- Approval Id
- 822148ed2cf67459
- Drug Name
- NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 60 MG/1.2ML
- Product Name
- NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 60 MG/1.2ML
- Approval Number
- SIN16912P
- Approval Date
- 2023-12-14
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- 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>The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous (SC) injection.</p>
<p>For patients switching from daily growth hormone medicinal products, the weekly therapy with NGENLA may be initiated on the day following their last daily injection.</p>
<p><u>Method of administration</u></p>
<p>NGENLA can be given in the abdomen, thighs, buttocks, or upper arms. The site of injection should be rotated weekly.</p>
<p>If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.</p>
<p>Administer NGENLA once weekly, on the same day each week, at any time of the day.</p>
<p><u>Dose titration</u></p>
<p>NGENLA dose may be adjusted as necessary, based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor 1 (IGF-1) concentrations. When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. IGF-1 values should be maintained below +2 standard deviation score (SDS).</p>
<p>Dose adjustments should be targeted to achieve average IGF-1 SDS levels in the normal range, i.e., between -2 and +2 (preferably close to 0 SDS). In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of NGENLA should be reduced by 15%. More than one dose reduction may be required in some patients.</p>
<p><u>Missed dose</u></p>
<p>If a dose is missed, administer NGENLA as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing scheduled.</p>
<p><u>Changing the dosing day</u></p>
<p>The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, the once weekly dosing should be continued.</p>
<p><strong>Please refer to the Instructions for Use for complete administration instructions</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p>NGENLA is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone (GH).</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>Based on experience with daily growth hormone products, NGENLA is contraindicated in patients with active tumors and/or malignancy.</p>
<p>Based on experience with pharmacologic amounts of daily growth hormone products, NGENLA is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>NGENLA is contraindicated in patients with known hypersensitivity to somatrogon (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) or any of its excipients (see 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
- H01AC08
- Atc Item Name
- somatrogon
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
