Mitomycin C Kyowa

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Generic Name: Mitomycin C Kyowa Brand Name(s): Generics only. No brands available.

Uses

What is Mitomycin-C Kyowa® (mitomycin) used for?

Mitomycin-C Kyowa® is commonly used for antimitotic and cytotoxic. It is used for the treatment of various types of cancer, such as:

  • Superficial bladder cancer
  • Metastatic breast cancer
  • Advanced squamous cell carcinoma of the uterine cervix
  • The stomach, pancreas, and lung (particularly non-small cell)
  • Liver cancer
  • Colorectal cancer
  • Cancer of the head and neck
  • Cancer of the prostate
  • Skin cancer
  • Leukemia and non-solid tumors
  • Sarcomas
  • Surgery, pre-operatively (esophageal squamous cell carcinoma) and post-operatively (gastric cancer)
  • Radiotherapy

How should I take Mitomycin-C Kyowa® (mitomycin)?

Mitomycin-C Kyowa® is a purple liquid. You will be injected into your bloodstream (intravenously) by your doctor. He or she will use a thin, short tube (a cannula) put into a vein in your arm. Or doctor may use a central line, a porta cath or a PICC line. These are long, plastic tubes that give the drugs directly into a large vein in your chest. The tube can stay in place throughout the whole course of treatment.

You usually have chemotherapy as a course of several cycles of treatment. The treatment plan for Mitomycin-C Kyowa® depends on which cancer you have. You can find out about how doctors plan chemotherapy.

How do I store Mitomycin-C Kyowa® (mitomycin)?

Store in the original package.

The reconstituted solution should be protected from light and stored in a cool place

After reconstitution, the solution is chemically and physically stable for 24 hours when protected from light and stored in a cool place. Do not refrigerate.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Precautions & warnings

What should I know before using Mitomycin-C Kyowa® (mitomycin)?

Mitomycin-C Kyowa® should be administered under the supervision of a physician experienced in cytotoxic cancer chemotherapy.

Local ulceration and cellulitis may be caused by tissue extravasation during intravenous injection and utmost care should be taken in administration. If extravasation occurs, it is recommended that the area is immediately infiltrated with sodium bicarbonate 8.4% solution, followed by an injection of 4 mg dexamethasone. A systemic injection of 200 mg of Vitamin B6 may be of some value in promoting the regrowth of tissues that have been damaged.

Patients should be carefully monitored with frequent laboratory testing (hematological test, liver function test, renal function test, etc.) paying particular attention to peripheral blood count including platelet count. No repeat dose should be given unless the leucocyte count is above 3.0 x 109/L or more and the platelet count is 90 x 109/L or more. The nadir is usually around four weeks after treatment, and toxicity is usually cumulative, with increasing risk after each course of treatment. Serious adverse reactions such as bone marrow depression may occur. If any abnormality is observed, appropriate measures such as reduction of the dose and suspension of administration should be taken.

Extravascular leakage may cause induration or necrosis at the injection site. Intraarterial administration may cause skin disorders such as pain, redness, erythema, blisters, erosion and ulceration which may lead to skin/muscle necrosis. Since the influx of the drug solution into other sites than the targeted site in the administration to the hepatic artery may cause gastroduodenal ulcer, hemorrhage, perforation, etc, the location of the end of the catheter and drug distribution area should be confirmed photographically or by other means, paying attention to possible deviation or shift of the catheter and infusion rate. Administration should be discontinued and appropriate measures should be taken, if any of such symptoms develops.

Severe renal toxicity has occasionally been reported to treatment and renal function should be monitored before starting treatment and again after each course.

Mitomycin-C Kyowa® should be administered with care in children and patients with the following:

  • Hepatic or renal dysfunction as adverse reactions may be enhanced.
  • Bone marrow depression and bleeding tendency as these may be exacerbated.
  • Infections as these may be aggravated due to bone marrow depression.
  • Varicella as fatal systemic disorders may occur.

In case administration of this drug is required in children or patients with reproductive possibility, potential effects on gonad should be considered. The safety of Mitomycin-C Kyowa® injection in children has not been established. Special attention should be paid to the manifestation of adverse reactions when administered in children.

Because elderly patients often have reduced physiological function, bone marrow depression, which may be protracted, and renal disorder are likely to occur. Administer Mitomycin-C Kyowa® with caution in this population while closely monitoring patient’s condition and paying special attention to the dose and dosing interval.

The occurrence of acute leukemia (in some cases following preleukemic phase) and myelodysplastic syndrome has been reported in the patients treated with Mitomycin-C Kyowa ® concomitantly with other antineoplastic agents.

Contraindicated case:

Patients who have demonstrated a hypersensitive or idiosyncratic reaction to Mitomycin-C Kyowa® or any of the components of the product in the past. Thrombocytopenia, coagulation disorders and increased bleeding tendency.

Is it safe during pregnancy or breastfeeding?

There isn’t enough information about the safety of using this medication during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication.

Side effects

What side effects can occur from Mitomycin-C Kyowa® (mitomycin)?

