Investor Relations




Product Sites:
ABLAVAR®
DEFINITY
®
TechneLite®
Cardiolite®

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com


Lantheus ProductsOur pioneering product portfolio includes ABLAVAR® (gadofosveset trisodium)—the first and only FDA approved blood pool contrast agent for magnetic resonance angiography (MRA), Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), one of the world’s leading cardiac perfusion imaging agents and DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading cardiac ultrasound contrast agent in the US.

For comprehensive information about our products, including full Prescribing Information, and support services, please select a product below:

arrow ABLAVAR® (gadofosveset trisodium)

Ordering Information:

To place an order call
1-800-299-3431


Product Information:
ABLAVAR® (gadofosveset trisodium) is a magnetic resonance angiography blood pool agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.

www.ABLAVAR.com

Material Safety Data Sheet (MSDS) (PDF)

Full Prescribing Information including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF) (PDF)

INDICATIONS: ABLAVAR® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

CONTRAINDICATIONS: History of a prior allergic reaction to a gadolinium-based contrast agent.

IMPORTANT SAFETY INFORMATION:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs.  Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
    • acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

ABLAVAR® Injection:  As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered.  As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.

In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.

Have emergency resuscitative equipment available prior to and during ABLAVAR® administration.

Please See Full Prescribing Information including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF)

ABLAVAR® List Price History

arrow DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
DEFINITY

Ordering Information:

Catalog Numbers
DE4 4-Vial Kit US
DE16 16-Vial Kit US

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension is a contrast agent used to enhance the quality of suboptimal echocardiograms.

Material Safety Data Sheet (MSDS) (PDF)

Full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

DEFINITY® Return Policy

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING:  Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)].  Most serious reactions occur within 30 minutes of administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

DEFINITY® List Price History

arrow Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

Ordering Information:

Catalog Numbers
CAPD 20-Vial Kit
CAKD 5-Vial Kit

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
Cardiolite® (Kit of the Preparation of Technetium Tc99m Sestamibi for Injection), a technetium-based radiopharmaceutical used in Single Photon Emission Computed Tomography (SPECT) myocardial perfusion imaging procedures. Cardiolite® is primarily used for detecting coronary artery disease and has been used to image more than 40 million patients in the U.S.1

www.Cardiolite.com

Material Safety Data Sheet (MSDS) (PDF)

Prescribing Information (PDF)

Indications and Usage:
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).

CONTRAINDICATIONS:
None known.

IMPORTANT SAFETY INFORMATION: 

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.  The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.

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.

WARNINGS AND PRECAUTIONS:
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.

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 CARDIOLITE® or MIRALUMA®.
MIRALUMA® is an identical compound used in breast imaging.

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.

Please see full Prescribing Information

arrow TechneLite® (Technetium Tc99m Generator)

Ordering Information:

To place an order call
1-800-299-3431

TechneLite Technetium Tc 99m Generator

Product Information:
The TechneLite® (Technetium Tc99m Generator) is a technetium-based generator that provides the essential medical isotope used by radiopharmacies to radiolabel Cardiolite® and other Tc-99m based radiopharmaceuticals used in nuclear medicine procedures.

www.TechneLite.com

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

TechneLite® Tc99m Yield Chart SUNDAY (PDF)

TechneLite® Tc99m Yield Chart MONDAY-FRIDAY (PDF)

INDICATIONS AND USAGE:
Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for:
Brain Imaging (including cerebral radionuclide angiography)
Thyroid Imaging
Salivary Gland Imaging
Placenta Localization
Blood Pool Imaging (including radionuclide angiography)
Urinary Bladder Imaging (direct isotopic cystography) for the detection of
vesico-ureteral reflux.
Nasolacrimal Drainage System Imaging
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:
Brain Imaging (including cerebral radionuclide angiography)
Thyroid Imaging
Blood Pool Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of
vesico-ureteral reflux. 

CONTRAINDICATIONS: None known.

Important Safety Information: 
Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc99m Injection.

