/dyslipidaemia">SEE MORE FROM SCIENCE</a>

<h3>Praluent®</h3>
Find more information on Indication, Administration and Mechanism of Action and watch videos about Praluent®.

<h3>Patient Website</h3>
Find resources and support for your patients on Praluent®. Find useful links about how patients can manage their cholesterol.

Get in touch with the Dyslipidaemia Team

Praluent® (alirocumab) Prescribing Information (GB)

Praluent® (alirocumab) Prescribing Information (NI)

DYSLIPIDEMIA

CARDIOLOGY

Praluent® (alirocumab) Administration

<a href="${link:{uuid:{55f30477-c7e2-49c0-8cfc-16966f28d4c2},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-GB-October-2022.pdf}}}">Prescribing Information(GB)</a>

<h2>Primary hypercholesterolaemia and mixed dyslipidaemia1</h2>
<ul>
 <li>PRALUENT®&nbsp;is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: 
 <ul>
 <li>in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or</li>
 <li>alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated</li>
 </ul></li>
</ul>
<h2>Established atherosclerotic cardiovascular disease1</h2>
<ul>
 <li>
 PRALUENT®&nbsp;is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels as an adjunct to correction of other risk factors:
 <ul>
 <li>
 in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies, or</li>
 <li>
 alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated</li>
 </ul></li>
</ul>

Therapeutic indications for Praluent® (alirocumab)

<a href="${link:{uuid:{9e0d6f97-2ebb-4422-92ab-569b89c7dfe0},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-NI.pdf}}}">Prescribing Information(NI)</a>

Figure © Sanofi.

Specific characteristics of Praluent® (alirocumab)

<h2>NICE GUIDANCE</h2>
Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if LDL-C concentrations are persistently above the thresholds specified in the table below despite maximal tolerated lipid-lowering therapy1&nbsp;and the company provides alirocumab with the discount agreed in the patient access scheme.

Table 1. Treatment groups and LDL-C thresholds for alirocumab prescribing&nbsp;(Adapted from NICE TA393)1

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td rowspan="2" style="background-color: black;">
 Patient populations</td>
 <th rowspan="2" style="background-color: rgb(0, 155, 195);">
 Without CVD</th>
 <th colspan="2" rowspan="1" style="background-color: rgb(0, 155, 195);">
 With CVD</th>
 </tr>
 <tr>
 <th style="background-color: rgb(0, 155, 195);">
 High risk of CVD†</th>
 <th style="background-color: rgb(0, 155, 195);">
 Very high risk of CVD‡</th>
 </tr>
 <tr>
 <td>
 Primary non-familial hypercholesterolaemia or mixed dyslipidaemia</td>
 <td>
 Not recommended&nbsp;at any LDL-C concentration</td>
 <td>
 Recommended only if LDL-C concentration is persistently above 4.0mmol/L</td>
 <td>
 Recommended only if LDL-C concentration is persistently above 3.5 mmol/L</td>
 </tr>
 <tr>
 <td>Primary heterozygous-familial hypercholesterolaemia</td>
 <td>Recommended only if LDL-C concentration is persistently above 5.0 mmol/L</td>
 <td colspan="2" rowspan="1">Recommended only if LDL-C concentration is peristently above 3.5 mmol/L</td>
 </tr>
 </tbody>
</table>

NICE recommended lipid-lowering pathway
†&nbsp;High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke, peripheral arterial disease.
‡&nbsp;Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).
Some patients with hypercholesterolaemia or mixed dyslipidaemia, including those with heterozygous familial hypercholesterolaemia (HeFH), do not reach NICE-recommended LDL-C goals despite lifestyle changes and maximal treatment with standard therapy (statins with or without ezetimibe)2-4
NICE did not make separate recommendations for patients with statin intolerance. NICE considered that people who cannot take statins may have higher than average LDL-C levels, and therefore may meet the LDL-C thresholds needed to start treatment with alirocumab.
NICE assessment
<ul>
 <li>The Technology Appraisal Guidance (TA393) for alirocumab was issued on 22 June 2016</li>
</ul>

<h2>SMC GUIDANCE</h2>
Alirocumab is a treatment option in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated, with the following restrictions:

Alirocumab is for specialist use only in patients at high cardiovascular (CV) risk with LDL-C values as shown in Table 1 below.
Table 1. Treatment groups and LDL-C values for Praluent®&nbsp;prescribing in NHS Scotland
<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 </tbody>
 <tbody>
 <tr>
 <td style="background-color:#009bc3">
 High risk patient group</td>
 <td>
 LDL-C threshold</td>
 </tr>
 </tbody>
 <tbody>
 <tr>
 <td style="background-color:#009bc3">
 HeFH</td>
 <td>
 ≥5.0mmol/L</td>
 </tr>
 <tr>
 <td style="background-color:#009bc3">
 HeFH and prior CV event</td>
 <td>
 ≥3.5mmol/L</td>
 </tr>
 <tr>
 <td style="background-color:#009bc3">
 Previous CV events</td>
 <td>
 ≥4.0mmol/L</td>
 </tr>
 <tr>
 <td style="background-color:#009bc3">
 Recurrent/polyvascular events</td>
 <td>
 ≥3.5mmol/L</td>
 </tr>
 </tbody>
</table>

Table adapted from SMC 1147/16 (2016)5
SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of Praluent®&nbsp;and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
* LDL-C concentrations must be persistently above defined thresholds

<h2>Get in touch with the Dyslipidaemia Team</h2>

NICE and SMC Guidance Praluent® (alirocumab) 

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