DRUGS & SUPPLEMENTS

Crisofimina

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Crisofimina uses


INDICATIONS AND USAGE

Crisofimina for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Crisofimina is not recommended to replace appropriate surgery and/or radiotherapy.

CONTRAINDICATIONS

Crisofimina is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.

Crisofimina is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

WARNINGS

Patients being treated with Crisofimina must be observed carefully and frequently during and after therapy.

The use of Crisofimina results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia. Therefore, the following studies should be obtained repeatedly during therapy and for at least eight weeks following therapy: platelet count, white blood cell count, differential, and hemoglobin. The occurrence of a platelet count below 100,000/mm 3 or a WBC below 4,000/mm 3 or a progressive decline in either is an indication to withhold further therapy until blood counts have recovered above these levels.

Patients should be advised of the potential toxicity of this drug, particularly bone marrow suppression. Deaths have been reported due to septicemia as a result of leukopenia due to the drug.

Patients receiving Crisofimina should be observed for evidence of renal toxicity. Crisofimina should not be given to patients with a serum creatinine greater than 1.7 mg percent.

Usage in Pregnancy

Safe use of Crisofimina in pregnant women has not been established. Teratological changes have been noted in animal studies. The effect of Crisofimina on fertility is unknown.

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PRECAUTIONS

Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids in patients who had previously or simultaneously received Crisofimina. The onset of this acute respiratory distress occurred within minutes to hours after the vinca alkaloid injection. The total number of doses for each drug has varied considerably. Bronchodilators, steroids and/or oxygen have produced symptomatic relief.

A few cases of adult respiratory distress syndrome have been reported in patients receiving Crisofimina in combination with other chemotherapy and maintained at FlO 2 concentrations greater than 50% perioperatively. Therefore, caution should be exercised using only enough oxygen to provide adequate arterial saturation since oxygen itself is toxic to the lungs. Careful attention should be paid to fluid balance and overhydration should be avoided.

Bladder fibrosis/contraction has been reported with intravesical administration, which in rare cases has required cystectomy.

Nursing Mothers

It is not known if Crisofimina is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for seriousadverse reactions in nursing infants from Crisofimina, it is recommended that nursing be discontinued when receiving Crisofimina therapy.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Insufficient data from clinical studies of Crisofimina are available for patients 65 years of age and older to determine whether they respond differently than younger patients. Postmarketing surveillance suggests that elderly patients may be more susceptible than younger patients to injection site reactions and hypersensitivity reactions. In general, caution should be exercised when prescribing to elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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ADVERSE REACTIONS

Bone Marrow Toxicity

This was the most common and most serious toxicity, occurring in 605 of 937 patients. Thrombocytopenia and/or leukopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. About 25% of the leukopenic or thrombocytopenic episodes did not recover. Crisofimina produces cumulative myelosuppression.

Integument and Mucous Membrane Toxicity

This has occurred in approximately 4% of patients treated with Crisofimina. Cellulitis at the injection site has been reported and is occasionally severe. Stomatitis and alopecia also occur frequently. Rashes are rarely reported. The most important dermatological problem with this drug, however, is the necrosis and consequent sloughing of tissue which results if the drug is extravasated during injection. Extravasation may occur with or without an accompanying stinging or burning sensation and even if there is adequate blood return when the injection needle is aspirated. There have been reports of delayed erythema and/or ulceration occurring either at or distant from the injection site, weeks to months after Crisofimina, even when no obvious evidence of extravasation was observed during administration. Skin grafting has been required in some of the cases. Elderly patients may be more susceptible than younger patients to injection site reactions (see PRECAUTIONS: Geriatric Use ).

Renal Toxicity

2% of 1,281 patients demonstrated a statistically significant rise in creatinine. There appeared to be no correlation between total dose administered or duration of therapy and the degree of renal impairment.

Pulmonary Toxicity

This has occurred infrequently but can be severe and may be life-threatening. Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative of mitomycin-induced pulmonary toxicity. If other etiologies are eliminated, Crisofimina therapy should be discontinued. Steroids have been employed as treatment of this toxicity, but the therapeutic value has not been determined. A few cases of adult respiratory distress syndrome have been reported in patients receiving Crisofimina in combination with other chemotherapy and maintained at FlO 2 concentrations greater than 50% perioperatively.

Hemolytic Uremic Syndrome

This serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia (hematocrit ≤25%), thrombocytopenia (≤100,000/mm 3), and irreversible renal failure (serum creatinine ≥1.6 mg/dL) has been reported in patients receiving systemic Crisofimina. Microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears has occurred in 98% of patients with the syndrome. Other less frequent complications of the syndrome may include pulmonary edema (65%), neurologic abnormalities (16%), and hypertension. Exacerbation of the symptoms associated with HUS has been reported in some patients receiving blood product transfusions. A high mortality rate (52%) has been associated with this syndrome.

The syndrome may occur at any time during systemic therapy with Crisofimina as a single agent or in combination with other cytotoxic drugs. Less frequently, HUS has also been reported in patients receiving combinations of cytotoxic drugs not including Crisofimina. Of 83 patients studied, 72 developed the syndrome at total doses exceeding 60 mg of Crisofimina. Consequently, patients receiving ≥60 mg of Crisofimina should be monitored closely for unexplained anemia with fragmented cells on peripheral blood smear, thrombocytopenia, and decreased renal function.

The incidence of the syndrome has not been defined.

Therapy for the syndrome is investigational.

