Gertikad - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gerticad

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 15,000 rubles.

Buy

Gerticad is a drug based on a humanized monoclonal antibody (IgG1) that blocks the proliferation of tumor cells with overexpression of HER2.

Release form and composition

Dosage form Gertikada - lyophilisate for the preparation of a concentrate for the preparation of a solution for infusion: powder or compressed porous mass from white to light yellow color, reduced to a transparent or slightly opalescent solution of colorless or light yellow color, when diluted with bacteriostatic water for injection (d / i) a transparent, colorless or slightly yellowish liquid is formed [preparation: 150 or 440 mg each in glass vials with a self-adhesive label; solvent: 20 ml in glass bottles; in a blister strip packaging 1 bottle of the drug (at a dose of 440 mg) and 1 bottle of solvent, in a cardboard box 1 blister strip packaging; in a cardboard box 1 bottle of the drug (at a dose of 150 mg)].

Composition for 1 bottle of the drug:

• active substance: trastuzumab - 150 or 440 mg;
• auxiliary components: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate-20.

Solvent - bacteriostatic water for d / i (composition: benzyl alcohol, water for d / i).

Indications for use

Application for metastatic breast cancer (BC) with tumor overexpression of HER2:

• monotherapy: after one or more chemotherapy regimens;
• complex treatment with docetaxel or paclitaxel: in the absence of previous chemotherapy (first line of therapy);
• complex treatment with aromatase inhibitors: in the case of positive hormonal receptors (estrogen / progesterone) in postmenopausal women.

Application in the early stages of breast cancer with tumor overexpression of HER2:

• adjuvant therapy: after surgery, completion of chemotherapy (adjuvant / neoadjuvant) and ionizing radiation (radiation therapy);
• complex treatment with docetaxel or paclitaxel: after adjuvant chemotherapy with doxorubicin and cyclophosphamide;
• complex treatment with adjuvant chemotherapy using docetaxel and carboplatin;
• complex treatment with neoadjuvant chemotherapy and subsequent adjuvant monotherapy with trastuzumab for locally advanced (including inflammatory) cancer or if the tumor is ≥ 2 cm in diameter.

Application for widespread adenocarcinoma of the stomach or esophageal-gastric junction with tumor overexpression of HER2: in combination treatment with capecitabine or fluorouracil (intravenous) and platinum in the absence of previous antitumor therapy of metastatic disease.

Contraindications

Absolute:

• Severe dyspnea at rest requiring supportive oxygen therapy or caused by lung metastases
• early stages of breast cancer in patients with a history of myocardial infarction, angina pectoris requiring treatment, chronic heart failure (CHF) II – IV functional classes according to the classification of the New York Cardiology Association (NYHA), left ventricular ejection fraction (LVEF) less than 55%, cardiomyopathy, arrhythmia, uncontrolled arterial hypertension, clinically significant heart defects, hemodynamically significant pericardial effusion (safety and efficacy of the drug in this category of patients have not been studied);
• simultaneous use with anthracyclines as part of adjuvant therapy in patients in the early stages of breast cancer;
• period of pregnancy and lactation;
• children and adolescents up to 18 years of age (in this age category of patients, the safety and efficacy of the drug have not been established);
• hypersensitivity to mouse proteins, trastuzumab and other components of the drug, including benzyl alcohol, as a preservative contained in bacteriostatic water d / and attached to multi-dose vials of 440 mg.

Gertikad is used with caution in heart failure, ischemia, arterial hypertension, concomitant lung diseases or metastases in the lungs, prior to the use of cardiotoxic drugs, including anthracyclines / cyclophosphamide, LVEF <50% and in elderly patients.

Method of administration and dosage

The solution for infusion, made from a concentrate prepared from the lyophilisate of Gerticad, is administered only by intravenous (IV) drip. The drug is not intended for intravenous jet or bolus administration.

Preparation of the drug for administration must be carried out in compliance with the rules of asepsis.

Preparation of concentrate for preparation of solution for infusion:

1. With a sterile syringe, directing a stream of solvent to the lyophilisate, slowly inject the solvent into the preparation; in a bottle with 440 mg of trastuzumab - 20 ml of bacteriostatic water d / i; in a bottle with 150 mg of trastuzumab - 7.2 ml of sterile water d / i.
2. To dissolve the lyophilisate, the bottle is gently rocked with rotary movements. The bottle must not be shaken!
3. After complete dissolution of the powder, hold the concentrate for ~ 5 minutes until the foam disappears; excessive foaming can make it difficult to collect the required dose from the vial.
4. The ready-to-use concentrate should be clear, colorless to pale yellow.

