DESFERAL (DESFERRIOXAMINE) 500MG Vial 10’S

DESFERAL contains desferrioxamine mesilate, a powerful iron chelating agent that binds excess iron in the body and removes it through urine and feces. Desferrioxamine also chelates aluminium, making it useful in aluminium toxicity.

DESFERAL is indicated for:

·       chronic iron overload due to regular blood transfusions (transfusion-dependent anaemias such as thalassaemia major, sickle cell disease, and myelodysplastic syndrome)

·       haemochromatosis where phlebotomy is not feasible; aluminium overload in patients on haemodialysis

·       and acute iron poisoning (emergency use).

In thalassaemia major, patients typically require lifelong blood transfusions that accumulate iron in organs (heart, liver, endocrine glands). Without chelation therapy, this iron overload causes organ damage and premature death. DESFERAL is a life-prolonging treatment in these patients.

DESFERAL is administered parenterally. Route and dose depend on the indication:

Chronic Iron Overload (Standard Chelation Therapy)

•       Subcutaneous (SC) infusion: 20–40 mg/kg/day infused over 8–12 hours (typically overnight), 5–7 days per week using a portable pump.

•       Intravenous (IV) infusion: 40–50 mg/kg/day, given during blood transfusions or as a slow IV infusion.

Acute Iron Poisoning

•       IV infusion: initially 15 mg/kg/hour, reduced after 4–6 hours. Maximum dose: 80 mg/kg in 24 hours. Given in emergency settings under close monitoring.

Aluminium Overload in Dialysis Patients

•       Given IV during the last hour of dialysis session. Dose based on serum aluminium levels.

Reconstitution

Dissolve each 500 mg vial in 5 mL of water for injection (final concentration 95 mg/mL). For IV infusion, dilute further with sodium chloride 0.9% or glucose 5%. Do not use solutions that are not clear.

Common Side Effects

•       Injection/infusion site reactions: pain, swelling, induration, erythema, eschar (especially with SC infusion).

•       Urine discolouration — red-brown (vin rose) urine from urinary excretion of the desferrioxamine-iron complex. This is expected and harmless.

•       Nausea, vomiting, abdominal pain.

•       Dizziness, headache.

Dose-Dependent Toxicity

•       Ocular toxicity: blurred vision, loss of visual acuity, night blindness, colour vision changes — associated with high doses or rapid infusion. Annual ophthalmology review is mandatory.

•       Audiological toxicity: high-frequency sensorineural hearing loss and tinnitus — annual audiology testing is essential.

•       Growth retardation: impaired bone growth in children (especially under 3 years of age) with high-dose therapy.

•       Pulmonary toxicity: adult respiratory distress syndrome (ARDS) with very high IV doses.

Serious Side Effects

•       Neurological disturbances: encephalopathy (usually in high aluminium load patients); seizures.

•       Severe allergic reactions: anaphylaxis — particularly with rapid IV infusion.

•       Yersinia and Mucor infections — desferrioxamine promotes growth of these organisms. Fever during therapy warrants urgent investigation.

Risk of Opportunistic Infections

Desferrioxamine chelates iron that is essential for human immune function. It can promote growth of iron-dependent organisms including Yersinia enterocolitica and Mucorales (causing mucormycosis). Any patient developing fever, diarrhoea, or symptoms of infection during DESFERAL therapy should have therapy suspended and urgent microbiological investigation performed. Mucormycosis is life-threatening and requires antifungal treatment (liposomal amphotericin B).

Sensory Monitoring

Ocular and auditory toxicity are dose-related. Annual ophthalmological and audiological examinations are mandatory in all patients on long-term therapy. If changes are detected, dose reduction or temporary discontinuation is required.

Therapeutic Index Monitoring

The Therapeutic Index (TI = mean daily dose in mg/kg divided by serum ferritin in mcg/L) should be maintained below 0.025 to minimise toxicity. High TI values indicate relative over-chelation.

Paediatric Dosing

In children under 3 years, DESFERAL should only be initiated when transfusion iron loading is documented. Maximum dose 40 mg/kg/day. Monitor height and bone age every 3 months — reduce dose if growth velocity falls.

Pregnancy

Desferrioxamine is teratogenic in animal studies. Avoid use in pregnancy unless the benefit clearly outweighs the risk. If treatment must continue, use the lowest effective dose after the first trimester.

•       Prochlorperazine (and other phenothiazines) — co-administration has caused temporary loss of consciousness; avoid combination.

•       Ascorbic acid (Vitamin C) — at doses above 500 mg/day, may enhance iron mobilisation but can also redistribute iron to the heart, worsening cardiac toxicity. Do not give Vitamin C to patients with cardiac failure due to iron overload.

•       Gallium-67 scintigraphy — desferrioxamine chelates gallium-67 and invalidates imaging results. Stop DESFERAL 48 hours before imaging.

•       Cardiotoxic drugs — additive cardiac risk; avoid iron overload in patients also receiving doxorubicin.

•       Store vials below 25 degrees Celsius. Do not freeze.

•       Protect from light. Keep in original packaging.

•       Reconstituted solution: stable for 24 hours at room temperature or 72 hours refrigerated (2–8 degrees Celsius). Discard unused reconstituted solution after this time.

•       Keep out of reach of children.

DESFERAL is a prescription-only medicine (POM) in Kenya, regulated by the Pharmacy and Poisons Board (PPB). It is a specialist product used in haematology, nephrology, and toxicology settings.

Access is typically through specialist haematology centres, dialysis units, and poison treatment centres. It must not be dispensed without a valid specialist prescription.

Monitoring Protocol

•       Serum ferritin: monthly target 500–1000 mcg/L (below 500 mcg/L increases risk of DESFERAL toxicity).

•       24-hour urinary iron excretion: useful for assessing chelation efficacy.

•       Liver iron concentration (LIC) by MRI T2*: annually in patients with significant iron overload.

•       Cardiac MRI T2*: annually — detect early myocardial iron deposition before cardiac dysfunction.

•       Ophthalmology (slit-lamp, fundoscopy, visual acuity, colour vision): annually.

•       Pure tone audiometry: annually.

•       Renal function (creatinine, eGFR): 6-monthly.

•       Height and weight in children: every 3 months.

Chelation Adequacy

The Therapeutic Index (TI) = mean daily desferrioxamine dose (mg/kg) divided by serum ferritin (mcg/L). Target TI less than 0.025. Adjust dose based on ferritin trends and TI to maximise efficacy while minimising toxicity.

Alternative Chelators

Oral chelators (deferasirox/Exjade, deferiprone/Ferriprox) may be considered for patients who are intolerant of or non-compliant with subcutaneous desferrioxamine. Combination chelation (DESFERAL + deferiprone) is sometimes used in patients with severe cardiac iron loading.

Why does my urine turn red-brown when I am on DESFERAL?

The red-brown (vin rose) colour of urine is caused by the excretion of ferrioxamine — the complex formed when desferrioxamine binds to iron. This is completely normal and actually confirms that the medicine is working and removing iron from your body.

Can I use DESFERAL during pregnancy?

DESFERAL should generally be avoided during pregnancy, particularly in the first trimester, as it may harm the developing baby. If you become pregnant or are planning a pregnancy while on this treatment, discuss urgently with your haematologist — they will weigh the risks and benefits and advise on the safest approach.

How long will I need to take DESFERAL?

For transfusion-dependent conditions like thalassaemia major, DESFERAL is typically a lifelong treatment as long as you continue to receive blood transfusions. Your iron levels (serum ferritin) will be monitored regularly to confirm that chelation is adequate and your organs are protected.