Herceptin is an anticancer drug used in the treatment of malignant tumors of the breast.
Release form and composition
Herceptin is produced in the form of a lyophilisate for the preparation of an infusion solution, the main active ingredient of which is trastuzumab.
L-histidine, L-histidine hydrochloride, α, α-trehalose dihydrate, polysorbate 20 were used as excipients in the preparation.
Herceptin is available in 150 and 440 mg in glass vials. The bottle of 150 mg is on sale complete with solvent.
Indications for use
According to the instructions, Herceptin is applied:
- In the early stages of breast cancer with HER2 tumor overexpression as adjuvant therapy after surgery, the end of neoadjuvant or adjuvant chemotherapy or radiation therapy;
- In metastatic breast cancer with tumor overexpression of HER2 as monotherapy (after chemotherapy), as well as in combination therapy with docetaxel or paclitaxel (without prior chemotherapy) and in combination with aromatase inhibitors with positive progesterone or estrogen receptors.
According to the instructions, Herceptin does not apply if the patient has an individual intolerance to the components of the drug.
Herceptin, according to the instructions, carefully prescribed for:
- Coronary heart disease;
- Conducting earlier treatment with cardiotoxic drugs, including anthracyclines and cyclophosphamide;
- Heart failure;
- The presence of concomitant lung diseases or lung metastases;
- Presence in the history of congestive heart failure;
- Arrhythmias resistant to therapy;
- Clinically significant heart defects;
- Angina pectoris requiring medical treatment;
- Transmural myocardial infarction;
and also in childhood.
Dosing and Administration
Herceptin, according to the instructions, is intended only for intravenous drip.
Before using Herceptin 440 mg, the contents of one vial are diluted with 20 ml of the solvent included in the preparation kit with a sterile syringe. In this case, the solvent stream should be sent directly to the lyophilisate. After this, it is necessary to gently shake the bottle with rotational movements (it is impossible to shake the solution) and let it stand for 5 minutes to avoid the formation of foam. The finished solution (concentrate) should be clear (colorless or pale yellow).
Before using Herceptin 150 mg, the contents of the vial are diluted with 7.2 ml of water for injection.
The volume of solution required to administer a loading dose of trastuzumab at 4 mg / kg, or a maintenance dose of 2 mg / kg, is calculated as follows: body weight in kilograms x 4 or 2 mg / kg (loading or maintenance dose) / 21 mg / ml .
The volume of solution required to administer a loading dose of trastuzumab at 8 mg / kg, or supporting at 6 mg / kg, is calculated as follows: body weight in kg x 8 or 6 mg / kg / 21 mg / ml.
The required volume of Herceptin solution is drawn from the vial and injected into the infusion bag with 0.9% sodium chloride solution. Then gently turn the bag to mix the solution. The solution is injected immediately after preparation.
- With metastatic breast cancer as monotherapy or combination therapy with docetaxel, paclitaxel or aromatase inhibitors - weekly. Loading dose is 4 mg / kg (within 90 minutes); supporting - 2 mg / kg. If the patient has transferred the previous dose well, the solution can be administered within 30 minutes;
- In the early stages of breast cancer - after 21 days. The loading dose is 8 mg / kg; maintenance - 6 mg / kg (within 90 minutes). If the pass in the performance of infusion was 7 days or less, then it is necessary to introduce the drug as quickly as possible at a dose of 6 mg / kg. Next, the drug is administered according to the established schedule. With a break of more than 7 days, it is necessary to first administer a loading dose of 8 mg / kg, then continue the treatment according to the prescribed schedule every 21 days at 6 mg / kg.
The duration of treatment with Herceptin in the early stages of breast cancer is one year, or until the disease progresses.
When using Herceptin, adverse reactions may develop (often):
- The body as a whole: pain in the breast, weakness, chills, chest pain, fever, peripheral edema, mucositis, lymphangiectatic edema;
- Infusion reactions: chills, nausea, fever, vomiting, tremor, pain, dizziness, cough, shortness of breath, skin rash, hypertension, weakness (during the first infusion);
- Musculoskeletal system: arthralgia, pain in the limbs, myalgia, ossalgia, spasms, muscle cramps.
- Skin and its appendages: rash, alopecia, erythema, violation of the structure of the nails;
- Digestive organs: diarrhea, nausea, vomiting, constipation, abdominal pain, stomatitis, gastritis;
- Nervous system: hypesthesia, paresthesia, headache, muscle hypertonus, anorexia;
- Respiratory: cough, sore throat, shortness of breath, nosebleeds, nasopharyngitis, nasal discharge;
- Bodies of sight: increased tearing, conjunctivitis.
- Organs of hearing: deafness.
When applying Herceptin should be borne in mind that:
- Treatment should be carried out only under strict medical supervision;
- Every three months, the patient’s heart function should be investigated;
- Elderly patients do not need to reduce the dose of the drug;
- The drug should not be mixed with other drugs;
- Before treatment, testing for HER2 tumor expression is required;
- Due to the possibility of protein aggregation, Herceptin is not compatible with glucose solution;
- Cyclophosphamide, epirubicin, doxorubicin increase the risk of cardiotoxic action.
- With each injection of the drug, it is necessary to monitor the patient's condition due to the risk of fever, chills, and other infusion reactions;
- With the development of reversible myelosuppression due to chemotherapy, the administration of Herceptin can be continued after the dose is reduced or chemotherapy is temporarily canceled with careful monitoring of complications caused by neutropenia;
- As the solvent Herceptin 440 mg sterile water for injection can be used;
- The concentrate prepared using the included solvent or water for injection is stable at a temperature of 2-8 ° C for 28 days. After this period, the remaining solution must be disposed of. The prepared concentrate is not subject to freezing / thawing.
The drug has no structural analogues.
Terms and conditions of storage
The drug is stored at a temperature of 2-8 ºC in places not accessible to children, no more than four years.