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Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 11994-001-55 (Billing 11994-0001-55)

by Lantheus Medical Imaging, Inc. · 5 VIAL in 1 BOX / 5 mL in 1 VIAL

This is a package of Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL Injection, Powder, Lyophilized, For Solution from Lantheus Medical Imaging, Inc., marketed since Dec 1990 and currently FDA-listed.

NDC 11994-0001-55
🏷️ FDA NDC (as labeled) 11994-001-55 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial Medicaid pays$108.17 / unit · 12 mo Per package$2,704.31 / 25 ml · Medicaid Pack sizes2 compare ↓
Product page 11994-0001-20 Also comes in: 20 vials 11994-001-20
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 11994-001-55 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
11994 labeler · 001 product · 55 package
Package marketed since
Dec 20, 1990
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1199400155 4
Medicaid fills, this package
1,830 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11994-001-55
Product NDC 11994-001
11-digit billing NDC 11994000155
NCPDP billing unit EA — each (per item)
UNII N6OU7HJ70P
Application # NDA019785
SPL Set ID 49662def-2fb9-47b2-8467-ca56f6006167
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-12-20
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94353080656400
GCN Seq No 066782
GCN 29167
HICL code 037226
Ingredient (HICL) Kit For Tc 99M/Sestamibi No.1
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6W
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics - Radioactive
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name CARDIOLITE PREPARATION KIT
FDB brand name Cardiolite
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066782
  • GCN: 29167
  • GPI-14 (Medi-Span): 94353080656400
  • HICL (First Databank): 037226
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 11994-001-55 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11994-0001-55. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name CARDIOLITE PREPARATION KIT Ingredient Kit For Tc 99M/Sestamibi No.1

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $108.17 $2,704.31 / 25 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11994-0001-20 11994-001-20 Main listing 20 VIAL in 1 BOX / 5 mL in 1 VIAL 2008-02-28 — Active
11994-0001-55 You're viewing this 5 VIAL in 1 BOX / 5 mL in 1 VIAL 1990-12-20 — Active

This pack accounts for about 32% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 vial in 1 box / 5 ml in 1 vial.
What NDC number is used to bill for this package of Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL Injection, Powder, Lyophilized, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kit for the Preparation of Technetium Tc99m Sestamibi 1 mg/mL 11994-0003-20 Lantheus 20 vials — AP FDA listed —
Cardiolite 1 mg/mLthis 11994-0001-55 Lantheus 5 vials — AP FDA listed —
Cardiolite 1 mg/mL 87333-0001-20 SHINE 20 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1990
On the market since
Dec 1990
📍
2026
Currently FDA-listed
36 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLantheus Medical Imaging, Inc.
Application holderSHINE SPECT USA LLC
FDA applicationNDA019785 (NDA)
Labeler code11994
First marketedDec 1990
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Lantheus Medical Imaging, Inc. labeler code 11994

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 211 words ▾

1. INDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.

CARDIOLITE ® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.

MIRALUMA ® is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).

For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).

2.1Image Acquisition Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay.

For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view. For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence: Beginning five minutes after the injection of Technetium Tc99m Sestamibi: ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts

2.2Radiation Dosimetry The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc99m Sestamibi injected intravenously are shown in Table 1.0. Table 1.0. Radiation Absorbed Doses from Tc99m Sestamibi Estimated Radiation Absorbed Dose Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117.

REST 2.0 hour void 4.8 hour void Organ rads/ 30 mCi mGy/ 1110 MBq rads/ 30 mCi mGy/ 1110 MBq Breasts 0.2 2.0 0.2

1.9Gallbladder Wall 2.0 20.0 2.0

20.0Small Intestine 3.0 30.0 3.0

30.0Upper Large Intestine Wall 5.4 55.5 5.4

55.5Lower Large Intestine Wall 3.9 40.0 4.2

41.1Stomach Wall 0.6 6.1 0.6

5.8Heart Wall 0.5 5.1 0.5

4.9Kidneys 2.0 20.0 2.0

20.0Liver 0.6 5.8 0.6

5.7Lungs 0.3 2.8 0.3

2.7Bone Surfaces 0.7 6.8 0.7

6.4Thyroid 0.7 7.0 0.7

7.0Ovaries 1.5 15.5 1.6

15.5Testes 0.3 3.4 0.4

3.9Red Marrow 0.5 5.1 0.5

5.0Urinary Bladder Wall 2.0 20.0 4.2

41.1Total Body 0.5 4.8 0.5

4.8STRESS 2.0 hour void 4.8 hour void Organ rads/ 30 mCi mGy/ 1110 MBq rads/ 30 mCi mGy/ 1110 MBq Breasts 0.2 2.0 0.2

