|
|||
|
DRUGS & SUPPLEMENTS
|
Nikableomicina
What are the side effects you encounter while taking this medicine? |
Nikableomicina uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- References
INDICATIONS AND USAGE
Nikableomicina for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma
Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Nikableomicina is poorer in patients with previously irradiated head and neck cancer.
Lymphomas
Hodgkin's disease, non-Hodgkin's lymphoma.
Testicular Carcinoma
Embryonal cell, choriocarcinoma, and teratocarcinoma.
Nikableomicina has also been shown to be useful in the management of:
Malignant Pleural Effusion
Nikableomicina is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
CONTRAINDICATIONS
Nikableomicina for Injection is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
WARNINGS
Patients receiving Nikableomicina must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function.
Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by Nikableomicina progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see ADVERSE REACTIONS : Pulmonary ).
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with Nikableomicina. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see ADVERSE REACTIONS : Idiosyncratic Reactions ).
Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy.
Usage in Pregnancy
Pregnancy Category D
Nikableomicina can cause fetal harm when administered to a pregnant woman. It has been shown to be teratogenic in rats. Administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the recommended human dose on a unit/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery and hydroureter. Nikableomicina is abortifacient but not teratogenic in rabbits at intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m2 basis) given on gestation days 6 to 18.
There have been no studies in pregnant women. If Nikableomicina for Injection is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Nikableomicina for Injection.
PRECAUTIONS
General
Patients with creatinine clearance values of less than 50 mL/min should be treated with caution and their renal function should be carefully monitored during the administration of Nikableomicina. Lower doses of Nikableomicina may be required in these patients than those with normal renal function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of Nikableomicina in humans is unknown. A study in F344-type male rats demonstrated an increased incidence of nodular hyperplasia after induced lung carcinogenesis by nitrosamines, followed by treatment with Nikableomicina. In another study where the drug was administered to rats by subcutaneous injection at 0.35 mg/kg weekly (3.82 units/m2 weekly or about 30% at the recommended human dose), necropsy findings included dose-related injection site fibrosarcomas as well as various renal tumors. Nikableomicina has been shown to be mutagenic both in vitro and in vivo. The effects of Nikableomicina on fertility have not been studied.
Pregnancy
Pregnancy Category D
See WARNINGS .
Nursing Mothers
It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Nikableomicina therapy.
Pediatric Use
Safety and effectiveness of Nikableomicina for Injection in pediatric patients have not been established.
Geriatric Use
In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients (see BOXED WARNING , WARNINGS , and ADVERSE REACTIONS : Pulmonary ). Other reported clinical experience has not identified other differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Nikableomicina is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
ADVERSE REACTIONS
Pulmonary
The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose. This toxicity, however, is unpredictable and has been seen in young patients receiving low doses. Some published reports have suggested that the risk of pulmonary toxicity may be increased when Nikableomicina is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with Nikableomicina and G-CSF.
Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to Nikableomicina sulfate has been extremely difficult. The earliest symptom associated with Nikableomicina sulfate pulmonary toxicity is dyspnea. The earliest sign is fine rales.
Radiographically, bleomycin-induced pneumonitis produces nonspecific patchy opacities, usually of the lower lung fields. The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity. However, these changes are not predictive of the development of pulmonary fibrosis.
The microscopic tissue changes due to Nikableomicina toxicity include bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema, and interstitial fibrosis. The acute stage may involve capillary changes and subsequent fibrinous exudation into alveoli producing a change similar to hyaline membrane formation and progressing to a diffuse interstitial fibrosis resembling the Hamman-Rich syndrome. These microscopic findings are nonspecific; eg similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.
To monitor the onset of pulmonary toxicity, roentgenograms of the chest should be taken every 1 to 2 weeks (see WARNINGS ). If pulmonary changes are noted, treatment should be discontinued until it can be determined if they are drug related. Recent studies have suggested that sequential measurement of the pulmonary diffusion capacity for carbon monoxide (DLCO) during treatment with Nikableomicina for Injection, USP may be an indicator of subclinical pulmonary toxicity. It is recommended that the DLCO be monitored monthly if it is to be employed to detect pulmonary toxicities, and thus the drug should be discontinued when the DLCO falls below 30% to 35% of the pretreatment value.
