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Novotaxel 80 Injection

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Brand Name: Novotaxel 80mg Injection
International Trade Name: Taxotere
Active Substance: Docetaxel
Strength: 80mg
Category: Anti-Cancer
Manufacturer: Therdose Pharma pvt Ltd
Pack: 1 Vial
Product Form: Injection
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Description of Novotaxel 80 (Docetaxel 80mg) injection  

Novotaxel injectable 80mg is a chemotherapeutic agent that is used in the management of numerous solid tumours, such as breast, lung, prostate, gastric, and head-and-neck tumours. It is a taxane antineoplastic agent which acts by stabilising the microtubules hence preventing their dismantling during mitosis as is the case with this group of drugs.

Indications of Novotaxel 80 (Docetaxel 80mg) injection

Novotaxel 80 is used to treat breast cancer, non- small- cell lung cancer, prostate cancer, gastric cancer, and head and neck cancer mainly. Depending on clinical consideration, the agent can be used as monotherapy or used concomitantly with other cytotoxic regimens.

Mechanism of action of Novotaxel 80 (Docetaxel 80mg) injection

Docetaxel interacts with the microtubules β -tubulin subunits, which leads to stabilisation of microtubules and inhibits depolymerisation in the microtubules. This disturbance is caused by interrupting assembly of the mitotic spindle needed to divide the cell and thus leading to cell-cycle arrest at the G2/M transition, and eventually to apoptosis of the malignant cells.

How to consume of Novotaxel 80 (Docetaxel 80mg) injection

Novotaxel 80 is administered to a patient intravenously by a qualified health-care worker in the hospital or oncology clinic facility. The dose and the duration of infusion as indicated by the oncologist depends on the body surface area, type of tumour and the tolerance of the patient. Pre-medication-taking (corticosteroids, antihistamines) is a matter of routine to prevent the occurrence of infusion related hypersensitivity reaction.

Side Effects of Novotaxel 80 (Docetaxel 80mg) injection  

  1. Common side effects
  • Hair loss
  • Infusion Fever and Chills
  • Mild diarrhea
  • Nausea or vomiting
  • Headache
  1. Serious side effects
  • Pain in the chest
  • Irregular heartbeat
  • Increased infection risk
  1. Rare side effects
  • Extreme increase in liver enzymes
  • Severe skin reactions
  • Hearing disturbances

Safety Advice for Novotaxel 80 (Docetaxel 80mg) injection

Cardiac examination (eg. Echocardiography or left ventricular ejection fraction) and regular liver and blood tests need to be performed on patients treated with Docetaxel to identify its side effects in the first place.

Breastfeeding: Interaction with the agent during lactation is not advisable since the agent may be released into breast milk and be dangerous to the baby.

Pregnancy: Docetaxel is not to be used in pregnant women because of the likelihood of harming a child, contraception should be used with effectiveness.

Alcohol: Intake of alcohol should be limited since it could increase the effect of hepatotoxicity.

Liver: Patients who have a history of hepatic disorders must use Docetaxel cautiously and with strict medical care as the drug may increase the level of hepatic enzymes.

Lungs: New cough, dyspnea and chest discomfort should be reported as soon as possible.

Kidney: Care should be taken in patients with severe renal failure.

Driving: It is possible that patients feel dizzy or fatigued, in this case the patients should avoid driving.

Interaction of Novotaxel 80 (Docetaxel 80mg) injection  

  • Drug-Drug Interaction :

Apalutamide x Docetaxel

It should be considered to use some alternative pharmacologic agents because the simultaneous use of apalutamide can reduce the therapeutic effects of Docetaxel by influencing the activity of enzymes in the liver.

Eluxadoline x Docetaxel

Use alternative drug because the use of Docetaxel will increase the effect of eluxadoline by decreasing it metabolism.

Dichlorphenamide x Docetaxel

The combination should be used with caution as the interaction lowers the levels of serum potassium.