1.8Gallbladder Wall 2.8 28.9 2.8

27.8Small Intestine 2.4 24.4 2.4

24.4Upper Large Intestine Wall 4.5 44.4 4.5

44.4Lower Large Intestine Wall 3.3 32.2 3.3

32.2Stomach Wall 0.6 5.3 0.5

5.2Heart Wall 0.5 5.6 0.5

5.3Kidneys 1.7 16.7 1.7

16.7Liver 0.4 4.2 0.4

4.1Lungs 0.3 2.6 0.2

2.4Bone Surfaces 0.6 6.2 0.6

6.0Thyroid 0.3 2.7 0.2

2.4Ovaries 1.2 12.2 1.3

13.3Testes 0.3 3.1 0.3

3.4Red Marrow 0.5 4.6 0.5

4.4Urinary Bladder Wall 1.5 15.5 3.0

30.0Total Body 0.4 4.2 0.4 4.2

2.3Instructions For Preparation Preparation of the Technetium Tc99m Sestamibi from the Kit for the Preparation of Technetium Tc99m Sestamibi is done by the following aseptic procedure: General Procedure: a. Prior to adding the Sodium Pertechnetate Tc99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found. Tear off a radiation symbol and attach it to the neck of the vial. b.

Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 52 words ▾

3. DOSAGE FORMS AND STRENGTHS CARDIOLITE ®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial. CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.

⛔ Contraindications 6 words ▾

4. CONTRAINDICATIONS None known. None known.

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. CARDIOLITE® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria.

In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging. Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®. Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either drug.

The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

5.1Warnings In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2 ). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling. Technetium Tc99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging.

Patients who receive CARDIOLITE® or MIRALUMA® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.

5.2General Precautions The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure. Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.

Contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc99m Injection is added, adequate shielding of the final preparation must be maintained. The components of the kit are sterile and non-pyrogenic.

It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. Technetium Tc99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc99m Injection containing oxidants should not be used.

Technetium Tc99m Sestamibi should not be used more than six hours after preparation. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

The most frequent exercise stress test endpoints sufficient to stop the test reported during controlled studies (two-thirds were cardiac patients) were: Fatigue 35% Dyspnea 17% Chest Pain 16% ST-depression 7%… [Excerpted — this section continues on DailyMed.]

⚠️ Warnings 185 words ▾

5.1Warnings In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2 ). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling. Technetium Tc99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging.

Patients who receive CARDIOLITE® or MIRALUMA® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.

🤒 Adverse Reactions ~2 min read ▾

6. ADVERSE REACTIONS Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient's genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials.

Cases of angina, chest pain, and death have occurred (see Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: Table

2.0Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose gender was not recorded. Body System Breast Studies Cardiac Studies Women n = 673 Women n = 685 Men n = 2361 Total n = 3046 Body as a Whole 21 (3.1%) 6 (0.9%) 17 (0.7%) 23 (0.8%) Headache 11 (1.6%) 2 (0.3%) 4 (0.2%) 6 (0.2%) Cardiovascular 9 (1.3%) 24 (3.5%) 75 (3.2%) 99 (3.3%) Chest Pain/Angina 0 (0%) 18 (2.6%) 46 (1.9%) 64 (2.1%) ST segment changes 0 (0%) 11 (1.6%) 29 (1.2%) 40 (1.3%) Digestive System 8 (1.2%) 4 (0.6%) 9 (0.4%) 13 (0.4%) Nausea 4 (0.6%) 1 (0.1%) 2 (0.1%) 3 (0.1%) Special Senses 132 (19.6%) 62 (9.1%) 160 (6.8%) 222 (7.3%) Taste Perversion 129 (19.2%) 60 (8.8%) 157 (6.6%) 217 (7.1%) Parosmia 8 (1.2%) 6 (0.9%) 10 (0.4%) 16 (0.5%) In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients.