Because of bleomycin's sensitization of lung tissue, patients who have received Nikableomicina are at greater risk of developing pulmonary toxicity when oxygen is administered in surgery. While long exposure to very high oxygen concentrations is a known cause of lung damage, after Nikableomicina administration, lung damage can occur at lower concentrations that are usually considered safe. Suggested preventive measures are:
- Maintain FIO2 at concentrations approximating that of room air (25%) during surgery and the postoperative period.
- Monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.
Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been reported during Nikableomicina for Injection infusions. Although each patient must be individually evaluated, further courses of Nikableomicina for Injection do not appear to be contraindicated.
Pulmonary adverse events which may be related to the intrapleural administration of Nikableomicina have been reported.
Idiosyncratic Reactions
In approximately 1% of the lymphoma patients treated with Nikableomicina for Injection, an idiosyncratic reaction, similar to anaphylaxis clinically, has been reported. The reaction may be immediate or delayed for several hours, and usually occurs after the first or second dose (see WARNINGS ). It consists of hypotension, mental confusion, fever, chills, and wheezing. Treatment is symptomatic including volume expansion, pressor agents, antihistamines, and corticosteroids.
Integument and Mucous Membranes
These adverse reactions have been reported in approximately 50% of treated patients. They consist of erythema, rash, striae, vesiculation, hyperpigmentation, and tenderness of the skin. Hyperkeratosis, nail changes, alopecia, pruritus, and stomatitis have also been reported. It was necessary to discontinue Nikableomicina therapy in 2% of treated patients because of these toxicities.
Scleroderma-like skin changes have been reported.
Skin toxicity is a relatively late manifestation usually developing in the second and third week of treatment after 150 to 200 units of Nikableomicina have been administered and appears to be related to the cumulative dose.
Intrapleural administration of Nikableomicina has been associated with local pain. Hypotension possibly requiring symptomatic treatment has been reported. Death has been reported in association with Nikableomicina pleurodesis in seriously ill patients.
Other
Vascular toxicities coincident with the use of Nikableomicina in combination with other antineoplastic agents have been reported. The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS), or cerebral arteritis. Various mechanisms have been proposed for these vascular complications. There are also reports of Raynaud's phenomenon occurring in patients treated with Nikableomicina in combination with vinblastine with or without cisplatin or, in a few cases, with Nikableomicina as a single agent. It is currently unknown if the cause of Raynaud's phenomenon in these cases is the disease, underlying vascular compromise, Nikableomicina, vinblastine, hypomagnesemia, or a combination of any of these factors.
Fever, chills, and vomiting have been reported. Anorexia and weight loss have been reported and may persist long after termination of this medication. Pain at tumor site, phlebitis, and other local reactions have been reported.
Malaise has been reported.
DOSAGE AND ADMINISTRATION
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
The following dose schedule is recommended:
Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin's Disease - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Nikableomicina appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Nikableomicina for Injection is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin's disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion -60 units administered as a single dose bolus intrapleural injection (see Administration: Intrapleural ).
Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
| CrCL can be estimated from the individual patient's measured serum creatinine (Scr) values using the Cockcroft and Gault formula: Males CrCL = [weight x (140 - Age)]/(72 x Scr) Females CrCL = 0.85 x [weight x (140 - Age)]/(72 x Scr) Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL. | |
| Patient CrCL (mL/min) | Nikableomicina for Injection, USP Dose (%) |
| 50 and above | 100 |
| 40 to 50 | 70 |
| 30 to 40 | 60 |
| 20 to 30 | 55 |
| 10 to 20 | 45 |
| 5 to 10 | 40 |
Administration
Nikableomicina for Injection may be given by the intramuscular, intravenous, subcutaneous or intrapleural routes.
Administration Precautions
Caution should be exercised when handling Nikableomicina for injection. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Nikableomicina for injection. If Nikableomicina for injection contacts the skin, immediately wash the skin thoroughly with soap and water. If contact with mucous membranes occurs, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Intramuscular or Subcutaneous
The Nikableomicina for Injection, USP 15 units vial should be reconstituted with 1 to 5 mL of Sterile Water for Injection, USP, Sodium Chloride for Injection, 0.9%, USP, or Sterile Bacteriostatic Water for Injection, USP. The Nikableomicina for Injection, USP 30 units vial should be reconstituted with 2 to 10 mL of the above diluents.
