Linfogebin Dosage

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Dosage of Linfogebin in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Non-Small Cell Lung Cancer: Single-Agent Use: Adults: The optimum dose schedule for Linfogebin has not been determined.

Recommended Dose: 1,000 mg/m2, given by 30-min IV infusion, repeated once weekly for 3 weeks, followed by a 1-week rest period. This 4-week cycle is then repeated.

Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Combination Use: Adults: Linfogebin in combination with cisplatin has been investigated using 2 dosage regimens.

One regimen used a 3-week schedule and the other used a 4-week schedule.

The 3-week schedule used Linfogebin 1,250 mg/m2, given by 30-min IV infusion on days 1 and 8 of each 21-day cycle. The 3-week schedule used cisplatin 75-100 mg/m2 on day 1 of each 21-day cycle, administered before the Linfogebin dose. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient.

The 4-week schedule used Linfogebin 1,000 mg/m2, given by 30-min IV infusion on days 1, 8 and 15 of each 28-day cycle. The 4-week schedule used cisplatin 75-100 mg/m2 on day 1 of each 28-day cycle, administered after the Linfogebin dose. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Pancreatic Cancer: Adults: Recommended Dose: 1,000 mg/m2, given by 30-min IV infusion. This should be repeated once weekly for up to 7 weeks followed by a week of rest.

Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Bladder Cancer: In patients with bladder cancer who cannot tolerate cisplatin-based combinations, Linfogebin monotherapy should be considered as a treatment option.

Single-Use Agent: Adults: Recommended Dose: 1,250 mg/m2, given by 30-min IV infusion. The dose should be given on days 1, 8 and 15 of each 28-day cycle. This 4-week cycle is then repeated. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Combination Use: Adults: Recommended Dose: 1,000 mg/m2, given by 30-min IV infusion. The dose should be given on days 1, 8 and 15 of each 28-day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m2 on day 1 following Linfogebin or day 2 of each 28-day cycle. This 4-week cycle is then repeated. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient. A clinical trial showed more myelosuppression when cisplatin was used in doses of 100 mg/m2.

Breast Cancer: Adults: Linfogebin in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on day 1 over approximately 3 hrs as an IV infusion, followed by Linfogebin ( 1,250 mg/m2) as a 30-min IV infusion on days 1 and 8 of each 21-day cycle. Dose reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Ovarian Cancer: Adults: Linfogebin in combination with carboplatin is recommended using Linfogebin 1,000 mg/m2 administered on days 1 and 8 of each 21-day cycle as a 30-min IV infusion. After Linfogebin, carboplatin should be given on day 1 consistent with target AUC of 4 mg/mL/min. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.

Dose Reduction: Hematological Toxicity: Patients receiving Linfogebin should be monitored prior to each dose for platelet, leucocyte and granulocyte counts and if there is evidence of toxicity, the dose of Linfogebin should be reduced or withheld.

Patients receiving Linfogebin should have an absolute granulocyte count of at least 1.5 (x 109/L) and a platelet count of ≥100 (x 109/L) prior to initiation of a cycle. Dose modifications of Linfogebin on day 8 and/or day 15 for hematological toxicity should be performed according to the guidelines as follows.

Linfogebin Monotherapy or in Combination with Cisplatin.

Linfogebin in Combination with Paclitaxel.

Linfogebin in Combination with Carboplatin.

Other Toxicity: Periodic physical examination and checks of liver and kidney function should be made to detect nonhematological toxicity. Dosage reduction with each cycle or dose omission within a cycle may be applied based upon the amount of toxicity experienced by the patient. Doses should be withheld until toxicity has resolved in the opinion of the physician.

Linfogebin is well-tolerated during the infusion, with only a few cases of injection site reaction reported. There have been no reports of injection site necrosis. Linfogebin can be easily administered on an outpatient basis.

What other drugs will affect Linfogebin?

Other drugs may affect Linfogebin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Linfogebin drug interactions (in more detail)

Linfogebin interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Linfogebin, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Radiotherapy: Concurrent (Given Together or Equal to or 7 Days Apart): Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of Linfogebin, frequency of Linfogebin administration, dose of radiation, radiotherapy planning technique, the target tissue and target volume. In a single trial where Linfogebin at a dose of 1,000 mg/m2 was administered concurrently for up to 6 consecutive weeks with therapeutic thoracic radiation to patients with NSCLC, significant toxicity in the form of severe and potentially life-threatening, esophagitis and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy (median treatment volumes 4,795 cm3). The optimum regimen for safe administration of Linfogebin with therapeutic doses of radiation has not yet been determined.

Radiation injury has been reported on targeted tissues (eg, esophagitis, colitis and pneumonitis) in association with both concurrent and noncurrent use of Linfogebin.

When given in combination with paclitaxel, cisplatin or carboplatin, the pharmacokinetics of Linfogebin were not altered. Linfogebin had no effect on paclitaxel pharmacokinetics.

Laboratory Tests: Therapy should be started cautiously in patients with compromised bone marrow function. As with other oncolytics, the possibility of cumulative bone marrow suppression when using combination or sequential chemotherapy should be considered.

Patients receiving Linfogebin should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy should be considered when drug-induced marrow depression is detected. For guidelines regarding dose modifications, see Dosage & Administration. Peripheral blood counts may continue to fall after the medicine is stopped.

Laboratory evaluation of renal and hepatic function should be performed periodically. Raised liver transaminases (AST/ALT) and alkaline phosphatase are seen in approximately 60% of the patients. These increases are usually mild, transient and not progressive and seldom lead to cessation of treatment. Increased bilirubin (WHO toxicity degrees 3 and 4) was observed in 2.6% of the patients. Hospira Linfogebin should be given with caution to patients with impaired hepatic function.

Administration of Linfogebin in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.

A few cases of renal failure, including hemolytic uremic syndrome have been reported.

Linfogebin should be administered with caution to patients with impaired renal function. Hospira Linfogebin treatment should be withdrawn if there is any sign of microangiopathic hemolytic anemia eg, rapidly falling hemoglobin levels with simultaneous thrombocytopenia, elevation of serum bilirubin, serum creatinine, urea or lactate dehydrogenase (LDH). Renal failure may be irreversible despite withdrawal of Hospira Linfogebin treatment and may require dialysis.


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References

  1. FDA/SPL Indexing Data. "B76N6SBZ8R: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Radiation-Sensitizing Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(+)-2'-Deoxy-2',2'-difluorocytidine hydrochloride: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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