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Bortenat 2mg (Bortezomib)

Brand: Natco
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BORTENAT 2MG

Description:

Bortenat 2mg is an antineoplastic drug, which is available in the form of lyophilized powder. Bortenat 2mg reversibly prevents the chymotryptic activity of the 20S submit of the proteasome and prohibits multiplication and induces apoptosis in Multiple Myeloma cell lines and patient tumor cells. Bortenat 2mg is a prescription drug provided under the guidance of medical practitioners.

Indication:

Indicated for the treatment of patients with Multiple myeloma

Indicated for the treatment of patients with mantle cell lymphoma as first-line in previously untreated patients or those who have relapsed

Pharmacology:

Bortenat 2mg mechanism of action:

Bortezomib is a type of cancer treatment drug called a proteasome inhibitor.

In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes used which bortezomib is mainly oxidatively metabolized through cytochrome P450 enzymes 3A4, 2C19, and 1A2, while bortezomib metabolism by CYP 2D6 and 2C9 enzymes is minor.

The major metabolic pathway is deboronation to form 2 deboronated metabolites which finally go through hydroxylation to various metabolites which are inactive as 26S proteasome inhibitors.

Pharmacokinetic:

Absorption:

The maximum plasma level of Bortenat 2mg occurs as 509ng/ml

Distribution:

The human plasma protein binding of Bortenat 2mg occurs as nearly 83%

Metabolism:

Major metabolic pathway: deboronation to form 2-deboronated metabolites which are inactive as 26S proteasome inhibitors

Bortenat 2mg is metabolized hepatically with the help of cytochrome P 450 enzymes 3A4, 2C19, & 1A2 by oxidation

Elimination:

The single dose IV: The half-life period occurs at 9 to 15 hours;

Multiple 1mg/m2 dosing: 40 to 193 hours

Multiple 1.3mg/m2 dosing: 76 to 108 hours

Bortenat 2mg dosage and administration:

In adults:

Mantle cell lymphoma:

The usual dose of Bortenat for untreated mantle cell lymphoma is;1.3mg/m2 of Bortenat administered as IV bolus given as two times weekly by combining with rituximab, cyclophosphamide, doxorubicin and tablet prednisolone for two weeks (day I, IV, VIII & XI) followed by 10-day rest period (day II through 21)

In recurrent stage:

The prescribed dose is 1.3mg/m2 administered as IV bolus or subcutaneous two times for two weeks (day I, IV, VIII & XI) followed by 10-day rest period (day II through 21)

The treatment followed for above 8 cycles may be given for once weekly for 4 weeks (day 1, 8, 15 & 22), followed by 13-day rest (days 23 through 35)

Multiple myeloma:

The usual recommended dose of Bortenat 2mg is 1.3mg/m2. The concentration of Bortezomib is 1mg/ml while administrating through IV.

Bortezomib should be used in co administration with oral melphalan & oral prednisolone for the period of nine 6-week therapy cycles.

In cycle 1 to 4, the frequency of Bortezomib should be given as a twice weekly.

In cycles 5 to 9, the frequency reduced to once weekly.

Between consecutive doses of Bortezomib, at least 72 hours should be elapsed.

Before starting the treatment with Bortenat, patients must be examining with;

Platelet counts 70 x 109 L, neutrophils counts 1 x 109L

Non-hematological toxicity resolved to grade 1.

In Relapse stage:

The recommended dose of Bortenat is 1.3mg/m2 should be administered through IV bolus or subcutaneous as two times for two weeks (day1, 4, 8, and 11) followed by a ten-day rest course (day 12 through 21).

Treatment schedule increased above 8 cycles may be taken once weekly for 4 weeks (day 1, 8, 15, and 22), followed by 13-day rest (day 23 over 35).

Generally, Bortenat is in lyophilized powder form; which is reconstituted by using 0.9% sodium chloride (NS)

Bortenat3.5mg should be reconstituted in 3.5ml NS

The route of administration is IV bolus

Intrathecal not use for administration

Bortenat side effects:

Most common side effects occurred after administration of Bortenat 2mg includes:

  • Black tarry stools
  • Bleeding gums
  • Blood in urine
  • Blurred vision
  • Body aches
  • Burning, crawling, itching, numbness, prickling
  • Chest pain
  • Cough producing mucus, dizziness, faintness, nerve pain, painful urination, pale skin, runny nose, sore throat, stuffy nose, swollen glands, sunken eyes, ulcer, dry mouth, ear congestion, loss of voice

Less common side effects:

  • Headache
  • Insomnia
  • Joint pains, arthralgia, myalgias
  • Swelling of the face, hands, feet or legs (edema).
  • Low white blood cell count. (This can put you at increased risk for infection.) 
  • Dyspnea
  • Dizziness
  • Rash
  • Dehydration
  • Upper respiratory tract infection
  • Cough
  • Bone pain
  • Anxiety
  • Muscle cramps
  • Heartburn
  • Abdominal pain
  • Low blood pressure
  • Itching
  • Blurring of vision
  • Blood test abnormalities:

Bortenat drug interaction:

Avoid Co administration with St. John’s wort to reduces the exposure of Bortenat

No clinical effect on Bortenat exposure while combination with melphalan-prednisone or dexamethasone alone

Strong CYP3A4 inhibitors: there is a chance of getting Bortenat toxicity; so, to reduce the dose of Bortenat while combination with CYP3A4 inhibitors

Strong CYP3A4 inducers: reduces the exposure of Bortenat.

Contraindication:

Hypersensitivity reaction occurs in patients who are contraindicated to Bortenat 2mg, boron, boric acid or glycine

Bortenat 2mg is given through IV bolus or subcutaneous; whereas intrathecal administration is contraindicated to the patients who are receiving Bortenat 2mg

Precaution & warning:

Thrombocytopenia and neutropenia

Tumor lysis syndrome

Hepatic toxicity

Embryo fetal toxicity

While taking Bortenat 2mg some adverse effects occurs care should be taken in the conditions like

Bortenat 2mg leads to peripheral neuropathy like burning sensation, hyperesthesia, hypoesthesia, paresthesia, neuropathic pain

Manage postural Hypotension by altering the antihypertensive agents, hydration, and administration of mineralocorticoids or sympathomimetics

Cardiac toxicity

Pulmonary toxicity like Acute Respiratory Distress Syndrome, pneumonitis, interstitial pneumonia, lung infiltration

Posterior reversible encephalopathy syndrome-stop the Bortenat 2mg therapy

Gastrointestinal toxicity-fluid or electrolyte replacements have to take

Pregnancy & lactation:

Bortenat 2mg is not recommended in pregnancy condition, it causes harm to fetus

Breast feeding is not recommended

Storage:

Bortenat 2mg vial should be stored at 20oC to 25oC (68oF to 77oF); excursion between 15oC to 30oC (59oF to 86oF)

Keep away from light and heat

Missed dose:

Bortenat 2mg is not a normal medicine used as an anti-cancer drug; it is not to be self-medicated

If patient missed to take the dose of Bortenat 2mg, must consult with a medical oncologist and followed the dosing schedules

Follow the advice given by physician and do not missed the cycles for course of therapy

  • Trade name Bortenat 2mg
  • Substance Bortezomib
  • Manufacturer Natco Pharma Limited
  • Packaging 2mg Bortezomib containing vial in a carton
  • Country of origin India
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