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Fremanezumab parenteral

Updated 2 Feb 2023 | Migraine prophylaxis

Presentation

Injections of fremanezumab.

Drugs List

  • AJOVY 225mg/1.5ml solution for injection pre-filled pen
  • AJOVY 225mg/1.5ml solution for injection pre-filled syringe
  • fremanezumab 225mg/1.5ml solution for injection pre-filled device
  • fremanezumab 225mg/1.5ml solution for injection pre-filled syringe
  • Therapeutic Indications

    Uses

    Migraine in adults: prophylaxis

    Prophylaxis of migraine in adults who have at least 4 migraine days per month.

    Dosage

    Adults

    225mg once monthly.

    Alternatively 675mg every three months.

    When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.

    Concomitant migraine preventive treatment may be continued if necessary.

    Additional Dosage Information

    A missed dose should be resumed as soon as possible at the indicated dose and regimen. A double dose should not be administered.

    Administration

    Fremanezumab is for subcutaneous injection only.

    Contraindications

    Children under 18 years
    Pregnancy

    Precautions and Warnings

    Patients over 65 years
    Breastfeeding
    Severe cardiovascular disorder
    Severe renal impairment

    Treatment to be initiated by specialist
    Do not use if contents have been frozen
    Record name and batch number of administered product
    Assess benefit within 3 months and evaluate continued need regularly
    Discontinue if hypersensitivity reactions occur
    Discontinue if serious allergic or anaphylactic reaction occurs

    Hypersensitivity reactions have been reported with the use of fremanezumab within hours to one month after administration.

    Pregnancy and Lactation

    Pregnancy

    Fremanezumab is contraindicated during pregnancy.

    The manufacturer recommends avoiding fremanezumab during pregnancy.

    At the time of writing there is limited data available regarding fremanezumab in pregnancy, animal studies do not indicate harmful effects with respect to reproductive toxicity.

    Lactation

    Use fremanezumab with caution during breastfeeding.

    The manufacturer advises caution if fremanezumab is used when breastfeeding. The presence of fremanezumab in human breast milk is unknown. However, human IgG is excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards, consequently, a risk to the infant cannot be excluded during this short period. Afterwards, fremanezumab could be considered during breastfeeding only if clinically needed. Effects on breastfed infants are unknown.

    LactMed (2020) indicates that since fremanezumab is a large protein molecule with a molecular weight of about 148,000, the amount in breast milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

    Side Effects

    Anaphylactic reaction
    Erythema at injection site
    Hypersensitivity reactions
    Induration (injection site)
    Itching (injection site)
    Local pain (injection site)
    Pruritus
    Rash
    Rash at injection site
    Swelling
    Urticaria

    Further Information

    Last Full Review Date: November 2021

    Reference Sources

    Summary of Product Characteristics: Ajovy 225mg pre-filled syringe for injection. Teva UK Ltd. Revised February 2022.

    Summary of Product Characteristics: Ajovy 225mg pre-filled pen for injection. Teva UK Ltd. Revised February 2022.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Fremanezumab. Last revised: 20 July 2020.
    Last accessed: 20 December 2021.

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