Frequently Asked Questions (FAQs)
LevisCD2
What is LevisCD2?
LevisCD2 is the brand name for Levilactobacillus brevis CD2 lozenges for the prevention and management of oral mucositis marketed by Wembrace biopharma Pvt. Ltd.
What is the composition of LevisCD2?
Each LEVISCD2 lozenge contains Live, lyophilized lactic acid bacteria Levilactobacillus brevis CD2 Not less than 2 billion CFU
What is a lozenge?
A lozenge is a solid dosage form designed to dissolve slowly in the mouth, containing active ingredients that provide a topical or systemic effect. It is flavoured and sweetened to be pleasant tasting, making it a suitable option for patients who have difficulty swallowing other solid medications.
What is the indication for LevisCD2?
For the prevention of radiotherapy and chemotherapy induced oral mucositis in cancer patients
How LevisCD2 works?
LevisCD2 contains Levilactobacillus brevis CD2 strain is a normal inhabitant of the mouth and intestinal flora and is also commonly found in dairy products. AD plays a major role in metabolism of arginine by converting it to citrulline and ammonia by competitive inhibition. It reduces the availability of arginine within the oral cavity to arginase, thus decreasing the production of polyamines, and to nitric oxide synthase, thus reducing the production of nitric oxide and leading to the attenuation of the inflammatory markers. Bacterial sphingomyelinase is known to hydrolyze the platelet-activating factor,18 a potent phospholipid mediator of inflammation, which has been reported for its role in inflammation and tissue injury associated with mucositis during radiation therapy.
What is the dosage of LevisCD2 ?
CTRT (for Adults) - One LEVISCD2 lozenge to be taken 4-6 times a day from the first day of therapy until 1 week after the last CRT administration (for the management of the oral mucositis). HSCT (Above 10 years): One LEVISCD2 lozenge to be taken 3-6 times a day 4 to 7 days before initiation of chemotherapy and to be continued until resolution of mucositis or till day +24 post stem cell infusion, whichever occurs early (for the Prevention of the oral mucositis)
How to Administer LevisCD2 ?
➢ LEVISCD2 lozenges are intended to be dissolved slowly in the mouth.
➢ For best results, LEVISCD2 lozenges must dissolve naturally in the mouth like a lozenge.
➢ Do not chew, crush or swallow the whole lozenge.
➢ Move the lozenge around the mouth until it dissolves completely.
➢ Do not consume anything 30 minutes before and after taking LEVISCD2
LevisCD2 can be given in case of Xerostomia
As per the company from where we are procuring LevisCD2, it taken can be taken while the patient is using such artificial saliva. There should not be any incompatibility or interactions.
What are the Drug interactions for LevisCD2?
No known drug interactions have been reported with LevisCD2.
What are the storage guideline for LevisCD2?
To be stored between 2-8 °C (in a refrigerator) protected from light and moisture. Do not freeze. Keep out of reach of children
What are the Contraindications for LevisCD2?
• Known Hypersensitivity to any of the ingredients mentioned above.
• Known neuromuscular dysfunction with impaired swallowing and cough reflex.
• Known cases of phenylketonuria.
What are adverse effect of LevisCD2, if there is an overdose?
No major adverse effects have been reported up to a maximum daily consumption of 180 billion CFU Levilactobacillus brevis CD2
Can LevisCD2 be given in pregnancy and lactation cases?
No data is available for LEVISCD2 usage in pregnant and lactating women.
What precautions to be exercised while administering LevisCD2 to pediatric and in geriatrics.
Caution should be exercised while administering LEVISCD2 in children and elderly for the choking hazard.
Docisol
What is Docisol?
Docisol is Nanoparticle docetaxel lipid suspension.
Whether DOCISOL is in liquid form or powder form?
It is a lyophilized powder which looks like white cake powder.
What are the strengths available in DOCISOL and what does it contains in the Sale pack?
It is available in 20 & 80 mg vials; the sale pack contains 1 vial of 20 or 80 mg and 1 unit of 5-micron needle.
What is the storage condition for DOCISOL?
Docisol to be stored at 2-8 degree celcius protect from light.
Whether Conventional Docetaxel and DOCISOL are same formulation
No
Whether DOCISOL and Conventional Docetaxel dosage and indications are same?
