Deferaziroks - instructions for use, doses, side effects, contraindications

Clinical and pharmacological group: & nbsp

Detoxifying agents, including antidotes

Included in the formulation

Jaden

pills inwards

Novartis Pharma AG Switzerland

Eksidzhad®

pills inwards

Novartis Pharma AG Switzerland

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

ONLS

АТХ:

V.03.A.C Iron-binding preparations

Pharmacodynamics:

The preparation forms a complex with ferric ions in the ratio of 2 to 1. The resulting complexes are soluble in water and excreted by the kidneys from the body. Slightly binds zinc and copper ions.

Pharmacokinetics:

Deferazirox is well absorbed after oral administration, the average half-lifein blood plasma is about 1.5-4 hours. Bioavailability - 70% (increase with admission 30 minutes before eating fatty foods), in children below. The connection with plasma proteins is 99%, metabolized in the liver (involving cytochrome P450 - 8%), intestinal hepatic recirculation. Eliminated by the kidneys (8%) and the gastrointestinal tract (84%). The half-life is between 8 and 16 hours.

Indications:

Chronic posttransfusion overload with iron (adults and children over two years old).

ICD-10

XIX.T36-T50.T45.4 Poisoning with iron and its compounds

XIX.T80-T88.T80 Complications associated with infusion, transfusion and medical injection

Contraindications:

Hypersensitivity, intolerance to galactose, severe lactase deficiency, glucosogalactose malabsorption, pregnancy, lactation.

Carefully:

Dysfunction of the liver and kidneys, Hypercreatinemia is higher than the norm of the age, the activity of hepatic transaminases increases more than 5-fold.

Pregnancy and lactation:

Category Food and Drug Administration (US Food and Drug Administration) - B. It is not recommended to apply deferazirox at pregnancy, except for cases when the expected benefit for the mother exceeds the possible risk for the fetus. It is not known whether deferazirox with human breast milk. Do not use deferazirox during lactation (breastfeeding).

Dosing and Administration:

Inside. The initial dose of 20 mg / kg per day, dose adjustment is carried out every 3-6 months in steps (5-10 mg / kg). It is not recommended to use a dose of more than 30 mg / kg, since experience with higher doses is limited.

Side effects:

From the skin: itching, rash, pigmentation.

On the part of the digestive system: gastritis, cholelithiasis, hepatitis, increased activity of hepatic transaminases, diarrhea, constipation, vomiting, dyspepsia, nausea, flatulence, gastralgia.

From the urinary system: proteinuria, hypercreatininaemia.

From the sense organs: maculopathy, early cataract, hearing loss.

From the nervous system: dizziness, sleep disturbance, anxiety, headache.

Other: swelling, hyperthermia, fatigue.

Overdose:

Nausea, headache, diarrhea, vomiting. Treatment - gastric lavage, symptomatic.

Interaction:

Do not allow simultaneous reception with aluminum-containing antacids, as well as drugs that form complexes with iron.

Special instructions:

It is necessary to monitor the activity of hepatic transaminases, serum creatinine, serum ferritin. Each year, children need to control body weight and height.

At reception during meal bioavailability deferaziroxa raises or increases in various degrees.

Before and during treatment with the drug it is recommended to regularly determine the severity of hearing and conduct an ophthalmological examination (including ophthalmoscopy of the fundus). In the case of hearing or visual impairment, it is recommended to consider reducing the dose or stopping treatment.

Therapy should be carried out by doctors with experience in the treatment of chronic post-transfusion overload with iron.

Impact on the ability to drive vehicles and manage mechanisms

When there is dizziness in the background of treatment, patients should be careful when driving vehicles and working with mechanisms.

Instructions

Deferazirox (Deferasiroxum)