Canmab (Trastuzumab 440mg)

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Canmab Injection conține un medicament pentru cancer cunoscut sub numele de Trastuzumab, care este clasificat farmacologic ca un anticorp monoclonal umanizat produs de tehnologia ADN recombinant. 440mg... Citeste mai mult
  • In stoc:
    In stoc
  • Marca: Biocon Ltd.
  • Trade name Canmab
  • Substance Trastuzumab 440mg
  • Manufacturer Biocon Ltd.
989,00
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Metode de livrare

Serviciu de curierat EMS

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CANMAB

DRUG PROFILE

Canmab is Injection contains a cancer drug known as Trastuzumab, which is pharmacologically classified as a humanized monoclonal antibody produced by recombinant DNA technology.

440mg Canmab is treatment is used to reduce the rate of reactivation and mortality.

One of the epidermal growth factor receptors is known as the human epidermal growth factor receptor (HER2), which plays a vital role in breast cancer.

This factor is responsible for cell replication.

Canmab is an FDA-approved product that is involved in the treatment of breast cancer.

Brand: Canmab

Active Ingredients: Trastuzumab

Strength: 440 mg

Mfg: Biocon

Package: Two bottles in a box; a vial containing Trastuzumab and a vial containing bacteriostatic water for injection

DRUG PRESCRIBING INFORMATION

Supportive treatment for breast cancer:

Canmab should be indicated as a supportive therapy for breast cancer, where HER2 affects positively or negatively in BC status.

There are therapeutic regimens consisting of cyclophosphamide, doxorubicin, paclitaxel or docetaxel.

There are therapeutic regimens with docetaxel and carboplatin

Anthracycline-based multimodal treatment as a sole agent.

Advanced breast cancer;

Canmab 440mg is indicated in the advanced stage of breast cancer by combining with

Paclitaxel was used as first-line therapy.

As a lone administrator for the treatment of HER2 -related breast tumors in patients who received no less than a chemotherapy regimen for metastatic infections.

Advanced Gastric Cancer:

Canmab 440mg is used to treat the metastatic status of gastric cancer by combining with cisplatin and Capecitabine or 5-fluorouracil.

This therapy is used in patients with gastric metastatic HER2 overexpression or gastro-oesophageal intervertebral adenocarcinoma who have not received previous treatment for metastatic disease.

MECHANISM OF ACTION

Canmab 440mg is a monoclonal antibody that follows HER2, inducing a cross-reactive reaction that causes disguise and down-regulation of HER2.

HER2 pathway is essential for cell multiplication, binding of Trastuzumab to place of HER2 causes inhibition of this activity.

This binding leads to mediated antibodies and determines the location of HER2 positive cells.

ABSORPTION

Canmab is a mediator of body-dependent cellular cytotoxicity.

The pharmacokinetic properties of Canmab are:

The total clearance of Trastuzumab increases with concentration depletion due to linear and non-linear excretion pathways.

DISTRIBUTION

Exposure to Trastuzumab is higher after the first cycle in breast cancer patients with 3 weekly schedules correlated with the Canmab Weekly Schedule.

The stationary level of Trastuzumab is higher in the field.

In breast cancer;

8 mg / kg + 6 mg / kg 3 times per week, the Cmin value is 29.4 ng / ml; The Cmax value is 178ng / ml and the AUC value is 1373ng.day / ml.

Metastatic GC;

8 mg / kg + 6 mg / kg 3 times per week, Cmin is 23.1 ng / ml; The Cmax value is 132ng / ml; The AUC is 1109 ng / day.

In breast cancer;

4 mg / kg + 2 mg / kg qw, the value of Cmin is 37.7 ng / ml; The Cmax value is 88.3 ng / ml; The AUC is 1066 ng / day.

In mild renal insufficiency: CrCl is 60 to 90 ml / min; Moderate CrCl is 30 to 60 ml / min.

The volume of distribution of Trastuzumab is 44 ml/kg.

METABOLISM

Metabolism Trastuzumab is produced intracellularly;

Trastuzumab is metabolized into peptides and amino acids.

ELIMINATION

Excretion is a complex procedure that is initiated by epithelial cells.

The terminal half-life of Trastuzumab ranges between 1.7 and 12 days at 10 and 500 mg relative doses.

The mean half-life is 28.5 days, the pharmacokinetics of Trastuzumab appear nonlinear, the high doses are related to the increase in mean half-life and depletion of clearance.

The elimination process of Trastuzumab is involved in IgG clearance through the reticuloendothelial system.