YES. DOCISOL Indications and dosage are same as that of Conventional Docetaxel.
Whether Premedication of corticosteroids is required for DOCISOL?
NOT REQUIRED. The premedication of corticosteroids is not required because DOCISOL is free from Polysorbate 80 / Tween 80 and Absolute alcohol.
Whether Special IV set is required for administration of DOCISOL?
A.NOT REQUIRED. They can use Normal IV (PVC/ Non-PVC) or Transfusion IV set which can ensure free flow into the patient vein. A doctor or nurse can decide the IV set as per the patient’s comfort.
Whether Chemo mixing person can use 16-gauge needle or similar needle to withdraw the reconstituted solution from the vial? before infusion into the infusion bag or bottle?
YES. Can be withdrawn using normal injection needle.
Whether the reconstitution procedure of DOCISOL is same as that of Conventional Docetaxel?
Both are different formulations, and both have different reconstitution procedures. For detailed reconstitution procedure please refer to the DOCISOL pack insert.
Whether chemo mixing person can use 0.9% NS or 5% Dextrose for initial reconstitution of lyophilized powder instead of WFI.?
A.Only Water for Injection (WFI) is recommended for initial reconstitution of lyophilized cake to form a uniform suspension. Docisol Lyophilized powder to be dissolved in aqueous media (WFI) before infusing into the infusion bag containing either Normal saline or Dextrose solution.
While initial reconstitution whether chemo mixing person can add the WFI direct to the Docisol cake or powder?
Not directly to the cake or powder. Water for Injection (WFI) should be added through the side wall of the vial through slow infusion method to avoid foam forming during the initial reconstitution process.
Whether chemo mixing person can shake the vial vigorously to dissolve the cake completely in WFI?
NOT RECOMMENDED. The chemo mixing person should rotate the vial very gently in between the palms for 2-3 minutes and to ensure no foams are formed during the initial reconstitution process.
Whether Doctor can switch the therapy protocol from conventional Docetaxel to DOCISOL without changing the dosage or therapy schedule?
YES. Doctors can switch the drug from conventional Docetaxel to DOCISOL without interrupting the therapy protocol or schedule.
If a patient develops hypersensitivity or side effects due to corticosteroids while administering conventional docetaxel, whether doctor can switch to DOCISOL in upcoming chemo cycle?
YES. Doctor can switch to DOCISOL from conventional docetaxel if patient had developed any side effects related to corticosteroids without interrupting the therapy cycle.
If a patient develops severe side effects related to Docetaxel, whether doctor switch the therapy to DOCISOL?
NO. If a patient develops a resistance to docetaxel or severe side effects due to conventional docetaxel, the doctor should evaluate the condition and switch to NON TAXANE regimen.
Whether the side effects are the same in DOCISOL as that of Conventional Docetaxel?
LESS compared to conventional Docetaxel. Hypersensitivity, Fluid retention, Peripheral neuropathy, Neutropenia, Fatigue is less compared to conventional docetaxel.
Whether Docisol can be used as weekly regimen instead of 3 weekly same as that of weekly paclitaxel.?
NO EVIDENCE of using weekly docetaxel (Docisol). Some doctors may use Low dose as weekly Regimen, but there is no documented evidence.
Is there any evidence that DOCISOL can be used as 2-weekly regimen?
YES. There is a recent study on mCRPC where 2-weekly low dose NDLS (50 mg/m2) were compared with 3 weekly NDLS and found to be effective and well tolerated.
Which kind of patients is preferred for Docetaxel lipid suspension?
The Patient with hyperglycemic, neuropathy, infusion related reactions, hypersensitivity due to corticosteroids, and patient having 3 weekly dosage regimens are preferred with DOCISOL.
How do I support my patient, since the Docisol is very costly compared to normal docetaxel?
Through our NISHTHA program (patient assistance program), your patient can avail one cycle free on purchase of 2 cycles which can reduce the financial burden of your patient.
Why should I prefer NDLS (Nanoparticle Docetaxel lipid suspension) over normal docetaxel.?
For lipid suspension Docetaxel there is no need of corticosteroid as premedication, less infusion time, no special IV set is required, lesser side effects, targets the cancer cell with precision, and easy to switch from Normal Docetaxel in case of hypersensitivity, fluid retention and neuropathy.