Siponimod x Docetaxel

It is recommended that clinical vigilance be observed because the combination might increase the risk of infection.

Phenytoin x Docetaxel 

This combination should be administered with care because the administration of Docetaxel can reduce the exposure to phenytoin by increasing the metabolism clearance of the latter.

  • Drug-Food Interaction:

Food:

There is no reported food interaction that is significant however, a balanced diet should be maintained.

  • Drug-Disease Interaction:

Infections: 

This medicine should not be used in patients with active infections as it can cause myelosuppression that will worsen the existing infections.

Conduction disorders: 

There is a need to be careful with the application of this therapeutic agent, as it has the propensity to cause severe conduction abnormalities.

Peripheral neuropathy: 

The treatment plan should be subject to stringent questioning because it is associated with the danger of triggering peripheral neuropathy.

Hepatic dysfunction: 

Patients with impaired hepatic activity should be treated with increased attention since the ones with moderately-to-severe hepatic activity are predisposed to hepatotoxicity.

Contraindication of Novotaxel 80 (Docetaxel 80mg) injection

The formulation is not recommended in patients who have hypersensitivity to docetaxel, who are extremely neutropenic, or who have uncontrolled infections.

Dosage of Novotaxel 80 (Docetaxel 80mg) injection  

Calculation of dosing regimen depends on type of tumour, weight of patient, and re-action.

Storage of Novotaxel 80 (Docetaxel 80mg) injection

The refrigeration level where the product should be kept is between 2 and 8°C, and the environment must be free of light. Freezing should be prohibited. The substance should not be accessible to the children.

Missed Dose of Novotaxel 80 (Docetaxel 80mg) injection

In case of a missed infusion, call the healthcare provider so as to reschedule. Do not give two ties its dose.

Other General Information of Novotaxel 80 (Docetaxel 80mg) injection

The long-term treatment can trigger exhaustion, neuropathy or xerosis. It is necessary to keep the patient hydrated properly, balance nutrition, and regularly cheque the progress. Atypical manifestations should be reported as soon as possible by the patients.

FAQs of Novotaxel 80 (Docetaxel 80mg) injection

  1. What is the reason behind the loss of hair with Docetaxel?

The drug interferes with the rapidly growing mass of cells, such as the dermal papilla cells of the hair follicles.

  1. Is neuropathy reversible?

In many cases, treatment of neuropathic symptoms improves after withdrawal of treatment, in spite of the urgency of reporting the symptoms early.

  1. Do you have allergic reactions?

Infusion reactions can take place; concomitant premedication is used to prevent this adverse effect.

  1. Is it possible to maintain normal functioning?

The normal activities can be generally continued, as long as the severe fatigue or dizziness do not arise.

  1. Is it taken either in isolation or in combination with other substances?

The agent is commonly used together with platinum based chemotherapeutics to improve therapy results.

Fact Box of Novotaxel 80 (Docetaxel 80mg) injection

Field Details
Generic/Molecule Name Docetaxel
Therapeutic Class Anti-neoplastic agent
Pharmacological Class Taxane (Microtubule stabilizer)
Dosage form Injection
Habit forming No
Indication Breast, lung, prostate, and other solid tumours

 

References
  1. Chu E, Sartorelli AC. Cancer Chemotherapy. In: Katzung BG, Masters SB, Trevor AJ, editors. Basic and Clinical Pharmacology. 11th ed. New Delhi, India: Tata McGraw Hill Education Private Limited; 2009. p. 951.
  2. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. pp. 422-23.
  3. Docetaxel Injection. Unterach, Austria: EBEWE Pharma Ges.m.b.H. Nfg.KG; 1996 [revised Mar. 2012. [Accessed 26 Mar. 2019] (online) Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf 
  4. Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006. Docetaxel. [Updated 2019 Jun 30]. [Accessed 18 Feb. 2020] (online) Available from: https://www.ncbi.nlm.nih.gov/books/NBK500901/

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