Mitomycin


Full Prescribing Info
Dosage/Direction for Use

Intravenous
Head and neck cancer
Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravenous
Gastric cancer

Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravenous
Prostate cancer

Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravenous
Pancreatic cancer

Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravenous
Metastatic breast cancer

Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravenous
Non-small cell lung cancer

Adult: Dosage requirement is individualised according to local protocols (refer to detailed product guideline). Usual dose: 10-20 mg/m2 may be repeated at intervals of 6-8 weeks if blood counts permit and may be adjusted according to previous haematological response. Alternatively, 4-10 mg (0.06-0.15 mg/kg) at 1-6 weekly intervals.
Reconstitution:
Dilute with sterile water for inj to a final concentration of 0.5 mg/mL. May further dilute in 0.9% NaCl or Na lactate to a concentration of 0.02-0.04 mg/mL.
Incompatibility: Incompatible with highly acidic substances.

Intravesical
Superficial bladder tumours

Adult: Usual dose: 20-40 mg instilled once weekly or 3 times a week for a total of 20 doses. Retain solution in the bladder for at least 1 hour by rotating dose contact with all areas of the bladder urothelium every 15 minutes. Alternatively, 4-10 mg (0.06-0.15 mg/kg) instilled once weekly or 3 times a week. For prophylaxis of recurrent cases: 20 mg every 2 weeks or 40 mg monthly or 3-monthly.
Incompatibility:
Incompatible with highly acidic substances.

Ophthalmic
Adjunct in ophthalmic surgery
Adult: As 0.2 mg/mL solution: Apply via saturated sponges to the surgical site of glaucoma filtration surgery. Keep the sponges on the treatment area for 2 minutes.
Reconstitution:
Reconstitute 0.2 mg with 1 mL of sterile water for inj, then shake to dissolve. Allow to stand at room temperature until the product has dissolved into solution.
Incompatibility: Incompatible with highly acidic substances.
Contraindications
Hypersensitivity to mitomycin. Thrombocytopenia, coagulation disorders, increased bleeding tendency, acute infections, serum creatinine >1.7 mg/dL. Pregnancy and lactation.
Special Precautions
Patient with bone marrow suppression (platelet count <100,000/mm3, WBC <4,000/mm3, or progressive decline in either), infections (e.g. varicella infection). Phakic patients (ophthalmic). Patient receiving blood product transfusions. Renal and hepatic impairment. Patient Counselling This drug may cause weakness and lethargy, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal function (e.g. serum creatinine) prior to treatment and after each course, CBC with differential during therapy and for ≥8 weeks following therapy; liver and pulmonary function tests frequently.
Adverse Reactions
Significant: Bone marrow suppression (e.g. leucopenia, thrombocytopenia), renal toxicity, local ulceration and cellulitis (IV), shock or anaphylactoid reaction (e.g. itching, rash, dyspnoea, flushing), neurologic abnormalities. Ophthalmic: Corneal or scleral damage (when given in doses >0.2 mg/mL or used for longer than 2 minutes), post-operative hypotony. Eye disorders: Retinal vein occlusion, conjunctival necrosis, haemorrhage (retinal, subconjunctival, suprachoroidal, vitreal), bleb-related infection. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, stomatitis. General disorders and administration site conditions: Malaise, pyrexia, asthenia. Injury, poisoning and procedural complications: Vascular pain, phlebitis, thrombus, induration or necrosis at the inj site. Investigations: Increased serum creatinine. Metabolism and nutrition disorders: Anorexia. Renal and urinary disorders: Intravesical: Cystitis, bladder fibrosis or contracted bladder (e.g. pollakiuria, dysuria), calcinosis. Skin and subcutaneous tissue disorders: Palmar-plantar erythrodysaesthesia, alopecia, pruritus, rash. Vascular disorders: Hypertension.
Potentially Fatal: Haemolytic-uraemic syndrome, sepsis, pulmonary toxicities (e.g. pulmonary oedema, interstitial pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary venoocclusive disease).
Overdosage
Symptoms: Increased adverse effects such as fever, nausea, vomiting, myelosuppression. Management: Supportive treatment.
Drug Interactions
Concomitant use with other chemotherapy agents (e.g. vinca alkaloids) may enhance adverse effects e.g. pulmonary toxicity, bone marrow suppression.
Action
Mitomycin, a highly toxic antineoplastic antibiotic, selectively inhibits the synthesis of deoxyribonucleic acid (DNA) by alkylating DNA to produce DNA cross-linking (primarily with guanine and cytosine pairs). It also suppresses cellular ribonucleic acid (RNA) synthesis at high concentrations. Although it is not a cell cycle specific agent, it is most active in the late G1 and early S phases.
Distribution: Widely distributed.
Metabolism: Metabolised primarily in the liver.
Excretion: Mainly via faeces; urine (approx 10%, as unchanged drug). Terminal half-life: Approx 50 minutes.
Storage
Intravenous: Store at 25°C. Protect from excessive heat >40°C. Reconstituted solution: Store at room temperature with stability of 7 days or refrigerate at 2-8°C with stability of 14 days. Protect from light. This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements. Intravesical: Store at 25°C. Protect from excessive heat >40°C. Reconstituted solution: Store at room temperature with stability of 7 days or refrigerate at 2-8°C with stability of 14 days. Protect from light. This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements. Ophthalmic: Store between 20-25°C. Protect from excessive heat and light. Reconstituted solution is stable for 1 hour at room temperature. This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01DC03 - mitomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on mitomycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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