Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Konakion MM Paediatric (Roche)

2 mg/0.2 mL in glass ampoules

Australian Medicines Handbook Section 7.4

Injecting neonates with vitamin K (phytomenadione) has been an effective method of preventing haemorrhagic disease of the newborn. In the early 1990s a possible link between these injections and childhood cancer was reported.1 Although other studies have not confirmed this link, the National Health and Medical Research Council advised that vitamin K could be given orally as an alternative to injection. The intramuscular formulation was not ideal for oral use and has now been replaced by a formulation which is approved for oral and intramuscular use.

Health professionals need to be aware that the new formulation has different regimens. Not only are repeat oral doses required for babies given vitamin K by mouth, but also for babies who are breast-fed following an injection. The regimens for prophylaxis are:

Healthy breast-fed neonates

  • 2 mg orally at birth, at 3-5 days and every two weeks thereafter while breast feeding
  • 1 mg intramuscularly at birth followed by either 1 mg intramuscularly or
  • 2 mg orally at 6-8 weeks (if the second dose is given orally, further doses every two weeks should be considered)

Healthy formula-fed neonates

  • 2 mg orally at birth and at 3-5 days
  • 1 mg intramuscularly at birth

Neonates at risk of haemorrhagic disease

  • 1 mg intramuscularly at birth second dose if fully breast-fed:
  • 1 mg intramuscularly at 6-8 weeks
  • 2 mg orally at 6-8 weeks and 2 mg orally every two weeks thereafter while breast feeding

To reduce the risk of late-onset bleeding, it is important to remind parents to ensure that the recommended repeat doses are given.