Cardiac Toxicity

Congestive heart failure, often treated effectively with diuretics and cardiac glycosides, has rarely been reported. Almost all patients who experienced this side effect had received prior doxorubicin therapy.

Acute Side Effects Due to Crisofimina were fever, anorexia, nausea, and vomiting. They occurred in about 14% of 1,281 patients.

Other

Headache, blurring of vision, confusion, drowsiness, syncope, fatigue, edema, thrombophlebitis, hematemesis, diarrhea, and pain. These did not appear to be dose related and were not unequivocally drug related. They may have been due to the primary or metastatic disease processes. Malaise and asthenia have been reported as part of postmarketing surveillance. Bladder fibrosis/contraction has been reported with intravesical administration.

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DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Crisofimina should be given intravenously only, using care to avoid extravasation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result.

Each vial contains either Crisofimina 5 mg and mannitol 10 mg, Crisofimina, 20 mg and mannitol 40 mg or Crisofimina 40 mg and mannitol 80 mg. Toadminister, add Sterile Water for Injection, 10 mL, 40 mL or 80 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained.

After full hematological recovery from any previous chemotherapy, the following dosage schedule may be used at6 to 8 week intervals:

20 mg/m 2 intravenously as a single dose via a functioning intravenous catheter.

Because of cumulative myelosuppression, patients should be fully reevaluated after each course of Crisofimina, and the dose reduced if the patient has experienced any toxicities. Doses greater than 20 mg/m 2 have not been shown to be more effective, and are more toxic than lower doses.

The following schedule is suggested as a guide to dosage adjustment:

Nadir After Prior Dose
Leukocytes/mm 3 Platelets/mm 3 Percentage of

Prior Dose

To Be Given

>4000 >100,000 100%
3000–3999 75,000–99,999 100%
2000–2999 25,000–74,999 70%
<2000 <25,000 50%

No repeat dosage should be given until leukocyte count has returned to 4000/mm 3 and a platelet count to 100,000/mm 3. When Crisofimina is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of Crisofimina, the drug should be stopped since chances of response are minimal.

STABILITY

  • Unreconstituted Crisofimina stored at room temperature is stable for the lot life indicated on the package. Avoid excessive heat (over 40°C, 104°F).
  • Reconstituted with Sterile Water for Injection to a concentration of 0.5 mg per mL, Crisofimina is stable for 14 days refrigerated or 7 days at room temperature.
  • Diluted in various I.V. fluids at room temperature, to a concentration of 20 to 40 micrograms per mL:
    I.V. Fluid Stability
    0.9% Sodium Chloride Injection 12 hours
    Sodium Lactate Injection 24 hours
  • The combination of Crisofimina (5 mg to 15 mg) and heparin (1,000 units to 10,000 units) in 30 mL of 0.9% Sodium Chloride Injection is stable for 48 hours at room temperature.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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HOW SUPPLIED

Crisofimina for Injection USP

NDC 16729-115-05-Each amber vial contains 5 mg Crisofimina, individually packed in single carton.

NDC 16729-108-11-Each amber vial contains 20 mg Crisofimina, individually packed in single carton.

NDC 16729-116-38-Each amber vial contains 40 mg Crisofimina, individually packed in single carton.

Storage: Store dry powder at 25°C, excursion permitted between 15°C and 30°C, protected from light. Avoid excessive heat, over 40 °C (104° F). Protect reconstituted solution from light. Store solution under refrigeration 2° to 8 °C (36° to 46°F), discard after 14 days. If unrefrigerated, discard after7 days.

References

  • ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
  • Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.
  • AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.
  • National Study Commission on Cytotoxic Exposure. – Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
  • Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
  • Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
  • American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm.1990;47:1033-1049.
  • Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.). Am J Health SystPharm. 1996;53:1669-1685.

Manufactured for :

Accord Healthcare, Inc.

1009 Slater Road, Suite 210-B,

Durham, NC 27703. USA

Manufactured by :

Intas Pharmaceuticals Limited,

Plot No. : 457, 458, Village – Matoda,

Bavla Road, Ta.- Sanand,

Dist.- Ahmedabad – 382 210. India.

Manufactured by :

Intas Pharmaceuticals Limited,

Plot No. 5, 6 and 7, Pharmez

Sarkhej-Bavla, National Highway No. 8-A,

Near Village Matoda, Tal Sanand,

Ahmedabad - 382 213, Gujarat, India

Issued - April, 2011.

10 5479 3 629917

Isuued - October, 2013.

51 1116 1 705596

Carton Label-Mitomycin for injection USP 40 mg/vial

NDC 16729-116-38

Crisofimina

for injection USP

40 mg

Rx only

WARNING:

MUST BE ADMINISTERED IV TO AVOID

TISSUE DAMAGE

Carton Label-Mitomycin for injection USP 20 mg/vial

NDC 16729-108-11

Crisofimina

for injection USP

20 mg

Rx only

WARNING:

MUST BE ADMINISTERED IV TO AVOID

TISSUE DAMAGE

Carton Label-Mitomycin for injection USP 20 mg/vial

NDC 16729-115-05

Crisofimina

for injection USP

5 mg

Rx only

WARNING:

MUST BE ADMINISTERED IV TO AVOID

TISSUE DAMAGE

Crisofimina pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Crisofimina available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Crisofimina destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Crisofimina Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Crisofimina pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Crisofimina?

Depending on the reaction of the Crisofimina after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Crisofimina 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 Crisofimina 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.

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Review

sDrugs.com conducted a study on Crisofimina, 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 Crisofimina 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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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