- Approval Id
- 49c4ab1e7daa7163
- Drug Name
- AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 70MG/ML
- Product Name
- AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 70MG/ML
- Approval Number
- SIN15543P
- Approval Date
- 2018-09-21
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Dosage and Administration</strong></p>
<p><strong>4.2.1 Dosage</strong></p>
<p>The recommended dose of AIMOVIG is 70 mg administered once monthly.</p>
<p>Some patients may benefit from a dosage of 140 mg administered once monthly. See Clinical Data (5.1.1) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>If AIMOVIG dose is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.</p>
<p><strong>4.2.2 Method of Administration</strong></p>
<p>AIMOVIG is administered subcutaneously.</p>
<p>AIMOVIG is intended for patient self-administration.</p>
<p>Administration should be performed by an individual who has been trained to administer the product. To administer the 140 mg dose, give two consecutive subcutaneous injections of 70 mg each of AIMOVIG, or a single subcutaneous injection of 140 mg.</p>
<p>For detailed instructions on storage, handling and administration, follow the directions provided in the “Instructions for Use and Handling (6.6)” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>Important Administration Instructions</strong></p>
<ul>
<li>Visually inspect AIMOVIG for particles and discoloration. AIMOVIG is a clear to opalescent, colorless to light yellow solution. Do not use if the solution is cloudy or discolored or contains flakes or particles.</li>
<li>Administer AIMOVIG subcutaneously in the abdomen, thigh, or upper arm. If you want to use the same injection site, make sure it is not the same spot you used for a previous injection. Do not inject into areas where the skin is tender, bruised, red, or hard.</li>
<li>Both the prefilled syringe and the prefilled SureClick® autoinjector/pen are for single use and designed to deliver the entire contents with no residual content.</li>
<li>The needle shield within the white or orange cap of the prefilled autoinjector and the gray needle cap of the prefilled syringe contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.</li>
</ul>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong></p>
<p>AIMOVIG is indicated for prophylaxis of migraine in adults.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Aimovig is contraindicated in patients with serious hypersensitivity to erenumab or to any of the excipients. [See Special Warnings (4.4) and Precautions for Use, Adverse Reactions (4.8) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
- Atc Code
- N02CX07
- Atc Item Name
- xn 02 cx 07
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