WARNINGS:
Radiation risks associated with the use of Sodium Pertechnetate
Tc 99m Injection are greater in children than in adults and, in general, the younger the
child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy.
These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

PRECAUTIONS:
Since the eluate does not contain an antimicrobial agent, it should not be used after 12
hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please see full Prescribing Information

arrow LEU TechneLite® (Technetium Tc99m Generator)

Ordering Information:

To place an order call
1-800-299-3431

LEU TechneLite Technetium Tc 99m Generator

Product Information:
The LEUTechneLite® (Technetium Tc99m Generator) is a technetium-based generator that provides the essential medical isotope used by radiopharmacies to radiolabel Cardiolite® and other Tc-99m based radiopharmaceuticals used in nuclear medicine procedures.

www.TechneLite.com

LEU TechneLite Generator Fact Sheet

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

TechneLite® Tc99m Yield Chart SUNDAY (PDF)

TechneLite® Tc99m Yield Chart MONDAY-FRIDAY (PDF)

INDICATIONS AND USAGE:
Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for:
Brain Imaging (including cerebral radionuclide angiography)
Thyroid Imaging
Salivary Gland Imaging
Placenta Localization
Blood Pool Imaging (including radionuclide angiography)
Urinary Bladder Imaging (direct isotopic cystography) for the detection of
vesico-ureteral reflux.
Nasolacrimal Drainage System Imaging
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:
Brain Imaging (including cerebral radionuclide angiography)
Thyroid Imaging
Blood Pool Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of
vesico-ureteral reflux. 

CONTRAINDICATIONS: None known.

Important Safety Information: 
Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc99m Injection.

WARNINGS:
Radiation risks associated with the use of Sodium Pertechnetate
Tc 99m Injection are greater in children than in adults and, in general, the younger the
child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy.
These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

PRECAUTIONS:
Since the eluate does not contain an antimicrobial agent, it should not be used after 12
hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please see full Prescribing Information

arrow NEUROLITE® (Kit for the Preparation of Technetium Tc99m Bicisate for Injection)

Ordering Information:

Catalog Numbers
NE2D 2-vial kit

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Neurolite(r) Returns

Customer letter 9/23/2013

Product Information:

NEUROLITE® (Kit of the Preparation of Technetium Tc99m Bicisate for Injection) is a SPECT brain imaging agent for localization of stroke in patients in whom stroke has already been diagnosed.

Prescribing Information (PDF)

Vial A Material Safety Data Sheet (MSDS) (PDF)

Vial B Material Safety Data Sheet (MSDS) (PDF)

INDICATIONS:

NEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.

NEUROLITE® is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions.

CONTRAINDICATIONS:
None known.

Important Safety Information:
In clinical trials, NEUROLITE® has been administered to 1063 subjects (255 normals, 808 patients).   In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to NEUROLITE®

The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis. 

WARNINGS:
None known.

PRECAUTIONS:

General
USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT.  TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION.  WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN.  DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.

Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.

As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

Please see full Prescribing Information

arrow Thallium 201 (Thallous Chloride Tl201 Injection)

Ordering Information:

  1. Refer to the chart below to convert into mCi's.
  2. For each mCi needed at administration time, multiply by the factor shown in your time zone.
  3. Total your mCi's for all administrations and round to the nearest whole mCi.
  4. Call your Lantheus Medical Imaging Customer Service Representative and place your order in mCi (7 mCi minimum order).

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
Thallium 201 (Thallous Chloride Tl201 Injection) is used in myocardial perfusion imaging for the diagnosis or localization of myocardial infarction.

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

INDICATIONS AND USAGE:

Thallous Chloride TI 201 Injection may be useful in myocardial perfusion imaging using either planar or SPECT (Single Photon Computed Tomography) techniques for the diagnosis and localization of myocardial infarction.  It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.

Thallous Chloride TI 201 Injection may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease).

It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate between recent myocardial infarction and ischemia.

Thallous Chloride TI 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels.  It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for postsurgical reexamination.  Thallous Chloride Tl 201 Injection has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

CONTRAINDICATIONS: None known.

Important Safety Information:
 Following the administration of Thallous Chloride Tl 201  Injection, adverse anaphylactoid reactions have been reported (characterized by cardiovascular, respiratory, and cutaneous symptoms), some severe enough to require treatment.  Hypotension, pruritus, flushing and diffuse rash which responds to antihistamines have been reported.  Other reported events include itching, nausea/vomiting, mild diarrhea, tremor, shortness of breath, chills, fever, conjunctivitis, sweating and blurred vision.

