Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

PULMOTECH MAA (BLA-210089)

(TECHNETIUM TC99M ALBUMIN AGGREGATED)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/25/2023 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

PULMOTECH MAA is contraindicated in patients with:

Severe pulmonary hypertension [see Warnings and Precautions (5.1)].
A history of hypersensitivity to albumin human.
Reactions have included anaphylaxis [see Warnings and Precautions (5.2)].

5 Warnings and Precautions

5.1 Patients with Pulmonary Hypertension

Subsection title revised

Additions and/or revisions underlined:

Deaths have been reported in patients with severe pulmonary hypertension after the administration of technetium Tc 99m albumin aggregated products [see Adverse Reactions (6)]. Assess patients for history or signs of pulmonary hypertension. PULMOTECH MAA is contraindicated in patients with severe pulmonary hypertension [see Contraindications (4)]. Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions.

5.2 Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with products containing albumin human, including PULMOTECH MAA [see Adverse Reactions (6)]. Obtain a history of allergy or hypersensitivity reactions. PULMOTECH MAA is contraindicated in patients with a history of hypersensitivity to albumin human [see Contraindications (4)]. Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection.

Monitor all patients for hypersensitivity reactions.

5.3 Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts

Newly added subsection:

In patients with right-to-left heart shunts, risk for temporary mechanical impediment to blood flow may exist due to the rapid entry of aggregated albumin into the systemic circulation. Administer the lowest possible number of particles of Technetium Tc 99m Albumin Aggregated Injection in these patients.

5.4 Radiation Risks

Additions and/or revisions underlined:

Technetium Tc 99m albumin aggregated contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.2)].

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in labeling:

Patients with Pulmonary Hypertension [see Warnings and Precautions (5.1)].

Hypersensitivity Reactions [see Warnings and Precautions (5.2)].

The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Disorders: Deaths in patients with severe pulmonary hypertension

Immune System Disorders: Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and syncope, urticaria, reddening of the face, sweating, and nausea

Skin and Subcutaneous Tissue Disorders: Injection site reactions

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Available data from case reports on Technetium Tc 99m Albumin Aggregated Injection use are insufficient to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Animal reproduction studies with technetium Tc 99m albumin aggregated have not been conducted. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m albumin aggregated is expected to be low (less than 0.50 mGy) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Technetium-99m is present in breast milk. There are no data on the effects of technetium Tc 99m albumin aggregated on the breastfed infant or the effects on milk production. PULMOTECH MAA is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower. Based on clinical guidelines, exposure of technetium Tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of Technetium Tc 99m Albumin Aggregated Injection.

The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for PULMOTECH MAA, any potential adverse effects on the breastfed child from technetium Tc 99m albumin aggregated or from the underlying maternal condition.

8.4 Pediatric Use

Additions and/or revisions underlined:

PULMOTECH MAA, after radiolabeling with technetium Tc-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). The safety profile of Technetium Tc99m Albumin Aggregated Injection is similar to the one in adults.

The safety and efficacy of PULMOTECH MAA have not been established for peritoneovenous shunt scintigraphy in pediatric patients.

8.5 Geriatric Use

Newly added subsection:

No formal studies of PULMOTECH MAA in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. In general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Adequate Hydration

Advise patients to drink a sufficient amount of water to ensure adequate hydration before their study and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Albumin Aggregated Injection in order to reduce radiation exposure [see Dosage and Administration (2.2)].

Pregnancy

Advise pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionucleotide procedure [see Use in Specific Populations (8.1)].

Lactation

Advise a lactating woman to temporally discontinue breastfeeding and to pump and discard breast milk for 24 hours after Technetium Tc 99m Albumin Aggregated Injection administration to minimize radiation exposure to a breastfed infant [see Use in Specific Populations (8.2)].