Prepared in bacteriostatic water for d / and the concentrate of the solution of the drug Gertikad is stable for 28 days at a temperature of 2 to 8 ° C and can be used repeatedly, since it contains a preservative. The unused residue should be destroyed after 28 days.

It is allowed to use as a solvent for the drug Gertikad 440 mg of sterile water d / and (not containing a preservative). In this case, the concentrate will be physically and chemically stable at temperatures from 2 to 8 ° C for no more than 24 hours, and after this time must be destroyed. The use of other solvents should be avoided.

Preparation of solution for infusion:

1. Determine the volume of solution required for the introduction of a loading or maintenance dose using the following formula: volume (ml) = body weight (kg) x dose (4 or 8 mg / kg - loading, 2 or 6 mg / kg - maintenance) / 21 (concentration of the prepared solution in mg / ml).
2. Collect the required volume from the vial with the prepared concentrate and enter it into the infusion bag containing 250 ml of 0.9% sodium chloride solution.
3. Turn the infusion bag several times to mix the solution, being careful to avoid foaming.
4. Visually check the solution before injection for mechanical impurities and discoloration.
5. Start infusion immediately after preparation of the solution. As an exception, it is allowed to store the prepared solution for infusion at a temperature of 2 to 8 ° C, but not more than 24 hours during the procedure for dissolving the concentrate and preparing the solution for infusion in compliance with validated controlled aseptic conditions; the specialist who prepared the solution is obliged to monitor compliance with the conditions and shelf life.

When disposing of an expired product or an unused concentrate / solution, the release of the medicinal substance into the environment should be minimized. It is impossible to dispose of through wastewater or methods used to destroy household waste, it is recommended, if possible, to use special systems for the disposal of drugs.

During each session of the administration of the drug Gerticad, the patient should be carefully observed for the appearance of chills, fever, and other infusion reactions (within 6 hours after the start of the first infusion and at least 2 hours after the start of subsequent ones). The treatment room should be equipped with an emergency kit, and the infusion should be performed by a healthcare professional with experience in treating anaphylaxis.

If infusion reactions occur, the procedure is interrupted, after the disappearance of symptoms of mild to moderate severity according to the NCI-CTC classification (General Toxicity Criteria of the National Cancer Institute in the United States), the infusion can be resumed. With the development of severe infusion reactions that threaten the patient's life, it is necessary to consider the advisability of further therapy with Gerticad.

Standard dosing regimen for the treatment of metastatic breast cancer:

• weekly infusions, loading dose: once, 4 mg / kg by intravenous drip infusion lasting 90 minutes;
• weekly infusions, maintenance dose: 2 mg / kg of body weight once a week 1 week after infusion of the loading dose by intravenous drip infusion (provided that the previous loading dose is well tolerated, the duration of the drip infusion is 30 minutes);
• alternative introduction once every 3 weeks, loading dose: one-time, 8 mg / kg by intravenous drip infusion lasting 90 minutes;
• alternative administration once every 3 weeks, maintenance dose: 6 mg / kg of body weight once a week 3 weeks after infusion of the loading dose by intravenous drip infusion (provided that the previous loading dose is well tolerated, the duration of the drip infusion is 30 minutes);
• combination therapy with docetaxel or paclitaxel: these drugs can be administered the next day after Gerticad, following the dosage requirements from the relevant instructions for their use, or immediately after infusion of trastuzumab, provided that they are well tolerated in previous injections;
• combination therapy with an aromatase inhibitor: it is allowed to administer Herticad and anastrozole on the same day, there is no data on the time limit for the administration of trastuzumab and anastrozole (the doses of anastrozole or other aromatase inhibitors must correspond to those required in the instructions for their use).

For the treatment of early stages of breast cancer with weekly administration of Gerticad or 1 time in 3 weeks, schemes similar to those described for the treatment of metastatic breast cancer are used.

The use of trastuzumab for the treatment of early stages of breast cancer with paclitaxel or docetaxel against the background of chemotherapy with doxorubicin and cyclophosphamide is carried out on a weekly basis simultaneously with chemotherapy (loading dose - 4 mg / kg, maintenance dose - 2 mg / kg). At the end of chemotherapy, trastuzumab monotherapy is continued according to the weekly schedule, or trastuzumab is administered once every 3 weeks. The total duration of the course from the first injection is 1 year and does not depend on the number of received or missed doses. Typically, when paclitaxel or docetaxel needs to be administered on the same day as trastuzumab, they are given first.

The use of Gerticad for the treatment of early stages of breast cancer in combination with docetaxel and carboplatin is carried out on a weekly basis simultaneously with chemotherapy (loading dose - 4 mg / kg, maintenance dose - 2 mg / kg). At the end of chemotherapy, trastuzumab monotherapy continues according to the scheme: 1 time in 3 weeks. Typically, if docetaxel, carboplatin, and trastuzumab are needed on the same day, docetaxel is given first, followed by carboplatin, and trastuzumab last.