WHEN TO TAKE THE DRUG

Canmab should be given as an intravenous infusion.

Do not administer Canmab IV or bolus.

Do not mix Canmab with other medicines.

DOSAGE REGIMENS

Supportive treatment for breast cancer:

Under this condition, total Canmab cycles are scheduled for 52 weeks.

In the combination of paclitaxel, docetaxel or docetaxel and carboplatin:

Canmab started at 4 mg/kg should be given as an intravenous infusion over 90 minutes, then resumed at 2 mg/kg of Canmab administered as an intravenous infusion over 30 minutes per week during chemotherapy in the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).

Last week, the Canmab dose is 6 mg/kg administered as an iv infusion over a period of 30 to 90 minutes for every 3 weeks.

Presented as a single specialist following the culmination of anthracycline-based chemotherapy regimens:

The initial dose of Canmab is 8 mg/kg administered as an intravenous infusion over 90 minutes.

The consecutive dose of 6 mg/kg of Canmab should be given as an iv infusion over a period of 30 to 90 minutes for every 3 weeks.

Prolonged support should not be recommended.

Advanced breast cancer:

Canmab should be administered at an initial dose of 4 mg/kg by combining with paclitaxel over a 90-minute period followed by a 6 mg/kg intravenous infusion over 30 to 90 minutes, every 3 weeks to the onset of the disease.

Metastatic gastric cancer:

The starting dose of Canmab for this condition is 8 mg/kg given iv infusion over a 90-minute period followed by a consecutive 6 mg/kg infusion over a period of 30 to 90 minutes every 3 weeks.

Important safety points depending on administration;

If the Canmab treatment interruption cycle is one week or less, the frequent maintenance dose (weekly program: 2 mg/kg, 3 weeks: 6 mg/kg) should be given as soon as possible.

The patient does not take an interval until the next scheduled cycle.

Maintenance dose The successive Canmab is should be taken within 7 days or 21 days, followed by weekly or 3 weeks.

If the patient does not take a Canmab dose for more than one week, then resume Canmab, such as the weekly program of 4 mg/kg; Weekly weekly schedules are 8 mg/kg to be administered within 90 minutes.

Infusion reactions;

In the event of infusion reactions, some precautions should be taken;

Reduce the infusion rate for mild or moderate infusion reactions.

In case of dyspnoea or hypotension, the infusion should be postponed.

For severe infusion or life-threatening reactions, Canmab infusion should be discontinued.

cardiomyopathy;

Before observing treatment with Canmab, patients who have left the ventricular ejection fraction should be monitored.

Stop the Canmab infusion for at least 4 weeks in any of the following cases;

or equal to a 16% reduction in LVEF from pre-therapy values

or equal to 10% reduction in EFEF from pre-therapy value

Administration;

Canmab contains 440 mg of Trastuzumab as active ingredient with 20 ml of bacteriostatic water for reconstitution.

440mg of Trastuzumab is reconstituted with 20ml of bacteriostatic injection water containing 1.1% of benzyl alcohol as a preservative.

Do not shake the vial and then gently rotate the vial until the contents dissolve well.

During reconstitution, the vial must be foamed, the vial should be kept aside for 5 minutes and a clear solution should be formed.

Clear solution only used for dilution.

In the case of suspended particles; should be thrown under aseptic conditions.

If Canmab should be reconstituted in sterile water for preservative injection, it should be used immediately and discard the unused portion.

If Canmab is reconstituted in bacteriostatic water for injection, the reconstituted solution should be stored at a temperature between 2 ° C and 8 ° C for 28 days after reconstitution.

After 28 days, the vial should not be used and should be discarded.

Dilution;

Depending on the dose of Canmab, the diluted volume should be determined.

Canmab should be diluted in 250 ml of 0.9%

Do not dilute with 5% dextrose.

Dilution should be done by inverting the bag and mixing the solution

The infusion solution should be compatible with polyvinyl or polyethylene chloride bags.

After dilution, the infusion bag should be kept at a temperature between 2 ° C and 8 ° C for up to 24 hours before use.

