Metastron

A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.

A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.

Additional postmarketing reactions include the following: hot flush.

Read the entire FDA prescribing information for Metastron (Strontium-89)

In the U.S.

• Metastron

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Radiopharmaceutical, Antineoplastic

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. You may need to have blood tests done regularly.

Follow these guidelines for 1 week after receiving strontium chloride Sr 89, to help reduce the chance of contaminating other persons or the environment:

• Use a normal toilet, if available, instead of a urinal.
• Strontium chloride Sr 89 is passed in the urine and feces. To prevent contamination of your home environment, flush the toilet twice after using.
• Wipe any spilled urine with a tissue and flush it away.
• Wash your hands after using or cleaning the toilet .
• Wash your clothes and bed linens immediately if they become soiled with your urine or blood. Wash them separately from other clothes.
• If you cut yourself, wash away any spilled blood .

Strontium chloride Sr 89 can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If your blood count becomes abnormally low, there are certain precautions you can take, to reduce the risk of infection or bleeding, such as:

• With abnormally low white blood cell counts:
  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• With abnormally low platelet blood counts:
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

• It is used to treat bone pain caused by cancer.

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.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling very tired or weak.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• More bone pain may rarely happen. Mild pain drugs may help. Call the doctor if this does not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store Metastron at home, talk with your doctor, nurse, or pharmacist about how to store it.

Strontium-89 decays by beta emission with a physical half-life of 50.5 days. The maximum beta energy is 1.463 MeV (100%). The maximum range of β- from Strontium-89 in tissue is approximately 8 mm.

Radioactive decay factors to be applied to the stated value for radioactive concentration at calibration, when calculating injection volumes at the time of administration, are given in Table 1.

None known.

Metastron is supplied in a 10 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield with approximately 3 mm lead wall thickness, package insert, and two therapeutic agent warning labels.

The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).

The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.

This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Illinois Adm. Code 330.260 (a) and Part 335 Subpart F.335.5010 or under equivalent licenses of the USNRC or an Agreement State.

NDC17156-524-01

Manufactured by:
GE Healthcare Ltd.
Amersham England

GE Healthcare
Medi-Physics, Inc.,
3350 North Ridge Avenue
Arlington Heights, IL 60004

Metastron is a trademark of GE Healthcare.

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

43-9000D
Revised February 2006