In 11 of these patients the pain appears to be associated with biopsy/surgical procedures. The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis, angioedema, arrythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi.

A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent. The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis, angioedema, arrythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi.

A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent. To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 17 words ▾

7. DRUG INTERACTIONS Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS In one study of 46 subjects who received CARDIOLITE® administration, the radioactivity in both children and adolescents exhibited blood PK profiles similar to those previously reported in adults. Lactation: Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.

( 8.2 )

8.1Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, 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 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary Limited data in the scientific literature on the presence of Technetium Tc99m Sestamibi in human milk, demonstrate that between 0.01% and 0.03% of maternal injected activity of technetium Tc99m Sestamibi was excreted in human milk. Technetium Tc99m Sestamibi accumulates in the lactating breast [see Clinical Considerations ] . There are limited data in the scientific literature on effects of Technetium Tc99m Sestamibi on the breastfed infant or on milk production The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Technetium Tc99m Sestamibi and any potential adverse effects on the breastfed infant from Technetium Tc99m Sestamibi or from the underlying maternal condition.

Clinical Considerations Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary because Technetium Tc99m Sestamibi excretion in breast milk is low. However, a lactating woman may restrict close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. No evidence of diagnostic efficacy or clinical utility of CARDIOLITE® scan was found in clinical studies of children and adolescents with Kawasaki disease. A prospective study of 445 pediatric patients with Kawasaki disease was designed to determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging to define a pediatric population with Kawasaki disease that was at risk of developing cardiac events.

Cardiac events were defined as cardiac death, MI, hospitalization due to cardiac etiology, heart failure, CABG or coronary angioplasty. The standard of truth was defined as cardiac events occurring 6 months following the administration of CARDIOLITE®. Only three cardiac events were observed at six months in this study.

In all three cases, the scan was negative. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. A ten year retrospective case history study of pediatric Kawasaki disease patients who completed CARDIOLITE® myocardial perfusion imaging and who had coronary angiography within three months of the CARDIOLITE… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 142 words ▾

8.1Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, 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 2-4% and 15-20%, respectively.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. No evidence of diagnostic efficacy or clinical utility of CARDIOLITE® scan was found in clinical studies of children and adolescents with Kawasaki disease. A prospective study of 445 pediatric patients with Kawasaki disease was designed to determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging to define a pediatric population with Kawasaki disease that was at risk of developing cardiac events.

Cardiac events were defined as cardiac death, MI, hospitalization due to cardiac etiology, heart failure, CABG or coronary angioplasty. The standard of truth was defined as cardiac events occurring 6 months following the administration of CARDIOLITE®. Only three cardiac events were observed at six months in this study.

In all three cases, the scan was negative. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. A ten year retrospective case history study of pediatric Kawasaki disease patients who completed CARDIOLITE® myocardial perfusion imaging and who had coronary angiography within three months of the CARDIOLITE® scan was designed to measure sensitivity and specificity of CARDIOLITE® scan.

Out of 72 patients who had both evaluable CARDIOLITE® scans and evaluable angiographic images, only one patient had both an abnormal angiogram and an abnormal CARDIOLITE® scan. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. In a clinical pharmacology study, 46 pediatric patients with Kawasaki disease received CARDIOLITE® administration at the following doses: 0.1 - 0.2 mCi/kg for rest, 0.3 mCi/kg for stress in one day studies; 0.2 mCi/kg for rest and 0.2 mCi/kg for stress in two day studies.

The radioactivity both in younger children and in adolescents exhibited PK profiles similar to those previously reported in adults (See Section 12 ). The radiation absorbed doses in adolescents, both at rest and stress, were similar to those observed in adults (see Section 2 ). When comparing weight-adjusted radioactivity (up to 0.3 mCi/kg) doses administered to adolescents and younger children to the recommended dose administered to adults (up to 30 mCi), the radiation absorbed doses in both adolescents and younger children were similar to those in adults.

