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Avastin instructions for use

Avastin instructions for use

Avastin belongs to the class of monoclonal antibodies, which are used to treat tumors.

Active substance: Bevacizumab.

pharmachologic effect

Avastin is a recombinant humanized antibody that not only binds, but also neutralizes the biochemical effects of the endothelial growth factor, leading to a disruption in the blood supply to the tumor and the death of its cells. In addition, the use of Avastin suppresses the progression of metastatic lesions originating from organs such as the pancreas, colon, prostate, and breast.



Pharmacokinetics

The drug has a very low clearance (ie, slowly withdrawn from the body) and a long half-life. This allows for an extended time interval to maintain the optimal therapeutic concentration of the drug in the blood for 2-3 weeks after a single infusion.

The use of Avastin in elderly patients without concomitant diseases can be carried out according to a standard scheme without correction of doses.

The possibility of using Avastin in patients with hepatic and renal insufficiency has not been studied.

At a low serum albumin concentration, the drug's activity and half-life can significantly increase.

Indications for use

  • Metastatic cancer with lesions of the large intestine (colorectal), with combined treatment using various fluoropyrimidine derivatives.
  • Inoperable metastatic lung lesions. In this case, the drug is used in conjunction with platinum preparations.
  • Metastatic or advanced kidney cancer. In this case, alpha-2a interferons are added to the first-line therapy.
  • Cancer of the fallopian tube, ovaries or primary tumors of the peritoneum. A combination pharmacotherapy with paclitaxel or carboplatin is beneficial.
  • Ineffective treatment of breast cancer with other drugs.
  • Therapy of tumor diseases in ophthalmology.

Method of administration and recommended doses

The drug is used only in a hospital under the supervision of a chemotherapist. Therapy of malignant tumors, if possible, should be carried out before the progression and the moment of generalization of the process.

The starting dose of Avastin is administered intravenously slowly for 90 minutes, while the patient's condition is monitored. In the event that the patient has transferred the infusion satisfactorily, subsequent drip infusions are performed somewhat faster - in 60 minutes. If the patient tolerates such a speed of administration of the drug satisfactorily, then the infusion time can be limited to 30 minutes later.

Important! Avastin can not be injected into the vein, as there is a high incidence of serious adverse reactions. Also, concentrate can not be diluted with glucose solution.

With tumor lesions of the colon, the dose of the drug is 5 mg / kg of body weight, while Avastin is administered 1 time in 14 days.

With tumorous lung diseases Avastin dose is selected at the rate of 7.5 mg / kg body weight. At the beginning of the course of treatment of the tumor, the described drug is used only in combination with platinum preparations, after a while they switch to monotherapy with Avastin. Multiplicity of administration of monoclonal antibody - 1 time in 3 weeks.

In renal lesions, the calculation of the dose occurs as follows: 10 mg / kg of body weight, with infusion being performed once every 2 weeks.

For tumors of the female genital area or peritoneum, Avastin at the beginning of treatment is combined with chemotherapy for 6 cycles. Then therapy with monoclonal antibodies is carried out for 15 months, the dose is 15 mg / kg body weight. Multiplicity of administration - 1 time in 21 days.

In metastatic breast cancers, the dose of Avastin is 10-15 mg / kg body weight. In this case, the drug is administered 1 time in 3 weeks.

Application in pediatric practice: at present there is no data on the safety profile of Avastin in children.

Rules for the preparation of a solution for infusion: due to the fact that antimicrobial agents are not added to the vial of antibodies, the solution must be prepared immediately before use with strict asepsis rules.

Concentrate is diluted only (!) Physiological solution of sodium chloride to the mark of 100 ml on the vial. In the event that more infusion is required, then dilution to a mark of 200 ml is permissible.

If the drug remained in the vial after intravenous infusion, it is strictly forbidden to use it for later administration.


Side effects

  • Perforation of the hollow organ of the gastrointestinal tract (in patients with tumorous diseases of the large intestine).
  • Bleeding in various vascular pools (most often - pulmonary with a similar localization of the tumor node).
  • Thromboembolic complications.
  • Arterial hypertension.
  • The appearance of protein in the urine (dose-dependent effect).
  • Extreme fatigue.
  • Nausea, abdominal pain, diarrhea.
  • Accession of infectious diseases.
  • Disturbance of limb sensitivity.
  • Reducing the number of leukocytes, hemoglobin and red blood cells.
  • Hyperglycemia.
  • Hypokalemia.

Contraindications

  • During pregnancy and breastfeeding.
  • Tumor metastases in the brain, not amenable to surgical treatment.
  • Hypersensitivity to the components of the drug.

Use during pregnancy and lactation

Given the fact that the mechanism of action of Avastin is based on the suppression of vascular development, the use of this drug during pregnancy can lead to the death of the fetus at any time.

Monoclonal antibodies can penetrate into the mother's milk and have undesirable effects on the newborn's body, so breastfeeding should be stopped during the treatment period, resuming no earlier than 6 months after the last infusion.

The conception of the child should be planned no earlier than 6 months after the end of Avastin therapy.

Overdose

With the infusion of the drug at a dose of 20 mg / kg, a number of patients developed complaints about migraines. In such cases, symptomatic pharmacotherapy is recommended. Avastin does not have specific antidotes.

Drug Interactions

The drug can be combined with other antineoplastic agents.

The effectiveness and safety profile of Avastin during radiation therapy have not been studied.

Form of issue

Concentrate intended for the preparation of an infusion solution. It is produced in vials of 4 or 16 ml capacity containing 100 or 400 mg of active substance, respectively.

Terms of leave from the pharmacy

Strictly according to the prescription.

Storage conditions

The drug is suitable for 2 years. In this case, concentrate should be stored at a temperature of 2 0 C to 8 0 C. Freeze the contents of the vial.

Analogues

Analogues of Avastin on the active substance at the present time does not exist. Such drugs for the mechanism of action include drugs: Arzerra, Acellbia, Vectibix, Herceptin, Kempas, Lucentis, Mabtera, Perieta, Removab, Rituximab and Erbitux.

Price for Avastin

Avastin concentrate for solution for infusion, 4 ml bottle - from 20,000 rub.

Avastin concentrate for solution for infusion, bottle 16 ml - from 55000 rub.

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