What is the Hertraz 440mg Injection ?

What is Hertraz 440 mg injection?

Hertraz 440 mg injection is a targeted anticancer formulation (injectable), with trastuzumab as its active ingredient. Trastuzumab is a completely humanized monoclonal antibody, which is specifically designed to bind to the human epidermal growth factor receptor 2 (HER2). It controls the growth and spread of cancer and aids in treatment in combination with other therapies. This formulation is meant for the treatment of HER2-positive cancers only. 

What are the Uses of Hertraz 440mg Injection ?

What are the Dosage Guidelines for Hertraz 440mg Injection ?

Hertraz 440 mg injection is administered through an IV infusion. The dosage of Hertraz 440 injection is decided based on the patient’s body weight.

HER2-Positive Breast Cancer

• Recommended dose: 
  • For a weekly schedule, initial dosing is 4 mg/kg given through an IV infusion. The maintenance dose is 2 mg/kg given once a week.
  • For a 3-week schedule, initial dosing is 8 mg/kg given through an IV infusion. The maintenance dose is 6 mg/kg, given once every 3 weeks.
  • Maximum dose: There is no fixed maximum dose, as the dosing is decided based on the patient’s body weight.
  • Missed dose instructions: If less than 7 days have passed since the scheduled dose, take the dose as soon as possible. If more than 7 days have passed since the scheduled dose, the Hertraz 440 mg cycle must be restarted, and the original schedule must be followed.
  • Overdose instructions: In case of an overdose, there is no specific antidote. Patients must be monitored for cardiac dysfunction and infusion reactions.

HER2-Positive Metastatic Gastric Cancer

• Recommended dose: For a 3-week schedule, initial dosing is 8 mg/kg given through an IV infusion. The maintenance dose is 6 mg/kg, given once every 3 weeks.
• Maximum dose: There is no fixed maximum dose, as the dosing is decided based on the patient’s body weight.
• Missed dose instructions: If less than 7 days have passed since the scheduled dose, take the dose as soon as possible. If more than 7 days have passed since the scheduled dose, the Hertraz 440 mg cycle must be restarted, and the original schedule must be followed.
• Overdose instructions: In case of an overdose, there is no specific antidote. Patients must be monitored for worsening conditions, and supportive care must be provided.
• HER2-Positive Gastroesophageal Junction (GEJ) Cancer
• Recommended dose: For a 3-week schedule, initial dosing is 8 mg/kg given through an IV infusion. The maintenance dose is 6 mg/kg, given once every 3 weeks.
• Maximum dose: There is no fixed maximum dose, as the dosing is decided based on the patient’s body weight.
• Missed dose instructions: If less than 7 days have passed since the scheduled dose, take the dose as soon as possible. If more than 7 days have passed since the scheduled dose, the Hertraz 440 mg cycle must be restarted, and the original schedule must be followed.
• Overdose instructions: In case of an overdose, there is no specific antidote. Patients must be monitored for worsening conditions, and supportive care must be provided.

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How does Hertraz 440mg Injection Work?

Hertraz 440 mg injection (trastuzumab) is a fully humanised monoclonal antibody and is one of the targeted therapies for HER2-positive tumours (tumours that are characterised by over-expression of the HER2 on their cell membrane). This receptor is typically found in breast and gastric cancer patients.

Normally, the Human Epidermal Growth Factor Receptor 2 (HER2) is a receptor that helps regulate cell growth and repair. In some tumors, the ERBB2 gene might be amplified, resulting in an excess of HER2 receptors on the cell membrane. Consequently, the increase of HER2 signalling and its downstream pathways (e.g., activation of PI3K/AKT and MAPK pathways) leads to uncontrolled proliferation of cells, decreased apoptosis (programmed cell death), increased angiogenesis (formation of new blood vessels), and aggressive tumour behaviour.

Hertraz 440 mg injection works by binding to the HER2 receptor’s extracellular portion, thus blocking downstream signalling pathways. This prevents the activation of the HER2 signalling pathways. Hence, the growth of tumour cells is slowed or sometimes, completely stopped. In addition to these mechanisms, trastuzumab utilizes a mechanism known as antibody-dependent cellular cytotoxicity (ADCC). In this mechanism, immune cells (e.g., natural killer cells) recognise the cancer cells coated with trastuzumab and kill these cells. Trastuzumab can also prevent the shedding of the HER2 receptor from the cancer cell and promote the internalisation and degradation of the HER2 receptor within the cell itself.

Through its ability to directly target the underlying molecular defect (e.g., HER2 overexpression), Hertraz 440 mg injection reduces the growth of the tumour and enhances overall survival. Hertraz 440 mg injection is more selective than traditional chemotherapy due to its more specific mechanism of action.

What are the Side Effects of Hertraz 440mg Injection ?

Serious / Life-Threatening Side Effects

(These effects require immediate medical attention.)