Adverse events were evaluated in 609 pediatric patients from the three clinical studies described above. The frequency and the type of the adverse events were similar to the ones observed in the studies of CARDIOLITE® in adults. Two of the 609 had a serious adverse event: one patient received a CARDIOLITE® overdose but remained asymptomatic, and one patient had an asthma exacerbation following administration.

🧓 Geriatric Use 117 words ▾

8.5Geriatric Use Of 3068 patients in clinical studies of CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 693 patients were 65 or older and 121 were 75 or older. Of 673 patients in clinical studies of MIRALUMA®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 138 patients were 65 or older and 30 were 75 or older. Based on the evaluation of the frequency of adverse events and review of vital signs data, no overall differences in safety were observed between these subjects and younger subjects.

Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 12 words ▾

10. OVERDOSAGE The clinical consequences of overdosing with CARDIOLITE® are not known.

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue. Animal studies have shown that myocardial uptake is not blocked when the sodium pump mechanism is inhibited.

Although studies of subcellular fractionation and electron micrographic analysis of heart cell aggregates suggest that Tc99m Sestamibi cellular retention occurs specifically within the mitochondria as a result of electrostatic interactions, the clinical relevance of these findings has not been determined. The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.

12.3Pharmacokinetics Pulmonary activity is negligible even immediately after injection. Blood clearance studies indicate that the fast clearing component clears with a t 1/2 of 4.3 minutes at rest, and clears with a t 1/2 of 1.6 minutes under exercise conditions . At five minutes post injection about 8% of the injected dose remains in circulation.

There is less than 1% protein binding of Technetium Tc99m Sestamibi in plasma. The myocardial biological half-life is approximately six hours after a rest or exercise injection . The biological half-life for the liver is approximately 30 minutes after a rest or exercise injection.

The effective half-life of clearance (which includes both the biological half-life and radionuclide decay) for the heart is approximately 3 hours, and for the liver is approximately 30 minutes, after a rest or exercise injection. The ideal imaging time reflects the best compromise between heart count rate and surrounding organ uptake. Myocardial uptake which is coronary flow dependent is 1.2% of the injected dose at rest and 1.5% of the injected dose at exercise.

Table 6.0 illustrates the biological clearance as well as effective clearance (which includes biological clearance and radionuclide decay) of Tc99m Sestamibi from the heart and liver. [Organ concentrations expressed as percentage of injected dose; data based on an average of 5 subjects at rest and 5 subjects during exercise]. Table

6.0Biological and Effective Clearance REST STRESS Heart Liver Heart Liver Time Biological Effective Biological Effective Biological Effective Biological Effective 5 min. 1.2 1.2 19.6 19.4 1.5 1.5 5.9 5.8 30 min. 1.1 1.0 12.2 11.5 1.4 1.3 4.5 4.2 1 hour 1.0 0.9 5.6 5.0 1.4 1.2 2.4 2.1 2 hours 1.0 0.8 2.2 1.7 1.2 1.0 0.9 0.7 4 hours 0.8 0.5 0.7 0.4 1.0 0.6 0.3

0.2A study in a dog myocardial ischemia model reported that Technetium Tc99m Sestamibi undergoes myocardial distribution (redistribution), although more slowly and less completely than thallous chloride Tl-201. A study in a dog myocardial infarction model reported that the drug showed no redistribution of any consequence. Definitive human studies to demonstrate possible redistribution have not been reported.

In patients with documented myocardial infarction, imaging revealed the infarct up to four hours post dose. 12.3.1 Metabolism The agent is excreted without any evidence of metabolism. 12.3.2 Elimination The major pathway for clearance of Tc99m Sestamibi is the hepatobiliary system.

Activity from the gall bladder appears in the intestines within one hour of injection. Twenty-seven percent of the injected dose is excreted in the urine, and approximately thirty-three percent of the injected dose is cleared through the feces in 48 hours.

🧬 Mechanism of Action 138 words ▾

12.1Mechanism of Action Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue. Animal studies have shown that myocardial uptake is not blocked when the sodium pump mechanism is inhibited.

Although studies of subcellular fractionation and electron micrographic analysis of heart cell aggregates suggest that Tc99m Sestamibi cellular retention occurs specifically within the mitochondria as a result of electrostatic interactions, the clinical relevance of these findings has not been determined. The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.

