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Accord Healthcare Launches Lenalidomide Capsules, Expanding Access to Essential Oncology Therapies

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)

Accord BioPharma’s HERCESSI™ (trastuzumab-strf) Gains Preferred Status on Express Scripts National Commercial Formularies

Accord Healthcare Announces Launch of Clomiphene Tablets, a generic of CLOMID®, for the Treatment of Ovulatory Dysfunction in Women Desiring Pregnancy

Accord BioPharma’s IMULDOSA® (ustekinumab-srlf) Added to Express Scripts National Commercial Formularies

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Therapeutic Area: Oncology

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim), for Cancer Patients with Treatment-Related Neutropenia or Patients with Severe Chronic Neutropenia

Accord BioPharma’s HERCESSI™ (trastuzumab-strf) Gains Preferred Status on Express Scripts National Commercial Formularies

Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)

Accord BioPharma, Inc. Announces Completion of UDENYCA® (pegfilgrastim-cbqv) Franchise Acquisition from Coherus BioSciences, Inc., Expanding U.S. Biosimilar Portfolio

Accord BioPharma, Inc. Recognizes Milestone as More Than 10,000 Patients Gain Access to CAMCEVI® (leuprolide)

Accord BioPharma Announces Agreement by Intas Pharmaceuticals, Ltd. to Acquire UDENYCA® (pegfilgrastim-cbqv) Business from Coherus BioSciences, Inc., Unlocking Potential for Continued U.S. Growth

Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer

Accord BioPharma and EVERSANA Announce Partnership to Support the Launch of CAMCEVI® for the Treatment of Advanced Prostate Cancer in Adults in the U.S.

Accord BioPharma, in Partnership with Foresee Pharmaceuticals, Launches CAMCEVI™ (Leuprolide) Injection Emulsion in the U.S. for the Treatment of Advanced Prostate Cancer in Adults

Accord BioPharma Announces U.S. Launch for CAMCEVI™ (Leuprolide) Injection Emulsion for the Treatment of Advanced Prostate Cancer in Adults

IMPORTANT SAFETY INFORMATION

Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.

CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction and spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.

Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.

Androgen deprivation therapy may prolong the QT/QTc interval. Consider periodic monitoring of electrocardiograms and electrolytes.

Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

Monitor serum levels of testosterone following injection of CAMCEVI.

Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.

The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

INDICATION

CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

Click here for full Prescribing Information.

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