Hikma’s Mitomycin for Injection, USP 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. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
According to IQVIA, US sales of Mitomycin for Injection were approximately $43 million in the 12 months ending November 2018.
Riad Mechlaoui, President of Injectables said, “We are excited to add Mitomycin for Injection to our oncology portfolio in the US, improving patients’ access to this important medicine. This demonstrates the successful execution of our strategy to expand our portfolio in key therapeutic areas.”
This new product introduction expands Hikma’s broad US offering of more than 90 injectable products and further solidifies our position as one of the top three suppliers of generic injectable products to US hospitals.
Important Safety Information for Mitomycin for Injection, USP, 20mg and 40mg:
WARNING
Mitomycin should be administered under the supervision of a qualified physician experienced in the use of
cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only
when adequate diagnostic and treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to
overwhelming infections in an already compromised patient, is the most common and severe of the toxic
effects of mitomycin.
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of
microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in
patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with
mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at
doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this
syndrome.
The incidence of the syndrome has not been defined.
WARNINGS AND PRECAUTIONS
Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the
past as well as in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to
other causes.
The following warnings and precautions should be taken when administering Mitomycin for Injection, USP:
• Patients be must be observed carefully during and after treatment.
• Advise patients of the potential toxicity of this drug.
• Safe use of mitomycin in pregnant women has not been established.
• It is recommended that women receiving mitomycin not breast feed because of the potential for serious adverse
events.
• Acute shortness of breath and severe bronchospasm have been reported following administration of vinca
alkaloids in patients who had previously or simultaneously received mitomycin.
• Respiratory distress syndrome may occur. Caution should be exercised using only enough oxygen to provide
adequate arterial saturation since oxygen itself is toxic to the lungs.
• Follow proper handling and disposal of anticancer drugs.
The following adverse reactions have been reported: bone marrow toxicity, integument and mucous membrane
toxicity, renal toxicity, pulmonary toxicity, hemolytic uremic syndrome, and cardiac toxicity.
Acute side effects of mitomycin were fever, anorexia, nausea, and vomiting.
Other adverse events include: headache, blurred vision, confusion, fatigue, thrombophlebitis, diarrhea, and pain.
Malaise and asthenia have been reported in postmarketing surveillance. Bladder fibrosis/contraction has been
reported with intravesical administration (not an approved route of administration).
For additional information, please refer to the Package Insert for full prescribing information, available on
www.hikma.com.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.