📦 How Supplied / Storage and Handling 215 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 11994-001-55) and twenty (20) vials (NDC # 11994-001-20), sterile and non-pyrogenic. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration.

Radiochemical purity should be checked prior to patient administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Prior to lyophilization the pH is between 5.3-5.9.

The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77° F) before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives.

Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels. This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S.

Nuclear Regulatory Commission, Agreement States or Licensing States.

📋 Description ~2 min read ▾

11. DESCRIPTION Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg Sodium Citrate Dihydrate - 2.6 mg L-Cysteine Hydrochloride Monohydrate - 1.0 mg Mannitol – 20 mg Stannous Chloride, Dihydrate, minimum (SnCl 2 ∙2H 2 O) - 0.025 mg Stannous Chloride, Dihydrate, (SnCl 2 ∙2H 2 O) - 0.075 mg Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 ∙2H 2 O) - 0.086 mg Prior to lyophilization the pH is 5.3 to 5.9.

The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 - 6.0).

No bacteriostatic preservative is present. The precise structure of the technetium complex is Tc99m[MIBI] 6 + where MIBI is 2-methoxy isobutyl isonitrile.

11.1Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981). . Photons that are useful for detection and imaging studies are listed below in Table 3.0. Table 3.0. Principal Radiation Emission Data Radiation Mean %/Disintegration Mean Energy (KeV) Gamma -2 89.07 140.5

11.2External Radiation The specific gamma ray constant for Tc99m is 5.4 microcoulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4.0.

To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000. Table 4.0. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 5.0.

Table

5.0 Physical Decay Chart; Tc99m Half-Life

6.02Hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration Time 1.000 8 .398 1 .891 9 .355 2 .794 10 .316 3 .708 11 .282 4 .631 12 .251 5 .562 6 .501 7 .447

💬 Information for Patients 105 words ▾

17. PATIENT COUNSELING INFORMATION CARDIOLITE ® and MIRALUMA ® are different names for the same drug. Patients should be advised to inform their health care provider if they had an allergic reaction to either drug or if they had an imaging study with either drug.

Lactation: Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pulmonary activity is negligible even immediately after injection. Blood clearance studies indicate that the fast clearing component clears with a t 1/2 of 4.3 minutes at rest, and clears with a t 1/2 of 1.6 minutes under exercise conditions . At five minutes post injection about 8% of the injected dose remains in circulation.

There is less than 1% protein binding of Technetium Tc99m Sestamibi in plasma. The myocardial biological half-life is approximately six hours after a rest or exercise injection . The biological half-life for the liver is approximately 30 minutes after a rest or exercise injection.

The effective half-life of clearance (which includes both the biological half-life and radionuclide decay) for the heart is approximately 3 hours, and for the liver is approximately 30 minutes, after a rest or exercise injection. The ideal imaging time reflects the best compromise between heart count rate and surrounding organ uptake. Myocardial uptake which is coronary flow dependent is 1.2% of the injected dose at rest and 1.5% of the injected dose at exercise.

Table 6.0 illustrates the biological clearance as well as effective clearance (which includes biological clearance and radionuclide decay) of Tc99m Sestamibi from the heart and liver. [Organ concentrations expressed as percentage of injected dose; data based on an average of 5 subjects at rest and 5 subjects during exercise]. Table

6.0Biological and Effective Clearance REST STRESS Heart Liver Heart Liver Time Biological Effective Biological Effective Biological Effective Biological Effective 5 min. 1.2 1.2 19.6 19.4 1.5 1.5 5.9 5.8 30 min. 1.1 1.0 12.2 11.5 1.4 1.3 4.5 4.2 1 hour 1.0 0.9 5.6 5.0 1.4 1.2 2.4 2.1 2 hours 1.0 0.8 2.2 1.7 1.2 1.0 0.9 0.7 4 hours 0.8 0.5 0.7 0.4 1.0 0.6 0.3

0.2A study in a dog myocardial ischemia model reported that Technetium Tc99m Sestamibi undergoes myocardial distribution (redistribution), although more slowly and less completely than thallous chloride Tl-201. A study in a dog myocardial infarction model reported that the drug showed no redistribution of any consequence. Definitive human studies to demonstrate possible redistribution have not been reported.

