AZEDRA® (iobenguane I 131) injection for intravenous use by Progenics Pharmaceuticals, Inc.



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Indications & Usage

INDICATIONS AND USAGE

 

AZEDRA is a radioactive therapeutic agent indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

 

 

Please see full Prescribing Information.

Dosage & Administration

DOSAGE AND ADMINISTRATION

 

· Verify pregnancy status in females of reproductive potential prior to

   administering AZEDRA.

· Block thyroid prior to administering AZEDRA.

· Do not administer if platelet count is less than 80,000/mcL or absolute neutrophil count

   is less than 1,200/mcL. 

· Administer AZEDRA intravenously as a dosimetric dose followed by two therapeutic doses

   administered 90 days apart.

· The recommended dosimetric dose is:

o Patients greater than 50 kg: 185 to 222 MBq (5 to 6 mCi)

o Patients 50 kg or less: 3.7 MBq/kg (0.1 mCi/kg)

· The recommended therapeutic dose for each of the 2 doses is:

o Patients greater than 62.5 kg: 18,500 MBq (500 mCi)

o Patients 62.5 kg or less: 296 MBq/kg (8 mCi/kg)

· Adjust AZEDRA therapeutic doses based on radiation dose estimates results from dosimetry,

   if needed.

 

 

Please see full Prescribing Information. 

Dosage Forms and Strength

DOSAGE FORMS AND STRENGTHS

 

Injection: 555 MBq/mL (15 mCi/ml) at TOC as a clear solution in a single-dose vial.

 

 

Please see full Prescribing Information.

Contraindications

CONTRAINDICATIONS

 

None.

 

Please see full Prescribing Information.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

 

· Risk from Radiation Exposure: Minimize radiation exposure consistent with institutional

   radiation safety practices and patient management procedures.

· Myelosuppression: Monitor blood cell counts. Withhold and dose reduce AZEDRA

   as recommended based on severity of cytopenia.

· Secondary Myelodysplastic Syndrome, Leukemia and Other Malignancies: The time

   to development of MDS or acute leukemia ranged from 12 months to 7 years.

· Hypothyroidism: Initiate thyroid-blocking medication prior to administration and continue after

   each dose. Monitor for hypothyroidism and thyroid-stimulating hormone levels before starting AZEDRA and annually thereafter.

· Elevations in blood pressure: Monitor blood pressure frequently during the first 24 hours

   after each therapeutic dose.

· Renal Toxicity: Monitor renal function during and after treatment.

· Pneumonitis: Monitor patients for signs and symptoms of pneumonitis and

   treat appropriately.

· Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive

   potential of the potential risk to a fetus and to use effective contraception.

· Risk of Infertility: May cause infertility.

 

 

Please see full Prescribing Information.

Adverse Reactions

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.

 

To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc. at 844-668-3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please see full Prescribing Information.

Drug Interactions

DRUG INTERACTIONS

 

· Drugs that Reduce Catecholamine Uptake or Deplete Stores: Discontinue these drugs prior to and following AZEDRA administration.

 

 

 Please see full Prescribing Information.

Use in Specific Populations

USE IN SPECIFIC POPULATIONS

 

· Lactation: Advise women not to breastfeed.

 

 

Please see full Prescribing Information.

ICD Codes

ICD-10-CM Code and Description

C74.10   Malignant neoplasm of medulla of unspecified adrenal gland

C74.11   Malignant neoplasm of medulla of right adrenal gland

C74.12   Malignant neoplasm of medulla of left adrenal gland

C75.5     Malignant neoplasm of aortic body and other paraganglia

C7A.1     Malignant poorly differentiated neuroendocrine tumors

C7A.8     Other malignant neuroendocrine tumors

D35.00   Benign neoplasm of unspecified adrenal gland

D35.01   Benign neoplasm of right adrenal gland

D35.02   Benign neoplasm of left adrenal gland

D35.6     Benign neoplasm of aortic body and other paraganglia

D44.7     Neoplasm of uncertain behavior of aortic body and other paraganglia

Z51.0     Encounter for antineoplastic radiation therapy

Information obtained from AZEDRA® (iobenguane I 131) injection for intravenous use by Progenics Pharmaceuticals, Inc.

Trademarks, registered or otherwise, are the property of their respective owner.
© 2020 Lantheus Holdings, Inc. All rights reserved.

 

PM-US-AZ-0395 2020

Please see full Prescribing Information

IMPORTANT SAFETY INFORMATION



Indication

 

AZEDRA® (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

 

Important Safety Information


Warnings and Precautions:

·       Risk from radiation exposure: AZEDRA contributes to a patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of AZEDRA are greater in pediatric patients than in adults. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with AZEDRA consistent with institutional good radiation safety practices and patient management procedures.

·       Myelosuppression: Severe and prolonged myelosuppression occurred during treatment with AZEDRA. Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia. Monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range. Withhold and dose reduce AZEDRA as recommended in the prescribing information based on severity of the cytopenia.

·       Secondary myelodysplastic syndrome, leukemia, and other malignancies: Myelodysplastic syndrome (MDS) and acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed a non-hematological malignancy.

·       Hypothyroidism: Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications starting at least 1 day before and continuing for 10 days after each AZEDRA dose to reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate for clinical evidence of hypothyroidism and measure thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA and annually thereafter.

·       Elevations in blood pressure: Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension defined as an increase in systolic blood pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in diastolic blood pressure to ≥100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.

·       Renal toxicity: Of the 88 patients who received a therapeutic dose of AZEDRA, 7% developed renal failure or acute kidney injury and 22% demonstrated a clinically significant decrease in glomerular filtration rate (GFR) measured at 6 or 12 months. Monitor renal function during and after treatment with AZEDRA. Patients with baseline renal impairment may be at greater risk of toxicity; perform more frequent assessments of renal function in patients with mild or moderate impairment. AZEDRA has not been studied in patients with severe renal impairment.

·       Pneumonitis: Fatal pneumonitis occurred 9 weeks after a single dose in one patient in the expanded access program. Monitor patients for signs and symptoms of pneumonitis and treat appropriately.

·       Embryo-fetal toxicity: Based on its mechanism of action, AZEDRA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating AZEDRA. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AZEDRA and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose.

·       Risk of infertility: Radiation exposure associated with AZEDRA may cause infertility in males and females. Radiation absorbed by testes and ovaries from the recommended cumulative dose of AZEDRA is within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

 

Adverse Reactions:

The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (≥10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).

 

Drug Interactions:

Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.

 

For important risk and use information about AZEDRA, please see full Prescribing Information.

 

To report suspected adverse reactions, contact Progenics Pharmaceuticals, Inc. at 844-668- 3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Reference:

 

AZEDRA® prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 08 2018.