Myoview

Name: Myoview

Overdose

No information provided.

Pregnancy

Information about this technetium-tc-99m-tetrofosmin-injection-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Breathing problems (eg, bronchoconstriction) or
  • Hypotension (low blood pressure) or
  • Stroke, history of—Use with caution. May make these conditions worse.

Before Using Myoview

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of technetium Tc 99m tetrofosmin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of technetium Tc 99m tetrofosmin injection in the elderly.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Breathing problems (eg, bronchoconstriction) or
  • Hypotension (low blood pressure) or
  • Stroke, history of—Use with caution. May make these conditions worse.

Uses of Myoview

  • It is used before a heart imaging test.

Indications and Usage for Myoview

Myoview is indicated for scintigraphic imaging of the myocardium following separate administrations under exercise and/or resting conditions. It is useful in the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium.

Myoview is also indicated for scintigraphic imaging of the myocardium to identify changes in perfusion induced by pharmacologic stress in patients with known or suspected coronary artery disease.

Myoview is also indicated for the assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients being evaluated for heart disease.

Adverse Reactions

Adverse events were evaluated in clinical studies (using an exercise/rest protocol) of 764 adults (511 men and 253 women) with a mean age of 58.7 years (range 29-94 years). The subjects received a mean dose of 7.67 mCi on the first injection and 22.4 mCi on the second injection of Myoview.

Deaths did not occur during the clinical study period of 2 days. Six cardiac deaths occurred 3 days to 6 months after injection and were thought to be related to the underlying disease or cardiac surgery. After Myoview injection, serious episodes of angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The respiratory arrest occurred within minutes of Myoview and pharmacologic stress dosing in a subject with underlying pulmonary disease. The patient was treated and fully recovered. Whether this event was caused by underlying disease or concurrent use of Myoview injection and a pharmacologic stress agent cannot be determined.

Overall cardiac adverse events occurred in less than 1% of subjects after Myoview injection.

The following events were noted in less than 1% of subjects:

Cardiovascular: angina, hypertension, Torsades de Pointes.

Gastrointestinal: vomiting, abdominal discomfort.

Hypersensitivity: cutaneous allergy, hypotension, dyspnea.

Special Senses: metallic taste, burning of the mouth, smell alteration.

There was a low incidence (less than 4%) of a transient and clinically insignificant rise in white blood cell counts following administration of the agent.

Adverse events were also evaluated in clinical studies using pharmacologic stress. In four studies of 438 adults (232 men and 205 women; gender was not recorded for one subject) with a mean age of 65.4 years (range 27-97 years; age was not recorded for two subjects) received a single pharmacologic stress agent. The subjects received a mean dose of 7.46-7.79 mCi on the rest/first injection and 22.12 - 33.79 mCi on the stress/second injection.

Among the 438 subjects, 319 experienced an adverse event (73%). Events occurring in ≥1% of the subjects included angina (39%), flushing (36%), dyspnea (28%), headache (14%), abdominal pain (11%), dizziness (7%), palpitations (2%), nausea (2%), hypotension (1%) and pain (1%). Events occurring in <1% include cough, arrhythmia, bronchospasm, ECG abnormalities, hypertension, vomiting and asthenia. Attribution of the above events to Myoview and/or the pharmacologic stress agent cannot be determined due to study design.

In additional ventricular function studies with 1 and 2 day dosing protocols, the overall adverse event profile was similar to previous reports and included one subject who was withdrawn for syncope.

Post-marketing experience

The following are spontaneously reported adverse reactions from post-marketing experience. Because the reports cite reactions reported spontaneously from worldwide post-marketing experience, frequency of reactions and the role of Myoview in their causation cannot be reliably determined. The most common adverse reactions reported included the following: rash, urticaria, abnormal vision, allergic reactions, and fever.

INSTRUCTIONS FOR THE PREPARATION OF Myoview INJECTION

USE ASEPTIC TECHNIQUE THROUGHOUT.

The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.

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

1) Place one of the vials in a suitable shielding container and sanitize the rubber septum with an isopropyl alcohol swab. Insert a sterile needle (the venting needle) through the rubber septum. 2) Using a shielded, 10 mL sterile syringe, inject the required activity of up to 240 mCi (8.8 GBq) technetium Tc99m generator eluate (diluted with Sodium Chloride Injection, USP) into the shielded vial (see Cautionary notes 1 and 2). Before removing the syringe from the vial, withdraw 2 mL of gas from above the solution. Remove the venting needle. Mix gently for 10 seconds to ensure complete dissolution of the powder. 3) Incubate at room temperature for 15 minutes. 4) Assay the total activity, complete the user radiation label and attach it to the vial. 5) Visually inspect the reconstituted solution at a safe distance through leaded glass. Do not use if it is not clear or if it contains foreign particulate matter. 6) Maintain adequate shielding of the radioactive preparation. 7) Store the reconstituted injection at 2°-25°C (36°-77°F) and use within 12 hours of preparation.