In patients with documented myocardial infarction, imaging revealed the infarct up to four hours post dose. 12.3.1 Metabolism The agent is excreted without any evidence of metabolism. 12.3.2 Elimination The major pathway for clearance of Tc99m Sestamibi is the hepatobiliary system.

Activity from the gall bladder appears in the intestines within one hour of injection. Twenty-seven percent of the injected dose is excreted in the urine, and approximately thirty-three percent of the injected dose is cleared through the feces in 48 hours.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES CLINICAL TRIALS: MYOCARDIAL IMAGING: In a trial of rest and stress CARDIOLITE ® imaging, the relationship of normal or abnormal perfusion scans and long term cardiac events was evaluated in 521 patients (511 men, 10 women) with stable chest pain. There were 73.9% Caucasians, 25.9% Blacks and 0.2% Asians.

The mean age was 59.6 years (range: 29 to 84 years). All patients had a baseline rest and exercise CARDIOLITE ® scan and were followed for 13.2 ± 4.9 months (range: 1 to 24 months). Images were correlated with the occurrence of a cardiac event (cardiac death or non-fatal myocardial infarction).

In this trial as summarized in Table 7.0, 24/521 (4.6%) had a cardiac event. Table

7.0Cardiac Events Baseline Scan Note: Similar findings were found in two studies with patients who had pharmacologic stress CARDIOLITE ® imaging. Proportion of patients with events by scan results Proportion of scan result in patients with events; N=24 Proportion of event-free patients by scan result Normal 1/206 (0.5%) 1/24 (4.2%) 205/206 (99.5%) Abnormal 23/315 (7.3%) p<0.01 23/24 (95.8%) 292/315 (92.7%) Although patients with normal images had a lower cardiac event rate than those with abnormal images, in all patients with abnormal images it was not possible to predict which patient would be likely to have further cardiac events; i.e., such individuals were not distinguishable from other patients with abnormal images.

The findings were not evaluated for defect location, disease duration, specific vessel involvement or intervening management. In earlier trials, using a template consisting of the anterior wall, inferior-posterior wall and isolated apex, localization in the anterior or inferior-posterior wall in patients with suspected angina or coronary artery disease was shown. Disease localization isolated to the apex has not been established.

In adults, Tc99m Sestamibi has not been studied or evaluated in cardiac disorders other than coronary artery disease. BREAST IMAGING: MIRALUMA ® was evaluated in two multicenter, clinical trials of a total of 673 woman patients. Overall the mean age was 52 (range 23 to 87 years).

The racial and ethnic representation was 70% Caucasian, 15% African-American, 14% Hispanic and 1% Asian. Both clinical studies evaluated women who were referred for further evaluation for either: 1) a mammographically detected (with varying degrees of malignant likelihood) but not palpable breast lesion (study A, n=387, mean age = 54 years), or 2) a palpable breast lesion (study B, n=286, mean age = 50 years). In both studies all patients were scheduled for biopsy.

MIRALUMA ® (20 - 30 mCi) was injected intravenously in a vein that was contralateral to the breast lesion in question. Planar imaging was completed with a high resolution collimator with a 10% window centered at 140 KeV, and 128 × 128 matrix. An initial marker image, that was not used in the data analysis, was obtained using a cobalt Co57 point source as a marker of a palpable mass.

Images were obtained 5 minutes after injection as follows: lateral image of the affected breast for 10 minutes, lateral image of the contralateral breast for 10 minutes, and an anterior image of both breasts for 10 minutes. For the lateral image the patients were positioned in a prone position. For the anterior image, the patients were supine.

The MIRALUMA ® scintigraphic images were read in a randomized method by two groups of three blinded readers. MIRALUMA ® uptake was scored as: normal (no uptake), equivocal, low, moderate, or high uptake. The results of MIRALUMA ® images and mammography were analyzed in comparison to histopathologic findings of malignant or non-malignant disease.

