MEGAFOL

What it is

MEGAFOL is a folic acid injection containing 15 mg of folic acid per 1 mL of solution. The injection is a clear, yellow solution. MEGAFOL may be administered by intramuscular, intravenous or subcutaneous injection. Although MEGAFOL can be given undiluted for intramuscular or subcutaneous use, it must be diluted before intravenous use.

Approved indications

— Megaloblastic anaemia where the anaemia has been proven to be due to folate deficiency only. — Prevention of folic acid deficiency in pregnancy and lactation.

Dosing overview

For treatment of megaloblastic anaemia in adults, 1–5 mg per day is recommended, with dosage adjusted according to the severity of the anaemia and the presence or absence of malabsorption syndromes. For pre-term infants less than 2 kg body weight, 100–200 micrograms daily should be used. For infants 5–12 months of age, satisfactory response has been obtained using 50 micrograms daily. For prophylaxis in pregnancy and lactation, 500 micrograms of folic acid per day prevented signs of folic acid deficiency in well-nourished pregnant women.

Key safety warnings

MEGAFOL may correct the haematological features of vitamin B12 deficiency without correcting the progressive neurological damage due to vitamin B12 deficiency; therefore vitamin B12 deficiency needs to be excluded before treatment with MEGAFOL alone. Patients receiving diphenylhydantoin treatment should be monitored for possible loss of seizure control following large doses of MEGAFOL. MEGAFOL does not correct folate deficiency due to dihydrofolate reductase inhibitors such as methotrexate; folinic acid should be used for this purpose. Caution is advised in patients who may have folate-dependent tumours.

Contraindications

MEGAFOL is contraindicated in patients who may be hypersensitive to it, although anaphylactic reactions are rare. MEGAFOL should not be prescribed for megaloblastic anaemia due to vitamin B12 deficiency.

PBS listing

The tablet 5 mg formulation is listed on the PBS with 2 items; one item is unrestricted and one is restricted, with an ex-manufacturer price of A$2.92.

Regulatory history

MEGAFOL 5 mg tablets were first listed on the ARTG on 20 September 1991, and MEGAFOL 0.5 mg tablets were first listed on 21 October 1991.