When using this drug, some adverse side effects may occur:

  • Leucopenia
  • Thrombocytopenia
  • Anorexia
  • Nausea/vomiting
  • Malaise
  • Weight loss
  • Bleeding tendency
  • Anemia

Nausea and vomiting are sometimes experienced immediately after treatment, but these are usually mild and of short duration.

Pulmonary toxicities such as pulmonary edema, interstitial pneumonia and pulmonary fibrosis (accompanied by fever, coughing, dyspnoea, abnormal x-ray findings, and eosinophilia), pulmonary hypertension and pulmonary veno-occlusive disease (PVOD) have been reported. If signs of these conditions are observed, discontinue treatment and take appropriate measures.

Skin toxicity may occur in a small proportion of patients, with side effects such as alopecia (although this is less frequent and less severe than with certain other cytotoxic agents). Palmar plantar erythrodysesthesia (PPE), bleeding, rashes and mouth ulcers have been reported.

Shock or anaphylactoid reaction may occur, patients should be carefully observed. If symptoms such as itching, rash, hot flush, sweating, dyspnea and decreased blood pressure occur, treatment should be immediately discontinued and appropriate measures should be taken.

Administration related Undesirable Effects

Cystitis, atrophy of the bladder, contracted bladder (pollakiuria, dysuria), calcinosis, bladder necrosis, bladder perforation and penile necrosis have been reported when given by intravesical instillation.

Administration to the hepatic artery may cause liver and biliary tract disorders such as cholecystitis, cholangitis (also sclerosing), biloma, bile duct necrosis and parenchymatous liver disorder. Drug distribution area should be confirmed photographically or by other means, and treatment should be discontinued and appropriate measures taken if any abnormal signs are noted.

The following administration related adverse reactions have also been reported: vascular pain, phlebitis, thrombus, induration or necrosis at the injection site, pain, redness erythema, blisters, erosion and ulceration which may lead to skin/muscle necrosis.

Interactions

What drugs may interact with Mitomycin-C Kyowa® (mitomycin)?

Mitomycin-C Kyowa® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Mitomycin-C Kyowa® should be administered with care when it is co-administered with other antineoplastic agents or irradiation. The adverse reactions of each drug may be enhanced, for example, bone marrow depression. With vinca alkaloids, adverse reactions of shortness of breath and bronchospasm may be enhanced.

Does food or alcohol interact with Mitomycin-C Kyowa® (mitomycin)?

Mitomycin-C Kyowa® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Mitomycin-C Kyowa® (mitomycin)?

Mitomycin-C Kyowa® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Mitomycin-C Kyowa® (mitomycin).

What is the dose of Mitomycin-C Kyowa® (mitomycin) for an adult?

Intravenous administration

Intravenously, the dose should be given as slowly as possible and with great care in order to avoid extravasation.

The usual dose is in the range of 4-10 mg (0.06-0.15 mg/kg) given at 1-6 weekly intervals depending on whether other drugs are given in combination and on bone marrow recovery.

In a number of combination schedules, the dose is 10 mg/m2 of body surface area, the course being repeated at intervals for as long as required. A course ranging from 40-80 mg (0.58-1.2 mg/kg) is often required for a satisfactory response when used alone or in combination. A higher dosage course may be given when used alone or as part of a particular combination schedule and total cumulative doses exceeding 2 mg/kg have been given.

Intra-arterial administration

For administration into specific tissues, Mitomycin-C Kyowa® can be given by the intra-arterial route directly into the tumors.

Dose reductions

Because of cumulative myelosuppression, patients should be fully re-evaluated after each course and the dose reduced if the patient has experienced any toxic effects. Doses greater than 0.6 mg/kg have not been shown to be more effective and are more toxic than lower doses.

Disease progression

If disease progression continues after two courses of treatment, the drug should be stopped since the chances of response are minimal.

Use in patients with bladder tumors

In the treatment of superficial bladder tumors, the usual dose is 20-40 mg dissolved in 20-40 ml of diluent, instilled into the bladder through a urethral catheter, weekly or three times a week for a total of 20 doses. The dose should be retained by the patient for a minimum of one hour. During this one-hour period the patient should be rotated every 15 minutes to ensure that the Mitomycin-C Kyowa® comes into contact with all areas of the bladder urothelium.

When the bladder is emptied in the voiding process, care must be taken to ensure that no contamination occurs locally in the groin and genitalia areas.

In the prevention of recurrent superficial bladder tumours, various doses have been used. These include 20 mg in 20 ml of diluent every two weeks and 40 mg in 40 ml of diluent monthly or three monthly. The dose is instilled into the bladder through a urethral catheter.

In both cases, the dose should be adjusted in accordance with the age and condition of the patient.

What is the dose of Mitomycin-C Kyowa® (mitomycin) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Mitomycin-C Kyowa® (mitomycin) available?

Mitomycin-C Kyowa® is available in the following dosage forms and strengths:

  • Mitomycin-C Kyowa® is contained within a colorless, type I or III glass vial with a rubber stopper and an aluminium seal.
  • The 10, 20 and 40 mg vials are packaged into cardboard cartons containing 1 or 5 vials. The 2 mg vials are packaged into cardboard trays with an overwrap containing 10 vials.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Mitomycin-C Kyowa®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 25, 2017 | Last Modified: March 25, 2017

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