Cardiac (very important)

• Cardiomyopathy (heart muscle damage)
• Congestive heart failure (CHF)
• Decreased left ventricular ejection fraction (LVEF)
• Arrhythmias (irregular heartbeat)
• Tachycardia/bradycardia
• Cardiogenic shock (rare)
• Pericardial effusion/pericarditis

Infusion & hypersensitivity reactions

• Severe infusion reactions
• Anaphylaxis / anaphylactic shock
• Bronchospasm
• Angioedema

Pulmonary toxicity

• Interstitial pneumonitis
• Pulmonary fibrosis
• Acute respiratory distress syndrome (ARDS)
• Pulmonary edema
• Respiratory failure
• Hypoxia

Hematologic toxicity

• Severe neutropenia
• Febrile neutropenia
• Thrombocytopenia
• Anemia
• Leukopenia

Renal toxicity

• Renal failure
• Nephrotic syndrome
• Glomerulopathy

Severe infections

• Sepsis
• Neutropenic sepsis
• Herpes zoster

Others

• Seizures
• Sudden death (rare)
• Oligohydramnios (pregnancy-related complication)

Very Common Side Effects (Less than 10%)

General/systemic

• Fever
• Chills
• Fatigue/asthenia
• Pain (generalized)

Gastrointestinal

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Loss of appetite (anorexia)
• Stomatitis (mouth sores)

Respiratory

• Cough
• Shortness of breath (dyspnea)
• Rhinitis / runny nose
• Nasopharyngitis

Blood-related

• Neutropenia
• Anemia
• Leukopenia
• Nervous system
• Headache
• Dizziness
• Insomnia
• Peripheral neuropathy
• Paresthesia (tingling)
• Dysgeusia (taste changes)

Skin

• Rash
• Acne
• Nail changes
• Hair loss (less common but reported)

Musculoskeletal

• Joint pain (arthralgia)
• Back pain
• Bone pain
• Muscle pain (myalgia)

Metabolic

• Weight loss
• Hypokalemia (low potassium)

Others

• Infusion reactions
• Infections
• Edema (swelling)

Common Side Effects (1–10%)

• Hypertension/hypotension
• Palpitations
• Lymphedema
• Constipation
• Dyspepsia
• Dysphagia
• Dry mouth
• Pancreatitis (rare but reported)
• Sinusitis
• Upper respiratory infections
• Asthma-like symptoms
• Pleural effusion
• Somnolence (sleepiness)
• Ataxia (coordination issues)
• Pruritus (itching)
• Dry skin
• Dermatitis
• Muscle spasms
• Neck pain
• Arthritis
• Malaise

Less Common / Rare Side Effects

• Fainting
• Urticaria (hives)
• Severe allergic reactions
• Pulmonary hypertension
• Brain edema
• Deafness
• Paresis (muscle weakness)
• Ventricular dysfunction
• Pericardial disease
• Angioedema

Other Reported Side Effects 

• Rapid weight gain
• Fluid retention
• Mood changes
• Depression-like symptoms
• Eye/vision disturbances
• Cold sores/herpes infections
• Nosebleeds
• Burning/tingling sensations
• Swelling of the face/limbs
• Difficulty swallowing
• Voice changes
• Ulcers in the mouth
• Sweating
• Sleep disturbances
•  

What are the Precautions Hertraz 440mg Injection ?

• Hertraz 440 mg injection must be administered only to HER2-positive confirmed cancer patients.
• The patients must be monitored continuously for any adverse reactions after an infusion.
• Doctors must make sure that the first infusion rate is slow (approximately 90 minutes).
• This drug must be administered carefully to patients with cardiac, renal, or hepatic impairment.
• Hertraz 440 mg injection is not meant for consumption by pregnant or breastfeeding women.
• While on Hertraz 440 mg therapy, patients must be regularly monitored for cardiac functions, vitals, blood profile, and signs of toxicity.
• Hertraz 440 mg injection administration must be immediately stopped if there are any signs of heart failure (e.g., swelling, breathlessness), severe infusion reactions, anaphylaxis, or serious lung complications.

Other Information

Frequently Asked Questions

What is the main indication treated using Hertraz 440 mg injection?

Hertra 440 is exclusively used in the treatment of those cancers with HER2-positive cells.

What does HER2-positive mean?

HER2-positive refers to the presence of receptors for human epidermal growth factors, which are essential for cell growth.

Is Hertraz 440 mg injection a chemotherapy agent?

Hertraz 440 mg injection is a targeted anti-cancer therapy and not a chemotherapy agent.

Can Hertraz 440 mg injection be used for non-HER2-positive cancers?

No. Hertraz 440 mg injection is only intended for HER2-positive cancer cases.

What is the most serious side effect caused by Hertraz 440 mg injection?

The most serious side effect caused by Hertraz 440 mg injection is cardiotoxicity (heart damage/heart failure).