As shown in Table 8.0 for the 483 evaluable patients, the sensitivity and specificity of any degree of MIRALUMA ® uptake appear to vary with the presence or absence of palpable mass. TABLE

8.0Overall MIRALUMA ® Blinded Results of Target Lesions Excludes all discordant lesions not identified at e… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 142 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In comparison with most other diagnostic technetium labeled radiopharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30 mCi at exercise) is high. Minimal exposure (ALARA) is necessary in women of childbearing capability. (See Section 2 .) The active intermediate, Cu(MIBI) 4 BF 4 , was evaluated for genotoxic potential in a battery of five tests.

No genotoxic activity was observed in the Ames, CHO/HPRT and sister chromatid exchange tests (all in vitro). At cytotoxic concentrations (> 20 µg/mL), an increase in cells with chromosome aberrations was observed in the in vitro human lymphocyte assay. Cu(MIBI) 4 BF 4 did not show genotoxic effects in the in vivo mouse micronucleus test at a dose which caused systemic and bone marrow toxicity (9 mg/kg, > 600 × maximal human dose).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 139 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In comparison with most other diagnostic technetium labeled radiopharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30 mCi at exercise) is high. Minimal exposure (ALARA) is necessary in women of childbearing capability. (See Section 2 .) The active intermediate, Cu(MIBI) 4 BF 4 , was evaluated for genotoxic potential in a battery of five tests.

No genotoxic activity was observed in the Ames, CHO/HPRT and sister chromatid exchange tests (all in vitro). At cytotoxic concentrations (> 20 µg/mL), an increase in cells with chromosome aberrations was observed in the in vitro human lymphocyte assay. Cu(MIBI) 4 BF 4 did not show genotoxic effects in the in vivo mouse micronucleus test at a dose which caused systemic and bone marrow toxicity (9 mg/kg, > 600 × maximal human dose).

📄 Package Label / Principal Display Panel 105 words ▾

PRINCIPAL DISPLAY PANEL - 5 Vial Box Lantheus Medical Imaging ® Cardiolite ® Kit for the Preparation of Technetium Tc99m Sestamibi for Injection CONTENTS AND STORAGE CONDITIONS: 1 Package Insert, 12 Radiation Labels and 5 Vials, each containing: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg Stannous Chloride Dihydrate - 0.075 mg; L-Cysteine Hydrochloride Monohydrate - 1.0 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg Store at 15-25°C (59-77°F). CONTAINS NO PRESERVATIVE. See Package Insert for dosage information.

Reconstitute with additive-free Tc99m and store at 15-25°C (59-77°F). Use within 6 hours of reconstitution. PRINCIPAL DISPLAY PANEL - 5 Vial Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.8K
Units reimbursed last 4 qtrs
3.3K
Gross reimbursed last 4 qtrs
$358.2K
Avg / prescription
$195.71
Avg / unit
$108.17
Latest quarter Q1 2026
426Rx
Fee-for-service vs managed care ⓘ
13% FFS 87% MCO
Fee-for-service · 244 Rx Managed care · 1,586 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 37 units · 0.6 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 400 units · 2.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 30 units · 0.4 per 100k residents IN Ohio: 769 units · 6.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 306 units · 0.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 521 units · 11.5 per 100k residents KY West Virginia: no data reported WV Virginia: 277 units · 3.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 40 units · 0.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 118 units · 11.4 per 100k residents DE Oklahoma: no data reported OK Louisiana: 60 units · 1.3 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 753 units · 3.3 per 100k residents FL
Units reimbursed · per 100k residents
0.411.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 11.5 /100k
2 Delaware 11.4 /100k
3 Ohio 6.5 /100k
4 Florida 3.3 /100k
5 Virginia 3.2 /100k
6 New York 2.0 /100k
7 Louisiana 1.3 /100k
8 California 0.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
20 vials11994-0001-20 3,886 Rx · $887,854
5 vials this page11994-0001-55 1,830 Rx · $358,158
Drug total (last 4 qtrs): 5,716 Rx · 10,153 units · $1,246,013 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cardiolite (this brand).

Top reported reactions

Nausea41
Rash32
Product Preparation Error29
Dyspnoea28
Urticaria28
Headache24
Dizziness19

Age at onset

Adult2
Elderly3

Reporter sex

367 reports
Male · 39%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization57
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lantheus Medical Imaging, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 vials (11994-0001-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Lantheus Medical Imaging, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 11993-0000-01 · Dersan 11994-0003-20 · Lantheus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.