VITA-B12

What it is

Vita-B12 Injection 1 mg/mL contains hydroxocobalamin acetate equivalent to hydroxocobalamin 1 mg. Vita-B12 Injection solution is a clear pale red liquid. Vita-B12 Injection is to be administered intramuscularly.

Approved indications

— Prophylaxis and treatment of pernicious (Addisonian) anaemia and other macrocytic anaemias associated with vitamin B12 deficiency. — Treatment of optic neuropathies such as tobacco amblyopia and Leber's optic atrophy.

Dosing overview

Key safety warnings

Do not use intravenously. Hypokalaemia and cardiac arrest have been reported when megaloblastic anaemia is treated intensively. Serum potassium is to be carefully monitored during the initial phase of treatment in pernicious anaemia. Diagnosis of vitamin B12-deficiency should be confirmed by laboratory investigation before institution of hydroxocobalamin (vitamin B12) therapy. Do not use hydroxocobalamin until diagnosis is fully established, as it may mask symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia. Folic acid may potentiate the neurological complications of vitamin B12 deficiency, so should not be administered to patients with pernicious anaemia. Treatment with hydroxocobalamin may unmask polycythaemia vera, because vitamin B12 deficiency may suppress the symptoms of this condition.

Contraindications

Known sensitivity to hydroxocobalamin or any other ingredient in Vita-B12 Injection. Known sensitivity to cobalt. Hydroxocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy.

PBS listing

Vita-B12 Injection 1 mg (as acetate) in 1 mL is listed on the PBS as 2 items with restricted access at an ex-manufacturer price of A$3.97.

Regulatory history

Vita-B12 Injection hydroxocobalamin acetate 1 mg/1 mL was first registered on the Australian Register of Therapeutic Goods on 23 March 2012.