- Approval Id
- c5e98e6f080cdc10
- Drug Name
- PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 75MG/ML
- Product Name
- PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 75MG/ML
- Approval Number
- SIN15228P
- Approval Date
- 2017-04-27
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Adults</em><br>
Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.</p>
<p>The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks, since the majority of patients achieve sufficient LDL-C reduction with this dosage. An alternative starting dosage for patients who prefer less frequent dosing is 300 mg once every 4 weeks (monthly). Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks.</p>
<p>For patients receiving Praluent 75 mg every 2 weeks, measure LDL-C levels within 4 to 8 weeks of initiating Praluent. If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. Reassess LDL-C within 4 to 8 weeks.</p>
<p>For patients receiving Praluent 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, since in some patients LDL-C can vary considerably between doses with this regimen. If LDL-C reduction is inadequate, the dosage may be adjusted to 150 mg every 2 weeks, starting the new dose on the next scheduled dosing date. Reassess LDL-C within 4 to 8 weeks.</p>
<p><em>HeFH in paediatric patients 8 years of age and older</em></p>
<img src="/TGIF/Praluent-Table1.png" alt="Praluent Dosage Table 1" /><br><br>
<p><em>Missed dose</em></p>
<p>If an every-2-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient’s original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.</p>
<p>If an every-4-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient’s original schedule. If the missed dose is not administered within 7 days, instruct the patient to administer the dose, starting a new schedule based on this date.</p>
<p><u>Special populations</u></p>
<p><em>Paediatric population</em><br>
The safety and efficacy of Praluent in children less than 8 years of age have not been established. No data are available.</p>
<p><em>Elderly</em><br>
No dose adjustment is needed for elderly patients.</p>
<p><em>Hepatic impairment</em><br>
No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal impairment</em><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Body weight</em><br>
No dose adjustment is needed in patients based on weight.</p>
<p><u>Method of administration</u></p>
<p>Subcutaneous use.<br>
Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.<br>
To administer the 300 mg dose, two 150 mg injections should be given consecutively at two different injection sites.<br>
It is recommended to rotate the injection site with each injection.<br>
Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.<br>
Praluent must not be co-administered with other injectable medicinal products at the same injection site.</p>
<p><em>Precautions to be taken before handling or administering the medicinal product</em><br>
The solution should be allowed to warm to room temperature prior to use (see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Each pre-filled pen is for single use only.</p>
<p><em>Paediatric patients 8 years of age and older</em><br>
In adolescents 12 years of age and older, it is recommended that Praluent be administered by or under the supervision of an adult.<br>
In children less than 12 years of age, Praluent must be given by a caregiver.</p>
<p><em>Adults</em><br>
Adult patients 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.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><u>Prevention of Cardiovascular Events</u><br>
Praluent 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 is indicated:</p>
<ul class="dash">
<li>to reduce the risk of non-fatal myocardial infarction, ischemic stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.</li>
</ul>
<p><u>Primary hypercholesterolaemia and mixed dyslipidaemia</u><br>
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:</p>
<ul class="dash">
<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>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
