Product Information
Registration Status: ActiveAJOVY
AJOVY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 225 MG/1.5ML is approved to be sold in Singapore with effective from 2020-05-08. It is marketed by DRUG HOUSES OF AUSTRALIA PTE LTD, with the registration number of SIN15937P.
This product contains Fremanezumab 225 mg/1.5 ml in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Vetter Pharma-Fertigung GmbH & Co. KG in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Fremanezumab is a genetically engineered humanized monoclonal antibody against human calcitonin gene-related peptide (CGRP) that is developed by Teva [A33105]. This therapy is given as a monthly subcutaneous injection and ongoing clinical trials for the agent are for episodic and chronic migraine as well as cluster headaches [A33114].
Indication
The ongoing trials for fremanezumab are for episodic and chronic migraine prevention and also for cluster headache [A33114].
Mechanism of Action
Fremanezumab is a genetically engineered humanized monoclonal antibody that is specifically directed against calcitonin gene-related peptide (CGRP) alpha and beta [A33105, A33114]. Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy [A33090]. Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients [A33090]. For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for fremanezumab to take advantage of in reversing the migraine-inducing activity of natural CGRP. The binding of fremanezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example. Studies have also shown that humanized monoclonal antibodies against CGRP have proven successful in reducing the frequency of migraine headaches in early clinical trials as a preventative therapeutic [A33112].
Pharmacokinetics
- Absorption
- Geometric mean ratios (GMRs) for Cmax for Japanese and Caucasian study subjects were 0.91, 1.04, and 1.14 for 225 mg, 675 mg, and 900 mg doses of fremanezumab [A33125]. GMRs for AUC (0-inf) were 0.96, 1.09, and 0.98, respectively [A33125]. Mean Tmax in a range of 5 to 11 days were similar across doses for both ethnicities as well [A33125].
- Distribution
- Readily accessible data regarding the volume of distribution of fremanezumab is not available.
- Metabolism
- Monoclonal antibody agents like fremanezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids [F94].
- Elimination
Clearance
Readily accessible data regarding the clearance of fremanezumab is not available.
Toxicity
The most common adverse events that led to discontinuation of fremanezumab therapy in a clinical trial for the agent include injection site erythema, injection site induration, diarrhea, anxiety, and depression [L2843].
Active Ingredient/Synonyms
Fremanezumab | Fremanezumab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.