The use of chemotherapy drugs is carried out in accordance with the requirements of the accompanying instructions and practical recommendations for the treatment of breast cancer.

Against the background of neoadjuvant chemotherapy, trastuzumab is administered according to the regimen once every 3 weeks for 10 cycles in combination with the following chemotherapy drugs:

• 1–3 cycles: doxorubicin at a dose of 60 mg / m ² and paclitaxel at a dose of 150 mg / m ² once every 3 weeks;
• 4–7 cycles: paclitaxel at a dose of 175 mg / m ² once every 3 weeks;
• 7-10 cycles: cyclophosphamide, methotrexate and fluorouracil on the 1st and 8th days every 4 weeks.

Adjuvant monotherapy with trastuzumab after surgery continues according to the regimen: 1 time in 3 weeks. The total duration of the course is 1 year.

Standard dosing regimen for the treatment of advanced gastric cancer:

• loading dose: 8 mg / kg body weight by intravenous drip infusion lasting 90 minutes;
• maintenance dose: 6 mg / kg of body weight once every 3 weeks, the first infusion - 3 weeks after the administration of the loading dose (provided that the previous loading dose is well tolerated, the duration of the drip infusion is 30 minutes).

Patients with metastatic breast cancer or advanced gastric cancer are treated with trastuzumab until the disease progresses. For patients with early breast cancer, trastuzumab is recommended for 1 year or until the disease recurs (whichever comes faster). Trastuzumab therapy for more than 1 year in patients with early stages of breast cancer is not recommended.

If a scheduled infusion of Gerticad is missed for ≤ 1 week, the drug should be administered at the usual maintenance dose as soon as possible, without waiting for the next scheduled administration. Further, the maintenance dose is applied in accordance with the previously established dosage regimen.

If the scheduled infusion of Gerticad is missed for ≥ 1 week, it is necessary to re-enter the loading dose by intravenous drip infusion for 90 minutes, and then continue the administration of the maintenance dose of the drug in the prescribed mode.

Correction of the dosage regimen is necessary in the event of chemotherapy-induced reversible myelosuppression. Gerticad therapy can be continued after a dose reduction or temporary discontinuation of chemotherapy, subject to careful monitoring of the course of complications due to neutropenia.

In the case of a decrease in LVEF more than 10 units from the initial value and below 50%, treatment should be suspended. LVEF is reassessed approximately 3 weeks later. If there is no improvement in LVEF, there is a further decrease in it, or symptoms of CHF appear, discontinuation of therapy is considered, provided that the risks for a particular patient are significantly higher than the expected benefit of treatment. All patients, regardless of the continuation or discontinuation of trastuzumab therapy, should consult a cardiologist for examination and observation.

Elderly patients do not need to reduce the dose of Gerticad.

With mild to moderate renal failure, changes in the dose of Gerticad are not required.

Data on the use of the drug in patients with severe renal failure and / or impaired liver function are limited or absent, therefore, it is not possible to give recommendations on the dosage of trastuzumab for this category of patients.

