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Azedra Approval History

Reviewed on Jul 31, 2018 by J.Stewart B.Pharm

FDA Approved: Yes (First approved July 30, 2018)
Brand name: Azedra
Generic name: iobenguane I 131
Dosage form: Injection
Company: Progenics Pharmaceuticals, Inc.
Treatment for: Pheochromocytoma; Paraganglioma

Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma.

PATIENT COUNSELING INFORMATION

Hydration Advise patients to drink at least 2 liters of liquid a day before, and for one week following each dose of Azedra to minimize irradiation of the bladder.

Radiation Risks Advise patients to minimize radiation exposure to household contacts consistent with institutional good radiation safety practices and patient management procedures.

Myelosuppression Advise patients to contact their health care provider for any signs or symptoms of neutropenia, thrombocytopenia, or anemia.

Secondary Myelodysplastic Syndrome, Leukemia and Other Malignancies Advise patients of the potential for secondary cancers, including myelodysplastic syndrome, acute leukemia, and other malignancies.

Hypothyroidism Advise patients to take thyroid-blocking agents as prescribed. Advise patients of the need for life-long monitoring for hypothyroidism.

Elevations in Blood Pressure Advise patients to contact their health care provider for signs or symptoms that may occur following tumor-hormone catecholamines release and possible risk of increased blood pressure during or 24 hours following each therapeutic Azedra dose.

Pneumonitis Advise patients to contact their health care provider for signs or symptoms of pneumonitis.

Drug Interactions Advise patients that some medicines interact with Azedra and to contact their health care provider before starting any over the counter medicines or herbal or dietary supplements.

Embryo-Fetal Toxicity Advise pregnant women and males and females of reproductive potential of the potential risk to a fetus.
Advise females to inform their health care provider of a known or suspected pregnancy.
Advise females of reproductive potential to use effective contraception during treatment with Azedra and for seven months after the final dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Azedra and for four months after the final dose.

Lactation Advise females not to breastfeed during treatment with Azedra and for 80 days after the final dose.

Infertility Advise females and males patients that Azedra may impair fertility.

ADVERSE REACTIONS

The most common Grade 3-4 adverse reactions (≥ 10%) were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting.

Development History and FDA Approval Process for Azedra

DateArticle
Jul 30, 2018Approval FDA Approves Azedra (iobenguane I 131) for Rare Adrenal Tumors
Mar 22, 2018Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131)
Dec 29, 2017Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma
Nov  2, 2017Progenics Pharmaceuticals Completes Submission of NDA for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma
Mar 30, 2017Progenics Pharmaceuticals Announces Positive Topline Results from Registrational Phase 2b Trial of Azedra

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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