What is Normosang used for?
- Treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria).
How does Normosang work?
Normosang injection contains human hemin, which is a substance derived from human blood. It is used to treat a group of conditions called acute hepatic porphyrias. These are rare inherited metabolic disorders that cause problems with the production of a protein called haem.
Haem (sometimes spelt heme) is needed by the body to produce haemoglobin, which is the red coloured protein that carries oxygen in the blood. Haem is also needed by the body to produce other haemoproteins, including some in the liver that are involved in metabolising drugs and other chemicals.
Haem is usually produced in the body through a complex pathway of chemical reactions. Each stage is controlled by a specific chemical called an enzyme. In porphyria, there is a defect with one or more of these specific enzymes. The enzyme defect stops one or more of the chemical reactions in the pathway from happening, and this stops the pathway from reaching its end and producing haem. Instead, it causes a build up of one or more of the intermediate chemicals in the pathway. These intermediate chemicals are called porphyrins. In hepatic porphyrias the porphyrins build up in the liver, causing symptoms such as severe abdominal pain, nausea, vomiting, constipation, confusion and more severe neurological problems such as muscle paralysis.
Usually, once the body has produced enough haem this stops the pathway from producing more haem until more is needed. However, if the pathway doesn't get to the end, the chemical reactions at the start will keep happening, causing more and more intermediate porphyrins to build up. This leads to an 'acute attack' of porphyria.
Human hemin injection is given to supplement the body with haem. This stops the body trying to produce haem naturally and so halts the formation of the intermediate porphyrins. This controls an acute attack of porphyria.
How is Normosang given?
- Normosang is given as a drip into a vein (intravenous infusion).
- The drip is usually given over at least half an hour, once a day for four days.
- The treatment should be started as soon as possible after the onset of an attack. The earlier the treatment starts, the greater its effectiveness.
Normosang should not be used in
- People who are allergic to any ingredient.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction after having this medicine you should inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been studied by the manufacturer. However, the manufacturer does state that to date, no after-effects have been observed in new-born babies whose mothers were treated with Normosang during their pregnancy. Clearly it should only be used during pregnancy if considered essential by your doctor. This is a specialist area and you should ask your doctor for further medical advice.
- It is not known if this medicine passes into breast milk and it should only be used to treat mothers who are breastfeeding if considered essential by your doctor. Again, this is a specialist area and you should ask your doctor or pharmacist for further advice about whether it is safe to continue breastfeeding during or straight after your treatment.
Possible side effects of Normosang
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Pain or swelling at the infusion site.
- Inflammation of the wall of the vein where the infusion is given, with a blood clot forming in the affected segment of vein (local thrombophlebitis).
- Fever (high temperature).
- Allergic reactions such as tongue swelling, skin rash or anaphylaxis (rare).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.
You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.
How can Normosang affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you are treated with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.
Human hemin may increase the production of haemoproteins in the liver that breakdown certain medicines, such as those listed below. This could decrease the level of these medicines in the blood and may make them less effective:
- oestrogens (including oral contraceptives)
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