Side effects

• infections and invasions: very often - nasopharyngitis; often - neutropenic sepsis, pharyngitis, cystitis, skin infections, shingles, sinusitis, influenza, rhinitis, urinary and upper respiratory tract infections, erysipelas, phlegmon; infrequently - sepsis;
• benign, malignant and unspecified tumors (including polyps and cysts): frequency unknown - progression of malignant tumors, progression of unspecified neoplasms;
• blood and lymphatic system: very often - anemia, neutropenia, febrile neutropenia, thrombocytopenia, leukopenia; frequency unknown - hypoprothrombinemia;
• immune system: often - allergic reactions; frequency unknown - anaphylactic reactions *, anaphylactic shock *;
• metabolism: very often - weight loss, anorexia; frequency unknown - hyperkalemia;
• psyche: very often - insomnia; often - depression, anxiety, impaired thinking;
• nervous system: very often - dysgeusia (distortion of taste perception), paresthesia, tremor, headaches **, dizziness; often - muscle hypertonicity, peripheral neuropathy, ataxia, drowsiness; rarely - paresis; frequency unknown - cerebral edema;
• organ of vision: very often - increased lacrimation, conjunctivitis; often dry eyes; frequency unknown - edema of the optic nerve head and retinal hemorrhage;
• organ of hearing and labyrinthine disorders: infrequently - deafness;
• cardiovascular system: very often - decrease / increase in blood pressure (BP) **, palpitations **, heart rhythm disturbances **, flutter (atrial / ventricular) **, decreased LVEF ***, hot flashes; often - cardiomyopathy, supraventricular tachyarrhythmia ***, vasodilation, heart failure (chronic) *, arterial hypotension ***; infrequently - pericardial effusion; frequency unknown - pericarditis, cardiogenic shock, bradycardia, gallop heart rate;
• respiratory system, chest and mediastinal organs: very often - shortness of breath *, wheezing ***, cough, rhinorrhea, nosebleeds; often - impaired lung function, pneumonia *, bronchial asthma, pleural effusion *; rarely - pneumonitis; frequency unknown - interstitial lung disease, pulmonary fibrosis *, respiratory failure *, lung infiltration *, acute pulmonary edema *, acute respiratory distress syndrome *, bronchospasm *, hypoxia *, decreased hemoglobin oxygen saturation *, orthopnea, laryngeal edema, pulmonary edema;
• gastrointestinal tract: very often - diarrhea, vomiting / nausea, stomatitis, lip swelling **, dyspepsia, abdominal pain, constipation; often - hemorrhoids, pancreatitis, dry mouth;
• liver and biliary tract: often - pain in the liver, hepatitis, hepatocellular damage; rarely, jaundice; frequency unknown - liver failure;
• skin and subcutaneous tissues: very often - erythema, rash, palmar-plantar syndrome, facial edema **, impaired nail structure, alopecia; often - dry skin, acne, ecchymosis, hyperhidrosis, itching, maculopapular rash, onychoclasia, urticaria, dermatitis; frequency unknown - angioedema;
• musculoskeletal and connective tissue: very often - muscle stiffness **, myalgia, arthralgia; often - back pain, arthritis, ossalgia, neck pain, muscle spasms, pain in the limbs;
• kidneys and urinary tract: often - kidney disease; frequency unknown - glomerulonephropathy, membranous glomerulonephritis, renal failure;
• during pregnancy, postpartum and perinatal conditions: the frequency is unknown - oligohydramnios, fatal hypoplasia of the lungs and impaired renal function and / or hypoplasia in the fetus;
• genitals and mammary gland: often - breast inflammation and / or mastitis;
• general reactions and disturbances at the infusion site: very often - asthenia, peripheral edema, chest pain, weakness, chills, flu-like syndrome, pain, infusion reactions, mucositis, fever; often - malaise, swelling;
• trauma, complications of manipulation, intoxication: often - bruise.

* Adverse reactions associated with death.

** Adverse reactions associated with infusion reactions (exact percentage not established).

*** Adverse reactions observed in combination therapy with taxanes after anthracyclines.

Overdose data have been reported. The administration of single doses of trastuzumab in an amount> 10 mg / kg has not been studied, at a dose of ≤ 10 mg / kg trastuzumab was well tolerated.

special instructions

It is imperative that the patient is tested for tumor expression of HER2 prior to starting trastuzumab therapy.

Gerticad therapy and all associated medical procedures are performed only under the supervision of a specialist physician experienced in cytotoxic chemotherapy, and the solution must be administered by specially trained medical personnel.

The attending physician is obliged to familiarize the patient with the peculiarities of using the drug and warn about possible complications and peculiarities of therapy.

Contained as a preservative in bacteriostatic water d / and complete with a multi-dose vial of 440 mg benzyl alcohol has a toxic effect on newborns and children under 3 years of age.

For patients with hypersensitivity to benzyl alcohol, the drug is diluted with water d / and, in this case, only one dose can be taken from each multi-dose vial, and the remaining drug should be disposed of.

Drug interactions

There have been no specific studies of drug interactions of trastuzumab in humans. According to the results of scientific studies, there was no clinically significant interaction with drugs used simultaneously, including doxorubicin, paclitaxel, docetaxel, capecitabine or cisplatin.

Due to the possibility of protein aggregation, trastuzumab is not compatible with 5% dextrose solution.

Do not mix or dissolve Gerticad lyophilisate with other drugs.

There were no signs of incompatibility between PVC, polypropylene or polyethylene infusion bags and trastuzumab solution.

Analogs

The analogues of Gerticada are: Trastuzumab, Herceptin.

Terms and conditions of storage

Store in a dark place at 2-8 ° C. Do not freeze. Keep out of the reach of children.

See the expiration date on the packaging.

Terms of dispensing from pharmacies

Dispensed by prescription.

Gertikad: prices in online pharmacies

Drug name Price Pharmacy

Gertikad 150 mg lyophilisate for preparation of concentrate for preparation of solution for infusion 1 pc. RUB 15,000 Buy

Gertikad 440 mg lyophilisate for preparation of concentrate for preparation of solution for infusion 1 pc. RUB 40,000 Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!