Universal reference book for medicines
Product name: ONICIT

Active substance: palonosetron

Type: Antiemetic medication of central action blocking serotonin receptors

Manufacturer: HELSINN BIREX PHARMACEUTICALS (Ireland) manufactured by PIERRE FABRE MEDICAMENT PRODUCTION (France)
Composition, form of production and packaging
Solution for
intravenous administration of 1 ml of 1 fl.

palonosetron 50 mg 250 mg

5 ml - bottles (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

The drug Onitsit (palonosetron) is a highly selective antagonist of serotonin receptors.
The mechanism of action is associated with the suppression of the emetic reflex by blocking the serotonin 5HT 3 receptors at the level of neurons of the central and peripheral nervous system. This mechanism is based on the prevention and treatment of nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy associated with an increase in serotonin, which, by activation of vagal afferent, containing 5HT 3 receptor fibers, causes a vomiting reflex. Onitsit does not inhibit or stimulate cytochrome P450 isoenzymes.
PHARMACOKINETICS

When administered intravenously at the recommended doses in the blood plasma, the concentration of the drug slowly decreases by elimination from the body.
The half-distribution period is 40 hours, the average plasma concentration is usually proportional to the applied dose.
Palonosetron is well distributed in tissues.
The volume of distribution is 6.9-7.9 l / kg. Binding to blood plasma proteins - 62%.
The drug is excreted by the kidneys, approximately 50% in the form of metabolites, the activity of which is less than 1% of the activity of palonosetron.

So, after a single intravenous injection of palonosetron at a dose of 10 μg / kg, approximately 80% of the drug is found in the urine for 144 hours.

After a single bolus administration, the total clearance is 173 ± 73 ml / min, the renal clearance is 53 ± 29 ml / min.
The half-life can be more than 100 hours (10% of patients).
Pharmacokinetics in different patient groups.

Patients with renal insufficiency.

Correction of the dose in patients with renal insufficiency is not required.

Patients with hepatic insufficiency.

Dose adjustment in patients with hepatic insufficiency is not required.

Children

Data on the use of the drug in children under 18 years are absent.

Patients of advanced age.

Correction of dose in elderly patients is not required.

INDICATIONS

- Prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy or radiotherapy (moderately and highly emetic).

DOSING MODE

The drug Onitsit is administered intravenously for at least 30 seconds at a dose of 0.25 mg approximately 30 minutes before the start of chemotherapy.

Do not administer the drug for the next seven days.

The effect of the drug on preventing nausea and vomiting caused by chemotherapy increases with the simultaneous administration of glucocorticosteroids.

SIDE EFFECT

The frequency of adverse reactions listed below was determined according to the following criteria: very often (not less than 1/10), often (more than 1/100, less than 1/10);
infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000); very rarely (less than 1/10000), including individual messages.
The most common adverse reactions: headache - up to 9%;
constipation - up to 5%.
Infrequently observed adverse reactions:

From the cardiovascular system: tachycardia, - bradycardia, extrasystoles, myocardial ischemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles, lowering of blood pressure (BP),

increased blood pressure, prolongation of the QT interval;
varicose veins, varicose veins.
From the nervous system: headache, dizziness, drowsiness, insomnia, paresthesia, peripheral sensory neuropathy, anxiety, euphoria.

From the digestive system: constipation, diarrhea, abdominal pain, dryness of the oral mucosa, flatulence, anorexia, hiccough.

From the urinary system: urinary retention.

From the skin and skin appendages: allergic dermatitis, itching, rash.

From the musculoskeletal system: arthralgia;

From the senses: increased sensitivity of the eyes - irritation, diplopia, amblyopia, impaired coordination of movements, tinnitus.

Changes in laboratory indicators: increased activity of "hepatic" transaminases, hypo- or hyperkalemia, hypocalcemia, hyperglycemia, hyperbilirubinemia, glucosuria, metabolic acidosis.

Other: increased fatigue, weakness, increased body temperature, hot flashes, a feeling of "heat", flu-like syndrome.

Very rare reactions occur at the injection site (burning, tightening, pain).

CONTRAINDICATIONS

- children's age till 18 years;

- pregnancy and the period of breastfeeding;

- Hypersensitivity to palonosetron, or to other components of the drug.

Caution should be used in patients with a tendency to increase the QT interval.

PREGNANCY AND LACTATION

Contraindicated during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Correction of the dose in patients with renal insufficiency is not required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Dose adjustment in patients with hepatic insufficiency is not required.

APPLICATION FOR CHILDREN

Contraindicated in children under 18 years.

APPLICATION IN ELDERLY PATIENTS

Correction of dose in elderly patients is not required.

SPECIAL INSTRUCTIONS

Oncites may cause an increase in the time of passage of the contents through the intestine.
Therefore, special control of the condition of patients with signs of intestinal obstruction is required.
Impact on the ability to drive vehicles and manage mechanisms

Since using the drug Onitsit can occur such undesirable phenomena as dizziness, drowsiness, fatigue, while driving a car and doing other potentially dangerous activities that require increased concentration and speed of psychomotor reactions, care must be taken.

OVERDOSE

Until now, there have been no cases of overdose, however, if any of these side effects increase, symptomatic therapy is necessary.

DRUG INTERACTION

Palonosetron is mainly metabolized by the isoenzyme CYP2D6, with the participation of the isoenzymes CYP3A4 and CYP1A2.
In the concentrations used, palonosetron does not inhibit or stimulate the formation of cytochrome P450.
Metoclopramide: Clinical studies have not shown the interaction of palonosetron with metoclopramide, which is an inhibitor of the CYP2D6 isoenzyme.

Inhibitors and inducers of the isoenzyme CYP2D6: may be combined with dexamethasone and rifampicin (inducers of the isoenzyme CYP2D6), and amiodarone, tselvexibib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline and terbinafine (inhibitors of the isoenzyme CYP2D6).

Glucocorticosteroids: Co-administration with glucocorticosteroids is safe.

Other medications: use together with analgesics, spasmolytic, anticholinergic drugs, other antiemetic agents.

Antineoplastic drugs: palonosetron does not decrease the activity of antitumor drugs (cisplatin, cyclophosphamide, cytarabine, doxorubicin, mitomycin).

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children! Shelf life - 5 years.
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