Darboren 25

Indications

Darbepoetin alfa is used to treat anaemia (a low red blood cell count) in:

• adults and children with long-term (chronic) kidney disease, whether or not they are on dialysis;
• adults with certain cancers (not blood cancers of the myeloid type) whose anaemia is caused by chemotherapy.

It helps reduce the need for blood transfusions.

How It Works

Healthy kidneys make a hormone called erythropoietin, which tells the bone marrow to make red blood cells. Damaged kidneys make too little, and chemotherapy can also slow red cell production. Darbepoetin alfa is a long-acting, laboratory-made form of this hormone. It stimulates the bone marrow to make more red blood cells, which raises the haemoglobin level.

Dosage and Administration

Darbepoetin alfa is an injection given under the skin or into a vein, usually by a doctor or nurse. Some patients are trained to inject it themselves at home.

The dose is worked out from body weight and haemoglobin level, as prescribed. It is usually given once a week, once every 2 weeks or once a month. The doctor adjusts the dose to keep haemoglobin in a safe target range and avoids raising it too fast or too high.

Iron levels are checked before and during treatment, and iron supplements are often needed. Do not shake the syringe. If a dose is missed, contact your doctor or nurse for advice.

Interactions

No important drug interactions are known. As haemoglobin rises, blood levels of Ciclosporin and Tacrolimus may change, so the doctor may check them more closely. Tell your doctor about all medicines you use.

Contraindications

Do not use Darbepoetin alfa if you:

• are allergic to Darbepoetin alfa, Erythropoietin or any ingredient of the product;
• have high blood pressure that is not controlled;
• have had pure red cell aplasia (the bone marrow stopping red cell production) after treatment with any erythropoietin product.

Side Effects

Common: high blood pressure, swelling, headache, rash, and pain, redness or bruising at the injection site.

Get urgent medical help if you have:

• chest pain, shortness of breath or a fast heartbeat;
• sudden weakness or numbness of the face, arm or leg, confusion, trouble speaking or a severe headache (signs of a stroke);
• pain, warmth or swelling in one leg, or sudden breathlessness (possible blood clot), or a clot in the dialysis access;
• a seizure (fit);
• a widespread rash with blisters or peeling skin;
• unusual tiredness, paleness or breathlessness that gets worse during treatment (possible pure red cell aplasia);
• swelling of the face or throat or difficulty breathing.

Pregnancy and Lactation

There is limited information on use in pregnancy. It is used only if the doctor decides it is clearly needed. It is not known whether Darbepoetin alfa passes into breast milk; the doctor will decide whether to continue breastfeeding or treatment.

Precautions and Warnings

• Keeping haemoglobin too high increases the risk of heart attack, stroke, blood clots and death. The doctor aims for the lowest dose that avoids transfusion.
• Blood pressure must be checked regularly and controlled.
• In patients with cancer, these medicines may shorten survival or speed up tumour growth in some cases; they are used only for chemotherapy-related anaemia and stopped when chemotherapy finishes.
• Tell your doctor if you have epilepsy, liver disease, sickle cell anaemia or a history of stroke or heart disease.
• Regular blood tests for haemoglobin and iron are needed.

Overdose

Too much can raise haemoglobin too high and cause dangerously high blood pressure. Contact your doctor at once. The doctor may pause treatment and, if needed, remove some blood.

Therapeutic Class

Haematopoietic agent; erythropoiesis-stimulating agent (ESA).

Storage

Store in a refrigerator at 2 to 8°C. Do not freeze and do not shake. Keep in the outer carton to protect from light. If allowed by the product leaflet, it may be kept at room temperature (below 25°C) for a short time only, as stated on the pack. Keep out of the reach of children.