- Approval Id
- a63cc8d8af1baf43
- Drug Name
- AJOVY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 225 MG/1.5ML
- Product Name
- AJOVY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 225 MG/1.5ML
- Approval Number
- SIN15937P
- Approval Date
- 2020-05-08
- Registrant
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Licence Holder
- TEVA PHARMACEUTICAL INVESTMENTS 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>The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.</p>
<p>Posology</p>
<p>Two dosing options are available:</p>
<ul>
<li>225 mg once monthly (monthly dosing) or</li>
<li>675 mg every three months (quarterly dosing)</li>
</ul>
<p>When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.</p>
<p>When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.</p>
<p><em>Missed dose</em><br>
If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be administered to make up for a missed dose.</p>
<p><em><u>Special Populations</u></em></p>
<p><em>Elderly</em><br>
There is limited data available on the use of fremanezumab in patients ≥65 years of age. Based on the results of population pharmacokinetic analysis, no dose adjustment is required (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 or hepatic impairment</em><br>
No dose adjustment is necessary in patients with mild to moderate renal impairment or 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>Paediatric population</em><br>
The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>Subcutaneous use.</p>
<p>AJOVY is for subcutaneous injection only. It should not be administered by the intravenous or intramuscular route. AJOVY can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, injection sites should be alternated.</p>
<p>Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional. For further instructions on administration, please refer to the patient information leaflet.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>AJOVY is indicated for the preventive treatment of migraine in adults.</p>
- 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
- N02CD03
- Atc Item Name
- fremanezumab
- Pharma Manufacturer Name
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
