Trastuzumab

When ATH:
A16AA02

Characteristic.

White or pale yellow powder.

Pharmacological action.
Antitumor, cytostatic.

Application.

Disseminated breast cancer с гиперэкспрессией HER₂ (monotherapy after one or more courses of chemotherapy for metastatic stage or in combination with paclitaxel as first line therapy).

Contraindications.

Hypersensitivity.

Restrictions apply.

Shortness of breath at rest, due to metastatic disease or concomitant lung diseases (increased risk of fatal infusion reactions); Patients at risk for cardiotoxicity (heart failure, hypotension, CHD, pretreated with anthracyclines and cyclophosphamide), childhood (safety and effectiveness in children have not identified).

Pregnancy and breast-feeding.

Maybe, if the effect of therapy outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Side effects.

From the digestive tract: nausea, vomiting, dyspepsia, anorexia, constipation, rare - hepatic dysfunction, hepatitis, hepatic failure, jaundice, pancreatitis.

Cardio-vascular system and blood (hematopoiesis, hemostasis): tachycardia, vasodilation, gipotenziya, heart failure, cardiogenic shock, cardiomyopathy, heartbeat; leukopenia, rarely - heart rhythm disturbance, reduced ejection fraction, thrombocytopenia, anemia; reducing prothrombin.

For the skin: itch, hyperhidrosis, xerosis, acne, maculo-papular rash, nail infections, alopecia.

From the respiratory system: bronchospasm, cough, breathlessness, nose bleed, lung, pleurisy, pharyngitis, rhinitis, sinusitis; pulmonary edema; gipoksiya, laryngeal edema, acute respiratory distress syndrome.

From the nervous system and sensory organs: dizziness, drowsiness or insomnia, paresthesia, ataxia, tremor, paresis, alarm, depression, neuropathy, deafness, rarely - coma, meningitis, swelling of the brain, intellectual impairment.

Allergic reactions: incl. anaphylaxis shock and anafilakticheskiy.

Other: general malaise, asthenia, fever, chills, flu-like symptoms, the development of infection, sepsis, peripheral edema, pain syndrome (abdominal pain, Chest, head, joints, bones, muscle, loin, neck); infusion reactions, accompanied by symptom: 1) - Chills, fever, nausea, vomiting, asthenia, tremor, pain, incl. headache, dizziness, breathlessness, gipotenziya, cough, rash (kupiruûtsâ nenarkotičeskimi analgesics and antigistaminnymi ASSETS); 2) - shortness of breath, gipotenziya, bronchospasm, gipoksiya, occurrence of wheezing in the lungs, tachycardia (can be fatal, require stopping the infusion, cropped beta adrenolytics, kortikosteroidami, oxygen therapy).

Cooperation.

You can not breed in 5% glucose solution (It causes aggregation protein) and mixed or diluted with other drugs.

Dosing and Administration.

B /, infusion, dose 4 mg / kg for 90 m, etc. - in a maintenance dose 2 mg / kg for 30 m (bad Portability is longer) 1 once a week.

Precautions.

Treatment should be under the supervision of the oncologist. Before treatment is required to test for the expression of tumor HER₂. In the course of treatment is necessary every 3 Months heart function closely monitored for early signs of cardiotoxicity (in the case of asymptomatic cardiac dysfunction - every 6-8 weeks). If persistent asymptomatic or clinically manifest decrease in cardiac output should consider discontinuing treatment or symptomatic therapy appointment (Diuretic, cardiac glycosides, ACE inhibitors). Bacteriostatic water for injection, supplied with the preparation as a preservative, It contains 1,1% benzyl alcohol, have toxic effects on infants and children up to three years. Patients with known hypersensitivity to benzyl alcohol as a solvent, use water for injection.

Cautions.

The solution should be prepared aseptically; careful not to shake (Foaming possible). Preparation of the solution: a vial of lyophilized powder slowly add 20 ml bacteriostatic water for injection, gently shake the bottle rotary movements (in the case of the foam to stand 5 m). Further from the vial with the concentrate solution (21 mg / ml) It recruited the necessary volume and introduced into the infusion bag with 250 ml 0,9% sodium chloride solution. Solution volume, necessary for introducing the load or maintenance dose is determined by the formula: weight (kg) required dose x (mg / kg) / 21 mg / ml. The solution should be administered immediately after preparation. Compatible with PVC and PE infusion bags.

Cooperation