WARNINGS:
In studying patients in whom myocardial infarction or ischemia is known or suspected, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure.  Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation equipment.
The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS:
Data are not available concerning the effect of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus) on the quality of Thallous ­Chloride TI 201 Injection scans.  Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected.

General

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Thallous Chloride TI 201 Injection, as all radioactive materials, must be handled with care and used with appropriate safety measures to minimize external radiation exposure to patients and to clinical personnel. 

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

Please see full Prescribing Information

LOCAL ADMINISTRATION TIME LOCAL TIME mCi CONVERSION
  EST CST MST PST
02:00 AM 0.945 0.954 0.963 0.972
03:00 AM 0.954 0.963 0.972 0.981
04:00 AM 0.963 0.972 0.981 0.991
05:00 AM 0.972 0.981 0.991 1.000
06:00 AM 0.981 0.991 1.000 1.010
07:00 AM 0.991 1.000 1.010 1.019
08:00 AM 1.000 1.010 1.019 1.029
09:00 AM 1.010 1.019 1.029 1.039
10:00 AM 1.019 1.029 1.039 1.049
11:00 AM 1.029 1.039 1.049 1.059
12:00 PM 1.039 1.049 1.059 1.069
01:00 PM 1.049 1.059 1.069 1.079
02:00 PM 1.059 1.069 1.079 1.089
03:00 PM 1.069 1.079 1.089 1.100
04:00 PM 1.079 1.089 1.100 1.110
05:00 PM 1.089 1.100 1.110 1.121
06:00 PM 1.100 1.110 1.121 1.132
07:00 PM 1.110 1.121 1.132 1.142
08:00 PM 1.121 1.132 1.142 1.153
arrow Gallium 67 (Gallium Citrate Ga67 Injection)

Ordering Information:

Catalog Numbers
GA6 6.6mCi
GA8 8.8mCi
GA12 13.2mCi
GA18 19.8mCi

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
Gallium 67 (Gallium Citrate Ga67 Injections) may be used to demonstrate the presence of the following malignancies: Hodgkin’s disease, lymphomas, and bronchogenic carcinomas.

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

INDICATIONS AND USAGES:
Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma.  Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

CONTRAINDICATIONS:

 None known.

Important Safety Information: 

Severe itching, erythema, and rash were observed in one patient of 300 studied.

The rare occurrence of hypersensitivity reactions or allergic reactions, skin rash, and nausea have been reported in association with Gallium 67 use.

WARNINGS: 

Because of the benzyl alcohol content, caution should be used in administration to newborns, particularly infants born prematurely, and individuals with impaired liver function.
The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS:

General

Abnormal gallium concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions.  Gallium Citrate Ga 67 Injection is intended for use as an adjunct in the diagnosis of certain neoplasms.  Certain pathologic conditions may yield up to 40% false negative gallium studies.  Therefore, a negative study cannot be definitively interpreted as ruling out the presence of disease.

Lymphocytic lymphoma frequently does not accumulate Gallium Ga 67 sufficiently for unequivocal imaging; and the use of gallium with this histologic type of lymphoma is not recommended at this time.

Gallium Ga 67 localization cannot differentiate between tumor and acute inflammation; and other diagnostic studies must be added to define the underlying pathology.

Gallium Citrate Ga 67 Injection, as well as any other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize external radiation exposure to patients and to clinical personnel. 

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.

Please see full Prescribing Information
arrow Xenon 133 (Xenon Xe 133 Gas)

Ordering Information:

Catalog Numbers
X110 = 1 x 10mCi Vial X120 = 1 x 20mCi Vial
X510 = 5 x 10mCi Vial X520 = 5 x 20mCi Vial

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

 

Product Information:
(Xenon Xe 133 Gas) is used for the evaluation of pulmonary function and for imaging the lungs.

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

Customer Letter - September 2014

Instructions for Xenon Xe-133 Shipping Container

INDICATIONS AND USAGE:
Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs.  It may also be applied to assessment of cerebral flow.

