London, 20 April 2018 – Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) announces that its wholly-owned US subsidiary West-Ward Pharmaceuticals Corp. (West-Ward), has launched Dexrazoxane for Injection, 250mg and 500mg vials, the generic equivalent to Zinecard®.
West-Ward’s Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. It should not be used with the initiation of doxorubicin therapy.
According to IQVIA, US sales of Dexrazoxane for Injection, 250mg and 500mg, were approximately $15 million in the 12 months ending February 2018.
Riad Mechlaoui, Chief Executive Officer of Injectables said, “We are very pleased to be adding Dexrazoxane for Injection to our oncology portfolio. By launching Dexrazoxane, we hope to reduce the shortage of this product in the US market.”
Important Safety Information
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when administering Dexrazoxane for Injection:
- Myelosuppression: Can add to the myelosuppression caused by chemotherapeutic agents. Monitor blood counts prior to and during each treatment.
- Concomitant Chemotherapy: Only use Dexrazoxane for injection in patients who have received a cumulative dose of 300 mg/m2 and are on continuing doxorubicin therapy. Do not use with chemotherapy initiation.
- Cardiac Toxicity: Dexrazoxane does not eliminate the risk of anthracycline-induced cardiac toxicity. Monitor cardiac function before and periodically during therapy.
- Secondary malignancies have been reported, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Dexrazoxane for injection is not indicated for use in pediatric patients.
- Embryo-Fetal Toxicity: Can cause fetal harm. If used during pregnancy, the patient should be apprised of the potential hazard to a fetus. Advise patients of reproductive potential to use highly effective contraception during treatment.
Do not use Dexrazoxane for injection with non-anthracycline chemotherapy regimens.
DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.
Reduce dosage in patients with renal impairment.
In clinical trials of Dexrazoxane for injection with Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC), patients experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without Dexrazoxane for injection.
Patient Counseling Information should be shared with the patient prior to administration.
 Zinecard® is a registered trademark of Pharmacia and Upjohn Company LLC