Information intended for healthcare professionals only.

This formulary decision guide was developed from content provided by Accord UK Ltd in a format developed by Guidelines in Practice.

View prescribing and adverse event reporting information here

Key points

FDG - Methofill

  • Methofill® Self Inject is a pre-filled injector containing methotrexate1
  • The self-injection device enables patients to confidently2 and easily3,4 administer a full dose
  • Methofill® Self Inject disposes into a ≥1.8 litre sharps bin and has a needle guard for sharp injury prevention5

 

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Drug name 

Methofill® (methotrexate)

Indications

  • Methofill® Self Inject is a pre-filled injector containing methotrexate and is indicated for:1
    • active rheumatoid arthritis in adult patients
    • polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate
    • severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients
    • mild to moderate Crohn’s disease ether alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Dosage

  • Methotrexate must be administered only once a week; it is advisable to determine an appropriate fixed day of the week for the injection1
  • Methofill® Self Inject is available in 10 strengths (50 mg/ml)1
  • See the Summary of Product Characteristics1 for dosage information.

Device

Methofill_Self_Inject_Image

  • Methofill® Self Inject contains a clear, yellow to brown solution1
  • Methofill® Self Inject is a pre-filled injector designed for self-administration; it contains a colourless pre-filled glass syringe with plunger stopper and embedded injection needle1
  • The device is easy to use3,4 and provides confidence that the full injection has been delivered2
    • large grip, which is easy to press down during delivery3
    • injection is completed when the orange body of the device is no longer visible1
    • a ‘click’ sound indicates full dose delivery1
    • a yellow band appears on the needle guard after use, indicating the needle guard has locked1
  • In a participant study with 30 participants (15 of whom had rheumatoid arthritis or psoriatic arthritis) delivering 60 injections to the abdomen and 60 to the thigh:
    • all participants stated they had no difficulty gripping or manipulating the device3
    • 100% of injections were delivered without discomfort or pain6
    • 90% of injections were rated ‘very easy’ or ‘easy’ to fully administer4
    • the participant felt ‘very confident’ or ‘confident’ they had delivered the full injection on 93% of occasions.2

Disposal and handling

  • Methotrexate is cytotoxic and should not come into contact with skin or mucosa; in the event of contamination, the affected area must be rinsed immediately with plenty of water1
  • Pregnant healthcare personnel should not handle or administer methotrexate1
  • Methofill® Self Inject dispose into a ≥1.8 litre sharps bin.

Instructions for use

  • Patients must be clearly informed that the therapy must be administered once a week, not daily1
  • Patients must be educated to use the proper injection technique; the first injection of methotrexate should be performed under direct medical supervision1
  • Methofill® Self Inject is for single use only and all of the contents should be used
  • The best places for the injection are the abdomen or thigh (for self-injection), with the option of the back of the arm if the patient is assisted by a healthcare provider or caregiver.

References

  1. Accord Healthcare Limited. Methofill solution for injection in pre-filled injector (7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg, 27.5 mg, 30 mg) – summaries of product characteristics. www.medicines.org.uk/emc/search?q=%22Methofill%22
  2. Data on File (UK&IE/MET/0005/05-17)
  3. Data on File (UK&IE/MET/0008/06-17)
  4. Data on File (UK&IE/MET/0006/05-17)
  5. Data on File (UK&IE/MET/0004/05-17)
  6. Data on File (UK&IE/MET/0009/06-17)

 

UK&IE/MET/0036/12-18b

Date of preparation: January 2019