CONTRAINDICATIONS:
None known.

Important Safety Information:
Adverse reactions related to the use of this agent have not been reported to date.

WARNINGS:
Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into environs not specifically protected by exhaust systems.

Xenon Xe 133 adheres to some plastics and rubber and should not be allowed in tubing or respirator containers.  The unrecognized  loss of radioactivity from  the dose for administration may render the study non-diagnostic.

The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS:
General:

Xenon Xe 133, as well as other  radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to patients and to clinical personnel. 

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.

Please see full Prescribing Information
arrow VIALMIX®
VIALMIX

Ordering Information:

Catalog Numbers
VMIX VIALMIX®*
*A VIALMIX® is provided at no charge to customers who use DEFINITY®

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
VIALMIX®is the activation device used with DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

When properly used, it ensures consistent activation of DEFINITY®.

VialMix User's Guide

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING:  Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)].  Most serious reactions occur within 30 minutes of administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

arrow INTELLIPIN® (Dispensing Pin)
IntelliPin

Ordering Information:

Catalog Numbers
IPIN Box of 4 Intellipins®

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

Product Information:
An alternative to needles. For use with activated DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension only. 

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING:  Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)].  Most serious reactions occur within 30 minutes of administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

arrow QUADRAMET® (Samarium SM 153 Lexidronam Injection)

 

Ordering Information:

Catalog Number
SM3-W QUADRAMET SM-153 EDTMP 5550MBq

To place an order call
1-800-299-3431
or visit
ecommerce.lantheus.com

 

Product Information:
QUADRAMET® (Samarium SM 153 Lexidronam Injection) is an injectable radiopharmaceutical used to treat bone pain associated with certain kinds of cancer.

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

INDICATIONS AND USAGE:
QUADRAMET® is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

SELECTED IMPORTANT RISK INFORMATION ABOUT QUADRAMET

Contraindications:
QUADRAMET® is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds

Warnings and precautions:
QUADRAMET® causes bone marrow suppression. Before administered, the patient's current clinical, hematological status, and bone marrow response history to myelotoxic agents should be considered. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other findings suggesting DIC. Blood counts should be monitored weekly for at least 8 weeks or until bone marrow recovery.
The potential for additive bone marrow toxicity of QUADRAMET® with chemotherapy or external beam radiation has not been studied. QUADRAMET® should not be administered concurrently with either of these treatments unless the benefits outweigh the risks and adequate marrow recovery has occurred.
QUADRAMET® can cause fetal harm. Women of childbearing potential should be advised to avoid becoming pregnant soon after receiving QUADRAMET®. If administered, pregnant patients should be apprised of the potential hazard to the fetus and the potential for serious adverse reactions in nursing infants.

Adverse reactions:
The most frequent events are leukopenia, thrombocytopenia, and spinal cord compression in patients with cervical, thoracic, or lumbar spine metastases.

Please see full Prescribing Information

arrow Fludeoxyglucose F 18 injection (FDG F 18) For Puerto Rico Customers

Ordering Information:

Puerto Rico
Lantheus MI Radiopharmaceuticals, Inc
150 Federico Costa , Suite 1
San Juan, PR 00918-1303

Customer Service:
Phone: 787-765-5598 Ext: 2504
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Phone: 787-765-5598 Ext: 2502

This information is intended for US customers. Approved labeling and indications vary by country. Please call customer service at 787-765-5598 Ext: 2504 for more information.

 


 

 

Product Information:
Fludeoxyglucose F 18 Injection is a Fluorine 18 based radiopharmaceutical used in Positron Emission Tomography (PET) imaging procedures in the oncology, cardiology and neurology setting.

Prescribing Information (PDF)

Material Safety Data Sheet (MSDS) (PDF)

INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

  • Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

  • Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion
    imaging.

  • Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

IMPORTANT SAFETY INFORMATION

Radiation Risks
Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Blood Glucose Abnormalities
In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F 18 Injection administration.

Adverse Reactions
Hypersensitivity reactions with pruritus, edema and rash have been reported; have emergency resuscitation equipment and personnel immediately available.

Please see full Prescribing Information.

 


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