Cautionary notes

1) The volume of (diluted) technetium Tc99m generator eluate added to the vial must be in the range 4-8 mL. 2) The radioactive concentration of the (diluted) Tc99m generator eluate must not exceed 30 mCi/mL (1.1 GBq/mL) when it is added to the vial. 3) The pH of the prepared injection should be in the range 7.5-9.0. 4) Safety and effectiveness of Myoview Injection were established using investigational material shown to have a radiochemical purity of at least 90% prior to administration to patients in clinical studies. 5) The contents of the Myoview vial are not radioactive. However, after the sodium pertechnetate Tc99m is added adequate shielding of the final preparation must be maintained. 6) The technetium Tc99m labeling reaction involved in the preparation of Myoview Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. 7) Sodium Chloride Injection, USP, must be used as the diluent. Do not use bacteriostatic sodium chloride as a diluent for sodium pertechnetate Tc99m injection because it may adversely affect the radiochemical purity and hence the biological distribution of the Myoview Injection. 8) The contents of the Myoview vial are sterile and pyrogen-free. The vial contains no bacteriostatic preservative. It is essential that the user follow the directions carefully and adhere to aseptic procedures during the preparation of the radiopharmaceutical.

Quality Control

An assay of the radiochemical purity of the prepared injection can be performed using the following chromatographic procedure.

Equipment and eluent

1) Pall ITLC/SG strip (2 cm x 20 cm) - Do not heat activate 2) Ascending chromatography tank and cover 3) 35:65 v/v mixture of acetone and dichloromethane 4) 1 mL syringe with 22-25 G needle 5) Suitable counting equipment

Method

1) Pour the 35:65 acetone:dichloromethane mixture into the chromatography tank to a depth of 1 cm. Cover the tank and allow to equilibrate with the solvent vapor. 2) Mark an ITLC/SG strip with a pencil line at 3 cm from the bottom and, using an ink marker pen, at 15 cm from the pencil line. The pencil line indicates the origin where the sample is to be applied and movement of color from the ink line will indicate the position of the solvent front when upward elution should be stopped. 3) Cutting positions at 3 cm and 12 cm above the origin (Rfs 0.2 and 0.8 respectively) should also be marked in pencil. 4) Using a 1 mL syringe and needle, apply a 10-20 µL sample of the prepared injection at the origin of the ITLC/SG. Place it in the chromatography tank immediately and replace the cover. Ensure that the strip is not adhering to the walls of the tank.

Note: A 10-20 µL sample will produce a spot with a diameter of 7-10 mm. Smaller sample volumes have been shown to give unreliable radiochemical purity values.

5) When the solvent reaches the ink line, remove the strip from the tank and allow it to dry. 6) Cut the strip into 3 pieces at the marked cutting positions and measure the activity on each using suitable counting equipment. Try to ensure similar counting geometry for each piece and minimize equipment dead time losses. 7) Calculate the radiochemical purity from:

% Myoview =
                 Activity of center piece    × 100
              Total activity of all 3 pieces

A value of at least 90% should be obtained in a satisfactory preparation.
Note: Free Tc99m pertechnetate runs to the top piece of the strip. Myoview runs to the center piece of the strip. Reduced hydrolyzed Tc99m and any hydrophilic complex impurities remain at the origin in the bottom piece of the strip.

Storage

Store the kit in a refrigerator at 2°-8°C (36°-46°F). The kit should be protected from light.

Store the reconstituted product at 2°-25°C (36°-77°F), using appropriate radiation shielding. Use product within 12 hours of preparation.

This reagent kit is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Code Adm. Section, Section 330.260(a) and 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, or an Agreement State.

Manufactured for:
GE Healthcare
Medi-Physics, Inc.
Arlington Heights, IL 60004

by:
GE Healthcare AS
Oslo, Norway

Patent No. 5,045,302 (r)

Distributed by:
GE Healthcare
Medi-Physics, Inc.
Arlington Heights, IL 60004
1-800-633-4123 (Toll Free)

Myoview is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

43-1011G-OSLO

Revised August 2006

1141011 USA

Myoview 
tetrofosmin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17156-024
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetrofosmin (Tetrofosmin) Tetrofosmin 0.23 mg
Inactive Ingredients
Ingredient Name Strength
Stannous Chloride Dihydrate 3 ug  in 1 
Disodium Sulphosalicylate 0.32 mg  in 1 
sodium D-gluconate 1 mg  in 1 
sodium hydrogen carbonate 1.8 mg  in 1 
Packaging
# Item Code Package Description
1 NDC:17156-024-05 5 VIAL (5 VIAL) in 1 KIT
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL
Myoview 
tetrofosmin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17156-026
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetrofosmin (Tetrofosmin) Tetrofosmin 0.69 mg
Inactive Ingredients
Ingredient Name Strength
Stannous Chloride Dihydrate 0.69 mg  in 1 
Disodium Sulphosalicylate 0.96 mg  in 1 
Packaging
# Item Code Package Description
1 NDC:17156-026-30 5 VIAL (5 VIAL) in 1 KIT
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL
Labeler - GE Healthcare, Medi-Physics, Inc.
Revised: 05/2007   GE Healthcare, Medi-Physics, Inc.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Shortness of breath.
  • A burning, numbness, or tingling feeling that is not normal.
  • Seizures.
  • Feeling sleepy.
  • Cough.
  • Very bad belly pain.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
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