Intravenous
The contents of the 15 units or 30 units vial should be dissolved in 5 mL or 10 mL, respectively of Sodium Chloride for Injection, 0.9%, USP, and administered slowly over a period of 10 minutes.
Intrapleural
Sixty units of Nikableomicina are dissolved in 50 to 100 mL Sodium Chloride for Injection, 0.9%, USP, and administered through a thoracostomy tube following drainage of excess pleural fluid and confirmation of complete lung expansion. The literature suggests that successful pleurodesis is, in part, dependent upon complete drainage of the pleural fluid and reestablishment of negative intrapleural pressure prior to instillation of a sclerosing agent. Therefore, the amount of drainage from the chest tube should be as minimal as possible prior to instillation of Nikableomicina. Although there is no conclusive evidence to support this contention, it is generally accepted that chest tube drainage should be less than 100 mL in a 24-hour period prior to sclerosis. However, Nikableomicina instillation may be appropriate when drainage is between 100 to 300 mL under clinical conditions that necessitate sclerosis therapy. The thoracostomy tube is clamped after Bleomcyin instillation. The patient is moved from the supine to the left and right lateral positions several times during the next four hours. The clamp is thenremoved and suction reestablished. The amount of time the chest tube remains in place following sclerosis is dictated by the clinical situation.
The intrapleural injection of topical anesthetics or systemic narcotic analgesia is generally not required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
Nikableomicina for Injection, USP contains sterile Nikableomicina sulfate equivalent to 15 units or 30 units of Nikableomicina.
NDC 61703-332-18, 15 units per vial, packaged individually.
NDC 61703-323-22, 30 units per vial, packaged individually.
Stability
The sterile powder is stable under refrigeration 2°C to 8°C (36°F to 46°F) and should not be used after the expiration date is reached.
Nikableomicina for Injection should not be reconstituted or diluted with 5% Dextrose Injection or other dextrose containing diluents. When reconstituted in 5% Dextrose Injection and analyzed by HPLC, Nikableomicina for Injection demonstrates a loss of A2 and B2 potency that does not occur when Nikableomicina for Injection is reconstituted in Sodium Chloride for Injection, 0.9%, USP.
Nikableomicina for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride.
REFERENCES
- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004 165.
- OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
- Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
434001
Hospira, Inc.
Lake Forest, IL 60045, USA
Product of Australia
Revision: 01/2013
Hospira logo
1 single dose vial
NDC 61703-332-18
Sterile
Rx only
Nikableomicina for Injection, USP
15 units per vial
For Intravenous, Intramuscular,
Subcutaneous and Intrapleural Use
Caution: Cytotoxic - Special Handling Procedures
434083
Carton NDC 61703-332-181 single dose vial
NDC 61703-323-22
Sterile
Rx only
Nikableomicina for Injection, USP
30 units per vial
For Intravenous, Intramuscular,
Subcutaneous and Intrapleural Use
Caution: Cytotoxic -
Special Handling Procedures
434085
Carton NDC 61703-323-22Nikableomicina pharmaceutical active ingredients containing related brand and generic drugs:
Nikableomicina available forms, composition, doses:
Nikableomicina destination | category:
Nikableomicina Anatomical Therapeutic Chemical codes:
Nikableomicina pharmaceutical companies:
Frequently asked Questions
Can i drive or operate heavy machine after consuming Nikableomicina?Depending on the reaction of the Nikableomicina after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nikableomicina not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Nikableomicina addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Nikableomicina, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Nikableomicina consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
Visitor reported useful
No survey data has been collected yetVisitor reported side effects
No survey data has been collected yetVisitor reported price estimates
No survey data has been collected yetVisitor reported frequency of use
No survey data has been collected yetVisitor reported doses
No survey data has been collected yetVisitor reported time for results
No survey data has been collected yetVisitor reported administration
No survey data has been collected yetVisitor reported age
No survey data has been collected yetVisitor reviews
There are no reviews yet. Be the first to write one! |
The information was verified by Dr. Rachana Salvi, MD Pharmacology