DRUG CALLED SIDE EFFECTS

The most common side effects;

  • cardiomyopathy
  • Infusion reactions
  • Fetal embryonic toxicity
  • Pulmonary toxicity
  • Chemotherapy-induced by neutropenia
  • hypertension
  • Dizziness
  • Reduce LVEF
  • palpitations
  • arrhythmia
  • myocardial
  • Cough
  • Chills
  • Edema
  • Asthenia
  • Sudden death
  • Autoimmune thyroiditis
  • neutropenia
  • hypokalemia
  • anemia
  • thrombocytopenia
  • Febrile neutropenia
  • Kidney failure
  • Flu
  • dyspnea
  • HATE
  • rhinitis
  • Pharyngolaryngeal pain
  • sinusitis
  • epistaxis
  • Pulmonary hypertension
  • Interstitial pneumonitis
  • Diarrhea / constipation
  • Nausea, vomiting
  • Dyspepsia
  • Abdominal pain
  • arthralgia
  • Back pain
  • Bone pain
  • Headache
  • paresthesia
  • Eczema
  • Nail disorder
  • itching
  • Fever

FOOD DRUG INTERACTION

The foods that will interfere with the activity of Trastuzumab are:

  • Grapefruit
  • Alcohol
  • Beef
  • Butter
  • Caviar, cheese, milk, pork, salt
  • Supplements with conjugated linoleic acid

Patients with breast cancer have low aberrant iron levels.

Patients who do not have iron deficiency should not take it;

Avoid eating spinach and dry beans because the body will absorb humans more efficiently than non-heme bees from these plant sources.

Turmeric containing an active constituent such as curcumin acts as an iron chelator and copper chelator.

Iron chelator means removing iron from the body.

Turmeric should not be used in breast cancer because it can reduce iron content in the body.

SAFETY MEASURES

cardiomyopathy;

Canmab is who receive patients has an increased risk of exposure to cardiac disorders.

To overcome the problem by;

Regularly monitor heart functions

Avoid using anthracycline after Canmab treatment

Ensure alternative therapy

Under severe conditions, therapy should be discontinued or discontinued.

Infusion reactions;

During treatment with Canmab, life-threatening infusion reactions occur.

Infusion-related events should be monitored frequently

Implantation of the infusion with Canmab treatment and initiation of supportive measures by the supply of epinephrine, corticosteroids, diphenhydramine, bronchodilators and oxygen.

In case of severe infusion reactions, stop treatment with Canamab permanently.

To overcome the problem, the patient should be treated with premedication before starting the infusion.

Damage to the fetal embryo;

Canmab is contraindicated to pregnancy.

Avoid becoming pregnant during this therapy.

Use effective contraceptives during treatment

Pulmonary Toxicity;

Some severe cases of pulmonary toxicity occur during treatment with Canmab.

Caution is recommended during treatment with Canmab.

Neutropenia induced by therapy;

There is a greater incidence of neutropenia during treatment with Canmab.

DRUG INTERACTION

If the patient treated with anthracycline after the end of treatment with Canmab may have the chance of suffering cardiac dysfunction. This adverse reaction occurs because of the large Trastuzumab disaster, depends on the PK analysis of the population.

Avoid anthracycline treatment for 7 months after stopping treatment with Canmab.

Under some exceptional circumstances, the patient should receive anthracycline; in this condition, the patient's cardiac function should be carefully monitored at regular intervals.

POSSIBLE CONTRAINDICATION

There is no possible contraindication.

Infusion reactions occur.

Hypersensitivity reactions occur because patients are contraindicated to the component present in Canmab.

PREGNANCY AND LACTATION

The load category in Canmab is D

Canmab 440mg should not suggest during pregnancy.

Breastfeeding is not recommended.

STORAGE AND HANDLING

Canmab vials should be kept at a refrigerator temperature of 2 ° C to 8 ° C

Keep the bottle away from heat and light

After reconstitution, the vial should be stored at 2 ° C to 8 ° C for 28 days.

The diluted Canmab bag should be stored at a temperature between 2 ° C and 8 ° C for 24 hours

MISSED DOSE

If the Canmab treatment interruption cycle is one week or less, the frequent maintenance dose (weekly program: 2 mg/kg, 3 weeks: 6 mg/kg) should be given as soon as possible.

The patient does not take an interval until the next scheduled cycle.

Maintenance dose The successive Canmab is should be taken within 7 days or 21 days, followed by weekly or 3 weeks.

If the patient does not take a Canmab dose for more than one week, then resume Canmab, such as the weekly program of 4 mg/kg; Weekly weekly schedules are 8 mg/kg to be administered within 90 minutes.

OVERDOSAGE

The maximum dose of Trastuzumab is greater than 8 mg/kg as a single dose.

In case of an overdose, the patient must be;

Provide support measures

Monitor signs and symptoms due to dosing

 

  • Trade name Canmab
  • Substance Trastuzumab 440mg
  • Manufacturer Biocon Ltd.
  • Country of origin India
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